Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 413, 416, 440, 442, 482, 483, 485, 486, 488, 491, and 493

[CMS-3267-F]

RIN 0938-AR49

Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule.

SUMMARY:

This final rule reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This final rule also increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. We are issuing this rule to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules. This is the latest in a series of rules developed by CMS over the last 5 years to reform existing rules to reduce unnecessary costs and increase flexibility for health care providers.

DATES:

These regulations are effective on July 11, 2014, with the exception of amendments to 42 CFR Part 483, which are effective May 12, 2014.

FOR FURTHER INFORMATION CONTACT:

Lauren Oviatt, (410) 786-4683. We have also included a subject matter expert under the “Provisions of the Proposed Rule and Analysis and Response to Public Comments” section for each provision set out in this final rule.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Summary and Background

A. Executive Summary of This Final Rule

1. Purpose

2. Summary of Major Provisions

3. Summary of Costs and Benefits

B. Legislative and Regulatory History

II. Provisions of the Proposed Rule and Analysis and Response to Public Comments

A. Ambulatory Surgical Centers

B. Intermediate Care Facilities for Individuals Who Are Intellectually Disabled

C. Hospitals

1. Governing Body (§ 482.12)

2. Medical Staff (§ 482.22)

3. Food and Dietetic Services (§ 482.28)

4. Nuclear Medicine Services (§ 482.53)

5. Outpatient Services (§ 482.54)

6. Special Requirements for Hospital Providers of Long-Term Care Services (“swing-beds”) (§ 482.66)

D. Transplant Centers and Organ Procurement Organizations

1. Reports to CMS (§ 482.74)

2. Transplant Outcome Review (§§ 482.80(c) and 482.82(c))

3. Volume and Clinical Experience Requirements (§§ 482.80(c)(2) and 482.82(c)(2))

4. Transplant Center Re-Approval Process

5. Technical Corrections

E. Long-Term Care Facilities

F. Rural Health and Primary Care

1. Critical Access Hospital (CAH) Provision of Services (§ 485.635(a))

2. CAH and RHC/FQHC (Rural Health Clinics/Federally Qualified Health Centers) Physician Responsibilities (§§ 485.631(b)(2) and 491.8(b)(2))

3. RHC/FQHC Definitions: Physician (§ 491.2)

4. Technical Correction

G. Solicitation of Comments on Reducing Barriers to Services in RHCs

1. Telehealth Services

2. Hospice Services

3. Home Health Services

4. Other Services

H. Clinical Laboratory Improvement Amendments of 1988 (CLIA)

III. Collection of Information Requirements

IV. Waiver of Delayed Effective Date for Revisions to § 483

V. Regulatory Impact Analysis

I. Summary and Background

A. Executive Summary of This Final Rule

1. Purpose

In Executive Order 13563, “Improving Regulations and Regulatory Review”, the President recognized the importance of a streamlined, effective, and efficient regulatory framework designed to promote economic growth, innovation, job-creation, and competitiveness. To achieve a more robust and effective regulatory framework, the President has directed each executive agency to establish a plan for ongoing retrospective review of existing significant regulations to identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined. This final rule responds directly to the President's instructions in Executive Order 13563 by reducing outmoded or unnecessarily burdensome rules, and thereby increasing the ability of health care entities to devote resources to providing high quality patient care.

2. Summary of the Major Provisions

This rule reduces regulatory burden on providers and suppliers by modifying, removing, or streamlining current regulations that are excessively burdensome.

•

Radiology services in ambulatory surgical centers:

We are reducing the requirements that Ambulatory Surgical Centers (ASCs) must meet in order to provide radiological services to patients. Our requirements will reflect only those services that ASCs are permitted to perform. ASCs are currently subject to the full hospital requirements for radiology services even though they are only permitted to provide limited radiologic services integral to the performance of certain surgical procedures.

•

Hospital registered dietitian privileges:

We are permitting registered dietitians and other clinically qualified nutrition professionals to be privileged to order patient diets under the hospital conditions of participation (CoPs).

•

Hospital supervision of radiopharmaceutical preparation:

We are revising the nuclear medicine services CoP to remove the modifier “direct” from the in-house preparation supervision requirement. The presence of a pharmacist, MD, or DO will no longer be required during the delivery of off-hour nuclear medicine tests. These changes are based on the Society of Nuclear Medicine and Molecular Imaging recommendations on this issue.

•

Hospital reclassification of swing-bed services:

We are revising the requirements by relocating the swing-bed services CoP to Subpart D, to classify swing beds as an optional service. This revision allows an accredited hospital's compliance with “swing bed” requirements to be evaluated by a CMS-approved accrediting organization. This reduces the burden on hospitals by not requiring an additional State survey agency survey specifically for “swing bed” approval.

•

Transplant centers reports to CMS:

The CoPs require transplant programs to notify CMS of certain changes related to the center's transplant program. The current system for transplant center data analysis, in effect, requires the centers to submit data which CMS routinely receives through other sources. This creates unnecessary paperwork and burden on the transplant program and does not contribute to Federal oversight. We are eliminating this redundant data submission requirement.

•

Transplant center re-approval process:

The current transplant survey process and regulatory criteria require programs be subject to an automatic onsite review of compliance with key CoPs under a 3-year re-approval cycle under particular conditions. This leads some transplant programs to undergo an onsite survey that may not be necessary to ensure a proper level of federal oversight, and it also does not always provide for the most effective method to target survey resources where they are most needed. In addition, since we are already receiving the data we need to determine if a center is complying with outcome requirements, eliminating this automatic re-approval cycle will not result in any reduction in Federal oversight of the center. It will, however, enable us to more efficiently use our survey resources. In lieu of the automatic 3-year re-approval cycle, we are providing more flexibility in the re-approval cycle to be able to focus survey attention where it is most needed. We are also clarifying the following—(1) the review of mitigating factors process could occur at any time there was non-compliance with the CoPs, and (2) that compliance with the CoPs is a continuous requirement, as already specified in § 488.61(c).

•

Long term care sprinkler deadline extension:

All buildings containing long term care (LTC) facilities were required to have automatic sprinkler systems installed throughout the building by August 13, 2013 (§ 483.70(a)(8)). Based on public feedback, we understand that some facilities were not able to meet the 2013 deadline. In order to maintain access to LTC facilities, and in recognition of financing difficulties faced by some providers, we are allowing LTC facilities the opportunity to apply for a deadline extension, not to exceed 2 years, if certain conditions apply. An additional extension may be granted for up to 1 year, depending on the need and particular circumstances.

•

CAH provision of services:

Critical Access Hospital (CAH) CoPs require that a CAH develop its patient care policies with the advice of “at least one member who is not a member of the CAH staff.” We believe that this provision is no longer necessary and that the original reasons for including this requirement (for example, lack of local resources and in-house expertise) have been effectively addressed. Also, based on our experience with CAHs and input from the provider community, it is a challenge for facilities to comply with this requirement. These challenges include the amount of time it takes to familiarize the non-staff member with the CAH's operations, high turnover, and, in many cases, the expense of paying outside personnel.

•

CAH, RHC, and FQHC physician responsibilities:

The regulations for CAHs, Rural Health Clinics (RHCs), and Federally Qualified Health Centers (FQHCs), require a physician to be present for sufficient periods of time, at least once in every 2 week period, except in extraordinary circumstances. Some providers in extremely remote areas or areas that have geographic barriers have indicated that they find it difficult to comply with the precise biweekly schedule requirement. Many rural populations have limited access to care due to a shortage of health care professionals, especially physicians. Recent improvements in, and expansion of, telemedicine services allow for physicians to provide certain types of care to remote facilities at lower costs. We are revising the CAH and RHC/FQHC regulations to eliminate the requirement that a physician must be onsite at least once in every 2-week period. CAHs and RHCS/FQHCs will continue to be required to have a physician onsite for sufficient periods of time depending on the needs of the facility and its patients.

Clinical Laboratory Improvement Amendments Revisions:

This final rule makes a number of clarifications and changes pertaining to CMS regulations governing proficiency testing referrals under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These changes prevent confusion on the part of laboratories, reduce the risk of noncompliance, and establish policies under which certain proficiency testing (PT) referrals by laboratories may not generally be subject to revocation of a CLIA certificate, or a two-year prohibition on laboratory ownership or operation that may be applied to an owner and an operator when a CLIA certificate is revoked.

•

Treatment of proficiency testing samples:

We are adding a clarifying statement that explicitly notes that the requirement to test PT samples in the same manner as patient specimens does not mean that it is acceptable to refer PT samples to another laboratory for testing even if that is the protocol for patient specimens.

•

Intentional referral carve-out:

We are carving out a narrow exception in our long-standing interpretation of what constitutes an “intentional” referral of PT samples. In these instances, the laboratory will be subject to alternate sanctions.

•

New definitions:

To clarify the stipulations of the intentional referral carve-out, we are also adding the following terms, with their definitions, to the regulation: Reflex testing, Confirmatory testing, and Distributive testing.

•

Application of the TEST Act:

We are also making a regulatory change, pursuant to the TEST Act, to acknowledge CMS's ability to substitute alternative sanctions in lieu of the two-year prohibition for the owner or operator when a CLIA certificate is revoked. In the May 2, 2014,

Federal Register

at 79 FR 25436, we published the Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral final rule with comment period (the “FQHC PPS/CLIA final rule with comment period”), which finalized proposals for implementing the TEST Act.

Provisions That Will Remove Obsolete or Duplicative Regulations or Provide Clarifying Information:

We are removing regulations set out in the Code of Federal Regulations (CFR) that have become obsolete and are no longer needed or enforced and clarifying other provisions.

•

Hospital medical staff:

We are clarifying the requirement that a hospital's medical staff must be composed of doctors of medicine or osteopathy but that it may also include, in accordance with State laws, including scope-of-practice laws, other categories of physicians (as set out at § 482.12(c)) and non-physician practitioners who are determined to be eligible for appointment by the governing body.

•

Transplant centers outcome review:

The transplant center CoPs state that, “[e]xcept for lung transplants, CMS will review adult and pediatric outcomes separately when a center requests Medicare approval to perform both adult and pediatric transplants.” Changes to the transplant center reporting system have made the separate review for lung transplant data obsolete. Therefore, we are removing this language.

•

Transplant center volume and clinical experience requirements:

The transplant center CoPs state that “[t]he required number of transplants must have been performed during the time frame reported in the most recent SRTR center-specific report.” The Scientific Registry for Transplant Recipients (SRTR) provides statistical information about transplant outcomes and transplant programs nationwide. Under the current regulations, however, there

is no requirement that a certain number of transplants be performed during a particular period that is covered in a single SRTR center-specific report. This has resulted in transplant centers being confused about the volume of transplants they are required to perform during any particular period of time covered by the SRTR center-specific reports. We are making changes to clarify the transplant volume and clinical experience requirements.

•

RHC/FQHC definition of physician:

The definition of a “physician” in the RHC/FQHC regulations does not conform to the definition of a “physician” in the Medicare payment regulations. We are revising the regulation to eliminate possible confusion in the provider community by making the definition consistent with that used in the Medicare payment regulations.

Final Provisions that Respond to Stakeholder Concerns:

We have identified changes to improve clarity and respond to concerns raised by the public.

•

Hospital governing body:

We are adding a new provision to the “Medical staff” standard of the governing body CoP. This new provision requires a hospital's governing body to directly consult periodically throughout the calendar year or fiscal year with the individual responsible for the organized medical staff of the hospital, or his or her designee. For a multi-hospital system using a single governing body to oversee multiple hospitals within its system, this provision requires the single governing body to consult directly with the individual responsible for the organized medical staff (or his or her designee) of each hospital within its system in addition to the other requirements finalized here. We are also removing the requirement for a medical staff member, or members, to be on a hospital's governing body.

•

Hospital medical staff:

We are retaining the current regulatory provision at § 482.22, but reinterpreting it to allow for either a unique medical staff for each hospital or for a unified and integrated medical staff shared by multiple hospitals within a hospital system. We are adding four new provisions to hold a hospital responsible for showing that it actively addresses its use of a system unified and integrated medical staff model. We are requiring that the medical staff members holding privileges at each separately certified hospital in the system have voted either to participate in a unified and integrated medical staff structure or to opt out of such a structure, and to maintain a hospital-specific separate and distinct medical staff for their respective hospital. We are requiring that the unified and integrated medical staff has bylaws, rules, and requirements that describe its processes for self-governance, appointment, credentialing, privileging, and oversight, as well as its peer review policies and due process rights guarantees, and which include a process for the members of the medical staff of each separately certified hospital (that is, all medical staff members who hold specific privileges to practice at that hospital) to be advised of their rights to opt out of the unified and integrated medical staff structure after a majority vote by the members to maintain a separate and distinct medical staff for their hospital. We are requiring that the unified and integrated medical staff is established in a manner that takes into account each hospital's unique circumstances, and any significant differences in patient populations and services offered in each hospital. We are also requiring that the unified and integrated medical staff gives due consideration to the needs and concerns of members of the medical staff, regardless of practice or location, and the hospital has mechanisms in place to assure that issues localized to particular hospitals are duly considered and addressed.

•

Practitioners permitted to order hospital outpatient services:

We are revising the Outpatient services CoP to allow for practitioners who are not on the hospital's medical staff to order hospital outpatient services for their patients when authorized by the medical staff and allowed by State law.

•

Hospital diet terminology:

We are updating terminology related to “diets” and “therapeutic diets” in the CoPs.

•

Request for comment on RHC services:

We sought public comment on potential changes we could make to regulatory or other requirements that could reduce barriers to the provision of telehealth, hospice, or home health services in an RHC. We summarize and respond to these public comments in this final rule.

Technical Corrections:

We are making technical corrections to some regulations.

•

Organ Procurement Organizations (OPOs):

We are making some technical corrections to the CoPs for OPOs.

•

Intermediate Care Facilities for Individuals with Intellectually Disabilities (ICFs/IID):

We are making some technical corrections to clarify state survey agency certification survey requirements for ICF/IIDs.

•

Rural Health Clinics (RHCs):

We are correcting a technical error in the regulations by amending § 491.8(a)(6) to conform to section 6213(a)(3) of OBRA '89 (Pub. L. 101-239), which requires that a nurse practitioner (NP), physician assistant (PA), or certified nurse-midwife (CNM) be available to furnish patient care at least 50 percent of the time the RHC operates.

