[No title available]

[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]

[Unknown Section]

[Pages 64201-64212]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: X09-91207]

[[Page 64201]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

Statement of Regulatory Priorities

The Department of Health and Human Services (HHS) is the Federal

Government's principal agency charged with protecting the health of all

Americans and providing essential human services. HHS responsibilities

include: Medicare, Medicaid, support for public health preparedness and

emergency response, biomedical research, substance abuse and mental

health treatment and prevention, assurance of safe and effective drugs

and other medical products, protection of our Nation's food supply,

assistance to low income families, the Head Start program, services to

older Americans, and direct health services delivery.

These programs constitute a substantial portion of the priorities of

the federal government, and, as such, the HHS budget represents almost

a quarter of all federal outlays, and the Department administers more

grant dollars than all other agencies combined.

Since assuming the leadership of HHS this year, Secretary Kathleen G.

Sebelius has sought to prioritize efforts to prepare the country for

H1N1 influenza, enhance security of the nation's food supply, implement

regulation of tobacco, stop the spread of HIV/AIDS and ensure that

those affected get the care and support they need, and successfully

build the country's healthcare infrastructure through distribution of

$167 billion in funding from the American Recovery and Reinvestment Act

of 2009. Further, the Secretary has worked closely with the President

on the Administration's efforts to enact meaningful reform of the

country's health care system, and the Department will focus

considerable effort on implementation of health care reform once passed

by the Congress.

The Department's regulatory priorities in the upcoming fiscal year

reflect the above goals, and include:

Tobacco Regulation

Each year in the United States, over 440,000 people die as a result of

cigarette smoking. This represents one in every five deaths in adults.

Reducing our nation's tobacco use will save lives, reduce health care

costs, and help reduce suffering from heart and lung diseases, cancer,

and other tobacco-related illnesses. As directed by the Family Smoking

Prevention and Tobacco Control Act, the Secretary would re-establish

the bulk of the provisions of the August 1996 final rule restricting

access to and promotion of tobacco products to minors when many adult

smokers begin their tobacco use habits.

Food Safety

The Department is committed to making dramatic improvements in our food

safety system. These efforts are guided in part by the recent findings

of the President's Food Safety Working Group which adopted a public-

health approach based on three core principles: prioritizing

prevention, strengthening surveillance and enforcement, and improving

response and recovery if prevention fails. The goal of this new agenda

is to shift emphasis away from mitigating public health harm by

removing unsafe products from the market place, to a new overriding

objective -- preventing harm by keeping unsafe food from entering

commerce in the first place. Progress has already begun on this new

strategy. One example is the recent egg safety rule, which requires

science-based measures to prevent Salmonella Enteritidis contamination

of shell eggs at the farm, as well as safe handling temperature

controls throughout the distribution chain. We intend to continue this

focus on prevention with upcoming rules on produce safety and Good

Manufacturing Practices modernization. The Department also looks

forward to continuing work with the Congress to transform our nation's

approach to food safety and strengthen our ability to prevent foodborne

illness.

Mental Health Parity

Congress passed and the President signed legislation in October of 2008

that was a major step forward in improving access to mental health and

substance abuse services for those who need them by requiring that all

financial requirements and treatment limitations applicable to mental

health and substance use disorders are no more restrictive than those

requirements and limitations placed on physical benefits. Critical to

the implementation of the law is the issuance of regulations to help

employers and insurers understand what is required of them. The

Secretary has directed the Centers for Medicare & Medicaid Services

(CMS) to work with the Departments of Treasury and Labor to craft these

regulations so as to guide employers and insurers on how to implement

this statute and meet the important goal of furthering the integration

of mental health and substance abuse services into primary health care.

Medicare Modernization

The Regulatory Plan highlights three final rules that would adjust

payment amounts under Medicare for physicians' services, hospital

inpatient and hospital outpatient services for fiscal year 2011. These

new payment rules reflect continuing experience with regulating these

systems, and will implement modernizations to ensure that the Medicare

program best serves its beneficiaries, fairly compensates providers,

and remains fiscally sound.

Healthcare Information Technology

Broad use of electronic health records has the potential to improve

health care quality, prevent medical errors, increase the efficiency of

care provision and reduce unnecessary health care costs, increase

administrative efficiencies, decrease paperwork, and improve population

health. Towards achieving these benefits, the Department will

promulgate a proposed rule that would provide financial incentives to

certain providers that meaningfully implement electronic health

records, and an interim final rule that sets standards for such records

that will enhance their interoperability, functionality, and utility.

Additionally, the Department will issue a proposed rule to implement

privacy provisions of the Health Information Technology for Economic

and Clinical Health (HITECH) Act that will strengthen privacy and

security protections that govern how health information is used and

disclosed in the face of the modernization of health recordkeeping.

Streamlining Drug & Device Requirements

Three Food and Drug Administration (FDA) proposed rules would

standardize the electronic submission of clinical study data, medical

device registrations, and adverse event reports. These rules will

enable the FDA to more quickly and efficiently process and review

information submitted, furthering their ability to both better protect

the public safety and more rapidly advance new innovations to the

market.

[[Page 64202]]

_______________________________________________________________________

HHS--Office of the Secretary (OS)

-----------

PROPOSED RULE STAGE

-----------

42. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH

INFORMATION; MODIFICATIONS TO THE HIPAA PRIVACY RULE UNDER THE HEALTH

INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-5, secs 13400 to 13410

CFR Citation:

45 CFR 160; 45 CFR 164

Legal Deadline:

NPRM, Statutory, February 17, 2010.

Abstract:

The Department of Health and Human Services Office for Civil Rights

will issue rules to modify the HIPAA Privacy Rule as necessary to

implement the accounting provisions of Section 13405(c) of the Health

Information Technology for Economic and Clinical Health Act (Title XIII

of the American Recovery and Reinvestment Act of 2009).

