Weekly Legislative & Regulatory Round-up

Week of June 26 - July 2, 2010

GAO reports

Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader GAO-10-645

Foreign Medical Schools: Education Should Improve Monitoring of Schools That Participate in the Federal Student Loan Program GAO-10-412

Information Technology: Management Improvements Are Essential to VA's Second Effort to Replace Its Outpatient Scheduling System GAO-10-579

Recovery Act: Increasing the Public's Understanding of What Funds Are Being Spent on and What Outcomes Are Expected GAO-10-581

OIG reports

Invalid Prescriber Identifiers on Medicare Part D Drug Claims (PDF) (OEI-03-09-00140)

Review of Medicaid Payments for Services Claimed for Deceased Beneficiaries in California (A-09-09-00110)

Review of Blue Cross Blue Shield Association’s Final Administrative Cost Proposal for Fiscal Year 2008 (A-05-09-00097)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3543	06/29/2010	Hagan, Kay (D-NC)	A bill to amend title XVIII of the Social Security Act to expand access to medication therapy management services under the Medicare prescription drug program; Referred to the Committee on Finance.
S. 3548	06/29/2010	Casey, Robert (D-PA)	A bill to provide for the extension of premium assistance for COBRA benefits; Referred to the Committee on Finance.
S. 3551	06/30/2010	Brown, Scott (R-MA)	A bill to provide a fully offset extension of emergency unemployment insurance assistance, enhanced Medicaid FMAP reimbursements, and summer employment for youth, and for other purposes; Referred to the Committee on Finance.
H.R. 5647	06/30/2010	Heller, Dean (R-NV)	A bill to provide a temporary extension of unemployment insurance, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committees on Appropriations, Education and Labor, the Budget, Oversight and Government Reform, and Energy and Commerce.
H.R. 5664	07/01/2010	Ellsworth, Brad (D-IN)	A bill to amend title I of the Patient Protection and Affordable Care Act to permit certain individuals losing their COBRA continuation coverage to have access to the high-risk health insurance pool program established under such title; Referred to the Committee on Energy and Commerce.
H.R. 5678	07/01/2010	Carnahan, Russ (D-MO)	A bill to amend the Public Health Service Act to provide grants for treatment of methamphetamine abuse, and for other purposes; Referred to the Committee on Energy and Commerce.
H.R. 5687	07/01/2010	Cuellar, Henry (D-TX)	A bill to extend changes to requirements for admission of nonimmigrant nurses in health professional shortage areas made by the Nursing Relief for Disadvantaged Areas Act of 1999; Referred to the Committee on the Judiciary.
H.R. 5690	07/01/2010	Gingrey, Phil (R-GA)	A bill to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system, and for other purposes; Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce.

Federal Register notices

June 28

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs: Changes to the Hospital and

Critical Access Hospital Conditions of Participation To Ensure

Visitation Rights for All Patients

ACTION: Proposed rule.

SUMMARY: This proposed rule would revise the Medicare conditions of

participation for hospitals and critical access hospitals (CAHs) to

ensure the visitation rights of all patients. Medicare- and Medicaid-

participating hospitals and CAHs would be required to have written

policies and procedures regarding the visitation rights of patients,

including those setting forth any clinically necessary or reasonable

restriction or limitation that the hospital or CAH may need to place on

such rights as well as the reasons for the clinical restriction or

limitation.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on August 27, 2010.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Quarterly Listing of Program

Issuances--January Through March 2010

ACTION: Notice.

SUMMARY: This notice lists CMS manual instructions, substantive and

interpretive regulations, and other Federal Register notices that were

published from January through March 2010, relating to the Medicare and

Medicaid programs.

DEPARTMENT OF THE TREASURY

Internal Revenue Service

DEPARTMENT OF LABOR

Employee Benefits Security Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Patient Protection and Affordable Care Act: Preexisting Condition

Exclusions, Lifetime and Annual Limits, Rescissions, and Patient

Protections

ACTION: Interim final rules with request for comments.

SUMMARY: This document contains interim final regulations implementing

the rules for group health plans and health insurance coverage in the

group and individual markets under provisions of the Patient Protection

and Affordable Care Act regarding preexisting condition exclusions,

lifetime and annual dollar limits on benefits, rescissions, and patient

protections.

DATES: Effective Date. These interim final regulations are effective on

August 27, 2010.

DEPARTMENT OF THE TREASURY

Internal Revenue Service

Requirements for Group Health Plans and Health Insurance Issuers

Under the Patient Protection and Affordable Care Act Relating to

Preexisting Condition Exclusions, Lifetime and Annual Limits,

Rescissions, and Patient Protections

ACTION: Notice of proposed rulemaking by cross-reference to temporary

regulations.

