# Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2020-09608 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** May 8, 2020 - **Citation:** 85 FR 27550 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 409, 410, 412, 413, 414, 415, 424, 425, 440, 483, 484, and 600 Office of the Secretary 45 CFR Part 156 [CMS-5531-IFC] RIN 0938-AU32 Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. SUMMARY: This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the coronavirus disease 2019 (COVID-19). Recognizing the critical importance of expanding COVID-19 testing, we are amending several Medicare policies on an interim basis to cover FDA-authorized COVID-19 serology tests, to allow any healthcare professional authorized to do so under State law to order COVID-19 diagnostic laboratory tests (including serological and antibody tests), and to provide for new specimen collection fees for COVID-19 testing under the Physician Fee Schedule and Outpatient Prospective Payment System, during the public health emergency (PHE) for the COVID-19 pandemic. Recognizing the urgency of this situation, and understanding that some pre-existing CMS rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on beneficiaries and the American public, we are amending several CMS policies and regulations in response to the COVID-19 PHE and recent legislation, as outlined in this IFC. These changes apply to physicians and other practitioners, hospice providers, federally qualified health centers, rural health clinics, hospitals, critical access hospitals (CAHs), community mental health centers (CMHCs), clinical laboratories, teaching hospitals, providers of the laboratory testing benefit in Medicaid, Opioid treatment programs, and quality reporting programs (QRPs) for inpatient rehabilitation facilities (IRFs), long-term care hospitals (LTCHs), skilled nursing facilities (SNFs), home health agencies (HHAs) and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. DATES: Effective date: These regulations are effective on May 8, 2020. Applicability date: The policies in this IFC are applicable beginning on March 1, 2020, or January 27, 2020, except as further described in the table in SUPPLEMENTARY INFORMATION . Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 7, 2020. ADDRESSES: In commenting, please refer to file code CMS-5531-IFC. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5531-IFC, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5531-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Rebecca Cole, (410) 786-1589, for general information, or contact one of the following: HHVBPquestions@cms.hhs.gov, for issues related to the HHVBP Model. HAPG_COVID-19@cms.hhs.gov, for issues related to scope of practice issues; additional flexibilities for hospital outpatient departments and CMHCs to furnish outpatient services at temporary expansion sites, including the beneficiary's home and expanded CMHCs; expansion of the extraordinary circumstances relocation exception policy for on-campus and excepted off-campus provider-based departments (PBDs) that relocate in response to the COVID-19 PHE; teaching physician policies, including time spent by residents at another hospital and the medical education methodology of counting teaching hospital beds; counting beds for provider-based rural health clinic payment level; services furnished by opioid treatment programs; modified requirements for ordering COVID-19 diagnostic laboratory tests; payment to hospitals and physician's offices for specimen collection; counting time for telehealth evaluation and management visits; method for updating the telehealth list during the PHE; paying for remote monitoring services; and increased payment for telephone evaluation and management visits (Note this email address has an underscore“_” between “HAPG” and “COVID-19”.) IRFCoverage@cms.hhs.gov, for issues related to the Medicare IRF benefits. DMEPOS@cms.hhs.gov, for issues related to section 3712 of the CARES Act. Hillary Loeffler, (410) 786-0456, HomeHealthPolicy@cms.hhs.gov, or HospicePolicy@cms.hhs.gov, for issues related to the Medicare home health and hospice benefits. PHPPaymentPolicy@cms.hhs.gov, for issues related to the Partial Hospitalization Program (PHP) and CMHC issues. MedicaidHomeHealthRule@cms.hhs.gov, for issues pertaining to the Medicaid home health benefit related to section 3708 of the CARES Act. Kari Vandegrift, (410) 786-4008, and Elizabeth November, (410) 786-4518 or SharedSavingsProgram@cms.hhs.gov, for issues related to the Medicare Shared Savings Program. Leigha Basini, (301) 492-4380, for issues related to the separate billing requirement. Sheri Gaskins, (410) 786-9274, for issues related to Medicaid laboratory flexibilities. Cassandra Lagorio, (410) 786-4554, for issues related to the BHP. Molly MacHarris, (410) 786-4461, or QPP@cms.hhs.gov, for issues related to the Merit-based Incentive Payment System (MIPS). NCDsPublicHealthEmergency@cms.hhs.gov, for issues related to national coverage determination and local coverage determination requirements. Joan Proctor, (410) 786-0949, or HHQRPQuestions@cms.hhs.gov, for issues related to the following Post-Acute Care QRPs: HH QRP, IRF QRP, LTCH QRP, and SNF QRP. Julia Venanzi, (410) 786-1471, for issues related to the Hospital VBP Program. Adam Rubin, (410-786-1919), for issues related to Certification of Home Health Services. SUPPLEMENTARY INFORMATION: The policies in this IFC are applicable beginning on March 1, 2020, or January 27, 2020, except as further described in the following table: Provision Applicability date Medicare Shared Savings Program—Expansion of Codes used in Beneficiary Assignment We are revising § 425.400 to expand the definition of primary care services used in the Shared Savings Program beneficiary assignment methodology for the performance year starting on January 1, 2020, and for any subsequent performance year that starts during the PHE for the COVID-19 pandemic, as defined in § 400.200, which includes any subsequent renewals. Modification to Medicare Rules and Medicaid Concerning Certification and Provision of Home Health Services We are revising §§ 409.41 through 409.48; 424.22; 424.507(b)(1); § 440.70(a)(2) and (3), and (b)(1), (2) and (4); and several sections of 42 CFR part 484 to include physician assistants, nurse practitioners, and clinical nurse specialists as individuals who can certify the need for home health services and order services. These changes are permanent, and applicable to services provided on or after March 1, 2020. Flexibility for Medicaid Laboratory Services We are revising § 440.30 to provide states with flexibility to provide Medicaid coverage for certain laboratory tests and X-ray services that may not meet certain requirements in § 440.30(a) or (b) (such as the requirement that tests be furnished in an office or similar facility). This flexibility is retroactive to March 1, 2020, during the period of the COVID-19 PHE and for any subsequent periods of active surveillance. The flexibility also applies to future PHEs resulting from outbreaks of communicable disease and subsequent periods of active surveillance. Requirement for Facilities to Report Nursing Home Residents and Staff Infections, Potential Infections, and Deaths Related to COVID-19 We are revising § 483.80 to establish explicit reporting requirements for long-term care (LTC) facilities to report information related to COVID-19 cases among facility residents and staff. These reporting requirements are applicable on the effective date of this IFC. Separate Billing and Segregation of Funds for Abortion Services We are delaying by 60 days the date when individual market qualified health plan (QHP) issuers must be in compliance with the separate billing policy for non-Hyde abortion services. Under this 60-day delay, individual market QHP issuers must comply with the separate billing policy beginning on or before the QHP issuer's first billing cycle following August 26, 2020. DME Interim Pricing in the CARES Act We are revising § 414.210 to provide increased fee schedule amounts in certain areas starting on March 6, 2020, and for the duration of the PHE for the COVID-19 pandemic. Merit-based Incentive Payment System (MIPS) Qualified Clinical Data Registry (QCDR) Measure Approval Criteria: —Completion of QCDR Measure Testing —Collection of Data on QCDR Measures For the reasons discussed in section II.R. of this IFC, we are delaying the implementation of the completion of QCDR measure testing policy by 1 year. Specifically, we are amending § 414.1400(b)(3)(v)(C) to state that beginning with the 2022 performance period, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination. This change is applicable on the effective date of this IFC. For the reasons discussed in section II.R. of this IFC, we are delaying the implementation of the collection of data on QCDR measures policy by one year. Specifically, we are amending § 414.1400(b)(3)(v)(D) to state that beginning with the 2022 performance period, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period. This change is applicable on the effective date of this IFC. Hospital VBP Program We are revising the extraordinary circumstances exception policy to allow CMS to grant an exception to hospitals located in an entire region or locale without a request and we are codifying the updated policy at § 412.165(c). This change is permanent, and is applicable beginning on the effective date of this IFC. IRF QRP We are revising the compliance date for the IRF QRP to October 1st of the year that is at least one full fiscal year after the end of the PHE. This change is applicable on the effective date of this IFC. LTCH QRP We are revising the compliance date for the LTCH QRP to October 1st of the year that is at least one full fiscal year after the end of the PHE. This change is applicable on the effective date of this IFC. HH QRP We are revising the compliance date for the HH QRP to January 1st of the year that is at least one full calendar year after the end of the PHE. This change is applicable on the effective date of this IFC. SNF QRP We are revising the compliance date for the SNF QRP to October 1st of the year that is at least two full fiscal years after the end of the PHE. This change is applicable on the effective date of this IFC. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view public comments. Table of Contents I. Background II. Provisions of the Interim Final Rule With Comment Period (IFC) A. Reporting Under the Home Health Value-Based Purchasing Model for CY 2020 During the COVID-19 Public Health Emergency B. Scope of Practice C. Modified Requirements for Ordering COVID-19 Diagnostic Laboratory Tests D. Opioid Treatment Programs (OTPs)—Furnishing Periodic Assessments via Communication Technology E. Treatment of Certain Relocating Provider-Based Departments During the COVID-19 PHE F. Furnishing Hospital Outpatient Services in Temporary Expansion Locations of a Hospital or a Community Mental Health Center (Including the Patient's Home) G. Medical Education H. Rural Health Clinics (RHCs) I. Durable Medical Equipment (DME) Interim Pricing in the CARES Act J. Care Planning for Medicare Home Health Services K. CARES Act Waiver of the “3-Hour Rule” and Modification of IRF Coverage and Classification Requirements for Freestanding IRF Hospitals for the PHE During the COVID-19 Pandemic L. Medicare Shared Savings Program M. Additional Flexibility Under the Teaching Physician Regulations N. Payment for Audio-Only Telephone Evaluation and Management Services O. Flexibility for Medicaid Laboratory Services P. Improving Care Planning for Medicaid Home Health Services Q. Basic Health Program Blueprint Revisions R. Merit-Based Incentive Payment System (MIPS) Qualified Clinical Data Registry (QCDR) Measure Approval Criteria S. Application of Certain National Coverage Determination and Local Coverage Determination Requirements During the PHE for the COVID-19 Pandemic T. Delay in the Compliance Date of Certain Reporting Requirements Adopted for IRFs, LTCHs, HHAs and SNFs U. Update to the Hospital Value-Based Purchasing (VBP) Program Extraordinary Circumstance Exception (ECE) Policy V. COVID-19 Serology Testing W. Modification to Medicare Provider Enrollment Provision Concerning Certification of Home Health Services X. Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges: Separate Billing and Segregation of Funds for Abortion Services Y. Requirement for Facilities To Report Nursing Home Residents and Staff Infections, Potential Infections, and Deaths Related to COVID-19 Z. Time Used for Level Selection for Office/Outpatient Evaluation and Management Services Furnished Via Medicare Telehealth AA. Updating the Medicare Telehealth List BB. Payment for COVID-19 Specimen Collection to Physicians, Nonphysician Practitioners and Hospitals CC. Payment for Remote Physiologic Monitoring (RPM) Services Furnished During the COVID-19 Public Health Emergency III. Waiver of Proposed Rulemaking IV. Collection of Information Requirements V. Response to Comments VI. Regulatory Impact Analysis Regulations Text CPT (Current Procedural Terminology) Copyright Notice Throughout this IFC, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2019 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. I. Background The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that was first detected in China and which has now been detected in more than 190 countries internationally, and all 50 States and the District of Columbia. The virus has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2”) and the disease it causes has been named “coronavirus disease 2019” (“COVID-19”). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of international concern”. On January 31, 2020, Health and Human Services Secretary, Alex M. Azar II, determined that a Public Health Emergency (PHE) exists for the United States to aid the nation's healthcare community in responding to COVID-19 (hereafter referred to as the PHE for the COVID-19 pandemic) and on April 21, 2020, Secretary Azar renewed, effective April 26, 2020, the determination that a PHE exists. On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. On March 13, 2020, the President of the United States declared the COVID-19 pandemic a national emergency. Coronaviruses are a large family of viruses that are common in people and many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people such as with MERS-CoV, SARS-CoV, and now with this new virus (SARS-CoV-2). The complete clinical picture with regard to COVID-19 is not fully known. Reported illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that much COVID-19 illness is mild, the Centers for Disease Control and Prevention (CDC) reports find that in the United States, between March 1 and 28, 2020, the overall laboratory-confirmed COVID-19-associated hospitalization rate was 4.6 per 100,000 population. 1 A pandemic is a global outbreak of disease. Pandemics happen when a new virus emerges to infect people and can spread sustainably, from person-to-person. The virus, SARS-CoV-2, that causes COVID-19 is infecting people and spreading easily worldwide from person-to-person because there is little to no pre-existing immunity. This is the first pandemic known to be caused by the emergence of a new coronavirus. 2 1 https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm. 2 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html. People in places where ongoing community spread of the virus that causes COVID-19 has been reported are at elevated risk of exposure, with the level of risk dependent on the location. Healthcare workers caring for patients with COVID-19 are at elevated risk of exposure. Close contacts of persons with COVID-19 also are at elevated risk of exposure. The CDC has reported that some people are at higher risk of getting very sick from this illness. 3 This includes: 3 https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e3.htm. • Older adults, with risk increasing by age. • People who have serious chronic medical conditions like: ++ Obesity ++ Cardiovascular disease ++ Diabetes mellitus ++ Hypertension ++ Chronic lung disease. The CDC has developed guidance to help in the risk assessment and management of people with potential exposures to COVID-19, including recommending that health care professionals make every effort to interview a person under investigation for infection by telephone, text monitoring system, or video conference. 4 4 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html. As the healthcare community establishes and implements recommended infection prevention and control practices, regulatory agencies under appropriate waiver authority granted by the PHE for the COVID-19 pandemic declaration are also working to revise and implement regulations that work in concert with healthcare community infection prevention and treatment practices. Based on the current and projected increase in the rate of incidence of the COVID-19 disease in the US population, and observed fatalities in the elderly population, who are particularly vulnerable due to age and co-morbidities, and additionally, the impact on health workers who are at increased risk due to treating the population, we believe that certain regulations should be reviewed and revised as appropriate to offer providers and suppliers additional flexibilities in furnishing services to combat the COVID-19 pandemic. We are addressing some of these regulations in a previous IFC which appeared in the April 6, 2020 Federal Register (85 FR 19230) with an effective date of March 31, 2020 (hereafter referred to as the “March 31st COVID-19 IFC”). In this interim final rule with comment period (IFC), we are revising additional regulations to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the programs under Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act (the Act), or in the identified programs authorized under the Affordable Care Act. In addition, we are implementing regulations in response to recent legislation including the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020), the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020), and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020). In this extraordinary circumstance, we recognize that the COVID-19 pandemic greatly increases the overall risk to public health. We believe that this increased risk results in an immediate change, not only in the circumstances under which services can safely occur, but also in to the business relationships among providers, suppliers, and practitioners. By increasing access to hospital and community mental health services furnished in temporary expansion locations of the hospital including the patient's home, increasing access to laboratory and diagnostic testing in a patient's home or other settings that could help to minimize transmission of communicable disease, and improving infection control, this IFC will provide the necessary flexibility for Medicare and Medicaid beneficiaries to be able to receive medically necessary services without jeopardizing their health or the health of those who are providing those services, while also minimizing the overall risk to public health. Notably, all final provisions included in this IFC are only for the duration of the PHE for the COVID-19 pandemic, unless otherwise indicated. We also acknowledge that the COVID-19 PHE has created a lack of predictability for many ACOs regarding the impact of expenditure and utilization changes on historical benchmarks and financial performance, created uncertainty around future program participation, and disrupted population health activities as clinicians, care coordinators, and financial and other resources are diverted to address immediate acute care needs. We are amending the Shared Savings Program regulations in order to address the impact of the COVID-19 pandemic and encourage continued participation by ACOs. In addition, this IFC also provides flexibility to states operating a BHP to seek certification for temporary significant changes to its BHP Blueprint that are directly tied to the PHE for the COVID-19 pandemic, including the ability to apply the changes retroactively to the start of the PHE. Finally, in light of these extraordinary circumstances and the immediate need for QHP issuers to divert resources to responding to the COVID-19 PHE, we are delaying by 60 days the date when individual market issuers must be in compliance with the separate billing policy. Under this 60-day delay, QHP issuers must comply with the separate billing policy beginning on or before the QHP issuer's first billing cycle following August 26, 2020. As QHP issuers and Exchanges work to respond to the COVID-19 PHE and implement and establish policies to ensure access to COVID-19-related care for enrollees, HHS is working to assess and extend regulatory flexibility to QHP issuers, Exchanges, and other health industry stakeholders where doing so may enable these stakeholders to divert existing resources to aiding the COVID-19 PHE response. We believe extending the deadline 60 days for QHP issuers and Exchanges to comply with the separate billing policy is appropriate so that they may adequately respond to and divert resources to address the COVID-19 PHE. Also, consistent with section 3708 of the CARES Act, we are expanding 42 CFR parts 409, 424.22, 424.507(b), 440.70 and part 484 to permit nurse practitioners (NPs), clinical nurse specialists (CNSs), and physician assistants (PAs) to certify the need for home health services and to order services in the Medicare and Medicaid programs. II. Provisions of the Interim Final Rule With Comment Period (IFC) In this IFC, we use the term, “Public Health Emergency (PHE),” as defined at 42 CFR 400.200. The definition identifies the PHE determined to exist nationwide by the Secretary of Health and Human Services (the Secretary) under section 319 of the Public Health Service Act on January 31, 2020, and renewed effective April 26, 2020, as a result of confirmed cases of COVID-19. A. Reporting Under the Home Health Value-Based Purchasing Model for CY 2020 During the COVID-19 PHE Through this IFC, we are implementing a policy to align the Home Health Value-Based Purchasing (HHVBP) Model data submission requirements with any exceptions or extensions granted for purposes of the Home Health Quality Reporting Program (HH QRP) during the PHE for COVID-19. We are also implementing a policy for granting exceptions to the New Measures data reporting requirements under the HHVBP Model during the PHE for COVID-19. Specifically, during the PHE for COVID-19, to the extent that the data that participating HHAs in the nine HHVBP Model states are required to report are the same data that those HHAs are also required to report for the HH QRP, HHAs are required to report those data for the HHVBP Model in the same time, form and manner that HHAs are required to report those data for the HH QRP. As such, if CMS grants an exception or extension that either excepts HHAs from reporting certain quality data altogether, or otherwise extends the deadlines by which HHAs must report those data, the same exceptions and/or extensions apply to the submission of those same data for the HHVBP Model. In addition, in this IFC, we are adopting a policy to allow exceptions or extensions to New Measure reporting for HHAs participating in the HHVBP Model during the PHE for COVID-19. As authorized by section 1115A of the Act and finalized in the CY 2016 HH PPS final rule (80 FR 68624), the HHVBP Model has an overall purpose of improving the quality and delivery of home health care services to Medicare beneficiaries. The specific goals of the Model are to: (1) Provide incentives for better quality care with greater efficiency; (2) study new potential quality and efficiency measures for appropriateness in the home health setting; and (3) enhance the current public reporting process. All Medicare certified HHAs providing services in Arizona, Florida, Iowa, Nebraska, North Carolina, Tennessee, Maryland, Massachusetts, and Washington are required to compete in the Model. The HHVBP Model uses the waiver authority under section 1115A(d)(1) of the Act to adjust Medicare payment rates under section 1895(b) of the Act based on the competing HHAs' performance on applicable measures. The maximum payment adjustment percentage increases incrementally over the course of the HHVBP Model in the following manner, upward or downward: (1) 3 percent in CY 2018; (2) 5 percent in CY 2019; (3) 6 percent in CY 2020; (4) 7 percent in CY 2021; and (5) 8 percent in CY 2022. Payment adjustments are based on each HHA's Total Performance Score (TPS) in a given performance year (PY), which is comprised of performance on: (1) A set of measures already reported via the Outcome and Assessment Information Set (OASIS), 5 completed Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) surveys, and select claims data elements; and (2) three New Measures for which points are achieved for reporting data. 5 OASIS is the instrument/data collection tool used to collect and report performance data by HHAs. The HHVBP Model utilizes some of the same quality measure data that are reported by HHAs for the HH QRP, including HHCAHPS survey data. The other HHVBP measures are calculated using OASIS data, which are still required to be reported during the PHE; however, we have given providers additional time to submit OASIS data ( https://www.cms.gov/files/document/covid-home-health-agencies.pdf ); claims-based data extracted from Medicare fee-for-service (FFS) claims; and New Measure data. To assist HHAs while they direct their resources toward caring for their patients and ensuring the health and safety of patients and staff, we are adopting a policy for the HHVBP Model to align the HHVBP data submission requirements with any exceptions or extensions granted for purposes of the HH QRP during the PHE for COVID-19. For the same reason, we are also establishing a policy for granting exceptions to New Measure reporting requirements for HHAs participating in the HHVBP Model during the PHE for COVID-19. Under this policy, to the extent CMS has granted an exception to the HH QRP (for 2019 Q4 and 2020 Qs 1-2 as noted below in this section), or may grant any future exceptions or extensions under this same program for other CY 2020 reporting periods, HHAs in the nine HHVBP Model states do not need to separately report these measures for purposes of the HHVBP Model, and those same exceptions apply to the submission of those same data for the HHVBP Model. In accordance with this policy, if CMS grants an exception or extension under the HH QRP that either excepts HHAs from reporting certain quality data altogether, or otherwise extends the deadlines by which HHAs must report those data, the same exceptions and/or extensions apply to the submission of those same data for the HHVBP Model. In response to the PHE for COVID-19, on March 27, 2020, we issued supplemental public guidance ( https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf ) excepting HHAs from the requirement to report any HH QRP data for the following quarters: • October 1, 2019-December 31, 2019 (Q4 2019). • January 1, 2020-March 31, 2020 (Q1 2020). • April 1, 2020-June 30, 2020 (Q2 2020). Under our policy to align HHVBP data submission requirements with any exceptions or extensions granted for purposes of the HH QRP during the PHE for COVID-19, HHAs in the nine HHVBP Model states are not required to separately report measure data for these quarters for purposes of the HHVBP Model. We note that with regard to the exception from the requirement to report Q4 2019 HH QRP data, we do not anticipate any issues in calculating the TPSs based on CY 2019 data under the HHVBP Model because HHAs had the opportunity to submit these Q4 2019 data on a rolling basis. In addition, to ensure that HHAs are able to focus on patient care in lieu of data submission during the PHE for COVID-19, in this IFC, we are establishing a policy to allow us to grant exceptions to New Measure reporting for HHAs participating in the HHVBP Model during the PHE for COVID-19. We are codifying these changes at § 484.315(b). In accordance with this policy, we are granting an exception to all HHAs participating in the HHVBP Model for the following New Measure reporting requirements : • April 2020 New Measures submission period (data collection period October 1, 2019-March 31, 2020). • July 2020 New Measures submission period (data collection period April 1, 2020-June 30, 2020). We note that although the data collection period for the April 2020 New Measures submission period began in 2019, the data collected during this period are used for the calculation of the TPSs for CY 2020 performance, not CY 2019 data. We further note that HHAs may optionally submit part or all of these data by the applicable submission deadlines. If we make the determination to grant an exception to New Measure data reporting for periods beyond the April and July 2020 submission periods, for example if the PHE for COVID-19 extends beyond the New Measure submission periods we have listed in this IFC, we will communicate this decision through routine communication channels to the HHAs participating in the HHVBP Model, including but not limited to issuing memos, emails and posting on the HHVBP Connect website ( https://app.innovation.cms.gov/HHVBPConnect ). We acknowledge that the exceptions to the HH QRP reporting requirements, as well as the modified submission deadlines for OASIS data and our exceptions for the New Measures reporting requirements, may impact the calculation of performance under the HHVBP Model for the performance year (PY) 2020. We also note that while we are able to extract the claims-based data from submitted Medicare FFS claims, we may need to assess the appropriateness of using the claims data submitted for the period of the PHE for COVID-19 for purposes of performance calculations under the HHVBP Model. We are evaluating possible changes to our payment methodologies for CY 2022 in light of this more limited data, such as whether we would be able to calculate payment adjustments for participating HHAs for CY 2022, including those that continue to report data during CY 2020, if the overall data is not sufficient, as well as whether we may consider a different weighting methodology given that we may have sufficient data for some measures and not others. We are also evaluating possible changes to our public reporting of CY 2020 performance year data. We intend to address any such changes to our payment methodologies for CY 2022 or public reporting of data in future rulemaking. B. Scope of Practice In December 2019, CMS issued a request for feedback in response to part of the President's Executive Order (E.O.) 13890 on “Protecting and Improving Medicare for Our Nation's Seniors,” seeking the public's help in identifying additional Medicare regulations which contain more restrictive supervision requirements than existing state scope of practice laws, or which limit health professionals from practicing at the top of their license (for a link to this request for feedback see https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf ). In response to this request, we received several recommendations from nonphysician practitioners (NPPs) that inform CMS policymaking to ensure an adequate number of clinicians are able to furnish critical services and tests during the COVID-19 PHE. According to the American Association of Nurse Practitioners, currently, twenty-two states and DC are considered Full Practice Authority (FPA) states because their licensure laws allow full and direct patient access to NPs. We are finalizing provisions that address several of those recommendations in this section of the IFC, on an interim basis for the duration of the PHE. We note that the responses to our request for information on these topics did not indicate the number of states having more flexible scope of practice rules than our federal regulations. In this rule, we are also seeking public feedback indicating the number of states to help us understand the scope of impact of these changes. 1. Supervision of Diagnostic Tests by Certain Nonphysician Practitioners Rapid expansion of COVID-19-related diagnostic testing capacity (such as lab tests and respiratory imaging) is a top priority in the strategy to combat the pandemic. In response to the request for feedback discussed above, PAs and NPs recommended regulatory changes that would allow them to supervise diagnostic tests because they stated that they are currently authorized to do so under their State scope of practice rules. We also received feedback from radiologists who did not support making any changes to our regulations that would result in any inappropriate expansion of the role of NPPs. Currently, under 42 CFR 410.32(a)(3) of our regulations, physicians and NPPs who are treating a beneficiary for a specific medical problem may order diagnostic tests when they use the results of the tests in the management of the beneficiary's specific medical problem. Specifically, NPPs who furnish services that would be physicians' services if furnished by a physician (that is, NPs, PAs, CNSs, clinical psychologists (CPs), clinical social workers (CSWs), and certified nurse-midwives (CNMs)), and who are operating within the scope of their authority under State law and within the scope of their Medicare statutory benefit may order diagnostic tests when they use the results of the tests in the management of the beneficiary's specific medical problem. However, under our current regulation at § 410.32(b), only physicians are generally permitted to supervise diagnostic tests. The regulation at § 410.32(b)(1) provides as a basic rule that all diagnostic tests paid under the Physician Fee Schedule (PFS) must be furnished under an appropriate specified minimum level of supervision by a physician as defined in section 1861(r) of the Act. Section 410.32(b)(2) then provides for certain exceptions to which the general basic rule does not apply. For instance, under § 410.32(b)(2)(v), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician does not apply for tests performed by an NP or CNS authorized under applicable state law to furnish the test. (We note that, as for all services they furnish, the NP or CNS necessarily would be working in collaboration with a physician under §§ 410.75 and 410.76, respectively). Similarly, at § 410.32(b)(2)(vii), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician does not apply for tests performed by a CNM authorized under applicable state law to furnish the test. There are not currently any exceptions under § 410.32(b)(2) for services furnished by PAs. As such, any diagnostic tests furnished by PAs would need to be under the appropriate level of supervision by a physician in accordance with § 410.32(b)(1). We note further that our regulation at § 410.32(b)(3) specifies that only a general level of physician supervision is required for diagnostic tests performed by a PA that the PA is legally authorized to perform under state law. Of course, all services furnished by PAs must meet the physician supervision requirements under § 410.74, which generally defers to state law requirements that address the requisite practice relationship between PAs and physicians, or requires certain documentation of the working relationship between the PA and physicians to supervise PA services if the issue is not addressed in state law. Thus, while NPs, CNSs, PAs, and CNMs are permitted to furnish diagnostic tests to the extent they are otherwise authorized under state law to do so, the regulations at § 410.32 does not address whether NPs, CNSs, PAs and CNMs may supervise others when furnishing diagnostic tests. In light of the need to reinforce and increase COVID-19-related diagnostic testing capacity throughout the duration of the PHE, and to increase the flexibility and availability of health care professionals to provide needed care, we are finalizing on an interim basis changes to our regulation at § 410.32(b) to add flexibility for NPs, CNSs, PAs, and CNMs, which are types of practitioners that have separately enumerated benefit categories under Medicare law that permit them to furnish services that would be physicians' services if furnished by a physician and be paid under Medicare Part B for the professional services they furnish directly and “incident to” their own professional services, to the extent authorized under their State scope of practice. The interim changes will ensure that these practitioners may order, furnish directly, and supervise the performance of diagnostic tests, subject to applicable state law, during the PHE. As we observe how rapidly the COVID-19 virus is transmitted in the population, we believe this policy will help to ensure that an adequate number of health care professionals are available to support critical COVID-19-related and other diagnostic testing needs, and provide needed medical care. This policy will support the rapid expansion of COVID-19-related diagnostic testing capacity to quickly identify affected individuals and protect against transmission of the virus to vulnerable populations, and help to address potential clinical workforce shortages that may impact access to services and other diagnostic tests that still need to be furnished during the PHE. Specifically, we are amending the regulation at § 410.32(b)(1) to specify in the basic rule that diagnostic tests covered under section 1861(s)(3) of the Act and payable under the PFS must be furnished under the appropriate level of supervision by a physician as defined under section 1861(r) of the Act or, during the PHE, by a NP, CNS, PA, and CNM, as described above. Additionally, we are amending the regulation at § 410.32(b)(2)(iii)(B) which addresses supervision of COVID-19-related diagnostic psychological and neuropsychological testing services to allow these services to be supervised by a NP, CNS, PA and CNM as described above, during the PHE, in addition to physicians and CPs who are currently authorized to supervise these tests. We are also amending the regulation at § 410.32 by adding a new paragraph (b)(2)(viii) to allow diagnostic tests to be performed by a PA without physician supervision (although as noted above, the regulation at § 410.74 continues to apply) when authorized to perform the tests under applicable state law. Furthermore, we are amending the regulation at § 410.32(b)(3) regarding the levels of supervision, to also authorize NPs, CNSs, PAs, and CNMs, as described above, during the PHE to provide the appropriate level of supervision assigned to diagnostic tests. Since we are adding PAs under § 410.32(b)(2)(viii) to the list of exceptions to the general basic rule for supervision during the PHE, and given that the physician supervision requirement in the regulation at § 410.74 continues to apply, we are removing the parenthetical regarding general physician supervision for diagnostic tests furnished by PAs from § 410.32(b)(3). We are also correcting the typographical error under § 410.32(d)(2)(i) regarding documentation and recordkeeping requirements to state that when ordering diagnostic tests, the physician (or qualified NPP, as defined in paragraph (a)(2) of this section), who orders the service must maintain documentation of medical necessity in the beneficiary's medical record. 2. Therapy—Therapy Assistants Furnishing Maintenance Therapy (PFS) We currently make payment under Medicare Part B for outpatient occupational and physical therapy (§§ 410.59(a) and 410.60(a), respectively) when they are furnished by an individual meeting qualifications in part 484 for an occupational therapist (OT) or physical therapist (PT), or an appropriately supervised occupational therapy assistant (OTA) or physical therapy assistant (PTA). This includes our policy for rehabilitative services for which improvement of the beneficiary's functional status is expected. However, in cases where it is medically necessary to maintain, prevent or slow the deterioration of a patient's condition, a separate policy requires the skills of a physical or OT, not a PTA or OTA, to carry out a therapist-established maintenance program, which is generally known as “maintenance therapy.” For services furnished by PTAs and OTAs, claims from therapists and providers are required to use the “CO” and “CQ” modifiers for their respective OTA and PTA therapy services, to indicate that a supervised therapy assistant performed the rehabilitative or maintenance therapy services. In response to the request for feedback discussed above, therapists and therapy providers pointed out that our Part B policy specifying that maintenance therapy requires the skills of a therapist is not consistent with the policy for services furnished in SNF and Home Health Part A settings where PTAs and OTAs are permitted to furnish these services. They recommended that we revise our policy to permit the treating therapist who established or is responsible for the maintenance program plan to determine when it is clinically appropriate to delegate the performance of maintenance therapy services to PTAs and OTAs, as they are charged with overseeing a patient's course of treatment and assigning responsibilities to assistants. They suggested that permitting PTAs and OTAs to furnish maintenance therapy services would give Medicare patients greater access to care and permit therapists and therapy providers more flexibility for resource utilization. To increase availability of needed health care services during the COVID-19 PHE, we believe it is appropriate to synchronize our Part B payment policies as suggested by the stakeholders, and to permit the PT or OT who established the maintenance program to delegate the performance of maintenance therapy services to a PTA or OTA when clinically appropriate. We believe that, by allowing PTAs and OTAs to perform maintenance therapy services, PTs and OTs will be freed up to furnish other services, including such services as non-medication pain management therapies that may reduce reliance on opioids or other medications, as well as those services related to the COVID-19 PHE that require a therapist's assessment and evaluation skills, including communication technology-based services (CTBS) that were made available for PTs, OTs and speech-language pathologists (SLPs) during the PHE in the March 31st COVID-19 IFC (85 FR 19245 and 19265 through 19266). 