Statement of Need:

The Office for Civil Rights will issue rules to modify the HIPAA

Privacy rule to implement the privacy provisions in sections 13400-

13410 of the Health Information technology for economic and clinical

health Act (Title XIII of division a of the American Recovery and

Reinvestment Act of 2009, Pub. L. 111-5). these regulations will

improve the privacy and security protection of health information.

Summary of Legal Basis:

Subtitle D of the Health Information Technology for Economic and

Clinical Health Act (Title XIII of the American Recovery and

Reinvestment Act of 2009) requires the Office for Civil Rights to

modify certain provisions of the HIPAA Privacy and Security Rules to

implement sections 13400-13410 of the Act.

Alternatives:

The Office for Civil Rights is statutorily mandated to make

modifications to the HIPAA Privacy and Security Rules to implement the

privacy provisions at sections 13400-13410 of the Health Information

Technology for Economic and Clinical Health Act (Title XIII of the

American Recovery and Reinvestment Act of 2009).

Anticipated Cost and Benefits:

These modifications to the HIPAA Privacy Rule are intended to benefit

health care consumers by strengthening the privacy and security

protections that govern how their health information is used and

disclosed by HIPAA covered entities and their business associates. The

Agency believes that there may be costs associated with the regulations

that will affect HIPAA covered entities and their business associates.

These may include costs to redraft existing business associate

contracts as well as for the training on new policies and procedures as

a result of these regulations.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 12/00/09

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

State

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Andra Wicks

Department of Health and Human Services

200 Independence Avenue SW.

Washington, DC 20201

Phone: 202 205-2292

Fax: 202 205-4786

Email: [email protected]

RIN: 0991-AB57

_______________________________________________________________________

HHS--OS

-----------

FINAL RULE STAGE

-----------

43. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS,

IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR

ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A

SECTION 610 REVIEW)

Priority:

Other Significant

Legal Authority:

42 USC 300jj-14

CFR Citation:

45 CFR 170

Legal Deadline:

Other, Statutory, December 31, 2009, Interim final rule.

Abstract:

The Department of Health and Human Services (HHS), Office of the

National Coordinator for Health Information Technology, will issue an

interim final rule with a request for comments to adopt an initial set

of standards, implementation specifications, and certification

criteria, as required by section 3004(b)(1) of the Public Health

Service Act.

Statement of Need:

This interim final rule represents the first round of what will be an

incremental approach to adopting standards, implementation

specifications, and certification criteria for health information

technology. The certification criteria adopted in this initial set

establish the technical capabilities and related standards that

certified electronic health record (EHR) technology will need to

include in support of the Medicare and Medicaid EHR Incentive Programs.

Summary of Legal Basis:

Section 3004(b)(1) of the PHSA requires the Secretary to adopt an

initial set of standards, implementation specifications, and

certification criteria by 12/31/09. This interim final rule is being

published to meet this requirement.

Alternatives:

No alternatives are available because the issuance of this regulation

is required by statute.

[[Page 64203]]

Anticipated Cost and Benefits:

We anticipate that there will be costs incurred as a result of the

interim final rule to prepare health information technology for

certification.

Benefits include improved interoperability and increased health

information technology adoption.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

Interim Final Rule 12/00/09

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

Federal

Agency Contact:

Steven Posnack

Policy Analyst

Department of Health and Human Services

Office of the Secretary

Office of the National Coordinator for Health Information Technology

200 Independence Avenue SW

Washington, DC 20201

Phone: 202 690-7151

RIN: 0991-AB58

_______________________________________________________________________

HHS--Food and Drug Administration (FDA)

-----------

PROPOSED RULE STAGE

-----------

44. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS

AND BIOLOGICS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect the private sector under PL 104-4.

Legal Authority:

21 USC 355; 21 USC 371; 42 USC 262

CFR Citation:

21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96

Legal Deadline:

None

Abstract:

The Food and Drug Administration is proposing to amend the regulations

governing the format in which clinical study data and bioequivalence

data are required to be submitted for new drug applications (NDAs),

biological license applications (BLAs), and abbreviated new drug

applications (ANDAs). The proposal would revise our regulations to

require that data submitted for NDAs, BLAs, and ANDAs, and their

supplements and amendments, be provided in an electronic format that

FDA can process, review, and archive.

Statement of Need:

Before a drug is approved for marketing, FDA must determine that the

drug is safe and effective for its intended use. This determination is

based in part on clinical study data and bioequivalence data that are

submitted as part of the marketing application. Study data submitted to

FDA in electronic format have generally been more efficient to process

and review.

FDA's proposed rule would require the submission of study data in a

standardized electronic format. Electronic submission of study data

would improve patient safety and enhance health care delivery by

enabling FDA to process, review, and archive data more efficiently.

Standardization would also enhance the ability to share study data and

communicate results. Investigators and industry would benefit from the

use of standards throughout the lifecycle of a study--in data

collection, reporting, and analysis. The proposal would work in concert

with ongoing agency and national initiatives to support increased use

of electronic technology as a means to improve patient safety and

enhance health care delivery.

Summary of Legal Basis:

Our legal authority to amend our regulations governing the submission

and format of clinical study data and bioequivalence data for human

drugs and biologics derives from sections 505 and 701 of the Act

(U.S.C. 355 and 371) and section 351 of the Public Health Service Act

(42 U.S.C. 262).

Alternatives:

FDA considered issuing a guidance document outlining the electronic

submission and the standardization of study data, but not requiring

electronic submission of the data in the standardized format. This

alternative was rejected because the agency would not fully benefit

from standardization until it became the industry standard, which could

take up to 20 years.

We also considered a number of different implementation scenarios, from

shorter to longer time-periods. The 2-year time-period was selected

because the agency believes it would provide ample time for applicants

to comply without too long a delay in the effective date. A longer

time-period would delay the benefit from the increased efficiencies,

such as standardization of review tools across applications, and the

incremental cost savings to industry would be small.

Anticipated Cost and Benefits:

Standardization of clinical data structure, terminology, and code sets

will increase the efficiency of the agency review process. FDA

estimates that the costs to industry resulting from the proposal would

include some one-time costs and possibly some annual recurring costs.

