Weekly Legislative & Regulatory Round-up
Week of May 1 - 7, 2010
| GAO reports |
VA Health Care: Progress and Challenges in Conducting the National Vietnam Veterans Longtitudinal Study GAO-10-658T
VA Health Care: Status of VA's Approach in Conducting the National Vietnam Veterans Longitudinal Study GAO-10-578R
| OIG reports |
Advisory Opinion 10-04 (PDF) (concerning a proposal by several imaging providers to offer free insurance pre-authorization services to patients and physicians)
Review of Iowa Medicaid Payments for Home Health Agency Claims (A-07-10-01081)
Monthly Recovery Act Report: March
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 3298 |
5/3/10 |
MARK UDALL (D-CO) |
A bill to establish a pilot program to reduce the increasing prevalence of overweight/obesity among 0-5 year-olds in-child care settings; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 5200 |
5/3/10 |
VAN HOLLEN (D-MD) |
A bill to amend title 5, United States Code, to extend eligibility for coverage under the Federal Employees Health Benefits Program with respect to certain adult dependents of Federal employees and annuitants, in conformance with amendments made by the Patient Protection and Affordable Care Act; Referred to the Committee on Oversight and Government Reform. |
S. 3315 |
5/3/10 |
SUSAN COLLINS (R-ME) |
A bill to amend title XVIII of the Social Security Act to protect Medicare beneficiaries' access to home health services under the Medicare program; Referred to the Committee on Finance. |
S. 3318 |
5/4/10 |
KIRSTEN GILLIBRAND (D-NY) |
A bill to amend title XVIII of the Social Security Act to eliminate contributing factors to disparities in breast cancer treatment through the development of a uniform set of consensus-based breast cancer treatment performance measures for a 6-year quality reporting system and value-based purchasing system under the Medicare Program; Referred to the Committee on Finance. |
H.R. 5216 |
5/5/10 |
TODD AKIN (R-MO) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Appropriations, Ways and Means, Education and Labor, the Judiciary, Natural Resources, House Administration, and Rules. |
| Federal Register notices |
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: ``National Hospital Adverse Event Reporting System:
Questionnaire Redesign and Testing.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3520. AHRQ invites the public to comment
on this proposed information collection.
National Hospital Adverse Event Reporting System: Questionnaire
Redesign and Testing
DATES: Comments on this notice must he received by July 2, 2010.
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: ``Standardizing Antibiotic Use in Long-Term Care Settings
SAUL) Study.'' In accordance with the Paperwork Reduction Act, 44
U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed
information collection.
Proposed Project: Standardizing Antibiotic Use in Long-Term Care Settings (SAUL)
DATES: Comments on this notice must be received by July 2, 2010.
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: ``Assessing the Impact of the National Implementation of
TeamSTEPPS Master Training Program.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment
on this proposed information collection.
DATES: Comments on this notice must he received by July 2, 2010.
Proposed Project:
Assessing the Impact of the National Implementation of TeamSTEPPS
Master Training Program
Office of the Secretary
HIPAA Privacy Rule Accounting of Disclosures Under the Health
Information Technology for Economic and Clinical Health Act; Request
for Information
ACTION: Request for information.
SUMMARY: Section 13405(c) of the Health Information Technology for
Economic and Clinical Health (HITECH) Act expands an individual's right
under the Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule to receive an accounting of disclosures of
protected health information made by HIPAA covered entities and their
business associates. In particular, section 13405(c) of the HITECH Act
requires the Department of Health and Human Services (``Department'' or
``HHS'') to revise the HIPAA Privacy Rule to require covered entities
to account for disclosures of protected health information to carry out
treatment, payment, and health care operations if such disclosures are
through an electronic health record. This document is a request for
information (RFI) to help us better understand the interests of
individuals with respect to learning of such disclosures, the
administrative burden on covered entities and business associates of
accounting for such disclosures, and other information that may inform
the Department's rulemaking in this area.