3. Therapy—Student Documentation (PFS) In the CY 2020 PFS final rule, 6 we simplified medical record documentation requirements and finalized a general principle to allow the physician, PA, or the advanced practice registered nurses (APRNs), specifically, NPs, CNSs, CNMs, and certified registered nurse anesthetist (CRNAs) who furnish and bill for their professional services to review and verify, rather than re-document, information included in the medical record by physicians, residents, nurses, students or other members of the medical team. We explained that this principle would apply across the spectrum of all Medicare-covered services paid under the PFS. We noted that the policy was intended to apply broadly, and accordingly amended regulations for teaching physicians, other physicians, PAs, and APRNs to expressly provide for this flexibility for medical record documentation requirements for professional services furnished by physicians, PAs and APRNs in all settings. 6 Medicare Program; CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule (84 FR 62568-63563). To increase the availability of clinicians who may furnish healthcare services during the PHE, we are announcing a general policy that there is broad flexibility for all members of the medical team to add documentation in the medical record which is then reviewed and verified (signed) by the appropriate clinician. Specifically, on an interim basis during the PHE for the COVID-19 pandemic, any individual who has a separately enumerated benefit under Medicare law that authorizes them to furnish and bill for their professional services, whether or not they are acting in a teaching role, may review and verify (sign and date), rather than re-document, notes in the medical record made by physicians, residents, nurses, and students (including students in therapy or other clinical disciplines), or other members of the medical team. We note that although there are currently no statutory or regulatory documentation requirements that would impact payment for therapists when documentation is added to the medical record by persons other than the therapist, we are discussing this issue in response to stakeholder concerns about burden and in consideration of the current COVID-19 PHE. Specifically, this policy will ensure that therapists, as members of the clinical workforce, are able to spend more time furnishing therapy services, including pain management therapies to patients that may minimize the use of opioids and other medications, rather than spending time documenting in the medical record. We emphasize that our established principle is focused on the clinician, as described above who furnishes and bills for their professional services rather than the individuals who may enter information into the medical record. We want to emphasize that information entered into the medical record should document that the furnished services are reasonable and necessary. 4. Pharmacists Providing Services Incident to a Physicians' Service In response to the request for feedback discussed above, numerous stakeholders asked us to clarify that pharmacists are permitted to provide services to Medicare beneficiaries incident to the professional services of a physician, like other clinical staff or certain other clinicians. These stakeholders have asked us, in particular, about pharmacists who provide medication management services. Medication management is covered under both Medicare Part B and Part D. We are clarifying explicitly that pharmacists fall within the regulatory definition of auxiliary personnel under our regulations at § 410.26. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist's state scope of practice and applicable state law. This clarification does not alter current payment policy for pharmacist services furnished incident to the professional services of a physician or NPP. Although fully consistent with current CMS policy, we believe this clarification may encourage pharmacists to work with physicians and NPPs in new ways that expand the availability of health care services during the COVID-19 PHE, and increase access to medication management of individuals with substance/opioid use disorder. We emphasize that consistent with the Controlled Substances Act (Pub. L. 91-513, enacted October 27, 1970), methadone should continue to be dispensed from certified and accredited Opioid Treatment Programs (OTPs) under the supervision of clinicians who have received appropriate training and fully understand the risks of that medication as is required by statute. C. Modified Requirements for Ordering COVID-19 Diagnostic Laboratory Tests The rapid expansion of COVID-19 diagnostic laboratory testing capacity is a top priority in our strategy to combat the pandemic. To that end, several large clinical diagnostic laboratory and pharmacy businesses are operating community testing sites across the country in cooperation with state and federal authorities. 7 In combination with the availability of point of care tests that provide rapid results, these sites are a key component in the expansion of COVID-19 testing capacity. 7 Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP Act, HHS, April 8, 2020, https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf. Under Medicare Part B, clinical diagnostic laboratory tests, including COVID-19 diagnostic tests, are paid for under the Clinical Laboratory Fee Schedule (CLFS), without any beneficiary cost-sharing requirements (coinsurance or Part B deductible). See generally sections 1861(s)(3), 1833(a)(1)(D)(i)(II), (b)(3)(A), (h)(5)(C) and (D), and 1834A of the Act, and 42 CFR part 414, subpart G. Under our current regulation at § 410.32(a), diagnostic laboratory tests such as the COVID-19 tests are covered only when they are ordered by a physician or other practitioner who is treating the beneficiary, and who uses the results of the test in managing the patient's specific medical condition. If a patient arrives at a community testing site without an order for the test from his or her physician or practitioner, Medicare would not currently cover the test. We have taken substantial steps to broaden access to safely-delivered care via telehealth and other communication technology-based services during the COVID-19 PHE in an attempt to ensure that a COVID-19 test could be ordered by a physician or other practitioner treating the beneficiary. Notwithstanding these flexibilities, not all beneficiaries have access to a doctor to obtain a COVID-19 diagnostic laboratory test. The most recently available results from the Medicare Current Beneficiary Survey indicated that only 70 percent of Medicare beneficiaries view a doctor's office as their source of care. In the same survey, 23 percent of beneficiaries indicated that a medical clinic, urgent care center, or hospital outpatient department (HOPD) was their source of care. HOPDs and urgent care clinics may not be able to furnish community patient visits because they are treating an excess number of patients already testing positive for the virus. The survey also indicated that 7 percent of beneficiaries reported no source of care. 8 We anticipate needing to test many Medicare beneficiaries quickly as part of the rapid expansion of COVID-19 testing capacity to combat the pandemic. Therefore, the need for a patient to first have a visit with a physician or practitioner to obtain an order for COVID-19 testing to meet Medicare ordering requirements could still present a significant barrier to patients who might otherwise seek a test. 8 Centers for Medicare & Medicaid Services. Medicare Current Beneficiary Survey Chart Book 2016. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/MCBS/Data-Tables-Items/2016Chartbook. Prior to the Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP Act, which HHS issued on April 8, 2020 (April Guidance), 9 state governments had sought to increase access to testing by removing prior authorization of COVID-19 tests in the commercial health insurance market. 10 States and State Boards of Pharmacy had also sought to increase physician capacity by permitting pharmacists to test for and treat influenza and streptococcus infections under protocols. 11 State Boards of Pharmacy have in turn sought to increase pharmacist capacity by relaxing pharmacist to pharmacy technician supervision ratios. 12 With growing supplies of tests and in light of the April Guidance we anticipate that States will look increasingly to pharmacists and other qualified healthcare professionals to order and furnish COVID-19 tests. 9 HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests, HHS, April 8, 2020, https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html. 10 Karen Pollitz, “Private Health Coverage of COVID-19: Key Facts and Issues,” Kaiser Family Foundation, March 18, 2020, https://www.kff.org/private-insurance/issue-brief/private-health-coverage-of-covid-19-key-facts-and-issues/. 11 National Alliance of State Pharmacy Associations (NASPA), Pharmacist Prescribing: “Test and Treat,” February 8, 2019, available at https://naspa.us/resource/pharmacist-prescribing-for-strep-and-flu-test-and-treat/ 12 NASPA. “COVID-19: Information from the States,” April 14, 2020, available at https://naspa.us/resource/covid-19-information-from-the-states/. Information provided by the CDC shows that the likelihood of severe outcomes of COVID-19 illness is highest in adults aged 65 and older and people with underlying health conditions, which suggests that the Medicare beneficiary population is at particularly high risk from the disease. 13 Additionally, as noted by the CDC in guidance on how to protect against COVID-19 infection, some studies have suggested that COVID-19 may be spread by people who are not showing symptoms. 14 We believe it is vital for Medicare beneficiaries to have broad access to COVID-19 testing so that they can properly monitor their symptoms, make prompt decisions about seeking further care, and take appropriate precautions to prevent further spread of the disease. 13 Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019—United States, February 12-March 28, 2020. MMWR Morb Mortal Wkly Rep 2020;69:382-386. DOI: http://dx.doi.org/10.15585/mmwr.mm6913e2. 14 Coronavirus Disease 2019 (COVID-19): How to Protect Yourself & Others, CDC, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Given the critical importance of expanding COVID-19 testing to combat the pandemic and the heightened risk that the disease presents to Medicare beneficiaries, we are amending our regulation at § 410.32(a) to remove the requirement that certain diagnostic tests are covered only based on the order of a treating physician or NPP. Under this interim policy, during the COVID-19 PHE, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law. Additionally, because the symptoms for influenza and COVID-19 might present in the same way, during the COVID-19 PHE, we are also removing the same ordering requirements for a diagnostic laboratory test for influenza virus and respiratory syncytial virus, a type of common respiratory virus. CMS will make a list of diagnostic laboratory tests for which we are removing the ordering requirements publicly available. We are removing the treating physician or NPP ordering requirement for these additional diagnostic laboratory tests only when they are furnished in conjunction with a COVID-19 diagnostic laboratory test as medically necessary in the course of establishing or ruling out a COVID-19 diagnosis or of identifying patients with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. We would not expect there to be any medical necessary reason to use the specimen for unrelated or repeat testing. When COVID-19 diagnostic laboratory testing becomes sufficiently prevalent, sensitive, and specific such that laboratory tests for influenza or related respiratory conditions are no longer needed to establish a definitive COVID-19 diagnosis, we expect that additional testing for influenza or related respiratory viral illness would no longer be medically necessary. We are also making conforming amendments to our regulations at § 410.32(d)(2) and (3) to remove certain documentation and recordkeeping requirements associated with orders for COVID-19 tests during the COVID-19 PHE, as these requirements would not be relevant in the absence of a treating physician's or NPP's order. While no order is required under Medicare, we do expect the entity submitting the claim to include the ordering or referring NPI information on the claim form when an order is written for the test, consistent with current billing instructions. When COVID-19 tests are furnished without a physician's or NPP's order as set forth in this regulation during the COVID-19 PHE, the laboratory conducting the tests is required to directly notify the patient of the results consistent with other applicable laws, as well as meet other applicable test result reporting requirements. Comprehensive and timely reporting of all testing results to local officials is critical to public health management of the pandemic, and we would expect any clinician or laboratory receiving results to report those results promptly, consistent with state and local public health requirements, typically within 24 hours. D. Opioid Treatment Programs (OTPs)—Furnishing Periodic Assessments via Communication Technology In the CY 2020 PFS final rule (84 FR 62634), we finalized an add-on code describing periodic assessments furnished by OTPs. The finalized add-on code is Healthcare Common Procedure Coding System (HCPCS) code G2077 ( Periodic assessment; assessing periodically by qualified personnel to determine the most appropriate combination of services and treatment ). The medical services described by this add-on code can be furnished by a program physician, a primary care physician or an authorized healthcare professional under the supervision of a program physician or qualified personnel such as NPs and PAs. The other assessments, including psychosocial assessments can be furnished by practitioners who are eligible to do so under their state law and scope of licensure. We note that to bill for the add-on code, the services need to be