One-time costs would include, among other things, the cost of

converting data to standard structures, terminology, and cost sets

(i.e., purchase of software to convert data); the cost of submitting

electronic data (i.e., purchase of file transfer programs); and the

cost of installing and validating the software and training personnel.

Additional annual recurring costs may result from software purchases

and licensing agreements for use of proprietary terminologies.

The proposal could result in many long-term benefits for industry,

including improved patient safety through faster, more efficient,

comprehensive, and accurate data review, as well as enhanced

communication among sponsors and clinicians.

Risks:

None.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

[[Page 64204]]

Agency Contact:

Martha Nguyen

Regulatory Counsel

Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research

10903 New Hampshire Avenue

Bldg. 51, Room 6224

Silver Spring, MD 20993-0002

Phone: 301 796-3471

Fax: 301 847-8440

Email: [email protected]

RIN: 0910-AC52

_______________________________________________________________________

HHS--FDA

45. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES

Priority:

Other Significant

Legal Authority:

PL 110-85; PL 107-188, sec 321; PL 107-250, sec 207; 21 USC 360(a)

through 360(j); 21 USC 360(p)

CFR Citation:

21 CFR 807

Legal Deadline:

None

Abstract:

FDA is proposing to amend the medical device establishment registration

and listing regulations at 21 CFR part 807 to reflect the electronic

submission requirements in section 510(p) of the Federal Food, Drug,

and Cosmetic Act (the Act). Section 510(p) was added to the Act by

section 207 of the Medical Device User Fee and Modernization Act of

2002 (MDUFMA), and later amended in September 2007 by section 224 of

the Food and Drug Administration Amendments Act of 2007 (FDAAA). This

proposed rule would require domestic and foreign device establishments

to submit registration and listing data electronically via the Internet

using FDA's Unified Registration and Listing System. This proposed rule

would convert registration and listing to a paperless process. However,

for those companies that do not have access to the Web, FDA would offer

an avenue by which they can register, list, and update information with

a paper submission. The proposed rule also would amend part 807 to

reflect the timeframes for device establishment registration and

listing established by sections 222 and 223 of FDAAA, and to reflect

the requirement in section 510(i) of the Act, as amended by section 321

of the Public Health Security and Bioterrorism Preparedness and

Response Act (BT Act), that foreign establishments provide FDA with

additional pieces of information as part of their registration.

Statement of Need:

FDA is proposing to amend the medical device establishment registration

and listing requirements under 21 CFR part 807 to reflect the

electronic submission requirements in section 510(p) of the Act, which

was added by section 207 of MDUFMA and later amended by section 224 of

FDAAA. FDA also is proposing to amend 21 CFR part 807 to reflect the

requirements in section 321 of the BT Act for foreign establishments to

furnish additional information as part of their registration. This

proposed rule would improve FDA's device establishment registration and

listing system and utilize the latest technology in the collection of

this information.

Summary of Legal Basis:

The statutory basis for our authority includes sections 510(a) through

(j), 510(p), 701, 801, and 903 of the Act.

Alternatives:

The alternatives to this rulemaking include not updating the

registration and listing regulations. Because of the new FDAAA

statutory requirements, and the advances in data collection and

transmission technology, FDA believes this rulemaking is the preferable

alternative.

Anticipated Cost and Benefits:

The Agency believes that there may be some one-time costs associated

with the rulemaking, which involve resource costs of familiarizing

users with the electronic system. Recurring costs related to submission

of the information by domestic firms would probably remain the same or

decrease because a paper submission and postage is not required. There

might be some increase in the financial burden on foreign firms since

they will have to supply additional registration information as

required by section 321 of the BT Act.

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 09/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Myrna Hanna

Regulations Staff

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO-66 Room 4436

Silver Spring, MD 20993

Phone: 301 796-5739

Fax: 301 847-8144

Email: [email protected]

RIN: 0910-AF88

_______________________________________________________________________

HHS--FDA

46. PRODUCE SAFETY REGULATION

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

21 USC 342; 21 USC 371; 42 USC 264

CFR Citation:

Not Yet Determined

Legal Deadline:

None

Abstract:

The Food and Drug Administration is proposing to promulgate regulations

setting enforceable standards for fresh produce safety at the farm and

packing house. The purpose of the proposed rule is to reduce the risk

of illness associated with contaminated fresh produce. The proposed

rule will be based on prevention-oriented public health principles and

incorporate what we have learned in the past decade since the agency

issued general good agricultural practice guidelines entitled ``Guide

to Minimize Microbial Food Safety Hazards for Fresh Fruits and

Vegetables'' (GAPs Guide). The proposed rule also will reflect comments

received on the agency's 1998 update of its GAPs guide and its July

2009 draft commodity specific

[[Page 64205]]

guidances for tomatoes, leafy greens, and melons. Although the proposed

rule will be based on recommendations that are included in the GAPs

guide, it does not make the entire guidance mandatory. FDA's proposed

rule would, however, set out clear standards for implementation of

modern preventive controls. The proposed rule also would emphasize the

importance of environmental assessments to identify hazards and

possible pathways of contamination and provide examples of risk

reduction practices recognizing that operators must tailor their

preventive controls to particular hazards and conditions affecting

their operations. The requirements of the proposed rule would be scale

appropriate and commensurate with the relative risks and complexity of

individual operation. FDA intends to issue guidance after the proposed

rule is finalized to assist industry in complying with the requirements

of the new regulation.

Statement of Need:

FDA has determined that enforceable standards (as opposed to voluntary

recommendations) for the production and packing of fresh produce are

necessary to ensure best practices are commonly adopted.

Summary of Legal Basis:

FDA's legal basis derives in part from sections 402(a)(4) and 701(a) of

the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(4)

and 371(a)). The agency has promulgated regulations that respond to a

number of the provisions of the 1986 amendments. This final rule would

address additional provisions of these amendments.