3. Summary of Costs and Benefits

a. Overall Impact

This final rule will create savings and reduce burden in many areas. Several of the changes create measurable monetary savings for providers and suppliers, while others create savings of time and administrative burden. We estimate one-time savings of $22 million for the sprinkler deadline extension in long term care facilities, and annual recurring savings of about $660 million for other provisions in this final rule.

b. Section-by-Section Economic Impact Estimates

The following table summarizes the provisions for which we are able to provide specific estimates for savings or burden reductions (these estimates are uncertain and could be substantially higher or lower, as explained in the regulatory impact analysis section of this rule):

Issue

Frequency

Estimated

savings or

benefits

($ millions)

Ambulatory Surgical Centers:

• Radiology Services

Recurring annually

41

Hospitals:

• Food and dietetic services

Recurring annually

459

• Nuclear medicine services

Recurring annually

77

Transplant Centers:

• Reports to CMS& Survey Changes

Recurring annually

<1

Long Term Care Facilities:

• Sprinkler Deadline Extension

One-time

22

Rural Health:

• CAH & RHC/FQHC Physician responsibilities

Recurring annually

76

• CAH Provision of services

Recurring annually

<1

CLIA:

• PT Referral

Recurring annually

2

Total

679

B. Legislative and Regulatory History

In January 2011, the President issued Executive Order 13563, “Improving Regulation and Regulatory Review.” Section 6 of that order requires agencies to identify rules that may be “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” In accordance with the Executive Order, the Secretary of the Department of Health & Human Services (HHS) published on August 22, 2011, a Plan for Retrospective Review of Existing Rules (

http://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system

). As shown in the plan, the Centers for Medicare & Medicaid Services (CMS) has identified many obsolete and burdensome regulations that could be eliminated or reformed to improve effectiveness or reduce unnecessary reporting requirements and other costs, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. CMS has also examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers of care. In addition, CMS has identified non-regulatory changes to increase transparency and to become a better business partner. For example:

• We have automated our review of Health Services Delivery tables, which gives Medicare Advantage (MA) applicants for participation as MA plans immediate feedback on their deficiencies before submitting applications so that they can address them up-front.

• We have changed the timeframes during which a Medicare durable medical equipment (DME) supplier may contact a beneficiary concerning refilling an order from 7 days to 15 days before the beneficiary's refill date.

• We have streamlined the Skilled Nursing Facility Discharge Assessment through Minimum Data Set (MDS) 3.0 which has been designed to improve the reliability, accuracy, and usefulness of the MDS. The change included the removal of data collections in the MDS that are not relevant to the measurement of quality or used for reimbursement purposes.

As explained in the plan, HHS is committed to the President's vision of creating an environment where agencies incorporate and integrate the ongoing retrospective review of regulations into Department operations to achieve a more streamlined and effective regulatory framework. The objectives are to improve the quality of existing regulations consistent with statutory requirements; streamline procedural solutions for businesses to enter and operate in the marketplace; maximize net benefits (including benefits that are difficult to quantify); and reduce costs and other burdens on businesses to comply with regulations. Consistent with the commitment to periodic review of the regulatory burden on providers and to public participation, HHS will continue to assess its existing significant regulations in accordance with the requirements of Executive Order 13563.

In accordance with these goals, we published two final rules on May 16, 2012. The first rule, titled “Reform of Hospital and Critical Access Hospital Conditions of Participation” (77 FR 29034), finalized updates to the Medicare CoPs and reduces regulatory burden for hospitals and CAHs. The second rule, titled “Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction” (77 FR 29002), addressed burdensome regulatory requirements for a broader range of healthcare providers and suppliers who provide care to Medicare and Medicaid beneficiaries. We proposed a second set of burden-reducing rules on February 7, 2013 (78 FR 9216). This final rule is a continuation of those efforts.

II. Provisions of the Proposed Rule and Analysis and Response to Public Comments

A. Ambulatory Surgical Centers

Section 1832(a)(2)(F)(i) of the Act specifies that Ambulatory Surgical Centers (ASCs) must meet health, safety, and other requirements as specified by the Secretary in regulation in order to participate in Medicare. The Secretary is responsible for ensuring that the Conditions for Coverage (CfCs) and their enforcement protect the health and safety of all individuals treated by ASCs, whether they are Medicare beneficiaries or other patients.

To implement the CfCs, we determine compliance through State survey agencies that conduct onsite inspections of ASC, applying these requirements to the ASCs they survey. ASCs also may be deemed to meet Medicare CfCs if they are accredited by one of the national accrediting organizations that have a CMS-approved Medicare ASC accreditation program.

The ASC CfCs were first published on August 5, 1982 (47 FR 34082), and were subsequently amended several times in the last four years. A final rule published on November 18, 2008 (73 FR 68502), revised four existing health and safety CfCs and created three new health and safety CfCs (42 CFR 416.41 through 416.43 and 416.49 through 416.52); a subsequent final rule amended the Patient rights CfC on October 24, 2011 (76 FR 65886); and most recently a final rule published on May 16, 2012, amended the requirements governing emergency equipment that ASCs must maintain (77 FR 29002).

Section 416.49(b) of Title 42 of the Code of Federal Regulations outlines the radiologic services requirements that ASCs must meet in order to be Medicare-certified. Since ASCs are facilities that operate exclusively to provide a specific range of surgical procedures (see § 416.2), they may provide radiologic services only to the extent that such services are an integral

part of the procedures they perform. Section 416.49(b)(1) states that the ASC must have procedures for obtaining radiological services from a Medicare-approved facility to meet the needs of patients. Section 416.49(b)(2) requires that the ASC's radiologic services must meet the hospital CoPs for radiologic services specified in § 482.26. However, since adopting this rule in 2008, we have learned that some of the hospital CoP requirements are unduly burdensome for ASCs to meet. In particular, the hospital CoP requirement to have a radiologist supervise the provision of radiologic services is unduly burdensome and overly aggressive, as many ASCs are having great difficulty locating a radiologist to supervise the minimal ASC radiologic services provided. The ASC CfCs were first published in 1982 and did not include a radiologist supervision requirement until the 2008 final rule. Moreover, the cost of privileging radiologists as members of an ASC's medical staff and paying radiologists' fees for oversight of radiology studies that are limited to those which are integral to a surgical procedure, with the results applied immediately by the operating physician, is often needlessly burdensome. The ASC governing body, as set out at § 416.41, is responsible for the oversight and accountability for the quality assessment and performance improvement program, and is responsible for ensuring that all policies and services provide quality healthcare in a safe environment. As such, the provision requires that the ASC governing body be responsible for determining if any procedures, now or in the future, require additional review by a radiologist. In addition, the medical staff CfC at § 416.45 requires such governing body be accountable for the medical staff, and to ensure that such staff members are legally and professionally qualified for the positions to which they are appointed and for the performance of the privileges granted. This includes, if applicable, assessing their competency in using imaging as an integral part of the procedures they perform.

In the February 7, 2013, proposed rule, we proposed to remove § 416.49(b)(1) and replace it with the requirement that radiologic services may only be provided when integral to procedures offered by the ASC and must meet the requirements specified in § 482.26(b), (c)(2), and (d)(2). We also proposed to remove the existing language at § 416.49(b)(2) and replace it with the requirement that an MD/DO who is qualified by education and experience in accordance with State law and ASC policies must supervise the provision of radiologic services. We stated that we believe these proposed changes to the ASC radiologic services requirements would assure the safety of these services while being less burdensome for Medicare-certified ASC facilities. We requested public comments on whether these proposed changes would allow for appropriate oversight of radiologic procedures conducted in ASCs.

We also noted that there is a technical error in § 416.42(b)(2) of the ASC CfCs and proposed to correct this error. Paragraph (b)(2) references “paragraph (d) of this section” but § 416.42 does not have a paragraph (d). We proposed to correct the error by referencing paragraph (c) of that section instead.

We received fifty-eight timely public comments on our proposed changes to the ASC radiologic services requirements. Commenters included individual clinicians, ASCs, organizations and national associations that represent ASCs, hospitals, healthcare corporations, the nuclear medicine industry, radiologists, and dentists. Overall, the majority of commenters were supportive of the goal of the proposed changes. Summaries of the major issues and our responses are set forth below.

All of the comments, with one exception, expressed strong support for the proposed changes to the oversight of radiologic services in an ASC. Two commenters recommended an alternative supervisory approach for ASC radiologic services, and more than half of the commenters specifically recommended that oversight of radiologic services be directly assigned to the governing body as part of their oversight and operation of the ASC. We did not receive any comments in regards to the technical changes made to § 416.42(b)(2), therefore we are incorporating those changes as proposed in this final rule.

Comment:

Two commenters supported the proposal to remove the radiologist supervision requirement in ASCs; however, they suggested that CMS require the supervision rules for ASCs to be the same as those for the Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS). They stated this policy change would allow for radiology studies to be performed under general, direct and personal supervision as defined in § 410.32(b)(3)(i) through (b)(3)(iii).

Response:

The regulations referenced at § 410.32(b)(3) are located in the Medicare payment rules at Part 410, Supplementary Medical Insurance Benefits General Provisions. They are part of § 410.32, which addresses the circumstances under which Medicare will pay for diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests. The diagnostic imaging supervision requirements are, therefore, not applicable to ASCs, since ASCs only furnish radiologic services that are integral to a surgical procedure being performed in the ASC.

Comment:

A majority of the commenters that supported our proposal to remove the radiologist supervision requirement of radiological services in ASCs also suggested that responsibility for radiologic services should be that of the governing body. Many commenters noted the importance for each ASC's governing body to have the flexibility to oversee radiologic services in keeping with the facility's policies and state law. Several commenters also stated that replacing the radiologist requirement with an MD/DO supervision requirement would not alleviate any financial or clinical burden, and would continue to be too narrow. For example, several dental facilities submitted comments that stated they would not be able to meet the requirement without significant burden, since their ASCs provide only dental services. These facilities do not have a MD or DO on staff, and would therefore continue to incur a burden to employ an extra staff member only to meet the radiological supervision requirements. ASCs that solely provide podiatry surgical services and employ only podiatrists would experience similar difficulties.

Response:

We agree with the suggestion of the commenters that requiring supervision of radiologic services to be provided by an MD or DO would still be too restrictive or burdensome for some ASCs. Accordingly, we are revising our proposed language that would have required a doctor of medicine or osteopathy to supervise the provision of radiologic services, to require the ASC governing body appoint an individual who has appropriate qualifications, in accordance with State law and ASC policies, to provide oversight of the ASC's radiologic services. The appointed individual would be responsible for assuring the ASC's compliance with the provisions of § 482.26(b), (c)(2), and (d)(2). We note that the referenced provisions address requirements related to safety for patients and personnel, such as use of safety precautions (shielding, and appropriate storage, use and disposal of radioactive materials) against radiation

hazards; regular equipment inspection and hazard correction; regular review of radiation workers for the amount of radiation exposure; use of radiologic equipment only by qualified personnel; and maintenance of imaging results or records. The person appointed to oversee radiologic services could be someone already working in the ASC who is qualified in accordance with State law and ASC policies. The ASC's governing body will continue to be required to ensure, through the credentialing and privileging process, that the operating surgeon is competent to perform procedures in the ASC safely when using imaging as an integral part of the surgical procedure.

Comment:

One commenter opposed the removal of the radiologist supervision requirement by stating that Independent Diagnostic Treatment Facilities (IDTFs) and ASCs need periodic supervision. In addition, the commenter gave examples, such as equipment repair and radiation badge monitoring, that he or she considered part of the supervision responsibilities of the radiologist.

Response:

We understand the importance of oversight of issues related to safety and quality in the provision of radiological services. However, after reviewing all of the comments, we believe we have found a suitable balance for radiologic services oversight in ASCs, since it requires continued oversight, through the privileging process, of the surgeon's skill in using radiologic services during a procedure, and by the governing body of day-to-day operational responsibility for oversight of all the other aspects of the ASC's radiologic services by an individual qualified in accordance with state law and ASC policies.

After consideration of the public comments received and discussed above, we are finalizing our proposed changes to § 416.49(b) with revisions. The revised regulation text at § 416.49(b)(2) in the final rule has been changed from “A doctor of medicine or osteopathy who is qualified by education and experience in accordance with State law and ASC policy must supervise the provision of radiologic services” to “If radiologic services are utilized, the governing body must appoint an individual qualified in accordance with State law and ASC policies who is responsible for assuring that all radiologic services are provided in accordance with the requirements of this section.”

Contact for ASC topics:

CAPT Jacqueline Leach, USPHS, (410) 786-4282.

B. Intermediate Care Facilities for Individuals With Intellectual Disabilities

In the May 16, 2012, final rule “Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction,” (77 FR 29002) we eliminated the requirement for time-limited agreements for Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs/IID) and replaced it with an open-ended agreement which, consistent with nursing facilities, would remain in effect until the Secretary or a State determined that the ICF/IID no longer met the ICF/IID CoPs. We also added a requirement that a certified ICF/IID would be surveyed, on average, every 12 months with a maximum 15-month survey interval. This requirement provides States with more flexibility relative to the current process. These changes were implemented by revising §§ 442.15, 442.109, and 442.110, and by removing § 442.16.

Section 442.105 describes circumstances for when a state survey agency may provide an annual certification of a facility found out of compliance with standards for ICF/IID's. Since time-limited certification is no longer required for ICF/IID's, this section serves no purpose and is confusing. Therefore, we proposed that this section be deleted. We also proposed to make a corresponding change to § 442.101(d)(3) by removing a reference to § 442.105.

A revision to § 442.110(b) made in the May 16, 2012 final rule extended the time for which a state may certify ICFs/IID with standard level deficiencies. However, the section inadvertently and incorrectly maintains time-limited certification for this sub-set of facilities. This is inconsistent with the revised survey regulation for ICFs/IID put in place in the May 16, 2012 final rule, and will create confusion and barriers to its successful implementation. Therefore, we proposed to delete § 442.110 in its entirety.