medically reasonable and necessary and that OTPs should document the rationale for billing the add-on code in the patient's medical record (84 FR 62647). In light of the PHE for the COVID-19 pandemic, during which the public has been instructed to practice self-isolation or social distancing, in the March 31st COVID-19 IFC, we revised § 410.67(b)(3) and (4) to allow the therapy and counseling portions of the weekly bundles of services furnished by OTPs, as well as the add-on code for additional counseling or therapy, to be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology during the PHE for the COVID-19 pandemic if beneficiaries do not have access to two-way audio/video communications technology, provided all other applicable requirements are met (85 FR 19258). In addition to the flexibilities described above, we have determined that it is also necessary to revise § 410.67(b)(7) on an interim final basis to allow periodic assessments to be furnished during the PHE for the COVID-19 pandemic via two-way interactive audio-video communication technology. In addition, in cases where beneficiaries do not have access to two-way audio-video communications technology, the periodic assessments may be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology, provided all other applicable requirements are met. We believe this change is necessary to ensure that beneficiaries with opioid use disorders are able to continue to receive these important services during the PHE for the COVID-19 pandemic. While we will allow this flexibility during the PHE for the COVID-19 pandemic, we expect that OTPs will use clinical judgment to determine whether they can adequately perform the periodic assessment over audio-only phone calls, and if not, then they should perform the assessment using two-way interactive audio-video communication technology or in person as clinically appropriate. Regardless of the format that is used, the OTP should document in the medical record the reason for the assessment and the substance of the assessment. Additionally, we note that SAMHSA has offered flexibilities to states to ensure that individuals being treated with medication for opioid use disorders can continue to receive their medication during the PHE for the COVID-19 pandemic. SAMHSA provides specific guidance for OTPs on its website at SAMHSA.gov/coronavirus. The following is a list of resources posted on the SAMHSA website as of the time of publication of this rule: • Opioid Treatment Program (OTP) Guidance (March 16, 2020) available at https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf. • OTP Guidance for Patients Quarantined at Home with the Coronavirus available at https://www.samhsa.gov/sites/default/files/otp-covid-implementation-guidance.pdf. • FAQs: Provision of Methadone and Buprenorphine for the Treatment of Opioid Use Disorder in the COVID-19 Emergency available at https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf. • COVID-19 Public Health Emergency Response and 42 CFR part 2 Guidance available at https://www.samhsa.gov/sites/default/files/covid-19-42-cfr-part-2-guidance-03192020.pdf. • Considerations for the Care and Treatment of Mental and Substance Use Disorders in the COVID-19 Epidemic: March 20, 2020 available at https://www.samhsa.gov/sites/default/files/considerations-care-treatment-mental-substance-use-disorders-covid19.pdf. E. Treatment of Certain Relocating Provider-Based Departments During the COVID-19 PHE 1. Background In 2015, the Congress addressed payments for services furnished by certain off-campus provider-based departments (PBDs) through section 603 of the Bipartisan Budget Act of 2015 (BBA 2015) (Pub. L. 114-74, enacted November 2, 2015). In the CY 2017 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System (ASC) proposed rule, we discussed the provisions of section 603 of the BBA 2015, which amended section 1833(t) of the Act (81 FR 45681). For the full discussion of our initial implementation of this provision, we refer readers to the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through 79719) and interim final rule with comment period (81 FR 79720 through 79729). Section 603 of the BBA 2015 amended section 1833(t) of the Act by amending paragraph (1)(B) and adding a new paragraph (21). As a general matter, under sections 1833(t)(1)(B)(v) and (t)(21) of the Act, applicable items and services furnished by certain off-campus outpatient departments (OPD) of a provider on or after January 1, 2017 are not considered covered OPD services as defined under section 1833(t)(1)(B) of the Act for purposes of payment under the OPPS and are instead paid “under the applicable payment system” under Medicare Part B if the requirements for payment are otherwise met. In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through 79719) and the interim final rule with comment period (81 FR 79720 through 79729), we established a number of policies to implement section 603 of the BBA 2015. Broadly, we finalized policies that define whether certain items and services furnished by a given off-campus PBD may be considered excepted, and thus, continue to be paid under the OPPS; established the requirements for the off-campus PBDs to maintain excepted status (both for the excepted off-campus PBDs and for the items and services furnished by excepted off-campus PBDs); and described the applicable payment system for non-excepted items and services (generally, the PFS). We created the “PO” modifier in the CY 2015 Outpatient Prospective Payment System Final Rule (79 FR 66910-66914), which is reported with every HCPCS code for all outpatient hospital items and services furnished in an excepted off-campus PBD of a hospital. In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699 through 79719) and the interim final rule with comment period (81 FR 79720 through 79729), we created the “PN” modifier to collect data for purposes of implementing section 603 of the BBA 2015 and also to trigger payment under the newly adopted PFS-equivalent rates (50 percent of the OPPS for CY 2017) for non-excepted items and services. In the CY 2018 PFS final rule (82 FR 53023 through 53030), the PFS Relativity Adjuster was revised to be 40 percent of the OPPS rate beginning in CY 2018. 2. Definition of Off-Campus Outpatient Department (OPD) Under section 603 of the BBA 2015, certain “off-campus departments of a provider” are considered “non-excepted” and paid under the “applicable payment system” instead of the OPPS. In defining the term “off-campus outpatient department of a provider,” section 1833(t)(21)(B)(i) of the Act specifies that the term means a department of a provider (as defined at 42 CFR 413.65(a)(2) as that regulation was in effect on November 2, 2015, the date of enactment of the BBA 2015) that is not located on the campus (as defined in § 413.65(a)(2)), of the provider or within the distance (described in the definition of campus) from a remote location of a hospital facility (as defined in § 413.65(a)(2)). The definition of “campus” in § 413.65(a)(2) includes the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office (RO), to be part of the provider's campus. We note that on March 30, 2020, the Secretary issued several waivers 15 under section 1135(b) of the Act in response to the PHE for the COVID-19 pandemic, including a waiver of Medicare's provider-based rules in § 413.65. Importantly, the waiver does not determine whether a PBD is excepted or non-excepted for purposes of section 603 of the BBA 2015, and the definitions in § 413.65 that section 603 cross-references, including the definition of campus at § 413.65(a)(2), remain relevant to that determination. 15 https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf. We note that the definition of “applicable items and services” specifically excludes items and services furnished by a dedicated emergency department as defined at 42 CFR 489.24(b). Section 1833(t)(21)(B)(ii) of the Act also excepts from the definition of “off-campus outpatient department of a provider,” for purposes of paragraphs (1)(B)(v) and (21)(B) of the section, an off-campus PBD that was billing under section 1833(t) of the Act with respect to covered OPD services furnished prior to November 2, 2015, the date of enactment of the BBA 2015. As a result, the definition of “off-campus outpatient department of a provider” does not include: • Off-campus PBDs that were billing under the OPPS for covered OPD services furnished prior to November 2, 2015; • PBDs located on the campus of a hospital; • Those PBDs within the distance (described in the definition of campus at § 413.65(a)(2), as of November 2, 2015) of a remote location of a hospital facility; or • Those PBDs determined by the CMS Regional Office to be part of the provider's campus. The items and services furnished by these excepted off-campus PBDs on or after January 1, 2017 continue to be paid under the OPPS. 3. Extraordinary Circumstances Policy In implementing section 603 of the BBA 2015, we recognized the need to determine the status of PBDs that had been excepted but subsequently relocated. In 42 CFR 419.48(a)(2), we established a policy that excepted off-campus PBDs that have not impermissibly relocated can remain excepted. Generally speaking, this means that excepted PBDs that relocate will typically lose their excepted status and be paid under the applicable payment system (generally the PFS) instead. In the CY 2017 OPPS/ASC final rule (81 FR 79705), we also explained that on-campus PBDs, which are considered excepted due to their on-campus status, that relocate off-campus would be considered non-excepted following their relocation. In other words, excepted on-campus and off-campus PBDs that relocate to an off-campus location are then typically paid the PFS-equivalent rate for items and services. In the CY 2017 OPPS/ASC proposed rule (81 FR 45684), we sought comment on potential extraordinary circumstances outside of a hospital's control that may lead a hospital to relocate an off-campus PBD. In the CY 2017 OPPS/ASC final rule (81 FR 79704 through 79706), we finalized a policy to allow excepted off-campus PBDs to relocate, temporarily or permanently, without loss of excepted status, for extraordinary circumstances outside of the hospital's control, such as natural disasters, significant seismic building code requirements, or significant public health and public safety issues. We also finalized that CMS Regional Offices would evaluate and approve or deny these relocation requests. In 2017, we provided additional subregulatory guidance on the process to request an extraordinary circumstances relocation exception, including the requested minimum information hospitals should submit to support such a request. 16 16 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf. 4. Extraordinary Circumstances for Relocating PBDs During the PHE for the COVID-19 Pandemic We continue to believe that our current extraordinary circumstances policy is appropriate under normal circumstances. However, we wish to give hospitals that provide services to Medicare beneficiaries the flexibility to respond effectively to the serious public health threats posed by the COVID-19 PHE. We are aware that many hospitals are repurposing existing clinical and non-clinical space for use as temporary expansion sites to furnish inpatient and outpatient care during the PHE for the COVID-19 pandemic. In addition, we recognize that many hospitals are financially constrained due to the reduction in volume caused by the PHE for the COVID-19 pandemic. 17 We believe these constraints may have led, in certain cases, to hospitals furloughing or otherwise laying off clinical staff. Congress recognized these financial constraints in the passage of the CARES Act and the $100 billion appropriation 18 for Medicare and Medicaid providers and suppliers for, among other things, health care-related expenses or lost revenues that are attributable to coronavirus. Nonetheless, we remain concerned that if an excepted PBD that was previously paid the OPPS rate relocates off-campus due to the COVID-19 PHE, some hospitals would have difficulty sustaining operations for necessary services during the COVID-19 PHE at the PBD if they were paid a reduced rate for services that would have otherwise been paid the OPPS rate but for the fact that the COVID-19 PHE necessitated the temporary relocation of the excepted off-campus or on-campus department. Recognizing the urgency of this situation and understanding that hospitals may need additional flexibilities and financial stability to quickly expand capacity to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are adopting a temporary relocation exception policy specific to the PHE for the COVID-19 pandemic so that hospitals can maintain treatment capacity and deliver needed care for patients. 17 For example, analysis of Medicare claims in the Integrated Data Repository paid through mid-April 2020 for hospital inpatient services furnished in the final week of March 2020 shows significant decreases (more than 50%), relative to claims paid through mid-April 2019 for hospital services furnished in the final week of March 2019, for certain high-volume elective procedures, like total knee arthroplasty and total hip arthroplasty. We note that any analysis of 2020 claims data is preliminary since providers have up to a year after a service is rendered to submit a claim. 