Alternatives:

An alternative to this rulemaking would be to update FDA's 1998 GAPs

Guide. However, even though the 1998 guidance has been well received

and widely adopted, outbreaks associated with fresh produce continue.

Outbreak investigations also continue to observe conditions and

practices that are not consistent with the voluntary recommendations.

FDA believes a regulation containing clear, enforceable standards would

be more effective in ensuring best practices are widely adopted.

Anticipated Cost and Benefits:

FDA estimates that the costs to more than 300,000 domestic and foreign

producers and packers of fresh produce from the proposal would include

one-time costs (e.g., new tools and equipment) and recurring costs

(e.g., monitoring, training, recordkeeping). FDA anticipates that the

benefits would be a reduction in foodborne illness and deaths

associated with fresh produce. Monetized estimates of costs and

benefits are not available at this time.

Risks:

This regulation would directly and materially advance the Federal

Government's substantial interest in reducing the risks for illness and

death associated with foodborne infections resulting from the

consumption of contaminated fresh produce. Less restrictive and less

comprehensive approaches have not been effective in reducing the

problems addressed by this regulation. FDA anticipates that the

regulation would lead to a significant decrease in foodborne illness

associated with fresh produce in the U.S.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 10/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Federalism:

Undetermined

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Samir Assar

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition

Office of Food Safety

5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1636

Email: [email protected]

RIN: 0910-AG35

_______________________________________________________________________

HHS--FDA

47. MODERNIZATION OF THE CURRENT FOOD GOOD MANUFACTURING

PRACTICES REGULATION

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

21 USC 342; 21 USC 371; 42 USC 264

CFR Citation:

21 CFR 110

Legal Deadline:

None

Abstract:

The Food and Drug Administration (FDA) is proposing to amend its

current good manufacturing practices (CGMP) regulations (21 CFR part

110) for manufacturing, packing, or holding human food. This proposed

rule would require food facilities to address issues such as

environmental pathogens, food allergens, mandatory employee training,

and sanitation of food contact surfaces. The proposed rule also would

require food facilities to develop and implement preventive control

systems. FDA is taking this action to better address changes that have

occurred in the food industry and thereby protect public health.

Statement of Need:

FDA last updated its food CGMP regulations for manufacturing, packing

or holding of human food in 1986. Modernizing these food CGMP

regulations to more explicitly address issues such as environmental

pathogens, food allergens, mandatory employee training, and sanitation

of food contact surfaces, as well as risk-based preventive controls,

would be a critical step in raising the standards for food production

and distribution. By amending 21 CFR 110 to modernize good

manufacturing practices, the agency could focus the attention of food

processors on measures that have been proven to significantly reduce

the risk of food-borne illness. An amended regulation also would allow

the agency to better focus its regulatory efforts on ensuring industry

compliance with controls that have a significant food safety impact.

Summary of Legal Basis:

FDA's legal authority to amend its CGMP regulations derives in part

from sections 402(a)(3), (a)(4) and 701(a) of the Federal Food, Drug,

and Cosmetic

[[Page 64206]]

Act (the Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section

402(a)(3) of the Act, a food is adulterated if it consists in whole or

in part of any filthy, putrid, or decomposed substance, or if it is

otherwise unfit for food. Under section 402(a)(4), a food is

adulterated if it has been prepared, packed, or held under insanitary

conditions whereby it may have become contaminated with filth or may

have been rendered injurious to health. Under section 701(a) of the

Act, FDA is authorized to issue regulations for the efficient

enforcement of the Act. FDA's legal basis also derives from section 361

of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives

FDA authority to promulgate regulations to control the spread of

communicable disease.

Alternatives:

An alternative to this rulemaking is not to update the CGMP

regulations, and instead to issue guidance on best practices regarding

environmental pathogens, food allergens, mandatory employee training,

sanitation of food contact surfaces, and risk-based preventive

controls. However, guidance is voluntary and unenforceable. FDA

believes a regulation containing clear, enforceable standards would be

more effective in ensuring protection of public health.

Anticipated Cost and Benefits:

FDA estimates that the costs from the proposal to domestic and foreign

producers and packers of processed foods would include new one-time

costs (e.g., adoption of written food safety plans, setting up training

programs, implementing allergen controls, and purchasing new tools and

equipment) and recurring costs (e.g., auditing and monitoring suppliers

of sensitive raw materials and ingredients, training employees, and

completing and maintaining records used throughout the facility). FDA

anticipates that the benefits would be a reduced risk of foodborne

illness and deaths from processed foods and from a reduction in the

number of safety related recalls.

Risks:

This regulation will directly and materially advance the federal

government's substantial interest in reducing the risks for illness and

death associated with foodborne infections. Less restrictive and less

comprehensive approaches have not been effective in reducing the

problems addressed by this regulation. The regulation will lead to a

significant decrease in foodborne illness in the U.S.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 10/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

Federalism:

Undetermined

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Paul South

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition (HFS-317)

Office of Food Safety

5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1640

Email: [email protected]

RIN: 0910-AG36

_______________________________________________________________________

HHS--FDA

-----------

FINAL RULE STAGE

-----------

48. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY

CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND

QUALITY FACTORS

Priority:

Other Significant

Legal Authority:

21 USC 321; 21 USC 350a; 21 USC 371; . . .

CFR Citation:

21 CFR 106 and 107

Legal Deadline:

None

Abstract:

The agency published a proposed rule on July 9, 1996, that would

establish current good manufacturing practice regulations, quality

control procedures, quality factors, notification requirements, and

records and reports for the production of infant formula. This proposal

was issued in response to the 1986 Amendments to the Infant Formula Act

of 1980. On April 28, 2003, FDA reopened the comment period to update

comments on the proposal. The comment period was extended on June 27,

2003, to end on August 26, 2003. The comment period was reopened on

August 1, 2006, to end on September 15, 2006.