We also proposed to delete language in § 442.105 and § 442.110 to make it consistent with the intent of the Burden Reduction I regulatory changes to standardize survey processes of ICFs/IID with those of nursing facilities and other certified providers with open-ended certification periods.

We received one comment on the proposed changes for ICFs/IID, which we discuss here:

Comment:

The commenter objected to the complete removal of all provisions found at 42 CFR 442.105 and 442.110. The commenter stated that, “the current rule changes are meant to remove reference to time limited certifications from the ICF/IID regulations, as well as to eliminate language rendered anachronistic by the move to open ended certification agreements.” The commenter further stated that while they appreciate the importance of clarifying the regulation, they believe that § 442.105 and § 442.110 contain valuable instructions for the surveyors that are not specified elsewhere in the regulation.

Specifically, the commenter mentioned that the complete removal of § 442.105 would remove any reference to the language in § 442.101, which states the requirements for obtaining notice of an ICF/IID's certification before a Medicaid agency executes a provider agreement under § 442.12, leaving only the requirement that the facility submit an acceptable plan of correction covering remaining deficiencies (standard level deficiencies). The commenter further stated that they believe this action removes from Federal regulation the specific requirement that facilities must ensure that any deficiencies do not jeopardize the health and safety of residents or limit the facility's capacity to serve them adequately. Absent this provision at § 442.105, the commenter believes that the only regulatory language addressing this need is located at § 442.117. However, the commenter states that the language at § 442.117 is limited to only situations of immediate jeopardy. The commenter recommended that CMS retain all the language of § 442.105 except § 442.105(d) which refers to a prior certification period.

Response:

We appreciate the concerns of the commenter that the complete removal of § 442.105 may limit the ability of the State Survey Agencies and CMS to deny certification to a facility whose deficiencies in the aggregate compromise the facility's ability to provide adequate services. However, we believe that § 442.101(d)(1) does provide this ability through the requirement that the ICFs/IID must meet the CoPs for certification. Deficiencies indicating a lack of ability to provide adequate services are cited at a Condition level and the facility cannot be certified or continue certification unless acceptable corrections are made. We believe that the provisions of deleted section § 442.105 are adequately covered by § 442.101(d)(1) and § 442.117. Therefore we are not changing our proposal based on this comment and are removing § 442.105 as proposed.

Comment:

The commenter also objected to the complete removal of § 442.110. The commenter stated that § 442.110 requires that a facility's

certification will be automatically cancelled on a specific date unless the State Survey Agency finds that standard level deficiencies have been corrected or sufficient progress toward correction has been made. The commenter feels that allowing a facility's continued certification to be predicated on correcting deficiencies found by the Survey Agency is an important regulatory tool and should be preserved. The commenter recommended that CMS retain § 442.110 and revise it to state that a facility's certification will be automatically cancelled on a specific date unless the State Survey Agency finds that the deficiencies are corrected or sufficient progress has been made and has a new plan for correction that has been accepted.

Response:

We agree with the commenter that it is critical to retain the regulatory language which requires that a facility correct cited deficiencies to retain their certification; however, we do not agree that § 442.110 must include a reference to automatic cancellation of certification. In response to this comment, we will retain existing § 442.110 with revisions stating that ICFs/IID may be certified with standard level deficiencies under § 442.101 only if: (1) the survey agency finds that all deficiencies have been satisfactorily corrected; or (2) the survey agency finds that the facility has made substantial progress in correcting the deficiencies and has a new plan of correction that is acceptable.

Contact for ICFs/IID Topics:

Martin Kennedy, 410-786-0784.

C. Hospitals

1. Governing Body (§ 482.12)

On May 16, 2012, we published a final rule, entitled “Reform of Hospital and Critical Access Hospital Conditions of Participation” (77 FR 29034). In that rule, we finalized changes to the requirements of the “Governing body” CoP, § 482.12, and adopted a policy to allow one governing body to oversee multiple hospitals in a multi-hospital system. Additionally, we added a requirement for a medical staff member, or members, from at least one hospital in the system to be included on the governing body as a means of ensuring communication and coordination between the governing body and the medical staffs of individual hospitals in the system. After publication of the rule, we received considerable feedback that the mandate requiring medical staff representation on the governing body of a hospital could cause unanticipated complications for many hospitals. We recognized that the provision to include a member of the medical staff on a hospital's governing body creates conflicts for some hospitals, particularly public and not-for-profit hospitals. Issues include, but are not limited to, potential conflicts with some State and local laws that require members of a public hospital's governing body to either be publicly elected or appointed by the State's governor or by some other State or local official(s).

Given the complexity of the issue, and in light of industry feedback, we reviewed this requirement and gathered the relevant background information on the issues raised by stakeholders. After consideration of the issues, we proposed to rescind part of the new requirement and to propose an alternative. Specifically, we proposed to remove the requirement for a medical staff member, or members, to serve on a hospital's governing body and proposed to add a requirement that the hospital's governing body directly consult with the individual responsible for the organized medical staff (or his or her designee). While we believe that it is important that our requirements avoid any unnecessary conflicts for hospitals, we believe that it is essential that the requirements also ensure that the medical staff perspective on quality of care is heard by a hospital's governing body. Therefore, we proposed to add a new provision to the “Medical staff” standard of the Governing body CoP at § 482.12(a)(10). This new provision would require a hospital's governing body to directly consult with the individual responsible for the organized medical staff of the hospital, or his or her designee. At a minimum, this direct consultation would require a discussion of matters related to the quality of medical care provided to patients of the hospital and must occur periodically throughout the fiscal or calendar year. We indicated in the proposed rule that this proposed language reflects our intention to leave some degree of flexibility for a hospital's governing body (or a multi-hospital system's governing body) to determine how often during the year its consultations with the individual responsible for the organized medical staff of the hospital (or his or her designee) would occur, and that we would expect these consultations to occur at least twice during either a fiscal or calendar year. Moreover, we indicated in the proposed rule that we would expect a hospital (or multi-hospital system) governing body to determine the number of consultations needed based on various factors specific to a particular hospital. These factors would include, but are not limited to, the scope and complexity of hospital services offered, specific patient populations served by a hospital, and any issues of patient safety and quality of care that a hospital's quality assessment and performance improvement program might periodically identify as needing the attention of the governing body in consultation with its medical staff. We also stated that we would expect to see evidence that the governing body is appropriately responsive to any periodic and/or urgent requests from the individual responsible for the organized medical staff of the hospital (or his or her designee) for timely consultation on issues regarding the quality of medical care provided to patients of the hospital.

Additionally, for a multi-hospital system using a single governing body to oversee multiple hospitals within its system, we proposed to require the single governing body to consult directly with the individual responsible for the organized medical staff (or his or her designee) of

each

hospital within its system in addition to the other requirements proposed. In the proposed rule, we stated that we believe this proposal represents the best solution for those hospitals that were unintentionally burdened by the requirement finalized in the May 16, 2012, rule, while still addressing the concerns of many stakeholders who responded to the final rule, many of whom firmly stated their belief that medical staff input on a hospital's governing body is essential to the continuing quality of patient care delivered in the hospital.

We received a total of 83 comments from individuals, medical societies, professional societies, hospital associations, and national organizations on this proposal. The comments reflected a mixed response to our proposal, generally divided between the response of physician and physician groups and hospitals and hospital groups. Here we respond to specific comments:

Comment:

Commenters generally asked that CMS retain the requirement for a member of the medical staff to be a member of the governing body and felt that physician representation on the governing body was critical to ensure adequate medical staff input into the quality of medical care provided to hospital patients. Some of these commenters felt that any conflict with state or local laws could be resolved without rescinding the provision requiring a medical staff member to be a member of the governing body. One commenter felt the conflict created by the requirement was overstated.

Response:

We appreciate the commenters' concerns. However, as discussed in the preamble to the proposed rule, the existing requirement posed unanticipated complications for many hospitals, especially public and government-owned institutions. We believe it is important to avoid such unnecessary conflicts and complications and that our proposal reflects the most efficient option for doing so. We considered deferring to state and local law as suggested, but remained concerned that such deference would not adequately address and resolve the complications and conflicts that we are addressing. We believe our proposal achieves an appropriate balance between the concerns raised by the commenters and the problems and conflicts created by requiring medical staff membership on the governing body.

Comment:

A number of commenters expressed support for our proposal to rescind the requirement. One commenter appreciated our acknowledgment of the legal issues created by the existing requirement.

Response:

We appreciate the commenters' support of our proposed changes.

Comment:

Generally, commenters were supportive of our intent to ensure meaningful communication between the governing body and the medical staff. Several commenters supported the provision as written, with one stating that CMS' alternative proposal will ensure a hospital's governing body hears the medical staff perspective on quality of care while leaving appropriate flexibility in the composition of the hospital's governing body.

Response:

We appreciate the commenters' support of our proposed changes.

Comment:

We received a number of comments expressing concern that the proposed consultation requirement would be overly burdensome, particularly for multi-hospital systems with a single governing body. One commenter stated that for systems with large numbers of hospitals and a single governing board, requiring separate consultations between each medical staff representative and the entire governing board would prove unworkable. One commenter suggested instead allowing for “a committee structure with representatives throughout the system and at a frequency that is flexible.” Other commenters suggested various committee-based options and greater flexibility in achieving the objectives of meaningful communication between the governing body and the medical staff.

Response:

Our proposal gives governing bodies flexibility to determine the most effective and efficient way to meet the requirement. We believe it allows sufficient flexibility for hospitals to meet this requirement in a manner appropriate to each organization. As written, this provision does not require separate consultations with each leader of each medical staff and does not exclude the possibility of consulting with multiple medical staff leaders simultaneously using some form of committee structure, so long as the direct consultation occurs periodically throughout the fiscal or calendar year and includes discussion of matters related to the quality of medical care provided to patients of each hospital. Similar to our discussion in the preamble to the May 16, 2012 Final Rule (77 FR 29038), we expect hospital governing bodies, especially a multi-hospital system's single governing body, to carefully consider the unique needs of the patient populations served by its member hospital(s) and their respective medical staffs when determining the number and the type of consultations needed to achieve the necessary communication between the governing body and the medical staff. Furthermore, this proposal does not preclude medical staff membership on the governing body.

Comment:

One commenter felt that the proposed provision would not achieve the objective of meaningful communication and several commenters stated that “[w]e do not accept the premise that `direct consultation,' no matter how frequent or in what form, is an adequate substitution for medical staff representation on a hospital's governing body.” One commenter stated that if this proposal is implemented, medical staffs would be unable to comply with § 482.12(a)(5) requiring “that the medical staff is accountable to the governing body for the quality of care provided to patients.”

Response:

We believe that our proposal will provide for meaningful communication between the governing body and the medical staff while avoiding the complications created by the current requirement. We are confused by the comment that the implementation of this proposed requirement would make it impossible for medical staffs to comply with the current requirement at § 482.12(a)(5) listed above or with § 482.22(b), which requires the medical staff to be “well organized and accountable to the governing body for the quality of the medical care provided to the patients.” The finalized requirement merely codifies the requirements applicable to communications regarding the hospital's quality of patient care, which should be occurring regularly between the governing body and the medical staff. We do not see how the addition of this requirement would make the medical staff

less

accountable to the governing body for the quality of care provided to patients in the hospital. By requiring direct consultation, we believe that the medical staff would be ensured a forum in which its collective voice can be heard regarding patient care. If anything, the requirement holds the governing body accountable to the medical staff for providing that forum through direct consultation.

Comment:

Several commenters requested examples of compliance or additional clarification regarding what constitutes “direct consultation.”

Response:

“Direct consultation” means that the governing body, or a subcommittee thereof, meets with the medical staff leader(s) either face-to-face or via a telecommunications system permitting immediate, synchronous communication.

Comment:

One commenter asked if having a member of the medical staff on the governing body would meet the consultation requirement.

Response:

As noted earlier, this proposal does not preclude including medical staff on the governing body, as full, non-voting, or ex-officio member(s). However, a hospital would meet the consultation requirement only if the medical staff member serving on the governing body is the same individual responsible for the organization and conduct of the hospital's medical staff, or his or her designee, and only if such membership includes meeting with the board periodically throughout the fiscal or calendar year and discussing matters related to the quality of medical care provided to patients of the hospital. If there were a change in the medical staff leadership and the bylaws governing terms and conditions of governing body membership did not allow for substitution of the new medical staff leader (or his or her designee) on the governing body, then the governing body would be expected to engage in direct consultation with the individual newly responsible for the organization and conduct of the medical staff (or his or her designee). It should be noted that if a hospital chooses to meet the requirement in this manner, there is nothing in the requirements to prohibit the hospital from including other medical staff members on the governing body in addition to the member responsible for the organization and conduct of the medical staff.

After consideration of the comments discussed above, we are finalizing the changes to § 482.12 as proposed.

2. Medical Staff (§ 482.22)

Similar to the issues regarding medical staff representation on the governing body that were discussed in the previous section, we also received a considerable amount of feedback regarding our responses in the May 16, 2012 final rule (77 FR 29061) where we discussed our interpretation of the Medical staff CoP at § 482.22 as requiring that each hospital have its own independent medical staff despite the arguable ambiguity of the regulatory language. After the publication of the May 16, 2012 final rule, it was brought to our attention that, over the years, this apparently ambiguous language might have led some stakeholders to interpret § 482.22 as allowing for separately certified hospitals, as members of a multi-hospital system, to share a unified and integrated medical staff. Therefore, we proposed to amend the introductory paragraph of § 482.22 to require that each hospital must have an organized and individual medical staff, distinct to that individual hospital, which operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients of that individual hospital.

Shortly after publication of the May 2012 final rule, it was also brought to our attention that some of the changes made to the hospital requirements at § 482.22(a), “Medical staff,” were not clear. Our intent in revising the provision was to provide the flexibility that hospitals need under federal law to maximize their medical staff opportunities for all practitioners, but within the regulatory boundaries of their State licensing and scope-of-practice laws. We believe that the greater flexibility for hospitals and medical staffs to enlist the services of non-physician practitioners to carry out the patient care duties for which they are trained and licensed will allow them to meet the needs of their patients most efficiently and effectively.