18 This appropriation is included in Title VIII of the CARES Act as part of the Public Health and Social Services Emergency Fund. For purposes of enabling greater hospital flexibility, and, in particular, enabling hospitals to rapidly develop temporary expansion sites for patient care, we are temporarily adopting an expanded version of the extraordinary circumstances relocation policy during the COVID-19 PHE to include on-campus PBDs that relocate off-campus during the COVID-19 PHE for the purposes of addressing the COVID-19 pandemic. Our policy has historically applied only to excepted off-campus departments that relocate to a different off-campus location for extraordinary circumstances outside of the hospital's control, that submit an extraordinary relocation exception request to their CMS Regional Office, and for which the CMS Regional Office evaluates and approves the request. However, on-campus departments that relocate on or after March 1, 2020 through the remainder of the PHE for the purposes of addressing the COVID-19 pandemic may also seek an extraordinary circumstances relocation exception so that they may bill at the OPPS rate, as long as their relocation is not inconsistent with the state's emergency preparedness or pandemic plan. We believe it is important for hospitals to align their PBD relocations with the state's emergency preparedness or pandemic plans to ensure continuity with state efforts, as well as efforts by other health care providers in their community, to mitigate the effects of the PHE for the COVID-19 pandemic. We note that this temporary extraordinary circumstances policy is time-limited to the PHE for COVID-19 to enable short-term hospital relocation of excepted off-campus and on-campus departments to improve access to care for patients during this time. The temporary extraordinary circumstances relocation policy established here will end following the end of the PHE for the COVID-19 pandemic, and we anticipate that most, if not all, PBDs that relocate during the COVID-19 PHE will relocate back to their original location prior to, or soon after, the COVID-19 PHE concludes. Hospitals that choose to permanently relocate these PBDs off-campus would be considered new off-campus PBDs billing after November 2, 2015, and therefore, would be required to bill using the PN modifier for hospital outpatient services furnished from that PBD location and would be paid the PFS-equivalent rate following the end of the COVID-19 PHE. Following the COVID-19 PHE, hospitals may seek an extraordinary circumstances relocation exception for excepted off-campus locations that have permanently relocated, but these hospitals would need to follow the standard extraordinary circumstances application process we adopted in CY 2017 19 and file an updated CMS-855A enrollment form to reflect the new address(es) of the PBD(s). We note that our standard relocation exception policy only applies to excepted off-campus PBDs that relocate; on-campus PBDs that wish to permanently relocate off-campus will not be able to receive an extraordinary circumstances relocation exception under the standard extraordinary circumstances relocation request process after the conclusion of the COVID-19 PHE. We also note that hospitals should not rely on having relocated the off-campus PBD during the COVID-19 PHE as the reason the off-campus PBD should be permanently excepted following the end of the COVID-19 PHE. In other words, the fact that the off-campus PBD relocated in response to the pandemic will not, by itself, be considered an “extraordinary circumstance” for purposes of a permanent relocation exception, although CMS Regional Offices will continue to have discretion to approve or deny relocation requests for hospitals that apply after the COVID-19 PHE, depending on if the relocation request meets the requirements for the normal extraordinary circumstances exception. Following the COVID-19 PHE, if temporarily relocated off-campus PBDs do not go back to their original location, they will be considered to be non-excepted PBDs and paid the PFS-equivalent rate. 19 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf. 5. New Exception Process for Extraordinary Circumstances Relocation of Existing On-Campus and Excepted Off-Campus PBDs We are also taking steps to streamline the process for the extraordinary circumstances relocation exceptions for purposes of addressing the COVID-19 pandemic during the PHE. Specifically, using the process outlined below, both excepted off-campus and on-campus PBDs may relocate to off-campus locations during the COVID-19 PHE and begin furnishing and billing for services under the OPPS in the new location prior to submitting documentation to the RO to support the extraordinary circumstances relocation request. Importantly, if the relocation is denied by the RO under the extraordinary circumstances policy, and the hospital did not bill for them using the “PN” modifier, any claims billed under the OPPS in the new location would need to be reprocessed as having been billed by a non-excepted PBD and will instead be paid the PFS-equivalent rate. Non-excepted off-campus departments will continue to be non-excepted during the COVID-19 PHE, even if they relocate, and thus, will continue to be paid the PFS-equivalent rate. They do not need to follow the process outlined below for relocation approval since they are already, and will continue to be, non-excepted. • Hospitals with on-campus and excepted off-campus PBDs that relocate due to the COVID-19 PHE in a manner that is not inconsistent with their state's emergency preparedness or pandemic plan should append modifier “PO” to OPPS claims for services furnished at the relocated PBDs. This modifier indicates a service that is provided at an excepted off-campus PBD and is paid the OPPS payment rate. • In place of the process adopted in the CY 2017 OPPS/ASC final rule with comment period (81 FR 79704 through 79705) and included in the existing subregulatory guidance under which off-campus PBDs can apply for an extraordinary circumstance relocation exception, 20 all hospitals that relocate excepted on- or off-campus PBDs to off-campus locations in response to the COVID-19 PHE should notify their CMS Regional Office by email of their hospital's CCN; the address of the current PBD; the address(es) of the relocated PBD(s); the date which they began furnishing services at the new PBD(s); a brief justification for the relocation and the role of the relocation in the hospital's response to COVID-19; and an attestation that the relocation is not inconsistent with their state's emergency preparedness or pandemic plan. We expect hospitals to include in their justification for the relocation why the new PBD location (including instances where the relocation is to the patient's home) is appropriate for furnishing covered outpatient items and services. 20 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Subregulatory-Guidance-Section-603-Bipartisan-Budget-Act-Relocation.pdf. To the extent that a hospital may relocate to an off-campus PBD that otherwise is the patient's home, only one relocation request during the COVID-19 PHE is necessary. In other words, the hospital would not have to submit a unique request each time it registers a hospital outpatient for a PBD that is otherwise the patient's home; a single submission per location is sufficient. Hospitals must send this email to their CMS Regional Office within 120 days of beginning to furnish and bill for services at the relocated on- or off-campus PBD. • To provide additional flexibility, for purposes of addressing the PHE for the COVID-19 pandemic, hospitals may divide their PBD into multiple locations during a relocation. That is, if a single excepted PBD location relocates to multiple off-campus PBD locations in response to the COVID-19 PHE and in a manner that is not inconsistent with the state's emergency preparedness or pandemic plan, it will be permissible for all of the off-campus PBDs to which the excepted PBD relocated to continue to bill under the OPPS under the temporary extraordinary circumstances policy that is in place during the COVID-19 PHE. In addition, for purposes of the COVID-19 PHE, hospitals may relocate part of their excepted PBD to a new off-campus location while maintaining the original PBD location. Said differently, if a hospital relocates part of an excepted PBD to one or more off-campus PBD locations, it would be permissible for the original excepted PBD location, as well as the relocated off-campus PBD location(s) of that excepted PBD, to continue to bill under the OPPS under the revised extraordinary circumstances policy that is in place during the COVID-19 PHE so long as the extraordinary circumstances policy in effect during the COVID-19 PHE (described earlier in this section) is followed. We believe these flexibilities are needed for hospitals to respond effectively to the COVID-19 PHE. For example, one PBD may need to utilize two locations to maintain separation between COVID-positive and COVID-negative patients. Further, the relocation or partial relocation of an excepted PBD for the extraordinary circumstance of the COVID-19 PHE could involve a single excepted PBD that relocates (or partially relocates) to a patient's home (for purposes of furnishing a covered OPD service), which under the Hospitals without Walls initiative, can be provider-based to the hospital during the COVID-19 PHE. We note that, during the COVID-19 PHE, a patient's home would be considered a PBD of the hospital when the patient is registered as a hospital outpatient (as discussed in section II.F. of this IFC) and is receiving covered OPD services from the hospital. However, in most cases we do not anticipate that excepted PBDs would need to relocate or partially relocate into many different new locations. Rather, we anticipate most multi-relocations or partial relocations would be to a limited number of locations as needed to respond to the COVID-19 PHE in a manner not inconsistent with the state's preparedness and pandemic plan, with the exception being multiple relocations to accommodate care in patient's homes. We also expect hospitals exercising this flexibility to be able to support that the excepted PBD is still the same PBD, just split into more than one location. For example, if the excepted PBD was an oncology clinic, we would expect that the relocated PBD(s) during the COVID-19 PHE would still be providing oncologic services, including in the patient's home to the extent such location is made provider based to the hospital. • If Medicare-certified hospitals will be rendering services in relocated excepted PBDs, but intend to bill Medicare for the services under the main hospital, no additional provider enrollment actions are required (for example, hospitals do not need to submit an updated CMS-855A enrollment form) for the off-campus relocated site during the COVID-19 PHE. Following the COVID-19 PHE, as noted in section II.E.4. of this IFC, hospitals that wish to permanently relocate their excepted PBD must file an updated CMS-855A enrollment form to reflect the new address(es) of the PBD(s). In summary, and as discussed in more detailed above, we are adopting a temporary extraordinary circumstances relocation exception policy for excepted off-campus PBDs that relocate off-campus during the COVID-19 PHE. We are extending that temporary policy to on-campus PBDs that relocate off-campus during the COVID-19 PHE, and permitting the relocating PBDs to continue to be paid under the OPPS. Finally, we are streamlining the process for relocating PBDs to obtain the temporary extraordinary circumstances policy exception. F. Furnishing Outpatient Services in Temporary Expansion Locations of a Hospital or a Community Mental Health Center (Including the Patient's Home) Infection control is one of the primary goals of many initiatives CMS has undertaken during the COVID-19 PHE. Through all of the flexibilities offered, we have concentrated on increasing providers' ability to furnish services at temporary expansion locations, including the patient's home, to limit the need for patients to receive care in the hospital itself, which could unnecessarily expose the patients or providers to the pandemic contagion. Among the types of services that beneficiaries would benefit from receiving at temporary expansion locations are those critical outpatient services that hospitals, CMHCs, and CAHs furnish in their service areas. HOPDs, in particular, furnish a wide array of services, from clinic visits and counseling services, to complex surgical procedures and emergency care. We have taken several actions to create regulatory flexibilities in response to the COVID-19 PHE, including publishing the March 31st COVID-19 IFC, issuing numerous blanket waivers of requirements for health care providers under section 1135 of the Act, and exercising the authority granted under section 1812(f) of the Act. Since that time, we have received many questions about how hospital outpatient services can be furnished when the patient is in a temporary expansion location, including his or her home, particularly for those hospital outpatient services that typically do not co-occur with a physician or NPP furnishing a professional service. Those services are billed only under the hospital OPPS when furnished by the hospital and there is no professional service that is separately billable under the PFS. In addition, we have received questions about how the hospital should bill during the COVID-19 PHE when the practitioners typically furnishing services in HOPDs are now instead furnishing professional services as Medicare telehealth services under section 1834(m) of the Act under the flexibilities provided by both the waiver of requirements under section 1135(b)(8) of the Act and the March 31st COVID-19 IFC. Because we continue to believe that it is important for beneficiaries to be able to receive care in temporary expansion locations to maintain infection control, we explain in this section the flexibilities that are available to hospitals to enable them to furnish outpatient services to beneficiaries in their homes (or other temporary expansion locations), when such a location is considered to be a PBD of the hospital, as permitted under the waivers in effect during the COVID-19 PHE. Under ordinary circumstances, Medicare would not pay for hospital outpatient therapeutic services that are furnished to a beneficiary in the beneficiary's home or any other location that could not ordinarily be provider-based to the hospital. Our regulations at § 410.27(a)(1)(iii) explicitly include a requirement that therapeutic outpatient hospital services must be furnished in the hospital or CAH or in a department of the hospital or CAH. However, as noted above, we have issued numerous blanket section 1135 waivers to give health care providers needed flexibility to address the COVID-19 PHE. 21 As part of this initiative, we have waived the requirements associated with becoming a PBD of a hospital at § 413.65, as well as certain requirements under the Medicare conditions of participation in §§ 482.41 and 485.623, to facilitate the availability of temporary expansion locations. Because of these waivers, during the COVID-19 PHE, temporary expansion locations, including beneficiaries' homes, can become PBDs of hospitals and therapeutic outpatient hospital services furnished to beneficiaries in these provider-based locations can meet the requirement that these services be furnished in the hospital so long as all other requirements are met, including the hospital conditions of participation, to the extent not waived, during the COVID-19 PHE. That is, while certain locations would not normally be permitted to be considered part of a hospital, during the COVID-19 PHE, the section 1135 waivers of the provider-based rules allow temporary expansion locations to become provider-based to the hospital to bill for medically necessary hospital outpatient therapeutic services furnished at those locations, assuming all other applicable requirements are met (including, to the extent not waived, the hospital conditions of participation). 