Statement of Need:

The Food and Drug Administration (FDA) is revising its infant formula

regulations in 21 CFR Parts 106 and 107 to establish requirements for

current good manufacturing practices (CGMP), including audits; to

establish requirements for quality factors; and to amend FDA's quality

control procedures, notification, and record and reporting requirements

for infant formula. FDA is taking this action to improve the protection

of infants who consume infant formula products.

Summary of Legal Basis:

The Infant Formula Act of 1980 (the 1980 act) (Pub. L. 96-359) amended

the Federal Food, Drug, and Cosmetic Act (the act) to include Sec. 412

(21 U.S.C. 350a). This law is intended to improve protection of infants

consuming infant formula products by establishing greater regulatory

control over the formulation and production of infant formula. In 1982,

FDA adopted infant formula recall procedures in subpart D of 21 CFR

part 107 of its regulations (47 FR 18832, April 30, 1982), and infant

formula quality control procedures in subpart B of 21 CFR Part 106 (47

FR 17016, April 20, 1982). In 1985, FDA further implemented the 1980

act by establishing subparts B, C, and D in 21 CFR Part 107 regarding

the labeling of infant formula, exempt infant formulas, and nutrient

requirements for infant formula, respectively (50 FR 1833, January 14,

1985; 50 FR 48183, November 22, 1985; and 50 FR 45106, October 30,

1985).

In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (PL 99-

570) (the 1986 amendments), amended Sec. 412 of the act to address

concerns that had been expressed by Congress and consumers about the

1980 act and its implementation related to the

[[Page 64207]]

sufficiency of quality control testing, CGMP, recordkeeping, and recall

requirements. The 1986 amendments: (1) state that an infant formula is

deemed to be adulterated if it fails to provide certain required

nutrients, fails to meet quality factor requirements established by the

Secretary (and, by delegation, FDA), or if it is not processed in

compliance with the CGMP and quality control procedures established by

the Secretary; (2) require that the Secretary issue regulations

establishing requirements for quality factors and CGMP, including

quality control procedures; (3) require that infant formula

manufacturers regularly audit their operations to ensure that those

operations comply with CGMP and quality control procedure regulations;

(4) expand the circumstances in which firms must make a submission to

the agency to include when there is a major change in an infant formula

or a change that may affect whether the formula is adulterated; (5)

specify the nutrient quality control testing that must be done on each

batch of infant formula; (6) modify the infant formula recall

requirements; and (7) give the Secretary authority to establish

requirements for retention of records, including records necessary to

demonstrate compliance with CGMP and quality control procedures. In

1989, the agency implemented the provisions on recalls (sections 412(f)

and (g) of the act) by establishing subpart E in 21 CFR part 107 (54 FR

4006, January 27, 1989). In 1991, the agency implemented the provisions

on record and record retention requirements by revising 21 CFR 106.100

(56 FR 66566, December 24, 1991).

The agency has already promulgated regulations that respond to a number

of the provisions of the 1986 amendments. The final rule would address

additional provisions of these amendments.

Alternatives:

The 1986 amendments require the Secretary (and, by delegation, FDA) to

establish, by regulation, requirements for quality factors and CGMPs,

including quality control procedures. Therefore, there are no

alternatives to rulemaking.

Anticipated Cost and Benefits:

FDA estimates that the costs from the final rule to producers of infant

formula would include first year and recurring costs (e.g.,

administrative costs, implementation of quality controls, records,

audit plans and assurances of quality factors in new infant formulas).

FDA anticipates that the primary benefits would be a reduced risk of

illness due to Cronobacter sakazakii and Salmonella spp in infant

formula. Additional benefits stem from the quality factors requirements

that would assure the healthy growth of infants consuming infant

formula. Monetized estimates of costs and benefits for this final rule

are not available at this time. The analysis for the proposed rule

estimated costs of less than $1 million per year. FDA was not able to

quantify benefits in the analysis for the proposed rule.

Risks:

Special controls for infant formula manufacturing are especially

important because infant formula, particularly powdered infant formula,

is an ideal medium for bacterial growth and because infants are at high

risk of foodborne illness because of their immature immune systems. In

addition, quality factors are of critical need to assure that the

infant formula supports healthy growth in the first months of life when

infant formula may be an infant's sole source of nutrition. The

provisions of this rule will address weaknesses in production that may

allow contamination of infant formula, including, contamination with C.

sakazakii and Salmonella spp which can lead to serious illness with

devastating sequelae and/or death. The provisions would also assure

that new infant formulas support healthy growth in infants.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 07/09/96 61 FR 36154

NPRM Comment Period End 12/06/96

NPRM Comment Period

Reopened 04/28/03 68 FR 22341

NPRM Comment Period

Extended 06/27/03 68 FR 38247

NPRM Comment Period End 08/26/03

NPRM Comment Period

Reopened 08/01/06 71 FR 43392

NPRM Comment Period End 09/15/06

Final Action 10/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Benson Silverman

Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition (HFS-850)

5100 Paint Branch Parkway

College Park, MD 20740

Phone: 301 436-1459

Email: [email protected]

Related RIN: Split from 0910-AA04

RIN: 0910-AF27

_______________________________________________________________________

HHS--FDA

49. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS

Priority:

Other Significant

Legal Authority:

21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC

374

CFR Citation:

21 CFR 803

Legal Deadline:

None

Abstract:

The Food and Drug Administration (FDA) is proposing to amend its

postmarket medical device reporting regulations to require that

manufacturers, importers, and user facilities submit mandatory reports

of medical device adverse events to the Agency in an electronic format

that FDA can process, review, and archive. FDA is taking this action to

improve the Agency's systems for collecting and analyzing postmarketing

safety reports. The proposed change would help the Agency to more

quickly review safety reports and identify emerging public health

issues.

Statement of Need:

The final rule would require user facilities and medical device

manufacturers and importers to submit medical device adverse event

reports in electronic format instead of using a paper form. FDA is

taking this action to improve its adverse event reporting program by

enabling it to more quickly receive and process these reports.