DATES: Submit comments on or before May 18, 2010.
National Institutes of Health
Submission for OMB Review; Comment Request; Investigating the
Causes of Post Donation Information (PDI): Errors in the Donor
Screening Process
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Proposed Changes to the Hospital Inpatient
Prospective Payment Systems for Acute Care Hospitals and the Long-Term
Care Hospital Prospective Payment System and Proposed Fiscal Year 2011
Rates; Effective Date of Provider Agreements and Supplier Approvals;
and Hospital Conditions of Participation for Rehabilitation and
Respiratory Care Services Medicaid Program: Accreditation Requirements
for Providers of Inpatient Psychiatric Services for Individuals Under
Age 21
ACTION: Proposed rule.
SUMMARY: We are proposing to revise the Medicare hospital inpatient
prospective payment systems (IPPS) for operating and capital-related
costs of acute care hospitals to implement changes arising from our
continuing experience with these systems. In addition, in the Addendum
to this proposed rule, we describe the proposed changes to the amounts
and factors used to determine the rates for Medicare acute care
hospital inpatient services for operating costs and capital-related
costs. These proposed changes would be applicable to discharges
occurring on or after October 1, 2010. We also are setting forth the
proposed update to the rate-of-increase limits for certain hospitals
excluded from the IPPS that are paid on a reasonable cost basis subject
to these limits. The proposed updated rate-of-increase limits would be
effective for cost reporting periods beginning on or after October 1,
2010.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Administrative Procedures for the Clinical Laboratory
Improvement Amendments of 1988 Categorization
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Patient Information Prototypes
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements for
Submission of Labeling for Human Prescription Drugs and Biologics in
Electronic Format
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
3, 2010.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: Combating Autism Act Initiative Evaluation (New)
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: ``Health Care and Other Facilities'' Construction
Program: Web-Based Status Reporting Form: (OMB No. 0915-0309)--
[Extension]
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: Children's Hospital Graduate Medical Education
Payment Program (CHGME PP) Annual Report (OMB No. 0915-0313)—Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Changes in Provider and Supplier
Enrollment, Ordering and Referring, and Documentation Requirements; and
Changes in Provider Agreements
ACTION: Interim final rule with comment period.
SUMMARY: This interim final rule with comment period implements several
provisions set forth in the Patient Protection and Affordable Care Act
(Affordable Care Act). It implements the provision which requires all
providers of medical or other items or services and suppliers that
qualify for a National Provider Identifier (NPI) to include their NPI
on all applications to enroll in the Medicare and Medicaid programs and
on all claims for payment submitted under the Medicare and Medicaid
programs. This interim final rule with comment period also requires
physicians and eligible professionals to order and refer covered items
and services for Medicare beneficiaries to be enrolled in Medicare. In
addition, it adds requirements for providers, physicians, and other
suppliers participating in the Medicare program to provide
documentation on referrals to programs at high risk of waste and abuse,
to include durable medical equipment, prosthetics, orthotics and
supplies (DMEPOS), home health services, and other items or services
specified by the Secretary.
DATES: Effective date: These regulations are effective on July 6, 2010.
Comment date: To be assured consideration, comments must be received at
one of the addresses provided below, no later than 5 p.m. on July 6,
2010.
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Administrative Detention and Banned
Medical Devices
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry, Food and Drug
Administration, and Foreign Governments: Fiscal Year 2010 Medical
Device User Fee Small Business Qualification and Certification
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Inspection by Accredited Persons
Program Under the Medical Device User Fee and Modernization Act of 2002
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Medical Device User Fee Cover
Sheet--Form FDA 3601
ACTION: Notice.
Food and Drug Administration
Determination That BREVIBLOC (Esmolol Hydrochloride) Injection,
250 Milligrams/Milliliter, 10-Milliliter Ampule, Was Withdrawn From
Sale for Reasons of Safety or Effectiveness
ACTION: Notice.