21 https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf. For purposes of clarifying regulatory flexibilities for hospital outpatient therapeutic services furnished to beneficiaries in their homes or other temporary expansion locations for the duration of the COVID-19 PHE, we considered hospital outpatient therapeutic services in three categories: (1) Hospital outpatient therapy, education, and training services, including partial hospitalization program services, that can be furnished other than in-person, and are furnished in a temporary expansion location (which may be the patient's home) that is a PBD of the hospital or an expanded CMHC; (2) hospital outpatient clinical staff services furnished in-person to the beneficiary in a temporary expansion location; and (3) hospital services associated with a professional service delivered by telehealth. We address each of these three categories in more detail below. 1. Hospital Outpatient and CMHC Therapy, Education, and Training Services In many cases, hospitals provide hospital outpatient therapy (including behavioral health), education, and training services that are furnished by hospital-employed counselors or other licensed professionals. Examples of these services include psychoanalysis, psychotherapy, diabetes self-management training, and medical nutrition therapy. With few exceptions, the Medicare statute does not have a benefit category that would allow these types of professionals (for example, counselors, nurses, and registered dieticians) to bill Medicare directly for their services. These services can, in many cases, be billed by providers such as hospitals under the OPPS or by physicians and other practitioners as services incident to their professional services under the PFS. Potentially the most prominent of these services are partial hospitalization program (PHP) services, which comprise an intensive outpatient program of psychiatric services provided as an alternative to inpatient psychiatric care for individuals who have an acute mental illness. We discuss treatment of PHP services separately within this section of this IFC. Outpatient therapy, education, and training services require communication and interaction. Facility staff can effectively furnish these services using telecommunication technology and, unlike many hospital services, the clinical staff and patient are not required to be in the same location to furnish them. We have already stated that section 1135 blanket waivers in effect during the COVID-19 PHE allow the hospital to consider the beneficiary's home, and any other temporary expansion location operated by the hospital during the COVID-19 PHE, to be a PBD of the hospital, so long as the hospital can ensure the locations meet all of the conditions of participation, to the extent not waived. In light of the need for infection control and a desire for continuity of behavioral health care and treatment services, we recognize the ability of the hospital's clinical staff to continue to deliver these services even when they are not physically located in the hospital. Provided a hospital's clinical staff is furnishing hospital outpatient therapy, education, and training services to a patient in the hospital (which can include the patient's home so long as it is provider based to the hospital), and the patient is registered as an outpatient of the hospital, we will consider the requirements of the regulations at § 410.27(a)(1) to be met. We remind readers that the physician supervision level for the vast majority of hospital outpatient therapeutic services is currently general supervision under § 410.27. This means a service must be furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the service. To facilitate public understanding of the types of services we believe can be furnished by the hospital to a patient in the hospital (including the patient's home if it is a PBD of the hospital) using telecommunications technology, we have provided on our website 22 a list of the outpatient therapy, counseling, and educational services that hospital clinical staff can furnish incident to a physician's or qualified NPP's service during the COVID-19 PHE to a beneficiary in their home or other temporary expansion location that functions as a PBD of the hospital when the beneficiary is registered as an outpatient of the hospital. We note that this list may not include every service that falls into this category and we intend to update the list periodically, to the extent that would be helpful for public awareness. 22 www.cms.gov. All services furnished by the hospital still require an order by a physician or qualified NPP and must be supervised by a physician or other NPP appropriate for supervising the service given their hospital admitting privileges, state licensing, and scope of practice, consistent with the requirements in § 410.27. We note that hospitals may bill for these services as if they were furnished in the hospital and consistent with any specific requirements for billing Medicare in general, including any relevant modifications in effect during the COVID-19 PHE. 23 We note that when these services are provided by clinical staff of the physician or other practitioner and furnished incident to their professional services, and are not provided by staff of the hospital, the hospital would not bill for the services. The physician or other practitioner should bill for such services incident to their own services and would be paid under the PFS. As always, documentation in the medical record of the reason and necessity of the visit is required. 23 https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page. a. Partial Hospitalization Program (PHP) A PHP is an intensive outpatient program of psychiatric services provided as an alternative to inpatient psychiatric care for individuals who have an acute mental illness, which includes, but is not limited to, conditions such as depression and schizophrenia. Section 1861(ff)(1) of the Act defines partial hospitalization services as the items and services described in paragraph (2) prescribed by a physician and provided under a program described in paragraph (3) under the supervision of a physician pursuant to an individualized, written plan of treatment established and periodically reviewed by a physician (in consultation with appropriate staff participating in such program), which sets forth the physician's diagnosis, the type, amount, frequency, and duration of the items and services provided under the plan, and the goals for treatment under the plan. Section 1861(ff)(2) of the Act describes the items and services included in partial hospitalization services. Section 1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished by a hospital to its outpatients or by a CMHC, as a distinct and organized intensive ambulatory treatment service, offering less than 24-hour-daily care, in a location other than an individual's home or inpatient or residential setting. Section 1861(ff)(3)(B) of the Act defines a CMHC for purposes of this benefit. In CY 2018, which is the most recent period for which we have complete PHP claims data, there were a total of 482,973 paid PHP days, including 394,311 paid PHP days for hospital-based providers and 88,662 paid PHP days for CMHCs. In comparison, inpatient psychiatric facilities (IPFs) billed 4,291,461 utilization days in FY 2019, the most recent period for which we have complete IPF claims data. Based on this comparison, we estimate that IPF services are utilized between 8 and 9 times more frequently than PHP services. Previously in this section, we identified that infection control is a primary goal of CMS initiatives undertaken during the COVID-19 PHE. We also believe continuity of behavioral health services is critical for those participating in a PHP, particularly at a time of heightened anxiety and uncertainty. As noted above, we have issued numerous blanket waivers under section 1135 of the Act, including for hospitals and CMHCs providing PHP services, to give health care providers needed flexibility to address the COVID-19 PHE and support the goal of infection control while maintaining access to partial hospitalization services and ensuring continuity of care for patients. Effective as of March 1, 2020 and for the duration of the COVID-19 PHE, a temporary expansion location where the beneficiary may be located, including a beneficiary's home, may be a PBD of the hospital, or may be a temporary extension of the CMHC (discussed in more detail below). Consistent with the goals of infection control and maintaining access, for the duration of the COVID-19 PHE only, providers can furnish certain partial hospitalization services remotely to patients in a temporary expansion location of the hospital or CMHC, which may include the patient's home to the extent it is made provider-based to the hospital or an extension of the CMHC. PHP services consist of unique combinations of services designated at section 1861(ff)(2) of the Act, including individual psychotherapy, patient education, and group psychotherapy. Certain PHP services such as these require communication and interaction, but do not require the clinical staff or patient to be in the same location, nor do clinical staff need to be in the hospital or CMHC when furnishing these PHP services. Therefore, the following types of services—to the extent they were already billable as PHP services in accordance with existing coding requirements prior to the COVID-19 PHE—can now be furnished to beneficiaries by facility staff using telecommunications technology during the COVID-19 PHE: (1) Individual psychotherapy; (2) patient education; and (3) group psychotherapy. Because of the intensive nature of PHP, we expect PHP services to be furnished using telecommunications technology involving both audio and video. However, we recognize that in some cases beneficiaries might not have access to video communication technology. In order to maintain beneficiary access to PHP services, only in the case that both audio and video are not possible can the service be furnished exclusively with audio. To be clear, services that require drug administration cannot be furnished using telecommunications technology. To facilitate public understanding of the types of PHP services that can be furnished using telecommunications technology by the hospital to a patient in the hospital (including the patient's home if it is a PBD of the hospital) or by the CMHC to a patient in an expanded CMHC location, we have provided on our website 24 a list of the individual psychotherapy, patient education, and group psychotherapy services that hospital or CMHC staff can furnish during the COVID-19 PHE to a beneficiary in their home or other temporary expansion location that functions as a PBD of the hospital or expanded CMHC when the beneficiary is registered as an outpatient. We note that this list may not include every service that falls into this category and we intend to update the list periodically, to the extent that would be helpful for public awareness. 