[[Page 64208]]

Summary of Legal Basis:

The Agency has legal authority under section 519 of the Federal Food,

Drug, and Cosmetic Act to require adverse event reports. The proposed

rule would require manufacturers, importers, and user facilities to

change their procedures to send reports of medical device adverse

events to FDA in electronic format instead of using a hard copy form.

Alternatives:

The alternatives to this rulemaking include not updating the medical

device reporting requirements and not requiring submission of this

information in electronic format. For over 20 years, medical device

manufacturers, importers, and user facilities have sent adverse event

reports to FDA on paper forms. Processing paper forms is a time-

consuming and expensive process. FDA believes this rulemaking is the

preferable alternative.

Anticipated Cost and Benefits:

The principal benefit would be to public health because the increased

speed in the processing and analysis of the more than 200,000 medical

device reports currently submitted annually on paper. In addition,

requiring electronic submission would reduce FDA annual operating costs

by $1.25 million.

The total one-time cost for modifying SOPs and establishing electronic

submission capabilities is estimated to range from $58.6 million to

$79.7 million. Annually recurring costs totaled $8.5 million and

included maintenance of electronic submission capabilities, including

renewing the electronic certificate, and for some firms the incremental

cost to maintain high-speed internet access.

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 08/21/09 74 FR 42310

NPRM Comment Period End 11/19/09

Final Action 09/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Myrna Hanna

Regulations Staff

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO-66 Room 4436

Silver Spring, MD 20993

Phone: 301 796-5739

Fax: 301 847-8144

Email: [email protected]

RIN: 0910-AF86

_______________________________________________________________________

HHS--FDA

50. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF

CIGARETTES AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

This action may affect State, local or tribal governments and the

private sector.

Legal Authority:

21 USC 301 et seq., The Federal Food, Drug, and Cosmetic Act; PL 111-

31, Family Smoking Prevention and Tobacco Control Act

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, March 22, 2010, Public Law 111-30 sections 6(c)(1)

and 102(a)(1).

Family Smoking Prevention and Tobacco Control Act Sec. Sec. 6(c)(1)

and 102(a)(1) require publication of this final rule within 270 days of

enactment.

Abstract:

This rule establishes regulations restricting the sale and distribution

of cigarettes and smokeless tobacco to children and adolescents,

implementing section 102 of the Family Smoking Prevention and Tobacco

Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the

Secretary to publish, within 270 days of enactment, a final rule

regarding cigarettes and smokeless tobacco. This final rule must be

identical, except for several changes identified in section 102(a)(2)

of FSPTCA, to part 897 of the regulations promulgated by the Secretary

of HHS in the August 28, 1996 issue of the Federal Register (61 FR

44396).

This final rule prohibits the sale of cigarettes and smokeless tobacco

to individuals under the age of 18 and requires manufacturers,

distributors, and retailers to comply with certain conditions regarding

access to, and promotion of, these products. Among other things, the

final rule requires retailers to verify a purchaser's age by

photographic identification. It also prohibits, with limited exception,

free samples and prohibits the sale of these products through vending

machines and self-service displays except in facilities where

individuals under the age of 18 are not present or permitted at any

time. The rule also limits the advertising and labeling to which

children and adolescents are exposed. The rule accomplishes this by

generally restricting advertising to which children and adolescents are

exposed to a black-and-white, text-only format. The rule also prohibits

the sale or distribution of brand-identified promotional, non-tobacco

items such as hats and tee shirts. Furthermore, the rule prohibits

sponsorship of sporting and other events, teams, and entries in a brand

name of a tobacco product, but permits such sponsorship in a corporate

name.

Statement of Need:

FDA is issuing this regulation as required in section 102 of FSPTCA.

Summary of Legal Basis:

The legal authority to issue this regulation includes section 102 of

FSPTCA.

Alternatives:

FDA's statutory requirement to issue this rule, in its current form,

does not provide for the consideration of any alternatives.

Anticipated Cost and Benefits:

Congress has recognized that tobacco use is the foremost preventable

cause of premature death in America. It causes over 400,000 deaths in

the United States each year, and approximately 8,600,000 Americans have

chronic illnesses related to smoking.

Based on FDA's prior analysis of a similar rule, implementing nearly

[[Page 64209]]

identical provisions (61 FR 44396), the Food and Drug Administration

(FDA) believes this rulemaking will have a significant economic impact.

Costs associated with this rulemaking will include one-time costs to

manufacturers to remove prohibited point-of-sale promotional items and

self-service displays. Most costs to retail establishments are

attributable to the new labor costs associated with the self-service

restrictions, costs for training employees to verify customer ages, for

routinely checking I.D.'s of young purchasers. There are also costs

seen by consumers in delay in checkout lines. Distributional and

transitional costs are also expected.

Risks:

Congress has found that these regulations will directly and materially

advance the Federal Government's substantial interest in reducing the

number of children and adolescents who use cigarettes and smokeless

tobacco and in preventing the life-threatening health consequences

associated with tobacco use. An overwhelming majority of Americans who

use tobacco products begin using such products while they are minors

and become addicted to the nicotine in those products before reaching

the age of 18. Tobacco advertising and promotion play a crucial role in

the decision of these minors to begin using tobacco products. Less

restrictive and less comprehensive approaches have not and will not be

effective in reducing the problems addressed by such regulations. The

reasonable restrictions on the advertising and promotion of tobacco

products contained in such regulations will lead to a significant

decrease in the number of minors using and becoming addicted to those

products.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

Final Rule 03/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal, Local, State, Tribal

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Philip R. Desjardins

Department of Health and Human Services

Food and Drug Administration

WO66, Room 5449

10903 New Hampshire

Silver Spring, MD 20993

Phone: 301 796-5683

Email: [email protected]

RIN: 0910-AG33

_______________________________________________________________________

HHS--Centers for Medicare & Medicaid Services (CMS)

-----------

PROPOSED RULE STAGE

-----------

51. ELECTRONIC HEALTH RECORD (EHR) INCENTIVE PROGRAM (CMS-

0033-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 111-5 (The American Recovery and Reinvestment Act of 2009, Title IV

of Division B, Medicare and Medicaid Health Information Technology)

CFR Citation:

Not Yet Determined

Legal Deadline:

Other, Statutory, October 1, 2010, Date can start incentive payments to

hospitals (Medicare).