Section 482.22(a), “Standard: Eligibility and process for appointment to medical staff,” currently requires a hospital's medical staff to be composed of doctors of medicine or osteopathy. It also allows for a hospital's medical staff to include other categories of non-physician practitioners determined as eligible for appointment by the governing body, in accordance with State law, including scope-of-practice laws. With the substitution of the term “non-physician practitioners” in the final rule (which replaced the term “other practitioners”), we might have unintentionally given the impression that the requirements now excluded other types of practitioners previously included among those eligible for appointment to the medical staff. In our guidance prior to the issuance of this final rule, we stated that a medical staff could include “other practitioners” such as doctors of dental surgery or of dental medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors, as those terms are defined and specified as physicians under section 1861(r) of the Act. Because part of § 482.22(a) states that a hospital's medical staff must include “doctors of medicine or osteopathy,” other types of physicians, such as those listed above, are inadvertently excluded from the term “medical staff.” Similarly, the new term “non-physician practitioner” therefore might also seem to exclude these other types of physicians simply by its use of the modifier, “non-physician,” since by the definition described at section 1861(r) of the Act, the practitioners are “physicians,” they cannot also be considered to be “non-physicians.” Our intention was not to exclude these types of physicians from the definition described in our regulations. Therefore, we believe it was appropriate to propose revisions to § 482.22(a) to clarify that the medical staff requirements still allow for these types of physicians as well as other types of non-physician practitioners to be eligible for appointment to a hospital's medical staff.

At § 482.22(a), we proposed to revise the current language to require that a hospital's medical staff must be composed of physicians and that it may also include, in accordance with State laws, including scope-of-practice laws, other categories of non-physician practitioners determined as eligible for appointment by the governing body. We indicated that the proposed substitution of the current terms, “doctors of medicine or osteopathy,” with the term “physicians,” would be consistent with the statutory language. We also proposed to substitute “must include” with “must be composed of” since we believe that this more accurately reflects the fact that hospital medical staffs are predominantly made up of physicians and would also emphasize the vital positions that physicians hold on these medical staffs. We stated that this proposed regulatory language would require that the medical staff be composed of physicians. Finally, we proposed to retain the language allowing for other types of non-physician practitioners (such as Advanced Practice Registered Nurses (APRNs), Physician Assistants (PAs), Registered Dietitians (RDs), and Doctors of Pharmacy (PharmDs)) to be included on the medical staff since we continue to believe that these practitioners, even though they are not included in the statutory definition of a physician, nevertheless have equally important roles to play on a medical staff and in the quality of medical care provided to patients in the hospital.

We received over 100 comments on our proposed changes to § 482.22 from individuals, national and State professional organizations, accreditation organizations, individual hospitals and multi-hospital systems, and national and State hospital organizations. Regarding the proposed requirement for a single medical staff for each individual hospital, there was a clear split among commenters with a pronounced difference of opinion on this issue between primarily physicians and their professional organizations on one side and hospitals, multi-hospital systems, an accreditation organization, and hospital organizations on the other. For the most part, physicians and their organizations were supportive of the proposed changes. However, there were some physicians, most clearly those who stated that they had experience with a unified and integrated medical staff for multiple hospitals within a system, who were opposed to our proposed changes. On the other side, hospitals and their organizations, along with accreditation organizations, were opposed to our proposed change to prohibit a unified and integrated medical staff structure for a multi-hospital system made up of separately certified member hospitals.

On the proposed changes to the composition of the medical staff requirements, the comments were mixed though generally supportive of the changes. A number of commenter asked for further clarification of these changes.

Here we respond to specific comments:

Comment:

Regarding the proposed changes to the composition of the medical staff, one commenter questioned whether non-physician practitioners and other practitioners (for example, podiatrists, dentists, and oral surgeons) would be granted hospital privileges and be allowed to practice if State law only permitted MDs and DOs to be medical staff members.

Response:

The requirement at § 482.22(a) has always allowed hospitals to grant medical staff membership for non-physician practitioners as well as

other practitioners who are not MDs/DOs only if such membership is in accordance with State law. Although our expectation is that all practitioners granted privileges are also members of the medical staff, if State law limits the composition of the medical staff to certain categories of practitioners, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for those specific categories of practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law. However, CMS has always expected a hospital and its medical staff to exercise oversight, such as credentialing and competency review, of those practitioners to whom it grants privileges, just as it would for those practitioners appointed to its medical staff.

Comment:

Several commenters expressed concerned with our referring to practitioners who are not MDs or DOs as “physicians.” One commenter stated that CMS was trying to undermine the traditional hospital medical staff leadership model composed solely or primarily of MDs and DOs by replacing that model with one composed largely of non-physician practitioners who are hospital employees.

Response:

As we stated above, the changes proposed as well as the current requirements do not require hospitals and their medical staffs to appoint practitioners other than MDs and DOs to their medical staffs. The requirement provides hospitals and medical staffs with an option of medical staff appointment for practitioners who are not MDs or DOs, not a requirement. However, in our attempts in the proposed rule to correct the omission of other categories of physicians (as defined in § 1861(r) of the Act and listed at § 482.12(c)(1)) in this requirement, we believe, based on some of the comments received, we might have further confused the issue of the composition of the medical staff. Therefore, we are finalizing a revision to § 482.22(a) in this rule that we believe will adequately present the required part of this provision and that part which is only optional. We are revising the regulatory language to now state that the “medical staff

must

be composed of

doctors of medicine or osteopathy,

” and that in accordance with State law, including scope-of-practice laws, the medical staff “

may also include other categories of physicians (as listed at § 482.12(c)(1)) and non-physician practitioners

who are determined to be eligible for appointment by the governing body.” [Emphasis added.]

Comment:

We received a large number of comments from individual physicians as well as national and State physician organizations that supported our proposed changes to reaffirm and make more explicit the requirement that each hospital to have its own medical staff, specifically those hospitals that are part of a multi-hospital system. These commenters stated they believed that allowing a multi-hospital system to have a unified and integrated medical staff instead of separate medical staffs for each hospital would destroy the concept of medical staff self-governance that is “a basic requirement” for TJC hospital accreditation and which is “mandated by some states.” Additionally, there were some comments from individuals as well as hospital leaders that stated that while they support the proposed requirement overall, they believed that there should be some allowance for hospitals within a system to share medical staff bylaws, rules, and regulations.

Conversely, we also received an equally large number of comments from hospitals, multi-hospital systems, national and State hospital organizations, and individual physicians that rejected these same proposed changes. These commenters offered both anecdotal evidence and preliminary research evidence to support their arguments that unified and integrated medical staffs provide the best means for multi-hospital systems to more efficiently standardize evidence-based “best” practices (for example, innovations that have been proven to reduce healthcare-associated infections (HAIs), hospital-acquired conditions (HACs), and readmissions) across member hospitals. A number of commenters also disputed claims that a unified and integrated medical staff structure for multiple hospitals within a system would undermine medical staff self-governance and pointed out that there is no evidence that the separate-medical-staff-for-each-hospital structure improves the quality of patient care or protects patient safety. A few commenters pointed to several specific benefits that can potentially be derived from a unified and integrated medical staff structure including:

• Increased opportunity to improve peer review processes.

• Improved patient safety through shared credentialing and privileging.

• More efficient sharing of knowledge and innovations among medical staff members.

• Better physician on-call coverage for specialties.

• Consistency with the move toward accountable care organizations and modern care delivery systems.

• More efficient coordination of emergency preparedness and community health planning.

Among the comments supporting unified and integrated medical staffs some stated that they believed that CMS should allow it as an option for hospitals that might not be using such a structure currently. One commenter argued that because the structure of a hospital's medical staff is commonly defined within medical staff bylaws, which must be approved by both the medical staff and the governing body, a multi-hospital governing body cannot unilaterally force the members of its separate hospital medical staffs to accept a single, unified, and integrated medical staff. This commenter stated that the members of the system's separate hospital medical staffs had voted many years ago to structure themselves as a unified medical staff because the majority of medical staff members believed that this was the best way for the system and its medical staffs to “achieve our goals for mutual integration.” The commenter further reinforced the idea that this change was not forced upon the separate medical staffs by stating that the medical staff and its members “were, and remain responsible for their self-governance.” The commenter recommended that hospital systems with separately certified hospitals that wish to adopt an integrated medical staff structure should be required to provide for an election or vote on the issue to ensure that the medical staff of each hospital is in agreement. One commenter also noted that unified medical staffs “are self-governing entities that can and do respect the diversity, viewpoints and concerns of medical staff members across the system.” Several commenters in support of unified medical staffs pointed out that many unified medical staffs rely on a system of committees made up of representatives from the various hospitals in a system. These commenters argued that while the unified medical staff model allows for more efficient patient care coordination, the committees and member representatives ensure that hospital-specific concerns are voiced, heard, and addressed by the unified medical staff and the governing body.

Other commenters pointed out the significant burden that would be imposed on hospitals already operating under this structure if CMS were to finalize the proposed requirement. They

pointed to the significant cost of dismantling the unified medical staffs under which many have been operating for several years in many accredited hospitals, in addition to the burden of having to establish new medical staffs at each such member hospital with new bylaws, rules, regulations, and committee structures. A few commenters also asserted that there might be inconsistency in CMS allowing for a single unified structure for a multi-hospital system's governing body (as we did in the May 12, 2012 final rule), but denying the same flexibility for its medical staff structure.

Finally, there were several commenters who stated that they while they disagreed with the proposed clarifications, and believed that a multi-hospital system should be allowed to have a unified and integrated medical staff, they believed that there should be specific parameters limiting how many member hospitals could possibly share a unified medical staff within a system. Commenters suggested establishing a specific number of hospitals or limiting the geographic range by state or metropolitan statistical area.

Response:

We appreciate all of the comments received on this issue. After carefully considering all of the arguments for and against allowing a multi-hospital system to use a unified and integrated medical staff structure for its member hospitals, we believe that it is in the best interest of hospitals, medical staff members, and patients to modify our proposed prohibition on the use of a unified and integrated medical staff for a multi-hospital system and its member hospitals so as to enable the medical staff of each hospital to voluntarily integrate itself into a larger system medical staff.

The fact that many hospital systems have been using a unified medical staff model for a number of years, without evidence showing that such a system is detrimental to patients or decreases the quality of care delivered, was a major factor in our decision to allow hospitals and their respective medical staffs the flexibility to decide which medical staff framework works best for their particular situations. The arguments against allowing this flexibility through the CoPs did not provide any evidence that having a single and separate medical staff for each hospital within a system was inherently superior to the unified and integrated model. We weighed this argument against the comments from the physician leaders and members of unified and integrated medical staffs who provided testimony and anecdotal evidence for the benefits of this type of structure. Additionally, we considered preliminary evidence that appears to show that hospitals using a unified medical staff might be achieving some success in reducing HACs, HAIs, and readmissions, and in improving patient safety and outcomes. One commenter, writing on behalf of a multi-hospital system that the commenter references as the largest in their State, stated that “we believe the concept of a single medical staff has substantially contributed to our success as an integrated delivery system and has accelerated our quality, safety and efficiency performance.” The commenter cited the system's achievements, which they believe are a result of this single and integrated medical staff model: Core measures in the top quartile with excellent value-based purchasing scores according to CMS; lower in-hospital mortality rates that are statistically significant, that is, 17 percent lower than expected; lower hospital readmission rates that are statistically significant, that is, 15 percent lower than expected; and the second lowest congestive heart failure readmission rate in the nation, according to published CMS data. We agree that it appears to be evident that a unified system medical staff would usually be better suited to standardizing best practices and implementing quality improvements than would the more fragmented structure of separate medical staffs.

While we do not agree with comments that stated that a unified and integrated medical staff would destroy medical staff self-governance, we appreciate that added flexibility allowing a multi-hospital unified medical staff might conceivably be implemented in a manner that fails to achieve the desired benefits. We also received comments suggesting that if flexibility were permitted, CMS should place parameters or limitations on the use of a unified medical staff. We believe that the specifics should be left up to the medical staffs and governing bodies to determine, but agree that basic parameters are advisable to address the concerns of commenters and ensure due consideration of the unique aspects of each involved hospital (such as requiring that the hospitals have considered the extent to which a medical staff can be shared among its member hospitals as defined in hospital and medical staff policy, by-laws, and protocols).

Therefore, we are revising the proposed requirement and finalizing it here by retaining the original and current language of the condition statement, which states that the hospital must have an organized medical staff that operates under bylaws approved by the governing body and is responsible for the quality of medical care provided to patients by the hospital. We believe that this will provide more flexibility for each hospital and medical staff to determine the medical staff framework which works best for their situation (for example, whether that decision is for a separate medical staff for each hospital or a unified and integrated medical staff for multiple hospitals with a system). We are also revising this CoP (at § 482.22(b)) to include new provisions that will hold a hospital responsible for showing that it actively addresses its use of a unified and integrated staff model. Under the provisions of this final rule, the unified medical staff would still be composed of medical staff members from each hospital in the system and each member would be eligible to take on a leadership role on the various committees and subcommittees just as he or she would if he or she were part of a separate medical staff. Further, a medical staff and a governing body would still need to work closely together, with the medical staff responsible for the quality of care provided and accountable to the governing body. Neither the governing body nor the medical staff may impose its will unilaterally. They are dependent on each other for the hospital's success. For medical staffs and multi-hospital systems that choose to exercise the flexibility provided by this CoP (to use a unified and integrated medical staff, after determining that such a decision is in accordance with all applicable State and local laws), these new provisions are aimed at ensuring that—

(1) The medical staff members of each separately certified hospital in the system (that is, all medical staff members who hold specific privileges to practice at that hospital) have voted by majority in accordance with medical staff bylaws, either to accept a unified and integrated medical staff structure according to provisions included in the medical staff bylaws or to opt out of such a structure and to maintain a separate and distinct medical staff for their respective hospital;

(2) The unified and integrated medical staff has bylaws, rules, and requirements that describe its processes for self-governance, appointment, credentialing, privileging, and oversight, as well as its peer review policies and due process rights guarantees, and which include a process for the members of the medical staff of each separately certified hospital (that is, all medical staff members who hold specific privileges to practice at that hospital) to be advised of their rights to

opt out of the unified and integrated medical staff structure after a majority vote by the members to maintain a separate and distinct medical staff for their hospital;

(3) The unified and integrated medical staff is established in a manner that takes into account each hospital's unique circumstances, and any significant differences in patient populations (such as low income or minority populations, rural populations, etc.) and services offered in each hospital (such as emergency services, psychiatric services, pediatric care, long term acute care, organ transplant services, dialysis, etc.); and

(4) The unified and integrated medical staff gives due consideration to the needs and concerns of members of the medical staff, regardless of practice or location, and the unified and integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.

