[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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="c0a1aea4b2a1eeb7a9a3abb380a8a8b3eea7afb6">[email protected]</a>
RIN: 0991-AB57
_______________________________________________________________________



HHS--OS

                              -----------

                            FINAL RULE STAGE

                              -----------




43. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="620f0310160a034c0c05171b070c220406034c0a0a114c050d14">[email protected]</a>
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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="7d10040f131c53151c13131c3d1b191c5315150e531a120b">[email protected]</a>
RIN: 0910-AF88
_______________________________________________________________________



HHS--FDA



46. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="8bf8eae6e2f9a5eaf8f8eaf9cbedefeaa5e3e3f8a5ece4fd">[email protected]</a>
RIN: 0910-AG35
_______________________________________________________________________



HHS--FDA



47. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="d3a3b2a6bffda0bca6a7bb93b5b7b2fdbbbba0fdb4bca5">[email protected]</a>
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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="c9abaca7baa6a7e7baa0a5bfacbba4a8a789afada8e7a1a1bae7aea6bf">[email protected]</a>
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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="5c31252e323d72343d32323d1c3a383d7234342f723b332a">[email protected]</a>
RIN: 0910-AF86
_______________________________________________________________________



HHS--FDA



50. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="28584041444158064c4d5b42495a4c41465b684e4c490640405b064f475e">[email protected]</a>
RIN: 0910-AG33
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




51. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="52373e3b28333037263a7c3a3d3e3e333c3612313f217c3a3a217c353d24">[email protected]</a>
Related RIN: Related to 0991-AB58
RIN: 0938-AP78
_______________________________________________________________________



HHS--CMS



52. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="1675776565777872647738747a77757d56757b65387e7e65">[email protected]</a> gov
RIN: 0938-AP79
_______________________________________________________________________



HHS--CMS



53. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="7e0a1718181f1007500d0907191b0c0a3e1d130d5016160d50191108">[email protected]</a>
RIN: 0938-AP80
_______________________________________________________________________



HHS--CMS



54. <bullet> 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="35545957504741541b51425c435051755658461b5d5d461b525a43">[email protected]</a>
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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="6802010546050911000d1f280b051b4600001b460f071e">[email protected]</a>
Related RIN: Related to 1210-AB30, Related to 1545-BI70
RIN: 0938-AP65
BILLING CODE 4150-24-S

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