Other, Statutory, January 1, 2011, Date can start incentive payments to

eligible professionals (Medicare).

Establishes policies and procedures required before the incentive

program can begin. Additionally supplemental payments are available in

2011 and 2012. If eligible professionals and hospitals are not

meaningful Electronic Health Record users by 2015 there will be a

Medicare payment adjustment imposed.

Abstract:

The Medicare and Medicaid Health IT provisions in the American Recovery

and Reinvestment Act of 2009 promote the adoption and meaningful use of

certified electronic health records (EHRs). The Recovery Act authorized

incentive payments for eligible professionals (EPS) and hospitals

participating in Medicare and Medicaid for becoming meaningful users of

certified EHRs. The law established maximum annual incentive amounts

and includes Medicare penalties for failing to meaningfully use EHRs

beginning in 2015 for professionals and hospitals that fail to adopt

certified EHRs.

Statement of Need:

This rule would implement provisions of the American Recovery and

Reinvestment Act of 2009 (Recovery Act) that authorizes incentive

payments to EPS and eligible hospitals participating in the Medicare

and Medicaid programs for adopting and becoming meaningful users of

certified EHR technology.

Summary of Legal Basis:

Title IV of Division B of the Recovery Act includes provisions to

promote the adoption of interoperable health information technology

(HIT) to promote the meaningful use of health information technology to

improve the quality and value of American health care. These provisions

together with Title XIII of Division A of the Recovery Act may be cited

as the ``Health Information Technology for Economic and Clinical Health

Act'' or the ``HITECH Act''. CMS is charged with developing the

incentive programs outlined in Division B, Title IV of the HITECH Act.

Alternatives:

There are no alternatives; this is a statutory requirement.

Anticipated Cost and Benefits:

Under Medicare, payment adjustments will be made starting in 2015 if

EPs and eligible hospitals are not meaningful users of certified EHR

technology. The benefits of the adoption of HIT are difficult to

quantify. There is the potential of reduced medical costs through

efficiency improvements. Additionally, HIT could help prevent medical

errors and adverse drug interactions.

Risks:

If this rule is not published, CMS will be unable to pay incentives for

the adoption and meaningful use of EHRs.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 12/00/09

Regulatory Flexibility Analysis Required:

Undetermined

[[Page 64210]]

Government Levels Affected:

State

Federalism:

Undetermined

Agency Contact:

Elizabeth S. Holland

Health Insurance Specialist

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mailstop S2-26-17

7500 Security Blvd.

Baltimore, MD 21244

Phone: 410 786-1309

Email: [email protected]

Related RIN: Related to 0991-AB58

RIN: 0938-AP78

_______________________________________________________________________

HHS--CMS

52. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE

SCHEDULE AND PART B FOR CY 2011 (CMS-1503-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

Social Security Act, sec 1102; Social Security Act, sec 1871

CFR Citation:

42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426

Legal Deadline:

Final, Statutory, November 1, 2010.

Abstract:

This major proposed rule would revise payment polices under the

physician fee schedule, as well, as other policy changes to payment

under Part B for CY 2011. (The statute requires the proposed and

subsequent final rule publish by 11/1/10.)

Statement of Need:

The statute requires that we establish each year, by regulation,

payment amounts for all physicians' services furnished in all fee

schedule areas. This major proposed rule would make changes affecting

Medicare Part B payment to physicians and other Part B suppliers.

The final rule has a statutory publication date of November 1, 2010, an

implementation date of January 1, 2011.

Summary of Legal Basis:

Section 1848 of the Social Security Act (the Act) establishes the

payment for physician services provided under Medicare. Section 1848 of

the Act imposes a deadline of no later than November 1 for publication

of the final physician fee schedule rule.

Alternatives:

None. This is a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for CY 2011.

Risks:

If this regulation is not published timely, physician services will not

be paid appropriately.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Cassandra Black

Director, Division of Practitoner Services

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mail Stop C4-01-26

7500 Security Blvd

Baltimore, MD 21244

Phone: 410 786-4545

Email: [email protected] gov

RIN: 0938-AP79

_______________________________________________________________________

HHS--CMS

53. PROPOSED CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE

PAYMENT SYSTEMS FOR ACUTE CARE HOSPITALS AND FY 2011 RATES AND TO THE

LONG-TERM CARE HOSPITAL PPS AND RY 2011 RATES (CMS-1498-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

Sec 1886(d) of the Social Security Act

CFR Citation:

42 CFR 412

Legal Deadline:

NPRM, Statutory, April 1, 2010.

Final, Statutory, August 1, 2010.

Abstract:

Proposed Changes to the Hospital Inpatient Prospective Payment Systems

for Acute Care Hospitals and FY 2011 Rates and to the Long Term Care

Hospital PPS and RY 2011 Rates

Statement of Need:

CMS annually revises the Medicare hospital inpatient prospective

payment systems (IPPS) for operating and capital-related costs to

implement changes arising from our continuing experience with these

systems. In addition, we describe the proposed changes to the amounts

and factors used to determine the rates for Medicare hospital inpatient

services for operating costs and capital-related costs. Also, CMS

annually updates the payment rates for the Medicare prospective payment

system (PPS) for inpatient hospital services provided by long-term care

hospitals (LTCHs). The proposed rule solicits comments on the proposed

IPPS and LTCH payment rates and new policies. CMS will issue a final

rule containing the payment rates for the 2011 IPPS and LTCHs at least

60 days before October 1, 2010.

Summary of Legal Basis:

The Social Security Act (the Act) sets forth a system of payment for

the operating costs of acute care hospital inpatient stays under

Medicare Part A (Hospital Insurance) based on prospectively set rates.