SUMMARY: Elsewhere in this issue of the Federal Register, the Treasury

Department and the IRS are issuing temporary regulations under the

Patient Protection and Affordable Care Act (the Affordable Care Act)

relating to preexisting condition exclusions, lifetime and annual

limits, rescissions, and patient protections. Those temporary

regulations are being issued at the same time that the Employee

Benefits Security Administration of the U.S. Department of Labor and

the Office of Consumer Information and Insurance Oversight of the U.S.

Department of Health and Human Services are issuing substantially

similar interim final regulations under the Employee Retirement Income

Security Act of 1974 and the Public Health Service Act. The temporary

regulations provide guidance to employers, group health plans, and

health insurance issuers providing group health insurance coverage. The

text of those temporary regulations also serves as the text of these

proposed regulations.

DATES: Written or electronic comments and requests for a public hearing

must be received by September 27, 2010.

Office of the National Coordinator for Health Information

Technology

HIT Policy Committee's Workgroup Meetings; Notice of

Meetings

ACTION: Notice of meetings.

Date and Time: The HIT Policy Committee Workgroups will hold the

following public meetings during July 2010: July 2nd Enrollment

Workgroup, 11 a.m. to 2 p.m./ET; July 6th, Privacy & Security Tiger

Team, 10 a.m. to 12 p.m./ET; July 8th Certification/Adoption Workgroup,

10 a.m. to 12 p.m./ET; July 9th Privacy & Security Tiger Team, 10 a.m.

to 1 p.m./ET; July 13th Privacy & Security Tiger Team, 10 a.m. to 1

p.m./ET; July 14th NHIN Workgroup, 10 a.m. to 1 p.m./ET; July 15th

Enrollment Workgroup, 11 a.m. to 2 p.m./ET; July 16th Privacy &

Security Tiger Team, 10 a.m. to 1 p.m./ET; July 19th Enrollment

Workgroup, 11 a.m. to 2 p.m./ET; July 23rd Privacy & Security Tiger

Team, 10 a.m. to 1 p.m./ET; July 27th Privacy & Security Tiger Team, 10

a.m. to 1 p.m./ET; July 29th Meaningful Use Workgroup, 9 a.m. to 5

p.m./ET; and July 30th Enrollment Workgroup, 11 a.m. to 2 p.m./ET.

Location: All workgroup meetings will be available via webcast; for

instructions on how to listen via telephone or Web visit http://

healthit.hhs.gov. Please check the ONC Web site for additional

information as it becomes available.

Office of the National Coordinator for Health Information

Technology

HIT Standards Committee's Workgroup Meetings; Notice of

Meetings

ACTION: Notice of meetings.

Date and Time: The HIT Standards Committee Workgroups will hold the

following public meetings during July 2010: July 14th Clinical

Operations/Vocabulary Task Force, 3 p.m. to 5 p.m. ET; and July 22nd

Clinical Operations Workgroup, 11 a.m. to 1 p.m. ET.

Location: All workgroup meetings will be available via webcast;

visit http: //healthit.hhs.gov for instructions on how to listen via

telephone or Web. Please check the ONC Web site for additional

information as it becomes available.

June 29

No relevant notices

June 30

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Agency Information Collection Activities; Submission for Office

of Management and Budget Review; Comment Request; Guidance for Industry

Entitled Hypertension Indication: Drug Labeling for Cardiovascular

Outcome Claims

ACTION: Notice.

Food and Drug Administration

Issues in the Design and Conduct of Clinical Trials for

Antibacterial Drug Development; Public Workshop

ACTION: Notice of public workshop.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency Information Collection Request; 30-Day Public Comment

Request

Proposed Project: Comprehensive Communication Campaign for HITECH

Act--OMB No. 0990-NEW--Office National Coordinator for Health

Information Technology (ONC).

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency Information Collection Request; 60-Day Public Comment

Request

Proposed Project: Regional Extension Center (REC) Cooperative

Agreement Program OMB No. 0990-NEW--Office of the National Coordinator

for Health Information Technology.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency Information Collection Request; 30-Day Public Comment

Request

Proposed Project: Application for Waiver of the 2-Year Foreign

Residence Requirement of the Exchange Visitor Waiver Program, OMB No.

0990-0001--Reinstatement without change, Office of the Secretary,

Office of Global Health Affairs.