Finally, we note that some commenters argued in support of a unified medical staff by pointing to our previous position permitting a single governing body for hospitals within a system. We believe that the CoPs pertaining to the governing body and medical staff are unique in their focus on governance processes. We are taking this opportunity to emphasize that permitting use of a system governing body or medical staff must not be construed as implying that compliance with any other hospital CoPs may also be demonstrated at the system (multi-hospital) level. Each separately participating hospital is required to demonstrate its compliance with all other hospital CoPs in order to participate in Medicare. Although there can be system approaches in many of these areas (such as infection control or quality assessment/performance improvement programs), each individual hospital must demonstrate that it fulfills the applicable CoP requirements.

3. Food and Dietetic Services (§ 482.28)

We proposed to revise the hospital requirements at § 482.28(b), “Food and Dietetic Services,” which currently requires that a therapeutic diet must be prescribed only by the practitioner or practitioners responsible for the care of the patient.

The Interpretive Guidelines (IGs) for this requirement, which are contained in the State Operations Manual (SOM) for surveyors, further state that “[in] accordance with State law and hospital policy, a dietitian may assess a patient's nutritional needs and provide recommendations or consultations for patients, but the patient's diet must be prescribed by the practitioner responsible for the patient's care.” State survey agencies have applied this requirement to mean that registered dietitians or other clinically qualified nutrition professionals (RDs) cannot be granted privileges by the hospital to order patient diets (or to order necessary laboratory tests to monitor the effectiveness of dietary plans and orders, or to make subsequent modifications to those diets based on the laboratory tests) since these practitioners have never been considered to be among those in the hospital who are “responsible for the care of the patient.” The responsibility for the care of the patient, and the attendant hospital privileges that accompany this responsibility, have traditionally and exclusively been the provenance of the physician, more specifically the MD and DO, and, to a lesser extent, the APRN and PA. Understanding the regulatory language and its interpretation, most hospitals have taken a very conservative approach toward the granting of privileges, especially ordering privileges, to other types of non-physician practitioners, including RDs. Consequently, most hospitals have withheld ordering privileges from RDs absent a clear signal from CMS and the subsequent and necessary changes to the CoPs that would allow them to do so.

After the publication of the October 24, 2011 proposed rule (76 FR 65891) and the May 16, 2012 final rule (77 FR 29034), “Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation,” it came to our attention that the regulatory language and the IGs for § 482.28(b) were too restrictive and lacked reasonable flexibility to allow hospitals to extend these specific privileges to RDs in accordance with State laws. We believe that RDs are the professionals who are best qualified to assess a patient's nutritional status and to design and implement a nutritional treatment plan in consultation with the patient's interdisciplinary care team. In order for patients to receive timely nutritional care, the RD must be viewed as an integral member of the hospital interdisciplinary care team, one who, as the team's clinical nutrition expert, is responsible for a patient's nutritional diagnosis and treatment in light of the patient's medical diagnosis. In the February 7, 2013 proposed rule, we provided research evidence that supports the changes we have proposed (78 FR 9222). Without the proposed regulatory changes allowing hospitals to grant appropriate ordering privileges to RDs, hospitals would not be able to effectively realize improved patient outcomes and overall cost savings that we believe would be possible with such changes.

It should be noted, because a few States elect not to use the regulatory term “registered” and choose instead to use the term “licensed” (or no modifying term at all), or because some States also recognize other nutrition professionals with equal or possibly more extensive qualifications, we proposed to use the term “qualified dietitian.” In those instances where we have used the most common abbreviation for dietitians, “RD,” throughout this preamble, our intention is to include all qualified dietitians and any other clinically qualified nutrition professionals, regardless of the modifying term (or lack thereof), as long as each qualified dietitian or clinically qualified nutrition professional meets the requirements of his or her respective State laws, regulations, or other appropriate professional standards.

In order for patients to have access to the timely nutritional care that can be provided by RDs, a hospital must have the regulatory flexibility either to appoint RDs to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital's appropriate medical staff rules, regulations, and bylaws. In either instance, medical staff oversight of RDs and their ordering privileges would be ensured. Therefore, we proposed revisions to § 482.28(b)(1) and (2) that would require that individual patient nutritional needs be met in accordance with recognized dietary practices. We would make further revisions that would allow for flexibility in this area by requiring that all patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or other clinically qualified nutrition professional as authorized by the medical staff and in accordance with State law. We believe that hospitals that choose to grant these specific ordering privileges to RDs may achieve a higher quality of care for their patients by allowing these professionals to fully and efficiently function as important members of the hospital patient care team in the role for which they were trained. In the proposed rule, we stated that we believe hospitals would realize significant cost savings in many of the areas affected by nutritional care.

We received over 100 comments on our proposed changes to § 482.28 from professional organizations, accreditation organizations, hospitals and hospital systems, and individuals. Overall, the majority of commenters were supportive of the proposed changes, though there were a large number of commenters who were opposed to the exclusive use of the terms “registered dietitian,” “qualified dietitian,” or “RD” for varied reasons. Here we respond to specific comments:

Comment:

As stated above, the majority of commenters were very supportive of the proposed changes with many citing improved patient care, greater efficiency in delivering dietary services, and significant cost savings as benefits that would be realized if the proposed changes were to be finalized. A few commenters provided references (to the same published studies that we cited) that offer evidence of the benefits that might be derived by hospitals if dietitians were granted ordering privileges as well as to guidelines, best practices, professional standards, and recommendations for the ordering of enteral and parenteral nutrition. Other commenters provided detailed information on the recognized training, education, and other qualifications that dietitians and nutrition professionals must meet in order to practice in their respective professions.

Response:

We appreciate the commenters' support of our proposed changes as well as the references to the research provided. We agree that these changes will benefit patients as well as the practitioners caring for them, and will allow hospitals to achieve greater efficiency and cost savings in the delivery of food and dietetic services to patients.

We also appreciate the information on the professional standards and guidelines for enteral and parenteral nutrition therapy provided as well that provided on the qualifications for the various dietetics and nutrition professions.

Comment:

One commenter, while agreeing with the intent of the proposed changes and many of the statements made in the preamble in support of these changes, did not agree with the use of the term “qualified dietitian” in the regulatory text. The commenter stated that “the terminology `registered dietitian' or `RD' is the nationally accepted designation for a professional who has met the minimum educational standards, [and] taken a registration exam complete with mandatory continuing professional education.” Similar to this commenter, a few individuals and one professional organization asked for CMS to use the term “registered dietitian” instead of “qualified dietitian,” or to clarify that the definition of qualified dietitian used here is consistent with the one currently found under the transplant center process requirements at § 482.94(e), which defines a qualified dietitian as “an individual who meets practice requirements in the State in which he or she practices and is a registered dietitian with the Commission on Dietetic Registration.” However, many of the registered dietitians who commented simply thanked CMS for the proposed changes, stated their support for them, and acknowledged the possible benefits that might be derived from the regulatory changes to § 482.28.

Conversely, one commenter, who included the names of 2,480 individuals who had signed on in support of the comment, stated that they cannot support “Medicare rules that create a monopoly for RDs at the expense of often better-qualified nutrition professionals.” Similarly, various comments from “nutritionists,” “nutrition professionals,” “certified clinical nutritionists,” and “certified nutrition specialists” argued that the rule would not serve patients since it excludes non-registered dietitians and other nutrition professionals and that the changes would create a practice monopoly for registered dietitians in hospitals. These commenters expressed the opinion that advanced degree nutrition professionals possess more extensive education and training backgrounds in nutrition than do registered dietitians. One commenter stated that they believe the professional organization representing registered dietitians is attempting to “exclude other nutritional specialists,” while many other commenters simply urged CMS to be “forward-looking by incorporating the most flexible, inclusive language to increase the qualified nutrition workforce rather than narrowing it to one private credential, essentially creating a monopoly.”

Response:

Our use of the term “registered dietitian,” in the proposed regulatory language, along with our use of this term and the terms “qualified dietitian” and “RD” in the preamble, was not meant to be exclusive of other nutrition professionals qualified to practice in the hospital setting. We agree with commenters that the regulatory language for § 482.28 should be inclusive of all qualified nutrition professionals. We do not agree with commenters who requested that we use the term “registered dietitian” or define “qualified dietitian” as an individual specifically registered with the Commission on Dietetic Registration. We agree that a more flexible approach would be the best way to ensure that patients benefit from the improved quality of care that these professionals can bring to hospital food and dietetic services. Additionally, we believe that it is best left to individual States to determine the regulatory processes by which these professions are governed and that hospitals, through their medical staff privileging processes, should be allowed the flexibility to determine the credentials and qualifications for dietitians and nutrition professionals, in accordance with their respective State laws if and when they choose to grant ordering privileges to these professionals. Therefore, we are revising our proposed regulatory language in this final rule to now require that all patient diets, “including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian

or qualified nutrition professional

as authorized by the medical staff and in accordance with

State law governing dietitians and nutrition professionals.

” [Emphasis added.]

Comment:

A few commenters suggested that the term, “therapeutic diets,” be clarified in the requirements as including both enteral and parenteral nutrition support because the commenters are concerned that the term might be interpreted as not including these nutrition modalities.

Response:

While we understand the commenter's concerns, we believe that we have made it very clear in the preamble to this rule as well as in the preamble to the proposed rule that we consider all patient diets to be therapeutic in nature, regardless of the modality used to support the nutritional needs of the patient, and that the term would most certainly include enteral and parenteral nutrition support. Further, we believe that our extensive discussion of the research evidence supporting ordering privileges for RDs in both the proposed rule's preamble and its regulatory impact section leaves very little room for misinterpretation of this term since much of our discussion centered on the RD's role and expertise in ordering parenteral nutrition for patients.

Comment:

Several commenters supported the proposed change and requested that CMS apply this revision to the Medicare requirements for long-term care facilities and other healthcare facilities in which RDs and nutrition professionals play a role.

Response:

We appreciate the commenters' support and suggestions,

but the recommendations are outside the scope of this rule. However, we will keep the suggestion to extend the proposed revisions to the requirements for other providers and suppliers in consideration if we pursue future rulemaking in these areas.

Comment:

One commenter noted that while these proposed changes address the nutritional aspects of diet management, they do not address “diet texture modification, which may be recommended by speech-language pathologists for patients with significant swallowing problems.” The commenter further states that since speech-language pathologists “are the professionals who typically assess individuals with swallowing disorders . . . they, like dieticians, should have the authority to order diets that reflect changes based on their expert recommendations.”

Response:

While we agree with the commenter that speech-language pathologists may be the professionals best qualified to make recommendations for patients with swallowing disorders, we do not believe that § 482.28 is the appropriate place for such a change. Additionally, we believe that the recent changes to the medical staff CoP (§ 482.22) with regard to non-physician practitioners allow hospitals to determine if specific categories of practitioners, along with individual practitioners within those categories, should be granted certain privileges within the hospital, including ordering privileges. The changes finalized here for § 482.28 in no way prohibit hospitals from granting specific ordering privileges to speech-language pathologists, or to other non-physician practitioners, as long as those privileges are in accordance with State laws and regulations, including scope-of-practice laws.

Comment:

Several commenters disagreed with CMS' assertion in the proposed rule that dietitians are the professionals best qualified to assess a patient's nutritional status and to design and implement a nutritional treatment plan. These commenters also disagreed with our statement in the proposed rule that “physicians often lack the training and educational background to manage the sometimes complex nutritional needs of patients with the same degree of efficiency and skill as registered dieticians.” These commenters further stated that they believe that “in some cases, such as post-abdominal surgery care, the physician is best suited to determine patient diet.” They urged CMS to clarify in the final rule that “in some cases, per medical staff directive, the dietician must defer to or consult with the physician responsible for the care of the patient.” The same commenters did agree with “CMS' deference to the authorization of the medical staff at § 482.28” and stated that they believe that “the medical staff should be the arbiter of policies regarding when a dietician is qualified to order patient diets in the hospital.”

Response:

We agree with the commenters that there are some cases where the dietitian or nutrition professional must defer to, or consult with, the practitioner responsible for the care of the patient, often the practitioner who admitted the patient. We further agree that the medical staff should determine which specific practitioners, including dietitians and nutrition professionals, are qualified for which specific privileges. However, we must point out that this requirement does not require hospitals and medical staff to grant or authorize specific privileges to specific practitioners, but only allows them the flexibility to do so if they choose, and only if State law allows for it.

Comment:

Another commenter asked for clarification on whether the proposed requirement only provides a hospital with the option of credentialing and privileging a dietitian.

Response:

The requirement, including the revisions we are finalizing here, does not require hospitals to credential and privilege dietitians as a condition of participation, but, as previously stated, allows for it as an option if consistent with State law.

Comment:

A few commenters stated that they were concerned about ordering diets for critically ill patients or making specific patients “NPO.” They further state that they would feel comfortable ordering diets only if there was a “'diet order per dietitian' order from the doctor.”

Response:

As we have stated, the requirement does not require dietitians and nutrition professionals to order diets, but only allows for it as an option if consistent with State law and if a hospital chooses to grant such privileges after considering the recommendations of its medical staff. An individual dietitian or nutrition professional would then need to apply for these ordering privileges.

Comment:

A few commenters asked for clarification on laboratory ordering privileges for dietitians as part of the proposed requirement. The commenters cited conflicts with the Medicare payment requirements as well as EHR incentives if dietitians were authorized to order lab and other diagnostic services.

Response:

As proposed, and as finalized here, the regulatory language did not include privileges for ordering lab or other diagnostic services by dietitians or nutrition professionals. However, the preamble to this section of the proposed rule did include a discussion of such privileges in the context of some of the research cited. Such privileges for dietitians and nutrition professionals are not required or specifically allowed by this requirement, but are instead an option left to hospitals and their medical staffs to determine in consideration of relevant State law as well as any other requirements and/or incentives that CMS or other insurers might have.