The Act requires the Secretary to pay for the capital-related costs of

hospital inpatient and Long Term Care stays under a prospective payment

system (PPS). Under these PPSs, Medicare payment for hospital inpatient

and Long Term Care operating and capital-related costs is made at

predetermined, specific rates for each hospital discharge. These

changes would be applicable to services furnished on or after October

1, 2010.

Alternatives:

None. This is a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for FY 2011.

Risks:

If this regulation is not published timely, inpatient hospital and LTCH

[[Page 64211]]

services will not be paid appropriately beginning October 1, 2010

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 04/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal

Federalism:

This action may have federalism implications as defined in EO 13132.

Agency Contact:

Tiffany Swygert

Health Insurance Specialist

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mailstop C4-25-11

7500 Security Blvd.

Baltimore, MD 21244

Phone: 410 786-4642

Email: [email protected]

RIN: 0938-AP80

_______________________________________________________________________

HHS--CMS

54. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT

SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2011 (CMS-

1504-P)

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

Sec 1833 of the Social Security Act

CFR Citation:

42 CFR 410 to 413; 42 CFR 416

Legal Deadline:

Final, Statutory, November 1, 2010.

Abstract:

This major proposed rule would revise the Medicare hospital outpatient

prospective payment system to implement applicable statutory

requirements and changes arising from our continuing experience with

this system. In addition, the proposed rule describes proposed changes

to the amounts and factors used to determine the payment rates for

Medicare hospital outpatient services paid under the prospective

payment system. The rule also proposes changes to the Ambulatory

Surgical Center Payment System list of services and rates. These

changes would be applicable to services furnished on or after January 1

annually. (The proposed and subsequent final rule must publish by 11/1/

10.)

Statement of Need:

Medicare pays over 4,200 hospitals for outpatient department services

under the hospital outpatient prospective payment system (OPPS). The

OPPS is based on groups of clinically similar services called

ambulatory payment classification groups (APCs). CMS annually revises

the APC payment amounts based on claims data, proposes new payment

polices, and updates the payments for inflation using the hospital

operating market basket. The proposed rule solicits comments on the

proposed OPPS payment rates and new policies. This rule does not impact

payments to critical access hospitals as they are not paid under the

OPPS. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs)

under the ASC payment system. CMS annually revises the payment under

the ASC payment system, proposes new policies, and updates payments for

inflation using the Consumer Price Index for All Urban Consumers (CPI-

U). CMS will issue a final rule containing the payment rates for the

2011 OPPS and ASC payment system at least 60 days before January 1,

2011.

Summary of Legal Basis:

Section 1833 of the Social Security Act establishes Medicare payment

for hospital outpatient services. The final rule revises the Medicare

hospital OPPS to implement applicable statutory requirements and

changes arising from our continuing experience with this system. In

addition, the proposed and final rules describe changes to the

outpatient APC system, relative payment weights, outlier adjustments,

and other amounts and factors used to determine the payment rates for

Medicare hospital outpatient services paid under the prospective

payment system as well as changes to the rates and services paid under

the ASC payment system. These changes would be applicable to services

furnished on or after January 1, 2011.

Alternatives:

None. This is a statutory requirement.

Anticipated Cost and Benefits:

Total expenditures will be adjusted for CY 2011.

Risks:

If this regulation is not published timely, outpatient hospital and ASC

services will not be paid appropriately beginning January 1, 2011.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal

Federalism:

Undetermined

Agency Contact:

Alberta Dwived

Health Insurance Specialist

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Mail Stop C5-01-26

7500 Security Blvd,

Baltimore,, MD 21244

Phone: 410 786-0763

Email: [email protected]

RIN: 0938-AP82

_______________________________________________________________________

HHS--CMS

-----------

FINAL RULE STAGE

-----------

55. HIPAA MENTAL HEALTH PARITY AND ADDICTION EQUITY ACT OF 2008

AMENDMENTS (CMS-4140-IFC)

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Unfunded Mandates:

Undetermined

Legal Authority:

Mental Health Parity and Addication Equity Act of 2008 (P.L.110-343)

CFR Citation:

45 CFR 146.136

[[Page 64212]]

Legal Deadline:

Final, Statutory, October 3, 2009, Interim final regulation.

Abstract:

This rule implements statutory changes to the Public Health Services

Act (PHSA) affecting the group health insurance markets and non-federal

governmental plans, made by the Mental Health Parity and Addiction

Equity Act of 2008.

Statement of Need:

This rule is needed to implement MHPAEA, which expands the existing

Mental Health parity law to include substance abuse disorders and to

require parity for mental health and substance abuse disorder benefits

in treatment limitations and financial requirements.

Summary of Legal Basis:

The Public Health Service Act and MHPAEA provide the authority to

implement this rule.

Alternatives:

Since this is a statutory requirement, no alternatives were considered.

Anticipated Cost and Benefits:

Promulgation of this rule will provide greater access to mental health

and substance abuse disorder treatments by requiring group health plans

to provide better coverage for those treatments.

Risks:

This rule addresses the risk of individuals not being able to obtain

necessary mental health and/or substance abuse disorder treatment

because of limited health coverage for those treatments. By increasing

access to treatment for mental health conditions and substance abuse

disorders, this rule will also reduce the stigma experienced by

millions of Americans who are afflicted with these conditions and allow

them to remain in the workforce.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

Request for Information 04/28/09 74 FR 19155

RFI Comment Period End 05/28/09

Interim Final Rule 01/00/10

Interim Final Rule

Comment Period End 03/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Agency Contact:

Jim Mayhew

Department of Health and Human Services

Centers for Medicare & Medicaid Services

7500 Security Boulevard

Baltimore, MD 21244

Phone: 410 786-9244

Email: [email protected]

Related RIN: Related to 1210-AB30, Related to 1545-BI70

RIN: 0938-AP65

BILLING CODE 4150-24-S