24 www.cms.gov. Although these services can be furnished remotely, all other PHP requirements are unchanged and still in effect, including that all services furnished under the PHP still require an order by a physician, must be supervised by a physician, must be certified by a physician, and must be furnished in accordance with coding requirements by a clinical staff member working within his or her scope of practice. In accordance with the longstanding requirements that are detailed in the Medicare Benefit Policy Manual, Pub 100-02, chapter 6, section 70.3, documentation in the medical record of the reason for the visit and the substance of the visit is required. As noted above, when these services are provided by clinical staff of the physician or other practitioner and furnished incident to their professional services, and are not provided by staff of the hospital or CMHC, the hospital or CMHC would not bill for the services. The physician or other practitioner should bill for such services incident to their own services and would be paid under the PFS. (i.) Hospital-Based PHP Providers As detailed above, in CY 2018, hospital-based providers furnished 394,311 paid PHP days to Medicare beneficiaries, approximately 81.6 percent of Medicare-paid PHP days in that year. As part of the initiative to promote infection control and maintain access to PHP services, we have waived the requirements for being a PBD of the hospital in § 413.65, as well as certain requirements under the Medicare conditions of participation in §§ 482.41 and 485.623, to facilitate the availability of temporary expansion locations. As noted above, for purposes of the COVID-19 PHE and effective as of March 1, 2020, a temporary expansion location where the beneficiary may be located, including a beneficiary's home, may be a PBD of the hospital where the location meets the non-waived conditions of participation. Together, these waivers allow hospitals to consider a temporary expansion location where the beneficiary may be located, including their homes, an HOPD only in the context of the COVID-19 PHE. Thus, for the duration of the COVID-19 PHE, we will consider the PHP services furnished by hospital clinical staff, when the beneficiary is registered as an outpatient of the hospital and in accordance with the supervising practitioner's scope of practice, to the beneficiary in a temporary expansion location where the beneficiary may be located, including a beneficiary's home, to have been furnished in the hospital so long as the temporary expansion location is made provider-based to the hospital. The hospital should bill for these services as if they were furnished in the hospital and consistent with any specific requirements for billing Medicare during the COVID-19 PHE. (ii.) Community Mental Health Centers A CMHC is a provider of PHP services defined under section 1861(ff)(3)(B) of the Act. As detailed above, in CY 2018, CMHCs furnished 88,662 paid PHP days to Medicare beneficiaries, approximately 18.4 percent of Medicare-paid PHP days in that year. For the duration of the COVID-19 PHE, we are waiving the restriction at § 485.918(b)(1)(iii) for the purpose of providing PHP services to CMHC patients in their homes, which will be considered a temporary expansion location of a CMHC. A temporary expansion location where the beneficiary may be located, including the beneficiary's home, can be considered part of a CMHC, and certain therapeutic services furnished to beneficiaries, when the beneficiary is registered as an outpatient of the CMHC, in these temporary expansion locations can meet the requirement that these services be furnished in the CMHC. Specifically, for the purposes of the COVID-19 PHE and effective as of March 1, 2020, we will consider temporary expansion locations where the beneficiary may be located, including a beneficiary's home, to be a part of the CMHC once a patient is registered as an outpatient of the CMHC, while PHP services are being furnished at that location by CMHC staff in accordance with the supervising practitioner's scope of practice. Therefore, we will consider services furnished in that location to have been furnished in the CMHC. The CMHC should bill for these services as if they were furnished in the CMHC and consistent with any specific requirements for billing Medicare during the COVID-19 PHE. 2. Hospital In-Person Clinical Staff Services in a Temporary Expansion Location (Which May the Home) Hospitals also provide services that are furnished by clinical staff under a physician's or qualified NPP's order that do not require professional work by the physician or qualified NPP, and thus, are billed only under the OPPS when furnished by the hospital and are not separately billable under the PFS. Wound care, chemotherapy administration, and other drug administration are examples 25 of these types of services. We note that while surgical services also fall under this category, we would not anticipate that they would be furnished in a home that becomes provider-based to the hospital, due to infection control and operating room requirements. In addition, there are several other hospital outpatient therapeutic services that require the hospital's clinical staff's presence to furnish the service. The current section 1135 blanket waivers in place during the COVID-19 PHE allow the patient's home to be considered an outpatient PBD of the hospital. With a primary goal of infection control and understanding that hospitals must meet the conditions of participation, to the extent not waived during the COVID-19 PHE, we are making the public aware of the flexibilities that exist during the COVID-19 PHE that enable hospitals to furnish these clinical staff services in the patient's home as an outpatient PBD and to bill and be paid for these services as HOPD services when the patient is registered as a hospital outpatient. Because these services have to be provided in person by clinical staff, these services cannot be furnished by telecommunication technology by the hospital. In these instances, hospital clinical staff must be physically present in the patient's home or other temporary expansion location that is provider based to the hospital to furnish the hospital outpatient therapeutic service. The physician supervision level must be met for these services, and we note that for the vast majority of therapeutic hospital outpatient services, the required supervision level is currently general supervision under § 410.27. This means a service is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the service. This includes non-surgical extended duration therapeutic services (NSEDTSs), which are services that can last a significant period of time, have a substantial monitoring component that is typically performed by auxiliary personnel, have a low risk of requiring the physician's or appropriate NPP's immediate availability after the initiation of the service, and are not primarily surgical in nature. Direct supervision is generally required for the initiation of these NSEDTs, followed by a general supervision requirement for the duration of the service. In the March 31st COVID-19 IFC, we changed the supervision requirement for NSEDTs to instead require a general level of supervision throughout the service, including at service initiation, for the duration of the COVID-19 PHE. 25 With regard to observation services, we note that to bill for observation services all existing requirements must be met. These requirements are identified in Chapter 4, Section 290 of the Medicare Claims Processing Manual. Importantly, during the time period that the patient is receiving services from the hospital clinical staff as a registered outpatient, the patient's place of residence cannot be considered a home for purposes of HHA services. This is because HHAs cannot bill for services furnished in PBDs of hospitals, and a patient's home has provider-based status when the patient is a registered hospital outpatient and HOPD services are being furnished. Because the home is not a traditional PBD, and because there are interactions with other types of providers or suppliers who may furnish services in the home, but not in the “hospital,” we note that hospitals should only consider the patient home to be provider-based to the hospital when the patient is registered as a hospital outpatient. When the patient is not receiving outpatient services by the hospital, the patient's home can be considered a home for purposes of the home health benefit and the HHA can furnish and bill for home health services. The hospital should be aware if the patient is under a home health plan of care, and it must not furnish services to the patient that could be furnished by the HHA while the plan of care is active. That is, to the extent that there is some overlap between the types of services a HHA and a HOPD can provide, and the patient has a current home health plan of care, the hospital should only furnish services that cannot be furnished by the HHA. The fact that these services can be furnished in a patient's home or another temporary expansion location that is temporarily provider based to the hospital does not change the requirements that all services furnished by the hospital require an order by a physician or qualified NPP and must be supervised by a physician or other NPP appropriate for supervising the service given their hospital admitting privileges, state licensing, and scope of practice consistent with the requirements in § 410.27. Hospitals should bill for these services as they ordinarily bill for services along with any specific billing requirements for relocating PBDs specific to billing during a COVID-19 PHE as discussed in section II.D. of this IFC (that is, appending the PO modifier for excepted items and services and the PN modifier for nonexcepted services). Information regarding the application of section 603 of the BBA 2015 to relocating PBDs is available in section II.F.4. of this IFC, as well as section II.E. of this IFC. 3. Hospital Services Accompanying a Professional Service Furnished Via Telehealth The majority of hospital services are furnished in conjunction with professional services of physicians and other practitioners. In these instances, practitioners furnish and bill separately for their professional services indicating the place of service as a HOPD, and the hospital bills separately to be paid for the clinical labor, equipment, overhead, and capital to support the delivery of that professional service. In the March 31st COVID-19 IFC, we instructed physicians and other practitioners furnishing telehealth services to beneficiaries in their homes as permitted during the COVID-19 PHE to bill for those services in the same way they would if they were furnishing the services in person (85 FR 19233). For many professionals, the HOPD is the usual location where they furnish services. For the duration of the COVID-19 PHE and effective March 1, 2020, when a practitioner who ordinarily practices in a HOPD furnishes a telehealth service to a patient who is located at home (or otherwise not in a telehealth originating site), they would submit a professional claim with the place of service code indicating the service was furnished in the HOPD and using the Current Procedural Terminology (CPT) telehealth modifier, modifier 95. Medicare would pay the practitioner under the PFS at the “facility” rate as if the service was furnished in the HOPD. We adopted the aforementioned interim rule because we believed that, but for the COVID-19 PHE, the physician or practitioner would likely have furnished the service in person at their usual practice location; and that the service was instead furnished via telehealth for purposes of infection control. The March 31st COVID-19 IFC did not provide for the hospital to submit any claim for the service under the aforementioned scenario. We acknowledge that when a physician or practitioner who ordinarily practices in the HOPD furnishes a telehealth service to a patient who is located at home, the hospital would often still provide some administrative and clinical support for that service. When a registered outpatient of the hospital is receiving a telehealth service, the hospital may bill the originating site facility fee to support such telehealth services furnished by a physician or practitioner who ordinarily practices there. This includes patients who are at home, when the home is made provider-based to the hospital (which means that all applicable conditions of participation, to the extent not waived, are met), under the current waivers in effect for the COVID-19 PHE. More specifically, when a telehealth service is furnished by a practitioner located at a distant site to a patient who is located in the HOPD, the hospital is presumed to provide administrative and clinical support resources. In such circumstances, section 1834(m)(2)(B) of the Act allows for an originating site facility fee to be paid to the hospital. Section 1834(m)(2)(B)(ii) of the Act further provides that no facility fee shall be paid to an originating site described in paragraph (4)(C)(ii)(X) (that is, the home). However, as described throughout this section, the patient's home may be considered a PBD of the hospital during the COVID-19 PHE if other applicable requirements (including the non-waived conditions of participation) are met. As noted above, because the home is not a traditional PBD, and because there are interactions with other types of providers or suppliers who may furnish services in the home, but not in the “hospital,” we note that hospitals should only furnish hospital outpatient services to a patient (who is registered as a hospital outpatient) after the patient's home has been made provider-based to the hospital for the provision of such services. In that event, the home would be serving as a PBD of the hospital, and as the originating site for the telehealth service furnished by a physician or practitioner located at a distant site. The originating site facility fee is the statutory payment that is made to the facility for providing the site where the patient is located, and any other administrative or clinical support, for a telehealth service. Therefore, during the COVID-19 PHE, when telehealth services are furnished by a physician or practitioner who ordinarily practices in the HOPD to a patient who is located at home or other applicable temporary expansion location that has been made provider based to the hospital, we believe it would be appropriate to permit the hospital to bill and be paid the originating site facility fee amount for those telehealth services, just as they would have ordinarily done outside of the COVID-19 PHE in this circumstance. As such, for the duration of the COVID-19 PHE, we are making the public aware that under the flexibilities already in effect, when a patient is receiving a professional service via telehealth in a temporary expansion location that is a PBD of the hospital, and the patient is a registered outpatient of the hospital, the hospital in which the patient is registered may bill the originating site facility fee for the service. As always, documentation in the medical record of the reason for the visit and the necessity of the visit is required. 4. Intersection With Payment Policy for Hospital Outpatient PBDs As discussed previously, we have waived 26 the requirements for being a PBD of the hospital in § 413.65, as well as certain requirements under the Medicare conditions of participation in §§ 482.41 and 485.623, to facilitate the availability of temporary expansion sites. Importantly, these waivers do not determine whether a PBD is excepted or non-excepted for purposes of section 603 of the BBA 2015, and the definitions in § 413.65 that section 603 cross-references, including the definition of campus at § 413.65(a)(2), remain relevant to that determination. However, in section II.E. of this IFC, we discuss a temporary extraordi [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2020-09608. Public record. Not legal advice.