In accordance with the comments discussed above, we are finalizing the proposed changes to § 482.28 with the revisions to the regulatory language as noted above.

4. Nuclear Medicine Services (§ 482.53)

The current requirement at § 482.53(b)(1) requires that the in-house preparation of radiopharmaceuticals be performed by, or under the direct supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. Direct supervision means that one of these professionals must be physically present in the hospital and immediately available during the preparation of all radiopharmaceuticals. Hospitals have reported to us that this requirement is extremely burdensome when the presence of a pharmacist or physician is required for the provision of off-hour nuclear medicine tests that require only minimal in-house preparation of radiopharmaceuticals. Information from stakeholders regarding this issue has revealed that minimal in-house preparation is required for most radiopharmaceuticals. Many are batch-prepared by the manufacturer for hospital use as a way of reducing radiation exposure of hospital personnel, ensuring that on-site hospital preparation of radiopharmaceuticals generally requires only a few final steps, if any.

We proposed to revise the current requirement at § 482.53(b)(1) by removing the term “direct.” We stated that, if finalized, the revised requirement would require that in-house preparation of radiopharmaceuticals be performed by, or under the supervision of, an appropriately trained registered pharmacist or doctor of medicine or osteopathy. We also stated that the revision to “supervision” from “direct supervision” would allow for other appropriately trained hospital staff to prepare in-house radiopharmaceuticals under the oversight of a registered

pharmacist or doctor of medicine or osteopathy, but it would not require that such oversight be exercised by the physical presence in the hospital at all times of one of these professionals, particularly during off-hours when such a professional would not be routinely present.

We stated that these changes would allow hospitals to establish their own policies on supervision of nuclear medicine personnel and the in-house preparation of radiopharmaceuticals. Absent a requirement for “direct” supervision, we expect most hospitals to follow the Society of Nuclear Medicine and Molecular Imaging recommendations on this issue and to no longer require a registered pharmacist or MD/DO to be on site for direct supervision when radiopharmaceuticals are prepared in-house by staff. We stated that the proposed change would directly reduce the burden of the current direct supervision requirement where it is most needed—in-house preparation of radiopharmaceuticals for after-hours/emergency performance of nuclear medicine diagnostic procedures (for example, coronary artery disease, pulmonary emboli, stroke, and testicular torsion). Given that an estimated 16 million nuclear medicine imaging and therapeutic procedures are performed each year in the United States, we would expect hospitals to achieve significant cost reductions in this area if they take advantage of the proposed change. We welcomed public comments on this proposed change.

We received several comments on our proposed change to § 482.53, primarily from professional organizations, hospitals and hospital systems, and individual nuclear medicine technologists. All commenters were supportive of the proposed change with no commenters opposed.

In accordance with the comments discussed above, we are finalizing the changes to § 482.53(b)(1) as proposed.

5. Outpatient Services (§ 482.54)

We proposed changes to the requirements at § 482.54, “Outpatient services.” Specifically, we proposed to add a new standard at § 482.54(c), entitled “Orders for outpatient services.” We proposed these revisions so that the regulations would codify Interpretive Guideline (IG) changes that we recently made regarding the ordering of outpatient services.

On May 13, 2011, CMS issued memorandum SC-11-28 (

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter11_28.pdf

). Among other things, this memorandum included preliminary guidance on who may order hospital rehabilitation (§ 482.56(b)) and respiratory care services (§ 482.57(b)(3)). On November 18, 2011, the final version of the revised IGs for these requirements was released. Subsequently, we received considerable feedback that this guidance, which was intended to expand the categories of practitioners who could order rehabilitation and respiratory care services beyond physicians and stated that all ordering practitioners had to hold medical staff privileges, was actually having the opposite effect and limiting practitioner orders for these services. In the area of outpatient rehabilitation services, in particular, stakeholders informed us that the revised guidance was posing a barrier to care because a substantial percentage of these services are provided in hospital outpatient rehabilitation facilities to patients referred by practitioners who are not on the hospital's medical staff and who do not hold medical staff privileges. We were advised that, in many cases, the referring practitioners are based in other States to which patients have traveled to receive specialized services. Clearly, these practitioners do not provide care in the patient's local hospital and are not interested in seeking medical staff privileges merely to refer patients for outpatient services.

It was not our intention to create barriers to care or to limit the ability of practitioners, who are appropriately licensed, acting within their scope of practice, and authorized under hospital policies, to refer patients for outpatient services. We distinguish these outpatient referral cases from cases where a practitioner provides care in the hospital, either to inpatients or outpatients, and must have medical staff privileges to do so. We subsequently issued new guidance on this rule. On February 17, 2012, CMS issued SC-12-17 (

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter12_17.pdf

), which clarified that outpatient services may be ordered by any practitioner responsible for the care of the patient, who is licensed and acting within his or her scope of practice in the State where he or she provides care to the patient, and who has been authorized by the medical staff and approved by the governing body to order specific outpatient services.

In light of the above, as indicated in the proposed rule, we believed it would be appropriate to revise § 482.54, the CoP governing outpatient services, which is silent on the issue of who may order such services, in order to explicitly address this issue. We proposed to revise the requirements to mean that orders for outpatient services may be made by any practitioner who is—

• Responsible for the care of the patient;

• Licensed in the State where he or she provides care to the patient;

• Acting within his or her scope of practice under State law; and

• Authorized in accordance with policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services.

Further, we stated that these proposed requirements would apply to all practitioners who are appointed to the hospital's medical staff and who have been granted privileges to order the applicable outpatient services; and all practitioners not appointed to the medical staff, but who satisfy the above criteria for authorization by the hospital for ordering the applicable outpatient services and for referring patients for such services. These requirements would also apply to all hospital services that may be offered on an outpatient basis, including services for which there is regulatory language that, in the absence of the clarifying language we propose herein, would appear to impose more stringent limits as to the practitioners who are permitted to order outpatient services. For example, § 482.53(c)(4) states, “Nuclear medicine services must be ordered only by practitioners whose scope of Federal or State licensure and whose defined staff privileges allow such referrals.” In practice, however, it is not unusual for physicians without medical staff privileges to refer their patients to the hospital for common outpatient nuclear medicine tests, such as myocardial perfusion scans used in conjunction with cardiac stress tests and hepatobiliary scans used in the detection of gallbladder disease. So long as the hospital's medical staff policies and procedures permit this, we do not believe our regulations should present a barrier. Another example concerns the administration of outpatient chemotherapy. In accordance with § 482.23(c), concerning preparation and administration of drugs, “Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under § 482.12(c), and accepted standards of practice.” In the absence of the clarification we stated that this language could be confusing, as some hospitals

might read it to preclude providing outpatient chemotherapy on the orders of a practitioner without privileges, which may or may not be desirable to the hospital. We believe that it is more appropriate if the hospital's medical staff and governing body determine what types of outpatient services they are comfortable with providing on the basis of an order (which might commonly also be called a “referral”) from a practitioner who does not hold medical staff privileges.

We expect these changes would be primarily neutral in terms of regulatory burden reduction for hospitals. Prior to the November 2011 revisions to the IGs, most, if not all, hospitals were already operating under what was considered standard industry practice with regard to the ordering of, and referral for, outpatient rehabilitation services by practitioners who were not on the hospital's medical staff. Since we moved quickly to clarify our outpatient services ordering policy through communications with stakeholders and further revisions to the IGs, we believe that most hospitals did not make changes to their policies and procedures that would have created burdens for them. We cannot rule out the possibility that some hospitals were deterred by the specific language of other CoPs, such as those governing nuclear medicine or administration of drugs, but we have not received information that would allow us to quantify this. We stated that this proposed change would clearly establish in regulation CMS policy on the ordering and referral of all outpatient services.

We received a total of 35 comments from individuals, medical societies, professional societies, hospital associations and national organizations on this proposal. The comments were generally supportive of our proposal. Here we respond to specific comments:

Comment:

Several commenters expressed support for our proposal, but suggested that the language be modified to add language to require that practitioners not appointed to the medical staff be authorized in accordance with both State law

and

policies adopted by the medical staff.

Response:

We appreciate the commenters' support. We also agree with the recommendation and have modified the proposed regulatory language as suggested.

Comment:

Several commenters expressed concern regarding both the burden and the practicality of requiring hospitals to obtain information about the current scope of practice for a practitioner in another state and then to determine if the practitioner's ordered services are within those parameters. These commenters believe that CMS should clarify the proposed requirement that the hospital must check the licensure status of the practitioner in the State where he or she provides care to the patient. They also asked if CMS expected the hospital to set up a credentials file for the non-medical staff practitioner who orders outpatient services, maintain information on his or her State scope of practice, and show that a determination was made that the ability to order the specific outpatient services was within his or her respective State scope of practice.

Response:

Hospitals have the flexibility to determine whether or not they will allow a practitioner who is not a member of the medical staff to order outpatient services as well as the ability to establish through medical staff bylaws and hospital policy other parameters for who will and who will not be authorized to order outpatient services. If a hospital is unable or unwilling to verify the respective State scope of practice, licensure, etc., for a practitioner, the hospital is not required to authorize the practitioner to order outpatient services in its facility. If a hospital does allow practitioners not on the hospital's medical staff to order hospital outpatient services, the hospital must be able to demonstrate compliance with the regulatory requirement.

Comment:

Several commenters noted that non-hospital providers of similar outpatient services do not have similar requirements and believe that hospitals should not be held to a higher requirement than non-hospital providers of similar services. They believe that requiring a higher standard of hospitals would be an unnecessary burden, increase hospital costs, and provide limited, or no, benefit to patients. Another commenter stated that the hospital CEOs with whom they have spoken believe that hospitals already have better policies than non-hospital providers of the same services that are not subject to the same regulatory requirements.

Response:

We are aware that there are other provider types who provide outpatient services and we understand the commenters' concerns about these providers having differing regulatory requirements. These other providers are subject to requirements specific to their particular setting that also include issues such as licensure, scope of practice, and facility policies and procedures. We believe the requirements that we have established in this rule are appropriate to the hospital setting and are necessary to ensure the health and safety of patients while also ensuring that we do not create unintentional barriers to care or unnecessary limitations on professional practice. We note that this clarification to the CoP for outpatient services creates an option for hospitals and not a requirement. A hospital is required to comply with this requirement only if it chooses to allow practitioners who are not members of the medical staff to order outpatient services.

Comment:

Several commenters supported the proposed revisions as written. One commenter stated that they supported the clarifying change as there was prior confusion that membership on the medical staff is required to order outpatient services. Another commenter noted that this change will improve patient access to crucial healthcare services and improve the efficiency and quality of care. They believe that it will prevent needless delays for consumers in accessing the care they need, and that it will promote earlier intervention, which they believe will in turn improve outcomes and reduce costs.

Response:

We appreciate the commenters' support for our proposal.

Comment:

One commenter believes that this change will “amp up medical spending, often for useless medical imaging and other diagnostic tests.”

Response:

We disagree. We understand that allowing practitioners who are not a member of the medical staff to order outpatient services has been a standard practice for many years for a majority of hospitals. We have not been presented with any evidence that our clarification will result in any increase in the number and types of outpatient services ordered. We believe that this clarification in policy will prevent the creation of new barriers to care, particularly for patients in rural areas. In addition, CMS has other regulatory mechanisms by which determinations are made as to whether specific outpatient services are medically reasonable and necessary.

Comment:

One commenter requested that CMS clarify what constitutes when a practitioner is responsible for the care of the patient asks whether this includes practitioners working under the supervision of, or in collaboration with, the treating physician as well as other practitioners otherwise involved in the care of the patient.

Response:

We expect that each hospital medical staff would address which categories of practitioners would be deemed “responsible for care of the patient” in their policies. Such practitioners could include: Any of the practitioners specified under § 482.12(c) who are involved in providing medical care to the patient; any practice partners

of the patient's attending physician who might be covering the physician's patients for a period of time if the physician is not available; any hospitalists, hospital intensivists, and specialty physicians who might have provided care to the patient during a prior hospital stay; any residents/fellows under the preceptorship or supervision of the patient's attending physician or hospitalist, intensivist or specialty physician during a prior hospital stay; and any non-physician practitioners involved in the patient's care.

Comment:

One commenter expressed concern about complying with this requirement in teaching hospitals. The commenter requested that CMS clarify that a teaching hospital would not be considered out of compliance with this requirement when they allow interns, residents, and fellows to order outpatient service as part of their training program, in accordance with the hospital's medical staff bylaws, rules, and regulations as well as any other related legal requirements related to with which the hospital must comply.

Response:

We do not see a conflict between this requirement and interns, residents, and fellows who are acting in accordance with their respective State's licenses and scope-of-practice laws, and their respective hospital's medical staff bylaws, rules, and regulations.

Comment:

One commenter recommends that CMS specify the timeframe and the duration of the verification process for such orders, as they vary in frequency and urgency.

Response:

We expect hospitals, when presented with a referral or order for outpatient services from a practitioner who does not have privileges at that hospital and for whom the hospital has not previously verified the practitioner's licensure, etc. to perform such verification before providing the ordered outpatient services to the patient. In accordance with the comments discussed above, we are finalizing the changes to § 482.54 as proposed with two minor revisions. On the recommendation of commenters, we are revising § 482.54(c)(4) by adding the phrase, “State law” so that the provision is now finalized to read, “. . . authorized in accordance with

State law and

policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services.” Additionally, we are also revising § 482.54(c)(4)(ii) by adding the phrase, “the medical staff” so that this provision is now finalized as applying to all practitioners “not appointed to the medical staff, but who satisfy the above criteria for authorization by

the medical staff and

the hospital for ordering the applicable outpatient services for their patients.” We believe that this additional revision is necessary to clarify that it is a hospital's medical staff that initially recommends authorizing these ordering privileges, after which the governing body, or the hospital, approves them.

6. Special Requirements for Hospital Providers of Long-Term Care Services (“Swing-Beds”) (§ 482.66)

Currently, these requirements are located in Subpart E of Part 482, Requirements for specialty hospitals. As such, the requirements fall outside of those requirements that can be surveyed by an Accreditation Organization (AO), such as TJC, AOA, or DNV, as part of its CMS-approved Medicare hospital accreditation program. We believe the requirements at § 482.66 would be more appropriately located under Subpart D of Part 482, optional hospital services, since swing-bed services are optional hospital services for eligible rural hospitals.