Health Resources and Services Administration

Agency Information Collection Activities: Two-Year Extension of

an Existing Information Collection; Proposed Collection: Comment

Request

Proposed Project: Performance Report for Grants and Cooperative

Agreements (OMB No. 0915-0061)—Revision

July 1

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: ``Assessing the Impact of the National Implementation of

TeamSTEPPS Master Training Program.'' In accordance with the Paperwork

comment on this proposed information collection.

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.

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.

Agency for Healthcare Research and Quality

Meeting of the National Advisory Council for Healthcare Research

and Quality

ACTION: Notice of public meeting.

SUMMARY: In accordance with section 10(a) of the Federal Advisory

Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the

National Advisory Council for Healthcare Research and Quality.

DATES: The meeting will be held on Friday, July 23, 2010, from 8:30

a.m. to 2:30 p.m.

ADDRESSES: The meeting will be held at the Eisenberg Conference Center,

Agency for Healthcare Research and Quality, 540 Gaither Road,

Rockville, Maryland 20850.

Agency for Healthcare Research and Quality

Notice of Meeting

SEP Meeting on: ARRA Limited Competition: AI-JRQ CE Delivery

Systems (RO1).

Date: July 22, 2010 (Open on July 22 from 8 a.m. to 8:15 a.m. and

closed for the remainder of the meeting).

Place: Doubletree Bethesda Hotel & Executive Meeting Center, 8120

Wisconsin Avenue, Conference Room TBD, Bethesda, Maryland 20852.

Agency for Healthcare Research and Quality

Notice of Meeting

SEP Meeting on: Accelerating Implementation of Evidence-Based

Findings through AHRQ networks (R18).

Date: July 23, 2010 (Open on July 23 from 12 p.m. to 12:15 p.m.

and closed for the remainder of the meeting).

Place: Doubletree Bethesda Hotel & Executive Meeting Center,

8120 Wisconsin Avenue, Conference Room TBD, Bethesda, Maryland

20852.

Agency for Healthcare Research and Quality

Notice of Meeting

SEP Meeting on: OS ARRA: CE Delivery Systems and Demonstration

Grants (R18).

Date: July 22, 2010 (Open on July 22 from 8 a.m. to 8:15 a.m.

and closed for the remainder of the meeting).

Place: Doubletree Bethesda Hotel & Executive Meeting Center,

8120 Wisconsin Avenue, Conference Room TBD, Bethesda, Maryland

20852.

Centers for Medicare & Medicaid Services

Medicare Program; Identification of Backward Compatible Version

of Adopted Standard for E-Prescribing and the Medicare Prescription

Drug Program (NCPDP SCRIPT 10.6)

ACTION: Interim final rule with comment period.

SUMMARY: This interim final rule with comment period identifies the

National Council for the Prescription Drug Programs (NCPDP) Prescriber/

Pharmacist Interface SCRIPT standard, Implementation Guide, Version 10,

Release 6 (Version 10.6), hereafter referred to as ``NCPDP SCRIPT

10.6,'' as a backward compatible update of the adopted NCPDP SCRIPT

8.1. This interim final rule with comment period therefore permits the

voluntary use of NCPDP SCRIPT 10.6 for conducting certain e-prescribing

transactions for the Medicare Part D electronic prescription drug

program.

DATES: Effective date: These regulations are effective on July 1, 2010.

The incorporation by reference of the publication listed in these

regulations is approved by the Director of the Federal Register as of

July 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.

Eastern Daylight Time (e.d.t.) on August 30, 2010.

Office of Public Health and Science

Establishment of the Advisory Group on Prevention, Health

Promotion, and Integrative and Public Health

ACTION: Notice.

AUTHORITY: Executive Order 13544, dated June 10, 2010, as statutorily

mandated under Section 4001 of the Patient Protection and Affordable

Care Act, Public Law 111-148, dated March 23, 2010. The Advisory Group

on Prevention, Health Promotion, and Integrative and Public Health will

be governed by provisions of the Federal Advisory Committee Act, Public

Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for

the formation and use of advisory committees.

SUMMARY: The U.S. Department of Health and Human Services announces

establishment of the Advisory Group on Prevention, Health Promotion,

and Integrative and Public Health, as directed by Executive Order

13544.

Health Resources and Services Administration

Notice of Availability of Draft Policy Document for Comment

ACTION: The Federal Tort Claims Act (FTCA) Policy Manual was developed

to serve as the primary policy source for information on FTCA for

Health Center Program grantees funded under section 330 of the Public

Health Service (PHS) Act (``section 330''). The Policy Manual is

currently posted on the Internet at http://bphc.hrsa.gov/

draftsforcomment/ftcamanual/.

DATES: Comments must be received by August 6, 2010.

July 2
No relevant notices.