Food and Drug Administration
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 023
ACTION: Notice.
Food and Drug Administration
Guidance for Industry on Documenting Statistical Analysis
Programs and Data Files; Availability
ACTION: Notice.
Food and Drug Administration
Town Hall Discussion With the Director of the Center for Devices
and Radiological Health and Other Senior Center Management
ACTION: Notice of public meeting; request for comments.
The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Town Hall Discussion With the Director of the Center
for Devices and Radiological Health and Other Senior Center
Management.'' The purpose of this meeting is to present the Center for
Devices and Radiological Health (CDRH) fiscal year (FY) 2010
priorities. In addition, FDA is interested in engaging in discussions
about issues that are of importance to the medical device industry.
Date and Time: The public meeting will be held on June 22, 2010,
from 9 a.m. to 5 p.m.
Location: The public meeting will be held at the Hilton Boston/
Woburn, Two Forbes Rd., Woburn, MA 01801. The meeting will not be
videotaped or Web cast.
Office of the Secretary
Early Retiree Reinsurance Program
ACTION: Interim final rule with comment period.
SUMMARY: This interim final rule with comment period (IFC) implements
the Early Retiree Reinsurance Program, which was established by section
1102 of the Patient Protection and Affordable Care Act (the Affordable
Care Act). The Congress appropriated funding of $5 billion for the
temporary program. Section 1102(a)(1) requires the Secretary to
establish this temporary program not later than 90 days after enactment
of the statute, which is June 21, 2010. The program ends no later than
January 1, 2014. The program provides reimbursement to participating
employment-based plans for a portion of the cost of health benefits for
early retirees and their spouses, surviving spouses and dependents. The
Secretary will reimburse plans for certain claims between $15,000 and
$90,000 (with those amounts being indexed for plan years starting on or
after October 1, 2011). The purpose of the reimbursement is to make
health benefits more affordable for plan participants and sponsors so
that health benefits are accessible to more Americans than they would
otherwise be without this program.
DATES: Effective Date: These regulations are effective on June 1, 2010.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
EST on June 4, 2010.
Office of the Secretary
Health Care Reform Insurance Web Portal Requirements
ACTION: Interim final rule with comment period.
SUMMARY: The Patient Protection and Affordable Care Act (the Affordable
Care Act) was enacted on March 23, 2010. It requires the establishment
of an internet Web site (hereinafter referred to as a Web portal)
through which individuals and small businesses can obtain information
about the insurance coverage options that may be available to them in
their State. The Department of Health and Human Services (HHS) is
issuing this interim final rule in order to implement this mandate.
This interim final rule adopts the categories of information that will
be collected and displayed as Web portal content, and the data we will
require from issuers and request from States, associations, and high
risk pools in order to create this content.
DATES: Effective Date: These regulations are effective on May 10, 2010.
Comment Date: To be assured consideration, comments must be
received at the address provided below, no later than 5 p.m. on June 4,
2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exception From
General Requirements for Informed Consent
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Investigational Device Exemptions
Reports and Records
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services; Agency Information
Collection Activities: Submission for OMB Review; Comment Request
1. Type of Information Collection Request: New Collection; Title of
Information Collection: Tribal Consultation State Plan Amendment
Template.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
Comment Request
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Federal
Qualification Application (42 CFR 417.140) and Medicare Health Care
Prepayment Plan Application (42 CFR 417.800).
Food and Drug Administration
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are
Not Individually Identifiable
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance on Informed Consent For
In Vitro Diagnostic Device Studies Using Leftover Human Specimens That
Are Not Individually Identifiable'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Food and Drug Administration
Device Improvements to Reduce the Number of Under-Doses, Over-
Doses, and Misaligned Exposures From Therapeutic Radiation; Public
Meeting; Request for Comments
ACTION: Notice of public meeting; requests for comments.