[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: andra.wicks@hhs.gov
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: martha.nguyen@fda.hhs.gov
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: myrna.hanna@fda.hhs.gov
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: samir.assar@fda.hhs.gov
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: paul.south@fda.hhs.gov
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: benson.silverman@fda.hhs.gov
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: myrna.hanna@fda.hhs.gov
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: philip.desjardins@fda.hhs.gov
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: elizabeth.holland@cms.hhs.gov
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: cassandra.black@cms.hhs 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: tiffany.swygert@cms.hhs.gov
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: alberta.dwived@cms.hhs.gov
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: jim.mayhew@cms.hhs.gov
Related RIN: Related to 1210-AB30, Related to 1545-BI70
RIN: 0938-AP65
BILLING CODE 4150-24-S