Therefore, we proposed to reassign all of the requirements for swing-bed services found currently at § 482.66, Subpart E, to § 482.58, Subpart D. This change would allow compliance with the swing-bed requirements to be evaluated for accredited hospitals during routine AO surveys. As indicated in the proposed rule, by no longer requiring an accredited hospital to undergo a separate survey by a State Survey Agency (SA) to determine continued compliance with the swing-bed requirements in addition to the AO survey for the other CoPs, this proposed change would likely reduce the burden on such a hospital. We welcomed public comments on this proposed change.

We received a total of 8 comments on our proposed changes to § 482.66, primarily from accreditation organizations and hospital organizations. Commenters were supportive of the proposed changes. There were no comments opposed to the proposed changes to § 482.66.

In accordance with the comments discussed above, we are reassigning all of the requirements for swing-bed services found currently at § 482.66, Subpart E, to § 482.58, Subpart D as proposed. We are also making conforming amendments to correct cross-references in §§ 413.24, 413.114, 440.1 and 485.606.

Contact for all hospital topics,

CDR Scott Cooper, USPHS, (410) 786-9465.

D. Transplant Centers and Organ Procurement Organizations

1. Reports to CMS (§ 482.74)

On March 30, 2007, we published the “Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Transplants Final Rule” (transplant center final rule, 72 FR 15198). In that rule, we required that transplant centers, among other things, report to CMS any significant changes related to the center's transplant program or changes that could affect its compliance with the CoPs. Among other things, transplant centers must notify us, under § 482.74(a)(2), whenever there is a decrease in the center's number of transplants or survival rates that could result in the center being out of compliance with the clinical experience (number of required transplants) or outcome (survival) requirements at § 482.82.

We routinely receive information about the number of transplants a center performs and survival information from all transplant centers. Transplant centers are required to submit these data to the Organ Procurement and Transplantation Network (OPTN) national database for transplantation. These data are provided to the Scientific Registry of Transplant Recipients (SRTR), which publicly releases outcome (survival) information every six months, after the data have been risk-adjusted. CMS also receives more recent survival information via the Social Security Master Death File. CMS receives clinical experience data and the Social Security Master Death File quarterly, as well as the risk-adjusted outcomes from the SRTR data every six months. Thus, CMS is essentially receiving the same information from the transplant programs individually that we receive routinely from one or more of the resources cited above.

In addition to the above, this notification requirement has also resulted in confusion for the transplant centers. The requirement states that transplant centers should notify CMS when they are out of compliance with a 3-year average of 10 transplants per year. Since the clinical experience standard is based on an average, a transplant center may not know if a given year's volume would be low enough to have the average fall below 10 per year and trigger reporting to CMS, particularly when the number of transplants to be performed in a future year is unknown.

Further, the requirement for notification of outcomes non-compliance is based on the difference

between the observed and the expected outcomes exceeding certain thresholds. However, the expected outcomes are not calculated until at least one year later when the one-year post-transplant tracking period for patient and graft survival is complete. The transplant program would not always know whether a given death or graft failure would put them out of compliance and require notification to CMS. Eliminating this notification requirement will also remove this confusion for the transplant centers.

Thus, the requirement for transplant centers to report a decrease in the center's number of transplants or survival rates when those results could result in the center being out of compliance with the measures in § 482.82 is unnecessary, confusing, and burdensome for transplant centers. Therefore, we proposed to eliminate the requirement at § 482.74(a)(2) that transplant centers notify us. The removal of this requirement would have no impact on the quality of care to transplant recipients, living donors, or potential donors, because our identification and follow-up processes for programs that do not meet § 482.82 remain unchanged.

We received a total of six comments on our proposed change to § 482.74 from health care providers and institutions, as well as from two national associations of transplant professionals. All of the commenters were supportive of the proposed change. We respond to specific comments below:

Comment:

Most of the commenters noted that data are already routinely submitted to the OPTN and then these data are provided to the SRTR, which publicly releases outcome (survival) information every six months, after the data have been risk-adjusted. CMS also receives more recent survival information via the Social Security Master Death File. CMS receives clinical experience data and the Social Security Master Death File quarterly, as well as the risk-adjusted outcomes from the SRTR data every six months. Thus, CMS is essentially receiving the same information from the transplant programs individually that we receive routinely from one or more of the resources cited above. The commenters noted that this process is time consuming, labor intensive, and duplicative.

Response:

We agree with the commenters. We believe that requiring transplant centers to report these data that are routinely available to CMS is unnecessary, confusing, and burdensome for transplant centers. In accordance with the comments discussed above, we are finalizing the change to § 482.74(a)(2) as proposed.

2. Transplant Outcome Review (§ 482.80(c) and § 482.82(c))

Sections 482.80(c), approval, and 482.82(c), reapproval, in the transplant center CoPs state that, “[e]xcept for lung transplants, CMS will review adult and pediatric outcomes separately when a center requests Medicare approval to perform both adult and pediatric transplants.” At the time the transplant center final rule was published (March 30, 2007), the adult data cohorts for lung transplants included transplant patients 12 years of age and older. As of June 2010, the adult data cohort includes only those transplant patients that are 18 years of age and older. The age categories for lung transplant patients are now the same as for all of the other transplants reported in the SRTR center-specific reports

(See OPTN/SRTR 2010 Annual Data Report, Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation: 2011).

We are reviewing the adult and pediatric outcomes separately for all programs that request Medicare approval to perform both adult and pediatric transplants, including the lung transplant program. This language, “except for lung transplants,” is no longer necessary. Therefore, we proposed to remove the exception language for lung transplants from §§ 482.80(c) and 482.82(c).

We received a total of two comments on our proposed changes to §§ 482.80(c) and 482.82(c) from a health care provider and institution, as well as a national association of transplant professionals. All of the commenters were supportive of the proposed changes. We respond to specific comments below:

Comment:

Both of the commenters supported the proposed deletion of the phrase, “except for lung transplants.” One commenter specifically noted that this change clarifies that “adult and pediatric outcomes will be reviewed separately for all [transplant] programs [when they] request Medicare approval to perform both adult and pediatric transplants, including lung transplant programs.”

Response:

We agree with the commenters. Since the age cohorts are now the same for all transplant patients, including lung transplants, this language is unnecessary and only causes confusion.

In accordance with the comments discussed above, we are finalizing the changes to §§ 482.80(c) and 482.82(c) as proposed.

3. Volume and Clinical Experience Requirements (§§ 482.80(c)(2) and 482.82(c)(2))

Regulations at §§ 482.80(c)(2) and 482.82(c)(2) both state “[t]he required number of transplants must have been performed during the time frame reported in the most recent SRTR center-specific report.” We proposed to modify this language to harmonize it with other parts of the current rule. Under the current rule, transplant centers are generally required, with some exceptions, to perform either 10 transplants over a 12-month period for initial approval (§ 482.80(b)) or an average of 10 transplants each year during the approval period (§ 482.82(c)(2)) (preceding reapproval). There is no requirement for a certain number of transplants to be performed during a particular period that would be covered in a single SRTR center-specific report. Thus, this language has resulted in transplant centers being confused about the number of transplants they are required to perform during any particular period of time covered by the SRTR center-specific reports. Therefore, we proposed to remove both §§ 482.80(c)(2) and 482.82(c)(2), and to redesignate the existing paragraph (c)(3) as (c)(2) to clarify the volume and clinical experience requirements.

We received a total of two comments on our proposed changes to §§ 482.80(c)(2) and 482.82(c)(2) from a health care provider and institution, as well as two national associations (writing together) for transplant professionals. All of the commenters were supportive of the proposed changes. We respond to specific comments below:

Comment:

Both comments noted that the requirement was confusing and the proposed change would provide clarification. One of the commenters specifically noted that “the SRTR uses a “rolling” time frame and [the current language] is therefore confusing.”

Response:

We agree with the commenters that the current language is confusing because there is no requirement for a transplant center to perform a certain number of transplants “during the time frame reported in the most recent SRTR center-specific report.” Removing this language as proposed will eliminate this confusion. In accordance with the comments discussed above, we are finalizing the changes to §§ 482.80(c)(2) and 482.82(c)(2) as proposed.

4. Transplant Center Re-Approval Process

Since the effective date of the CoPs, June 28, 2007, we have completed the initial surveys of all transplant programs that participate or seek participation in Medicare (approximately 845 transplant centers in 245 transplant hospitals), and have started conducting re-approval surveys. The current process and regulatory criteria require, under particular conditions, an automatic onsite review of all CoPs under a 3-year re-approval cycle. We believe that onsite surveys for some of these transplant centers are advisable to promote the health and safety of the patients who receive a transplant in those centers. However, we believe that the time period between recertification surveys should be more flexible, certain current requirements for an onsite survey following evidence of a violation of some CMS requirements may not be necessary, and such regulatory requirements for selecting the facilities that would undergo an onsite survey do not always effectively target survey resources where they are most needed.

We proposed to remove the automatic 3-year re-approval process in favor of a schedule in which each transplant program still has a full onsite recertification survey but the time interval between such surveys for any one program may be longer or shorter than once every three years. In addition, we plan to maintain, via CMS policy, a maximum time interval within which we expect an onsite survey to occur with respect to individual transplant centers. We have a variety of sources we use to generate targeted quality information that can be used to determine the circumstances and frequency under which an onsite survey is best conducted. Examples include previous complaint surveys, prior onsite survey results, issues found during surveys of the broader hospital CoPs, data and information from the Health Resources and Services Administration (HRSA) and the SRTR, notifications of program inactivity, key personnel changes, articles from the press about quality issues, and information submitted by the program through the mitigating factors (MF) process.

We also proposed to (1) clarify that the review of mitigating factors may occur at any time if there is non-compliance with the CoPs, and (2) remove language stating that a transplant program is approved for 3 years. However, it is expected that compliance with CMS requirements is continuous, as is expected of all Medicare providers and suppliers.

Currently the regulations require that we review each transplant program's data before the end of 36 months after the program's prior approval. The regulations require a review of most other CoPs if we find that there is non-compliance with the requirements at § 482.82(a) for timeliness of data submission to the OPTN, or non-compliance with the requirements at § 482.82(b) for clinical experience, or at § 482.82(c) for patient and graft survival outcomes. An onsite survey for analysis of these data is the most common method of conducting such a review, but we have found that an onsite review for deficiencies in these areas is not always necessary if CMS determines that communication with the program and offsite analysis of information submitted by the hospital will suffice to make a final determination and/or approve a plan of correction. For instance, CMS regulations require that transplant programs submit 95 percent of their OPTN forms within 90 days of their due date. On a quarterly basis, we receive data from the OPTN that provides us with the number of forms due for each program and the number that were submitted within the required timeframe. Based on the 3-year period from mid-2008 through mid-2011, 73 transplant programs had data submission rates below 95 percent and, if due for re-approval, would have required an onsite survey. Of these 73, most (43 programs) had average data-submission rates between 90 and 95 percent. While remedial action is necessary in every case, it does not follow that these 43 programs required an automatic, onsite survey. We proposed that we can take action to address the non-compliance (such as through direct communication with hospital officials and, if necessary, application of remedies already available in law or regulation) while reserving for CMS's discretion the decision of whether or not an onsite survey is necessary or advisable.

We also receive data on a quarterly basis about the number of transplants performed at each center. Because of this data transfer, we are routinely aware of the average number of transplants being performed by or at a given transplant program. There are circumstances where it would not be in the public interest to spend the resources to perform a full onsite transplant center survey solely because the 3-year average volume is low. For example, if a transplant program had performed an average of 9.3 transplant surveys over the prior 3-year period (fewer than the current requirement of an average of 10 per year), and the most recent year indicated 14 transplants performed, sending a full team to do an onsite survey of all CoPs, for this reason alone, may not make the best use of limited resources for the hospital or for CMS.

Of the approximately 845 total transplant programs, 442 are required to meet clinical experience requirements (that is, volume requirements). Pediatric transplant programs and adult heart/lung and adult pancreas programs do not have to meet clinical experience requirements (§§ 482.80(d) and 482.82(d)). Using clinical experience data from October 1, 2008 through September 30, 2011, 30 transplant programs that were required to meet experience requirements had performed fewer than the required number of 10 transplants per year on average. If due for re-approval, these 30 programs would have required an onsite survey regardless of any other evidence CMS may have had from history, recent program improvements, or the most recent clinical experience.

We monitor and enforce Medicare's requirements for patient and graft survival rates every 6 months based on the most recent report from the SRTR. A program is out of compliance if its observed patient and graft survival is significantly lower than expected to such an extent that it crosses three thresholds set out in the CoPs at § 482.82: The observed minus expected is greater than 3, the observed divided by expected is greater than 1.5, and the one-sided p-value is less than .05 (§ 482.82(c)(3)).

We follow up with these transplant programs through an offsite survey, an onsite complaint survey, or an onsite full re-approval survey. These follow-up activities are conducted by the CMS Regional Office, a federal contractor, or the State Survey Agency (acting on CMS's behalf). The follow-up occurs at the time of non-compliance and does not wait until the re-approval survey occurs. Following the citation of an outcomes deficiency and the establishment of a date for prospective termination from Medicare participation, programs may submit an application for mitigating factors (MF) based on non-compliance with the outcomes CoP. We provide ample time between the citation and the prospectively scheduled Medicare termination date for the program to provide evidence and, via conference call, discussion of the evidence that would support the mitigating factors request. If the MF request is approved, we specify the time period for the MF

approval and remove the prospectively scheduled Medicare termination.

We also proposed to provide at the new § 488.61(c)(3)(v) an example of a set of mitigating factors that we would consider. We have granted a very small number of MF requests on the basis of the categories currently used as examples in the regulation, such as natural disasters (one case) or access to care (one case). However, we have more frequently granted MF requests in cases where the transplant center has implemented substantial program improvements that address root causes of past graft failures and/or patient deaths, has institutionalized those improvements so they may be sustained over time, and has been able to demonstrate recent outcomes data with sufficient volume and with sufficient post-transplant survival periods such that we conclude that the program is in present-day compliance with the outcomes requirements in the regulation, but for the data time lag inherent in the SRTR reports upon which we otherwise rely. CMS has approved an MF request for 35 transplant programs on this basis since the implementation of the regulation in 2007. Additional MF approvals have been made pursuant to dialogue and a binding System Improvement Agreement between CMS and the transplant center that the hospital will engage in a clear regimen of quality improvement and the hospital subsequently demonstrated both substantial completion of that regimen and improved outcomes. We believe that the addition of this example in the body of the regulation will provide better guidance for transplant centers, offer encouragement for the productive application of hospital staff expertise in making program improvements that increase patient and graft survival, and promote government transparency.

