Weekly Legislative & Regulatory Round-up
Week of August 29 - September 4
| GAO reports |
Disaster Recovery: Experiences from Past Disasters Offer Insights for Effective Collaboration after Catastrophic Events GAO-09-811
Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together GAO-09-647
Private Health Insurance: Research on Competition in the Insurance Industry GAO-09-864R
| OIG reports |
Advisory Opinion 09-15 (concerning an exclusive contract for ambulance transport services between a municipality and an ambulance company that provides reimbursement to the city for the costs of providing emergency dispatch services and for monitoring the quality of the emergency ambulance operation)
Advisory Opinion 09-14 (concerning an exclusive contract for ambulance transport services between a township and an ambulance company that provides for reimbursement to the township for the costs of providing emergency dispatch services)
Power Wheelchairs in the Medicare Program: Supplier Acquisition Costs and Services (OEI-04-07-00400)
Beneficiary Utilization of Albuterol and Levalbuterol Under Medicare Part B (OEI-03-07-00440)
Payments for Ambulance Transportation Provided to Beneficiaries in Skilled Nursing Stays Covered Under Medicare Part A in Calendar Year 2006 (A-01-08-00505)
| Bills introduced |
No bills introduced.
| Federal Register notices |
DEPARTMENT OF DEFENSE
Office of the Secretary
TRICARE; Reimbursement of Critical Access Hospitals (CAHs)
ACTION: Final rule.
SUMMARY: This rule implements the statutory provisions that TRICARE
payment methods for institutional care be determined to the extent
practicable in accordance with the same reimbursement rules as those
that apply to payments to providers of services of the same type under
Medicare. This final rule implements a reimbursement methodology
similar to that furnished to Medicare beneficiaries for services
provided by critical access hospitals (CAHs).
DATES: Effective Date: This rule is effective December 1, 2009.
Office of the Secretary
TRICARE; Diabetic Education
ACTION: Proposed rule.
SUMMARY: The Department of Defense is publishing this proposed rule to
clarify TRICARE coverage for diabetic education. This rule introduces
new definitions and addresses revisions or omissions in policy or
procedure inadvertently missed in previous regulatory changes
pertaining to diabetic education.
DATES: Written comments received at the address indicated below by
October 30, 2009 will be accepted.
Office of the Secretary
TRICARE; Extended Care Health Option
ACTION: Proposed rule.
SUMMARY: The Department of Defense is publishing this proposed rule to
implement the requirements enacted by Congress in Section 732 of the
Duncan Hunter National Defense Authorization Act for Fiscal Year 2009
which changes the limit of the Government's share of providing certain
benefits under the Extended Care Health Option (ECHO) from $2,500 per
month to $36,000 per year, and for other non-legislated changes to the
ECHO.
DATES: Comments received at the address indicated below by October 30,
2009 will be accepted.
Office of the Secretary
TRICARE; Off-Label Uses of Devices; Partial List of Examples of
Unproven Drugs, Devices, and Medical Treatments or Procedures
ACTION: Proposed rule.
SUMMARY: The Department of Defense is publishing this proposed rule to
revise the definition of ``unlabeled or off-label drug'' to ``off-label
use of a drug or device.'' This revision is consistent with the
regulatory framework under the Federal Food, Drug, and Cosmetic Act.
Additionally, this rule removes the partial list of examples of
unproven drugs, devices, and medical treatments or procedures
proscribed in TRICARE regulations. As it is determined that reliable
evidence demonstrates that previously unproven drugs, devices, and
medical treatments or procedures have proven medical effectiveness,
TRICARE has removed them from the list and authorized medically
necessary care. This revision removing the partial list is necessary as
the list will never be completely current, and is only a partial list
of examples. The removal of this partial list does not change or
eliminate any benefits that are currently available under the TRICARE
program.
DATES: Written comments received at the address indicated below by
October 30, 2009 will be accepted.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice Regarding 340B Drug Pricing Program--Children's Hospitals
ACTION: Final notice.
SUMMARY: Section 340B of the Public Health Service Act (section 340B)
and section 1927(a) of the Social Security Act (section 1927(a))
implement a drug pricing program in which manufacturers who sell
covered outpatient drugs to covered entities must agree to charge a
price that will not exceed an amount determined under a statutory
formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L.
109-171) (section 6004) added certain qualifying children's hospitals
to the list of covered entities eligible to access 340B discounted
drugs. The purpose of this notice is to inform interested parties of
final guidelines regarding the addition of children's hospitals that
meet certain requirements, specifically: (1) The process for the
registration of children's hospitals to the 340B Program; and (2) the
obligation of manufacturers to provide the statutorily mandated
discount to those children's hospitals.
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Health IT Community Tracking Study 2009.'' In accordance
with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this proposed information collection.
DATES: Comments on this notice must be received by October 1, 2009.
SUMMARY: Recently, Section 132 of the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA), Public Law 110-275, authorized a new
incentive program for eligible individual providers who are successful
e-prescribers. In addition, Section 4101 of the American Recovery and
Reinvestment Act of 2009 (ARRA), Public Law 111-5, provides incentives
for meaningful use of electronic health record technology, which
includes the use of e-prescribing. AHRQ proposes to conduct a qualitative research study designed to
help build knowledge on how the e-prescribing features required under
MIPPA are actually being implemented and used by physicians and
pharmacies in 12 nationally representative communities.
Food and Drug Administration
Guidance for Industry on Labeling of Nonprescription Human Drug
Products Marketed Without an Approved Application as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act:
Questions and Answers; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Labeling of Nonprescription Human
Drug Products Marketed Without an Approved Application as Required by
the Dietary Supplement and Nonprescription Drug Consumer Protection
Act: Questions and Answers.'' This guidance is intended to assist
industry in complying with the labeling requirements for
nonprescription (over-the-counter (OTC)) human drugs marketed without
an approved application established by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate
guidance, issued by the Center for Food Safety and Applied Nutrition on
complying with the labeling requirements for dietary supplements, is
announced elsewhere in this issue of the Federal Register.
Food and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent
Extension; TAPENTADOL HYDROCHLORIDE
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Collection of Information for Agency for Healthcare Research
and Quality's (AHRQ) Hospital Survey on Patient Safety Culture
Comparative Database.'' In accordance with the Paperwork Reduction Act
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be received by November 2, 2009.
Agency for Healthcare Research and Quality
Common Formats for Patient Safety Data Collection and Event
Reporting
ACTION: Notice of Availability--Common Formats Version 1.0.
SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26 (Patient Safety Act), provides for the formation
of Patient Safety Organizations (PSOs), which collect, aggregate, and
analyze confidential information regarding the quality and safety of
healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23)
authorizes the collection of this information in a standardized manner,
as explained in the related Patient Safety and Quality Improvement
Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the
Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized
by the Secretary of HHS, AHRQ coordinates the development of a set of
common definitions and reporting formats (Common Formats) that allow
healthcare providers to voluntarily collect and submit standardized
information regarding patient safety events. The initial release of the
formats, Version 0.1 Beta, was announced in the Federal Register on
August 29, 2008: 73 FR 50974-50976. The purpose of this notice is to
announce the availability of the expanded and enhanced Common Formats
Version 1.0 and the process for their continued development and
refinement.
DATES: Ongoing public input.
Office of the National Coordinator for Health Information
Technology
HIT Policy Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Name of Committee: HIT Policy Committee.
Date and Time: The meeting will be held on September 18, 2009, from
8:30 a.m. to 3 p.m./Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700.
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee Advisory Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on September 15, 2009, from
9:00 a.m. to 3 p.m./Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700.
National Committee on Vital and Health Statistics
Time and Date:
September 22, 2009, 9 a.m.-3 p.m.
September 23, 2009, 10 a.m.-4 p.m.
Place: Marriott Washington Hotel, 1221 22nd Street, NW.,
Washington, DC 20037.
Status: Open.
Office of Disease Prevention and Health Promotion, Office of
Public Health and Science, Office of the Secretary
Meeting of the Secretary's Advisory Committee on National Health
Promotion and Disease Prevention Objectives for 2020
ACTION: Notice.
SUMMARY: As stipulated by the Federal Advisory Committee Act, as
DATES: The Committee is scheduled to meet for two days, on September 17
and 18, 2009. The meeting will be held from 9 a.m. to 5 p.m. Eastern
Daylight Time (EDT) on September 17, and from 9 a.m. to 3 p.m. EDT on
September 18.
ADDRESSES: Department of Health and Human Services, Room 800 Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Health and Nutrition Examination Survey (NHANES) DNA
Samples: Guidelines for Proposals To Use Samples and Cost Schedule
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
TITLE: Hospital Wage Index Occupational Mix Survey and Supporting Regulations
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of Information Collection: Hospital Wage
Index Occupational Mix Survey and Supporting Regulations in 42 CFR,
Section 412.64;
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
TITLE: Request for Expedited Review of Denial of Premium Assistance
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the Agency's function; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Request for
Expedited Review of Denial of Premium Assistance; Use: The American
Recovery and Reinvestment Act of 2009 provides for premium assistance
and expanded eligibility for health benefits under both the
Consolidated Omnibus Budget Reconciliation Act of 1986, commonly called
COBRA, and comparable State continuation coverage programs.
Food and Drug Administration
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability
ACTION: Notice of availability.