We received a total of twelve comments from nine commenters on our proposed changes to § 488.61(c) from health care providers, institutions, and associations, as well as two national associations for transplant professionals and one national accrediting organization. Overall, the majority of commenters were supportive of the proposed changes. We respond to specific comments below:

Comment:

Two of the commenters disagreed with our proposal to remove the automatic three-year re-approval process. One commenter, a healthcare professional, stated that the OPTN does not do a good job of monitoring programs that have failed to meet outcome requirements or have otherwise failed to maintain their programs. The commenter indicated that CMS should realize, after six years of routine surveys, that many of the programs that are not in compliance with the CoPs are unwilling or unable to meet the requirements in the CoPs, even knowing that they would be surveyed. The commenter noted that one of the reasons for the transplant center CoPs was because of the “very public problems” in transplant programs. The commenter also said he thought it was foolish for CMS to abandon its most effective tool, the routine survey.

Response:

We disagree with this commenter. Although we agree with the commenter that the onsite survey is an effective tool for ensuring compliance with the transplant center CoPs, we also believe onsite surveys are not necessary for all transplant centers. As discussed above, the current requirement for automatic, onsite surveys for transplant centers based solely on that transplant center's failure to be in compliance with the data submission, clinical experience, or outcome requirements in § 482.82 is often an inefficient use of CMS's survey resources. Transplant centers that are not in compliance with these requirements certainly require CMS follow-up; however, we believe that the type of follow-up should be up to CMS's discretion. Requiring automatic, onsite surveys, regardless of the degree and type of non-compliance, will inevitably result in onsite surveys being conducted at transplant centers when another type of follow-up would have adequately addressed the non-compliance with a more efficient use of CMS' limited survey resources.

Comment:

Another commenter, a national accrediting organization, expressed concern over CMS not conducting on-site surveys unless the results of data analysis warranted such a review. Data gleaned from the SRTR may not be a reliable indicator of the quality of the care being delivered and the commenter did not believe that this should be the sole determinant of whether there should be an on-site survey. The commenter stated that the proposed method by which the data would be collected by CMS raises concern about whether organizations that are found deficient would have the opportunity to amend their practices before they are penalized. Transplant centers that submit unreliable data, which may or may not contain balancing measures to account for the complexities of its individual populations, risk not meeting the CMS threshold for quality care and potential unwarranted penalties. The commenter also noted that, in their experience, surveying healthcare facilities supports the need for validation of data and documentary evidence with onsite review and that they believe the proposed approach is inconsistent with CMS' evaluation of quality and safety of other high-risk healthcare programs and services.

Response:

We disagree with this commenter. We will continue to conduct onsite surveys of all transplant centers. We are eliminating the 3-year approval period, which previously included a policy that onsite surveys be triggered by the failure of a center to be in compliance with the data submission, clinical experience, or outcome requirements in § 482.61(c). CMS is constantly enforcing the transplant center CoPs through the review of data from the SRTR, offsite surveys, and complaint surveys. In addition, as stated above, we will also be establishing, through CMS subregulatory policy, a maximum time interval within which we expect that each transplant center will have an onsite survey.

Regarding the commenter's concern about the SRTR data, we are obligated by the OPO CfCs to use SRTR's data (at § 486.318(a)(2) and (b)(2)). In addition to the SRTR data, we also review data from other sources and other information in determining when to survey OPOs. For example, we may conduct a survey when we receive a complaint from a healthcare provider or the public. We may also decide to conduct a survey after receiving information through another governmental agency or the media.

In regards to the commenter's concern about transplant centers having the ability to make changes to their programs before being penalized by CMS, we believe that all of the transplant centers monitor their performance on the requirements. In addition, transplant centers are required to have a comprehensive, data-driven quality assessment and performance improvement (QAPI) program that is designed to monitor and evaluate the center's performance of all transplantation services as set forth in § 482.98. Therefore, transplant centers should be aware of any problems in their programs and be working towards improving their performance.

CMS constantly monitors and enforces the transplant center CoPs through the review of available data, offsite surveys, and complaint surveys. In addition, we are not abandoning the onsite survey process. Our proposal simply allows us to use discretion, based upon our extensive experience with transplant centers, to determine when an onsite survey is necessary and

when another type of follow-up is appropriate. Also, CMS will be establishing via policy a maximum time interval within which an onsite survey must occur.

Comment:

One commenter, a healthcare institution, noted that our proposed addition to the examples of mitigating factors CMS would consider in the re-approval of a transplant center in § 488.61(c) should be in set forth in paragraph (c)(4), not paragraph (c)(3).

Response:

We agree with the commenter. The examples of the mitigating factors CMS will consider are set forth in § 488.61(c)(4) and the proposed additional example should also be located in that section. Therefore, we will be finalizing our additional example of a mitigating factor as proposed; however, we will be re-designating it so that it is set forth at § 488.61(c)(4)(v).

After consideration of the comments discussed above, we are finalizing the changes to § 488.61(c) as proposed, except for re-designating proposed § 488.61(c)(3)(v) as § 488.61(c)(4)(v).

5. Technical Corrections

On May 31, 2006, we published the Conditions for Coverage for Organ Procurement Organizations (OPOs) Final Rule (OPO final rule 71 FR 30982). We have discovered that there were some technical errors in that rule. Therefore, we proposed to make the following technical corrections:

• Section 486.306 states, in paragraph (a), that “An OPO must make available to CMS documentation verifying that the OPO meets the requirements of paragraphs (b) through (d) of this section . . .” This section only contains paragraphs (a), (b), and (c). We proposed to delete the reference to “(d)” in paragraph (a) and insert “(c)” in its place. This paragraph would then read, “the OPO meets the requirements of paragraphs (b) and (c) of this section . . .”

• Section 486.308(b)(1) reads, in part, “if additional time is needed to select a successor OPO to an OPO that has been de-certified.” We proposed to remove the “to” between the two “OPOs” and replace it with “for” in this sentence. The paragraph would then read, “if additional time is needed to select a successor OPO for an OPO that has been de-certified.”

• Section 486.344(d)(2)(ii) reads, in part, “If the identify of the intended recipient is known. . . .” We intended to say the “identity” of the intended recipient. We proposed to remove the word “identify” and replace it with “identity.” The clause would then read, “If the identity of the intended recipient is known . . .”

We received one public comment in response to these proposed technical corrections. That commenter supported the corrections as proposed. Therefore, we are finalizing these changes as proposed.

In addition to the comments we received concerning our proposed changes, we also received comments that were extraneous to those changes. Since these comments address issues beyond the scope of this rule, we will not specifically respond to them here. However, we have reviewed these comments and will consider them in any future rulemaking.

Contact for all transplant center and OPO topics:

Diane Corning, (410) 786-8486.

E. Long-Term Care Facilities

On August 13, 2008, we published a final rule requiring all buildings containing long term care facilities to have automatic sprinkler systems installed throughout the building (73 FR 47075). The deadline for meeting this requirement was August 13, 2013. The regulation requires that all facilities be in compliance. On August 16, 2013, CMS issued a memorandum to State survey agencies describing enforcement guidelines for this requirement (see Survey & Certification Memorandum SC-13-55, accessible at

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-55.pdf

). Life Safety Code (LSC) surveys will continue to occur as part of normally-scheduled annual surveys, or as part of a complaint visit in which LSC deficiencies are noted or referred. LSC surveys that find a facility to be without a complete automatic sprinkler system installed in accordance with

NFPA 101, LSC, 2000 Edition and NFPA 13, Installation of Sprinkler Systems, 1999 edition

will be cited as not in compliance with CMS requirements. Facilities that are cited for not meeting the sprinkler requirement will be required to submit a plan of correction (POC) to correct the deficiency.

The 2008 final rule was based on a CMS analysis of fire safety in nursing homes, and the agency's conclusion that fire safety protections would clearly be improved by ensuring that all facilities be fully sprinklered within a reasonable period of time. Based on recent public comments and input, we believe that some facilities were not able to meet the August 2013 deadline due to the magnitude of the enterprise they are undertaking (such as large scale construction of a replacement facility) combined with recent financial and construction constraints. We therefore proposed to allow certain long term care facilities to apply for a temporary deadline extension of the sprinkler system requirement, under very limited circumstances, if they are unable to meet the deadline. Our intent is to establish a rigorous review process for all deadline extension requests. Upon finalization of this rule, CMS will continue to cite facilities that do not meet the requirement, except that CMS may grant extensions of the due date to the relatively small number of facilities that meet the extenuating circumstances set forth below.

We proposed to add a provision at § 483.70(a)(8)(iii) that would allow long term care facilities the opportunity to apply for a deadline extension, not to exceed 2 years, if all of the following conditions apply:

• The facility is in the process of replacing its current building, or undergoing major modifications in all unsprinklered living areas and that requires the movement of corridor, room, partition, or structural walls or supports to improve the living conditions for residents, in addition to the installation of a sprinkler system;

• The facility demonstrates that it has made the necessary financial commitments to complete the building replacement or modification;

• The facility has submitted construction or modification plans to the State and local authorities that are necessary for approval of the replacement building or modification prior to applying for the deadline extension; and

• The facility agrees to complete interim steps to improve fire safety of the building while the construction is being completed, as determined by CMS. This could include a fire watch, installation of temporary exits and temporary smoke detection systems, or additional smoke detection systems in the area of construction, increased fire safety inspections, additional training and awareness by staff, and additional fire drills.

An extension may be granted for up to 2 years, depending on the need and particular circumstances. We would determine the length of the extension based on the information submitted by the facility.

We also proposed to add a provision at § 483.70(a)(8)(iv) that would allow for a renewal of the deadline extension for an additional period, not to exceed 1 additional year. We proposed that a facility could only apply for a single extension renewal.

We received a total of 13 comments on our proposed sprinkler deadline extension provision from individuals and organizations such as accrediting bodies, patient advocacy groups, health care systems, and LTC facilities. Overall, the majority of commenters were supportive of the proposed changes. Here we respond to specific comments:

Comment:

The majority of commenters supported the proposal and thanked us for the opportunity to comment in support of the proposal. Several commenters disagree with our proposal to grant extensions. One commenter expressed that allowing for this extension could compromise the safety of nursing homes patients, as they are continuing to live in facilities that do not have sprinklers in them during the extension period. In addition, one commenter felt that only facilities that are currently unoccupied should be able to apply for this extension to ensure the safety of patients and staff.

Response:

We thank the commenters who expressed support for our proposal and agree that this regulation is necessary in order to allow facilities that have run into issues the opportunity to become compliant while also continuing to provide the safest environment possible for all patients and staff.

We understand that the commenters disagree with the proposal to grant extensions in certain circumstances because they feel that facilities have had ample time to come into compliance with the sprinkler requirement. Some facilities will not be able to meet the deadline and will need the extension to allow for the completion of construction. If the facilities are not given an extension it may cause facilities to be closed and will require patients to be moved to other facilities that may be further away and not as easily accessible. An example of unforeseen issues that may have caused a facility to be unable to meet the 2013 deadline may be delayed construction or depleting funds. For example, many providers established financial plans to construct a replacement facility that would comply with the sprinkler requirement, or to effect substantial building modifications that would include fund sprinkler compliance projects. However, following the initial CMS final rule in 2008 that mandated automatic sprinkler systems, a number of such facilities found their financial gains disappear due to the national recession, depleting the project funds, or making it impractical to sell an existing facility where the sale was necessary to fund the replacement facility. Also, challenges have come from the recent natural disasters such as Hurricane Irene in 2011 and Superstorm Sandy in 2012, causing delays in project starts and creating a backlog of projects.

We also understand the safety concerns of the commenters who disagreed with our proposal. We share their goal of improving safety for all long term care facility residents while continuing to assure resident stability and access to much needed long term care services. We are requiring that, as part of receiving an extension, a facility must implement interim fire safety measures. Interim measures may include the initiation of a fire watch, installation of temporary exits, installation of temporary smoke detection or smoke alarm systems, and increased fire safety training or fire drills for staff or other means to ensure the continued fire safety of the residents of the facility.

Comment:

One commenter observed that recent natural disasters, including Hurricane Irene and Superstorm Sandy, have significantly impaired the ability of some nursing homes to meet the August 13, 2013, deadline to achieve full sprinkler status. The commenter observed that recent challenges from Superstorm Sandy in late 2012 caused delays in project starts and a backlog of construction projects and requested that we provide for an additional extension one year beyond what we proposed.

Response:

We agree that natural disasters are a valid reason for a delay in compliance with the August 13th deadline. In reviewing the comments, we concluded that the original CMS proposal did not fully accommodate the significant impairments that might result from a major disaster. While section 1135 of the Act allows the Secretary to waive certain requirements in the case of a declared public health emergency, construction delays and financial hardships occasioned by a major disaster may extend far beyond the date of a declared public health emergency. While we still intend that any authority for an extension of the sprinkler deadline be narrowly construed, in this final rule we have added explicit recognition of a major disaster event as a potential basis for an extension of the due date at § 483.70(a)(8)(iii). We do believe that three years is a considerable amount of time in which to complete the construction, even if a facility is impacted by a natural disaster. Therefore, we are finalizing the extension timeframe as proposed.

Comment:

Some commenters have seemingly used the public comment process to apply for an extension, while others explicitly requested an explanation of the process.

Response:

We appreciate the opportunity to explain the process for submitting an application. As we proposed, and are finalizing in this rule, a facility must meet the following criteria in order to qualify for an extension:

1. The facility is in the process of replacing its current building, or undergoing major modifications in all unsprinklered living areas and that requires the movement of corridor, room, partition, or structural walls or supports to improve the living conditions for residents, in addition to the installation of a sprinkler system or has had its planned sprinkler installation so impaired by a disas

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