Weekly Legislative & Regulatory Round-up

Week of May 22 - 28, 2010

GAO reports

VA Health Care: Reporting of Spending and Workload for Mental Health Services Could Be Improved GAO-10-570

Nursing Homes: Some Improvement Seen in Understatement of Serious Deficiencies, but Implications for the Longer-Term Trend Are Unclear GAO-10-434R

Recovery Act: States' and Localities' Uses of Funds and Actions Needed to Address Implementation Challenges and Bolster Accountability GAO-10-604

Recovery Act: States' and Localities' Uses of Funds and Actions Needed to Address Implementation Challenges and Bolster Accountability (Appendixes) GAO-10-605SP

OIG reports

Advisory Opinion 10-06 (PDF) (concerning a patient assistance program that assists underinsured patients with their prescription drug co-payment obligations)

Review of the State of Wisconsin’s Reporting Fund Recoveries for Federal and State Medicaid Programs on the Form CMS-64 for Fiscal Years 2006 and 2007 (A-05-08-00067)

Performance Data for the Senior Medicare Patrol Projects: May 2010 Performance Report (PDF) (OEI-02-10-00100)

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3401	05/24/2010	BURR, RICHARD (R-NC)	A bill to provide for the use of unobligated discretionary stimulus dollars to address AIDS Drug Assistance Program waiting lists and other cost containment measures impacting State ADAP programs; Referred to the Committee on Health, Education, Labor, and Pensions
S. 3407	05/25/2010	FEINGOLD, RUSS (D-WI)	A bill to improve the quality of care in nursing homes, help families make informed decisions, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions
S. 3413	05/25/2010	FEINGOLD, RUSS (D-WI)	A bill to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries; Referred to the Committee on Finance.
S. 3414	05/25/2010	HARKIN, TOM (D-IA)	A bill to ensure that the Dietary Supplement Health and Education Act of 1994 and other requirements for dietary supplements under the jurisdiction of the Food and Drug Administration are fully implemented and enforced, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3415	05/25/2010	FEINGOLD, RUSS (D-WI)	A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3419	05/25/2010	MERKLEY, JEFF (D-OR)	A bill to exclude from consumer credit reports medical debt that has been in collection and has been fully paid or settled, and for other purposes; Referred to the Committee on Banking, Housing, and Urban Affairs.
S. 3422	05/25/2010	WYDEN, RON (D-OR)	A bill to require the provision to members of the reserve components of the Armed Forces upon their mobilization and demobilization of a comprehensive statement of the medical care to which they are entitled as a result of mobilization; Referred to the Committee on Armed Services.
H.R. 5385	05/25/2010	CARNEY, CHRISTOPHER (D-PA)	A bill to amend title 38, United States Code, to direct the Secretary of Veterans Affairs to establish a toll-free hotline to assist mental health professionals at institutions of higher learning, to provide training to mental health professionals at institutions of higher learning, and for other purposes; Referred to the Committee on Veterans' Affairs.
H.R. 5389	05/25/2010	HEINRICH, MARTIN (D-NM)	H.R. 5389. A bill to amend title XVIII of the Social Security Act to provide for coverage of clinical pharmacist practitioner services under part B of the Medicare Program; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5392	05/25/2010	KENNEDY, PATRICK (D-RI)	A bill to establish a Council on Integration of Health Care Education, to provide for implementation of the recommendations of the Council, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor.
H.R. 5417	05/26/2010	BERNICE JOHNSON, EDDIE (D-TX)	A bill to amend titles XIX and XVIII of the Social Security Act, as amended by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, with respect to payment of disproportionate share hospitals (DSH) under the Medicare and Medicaid programs; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H.R. 5421	05/27/2010	BROUN, PAUL (R-GA)	A bill to repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, repeal the 7.5 percent threshold on the deduction for medical expenses, provide for increased funding for high-risk pools, allow acquiring health insurance across State lines, and allow for the creation of association health plans; 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, Rules, and House Administration.
H.R. 5424	05/27/2010	HERGER, WALTER (R-CA)	A bill to repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 and enact the Common Sense Health Care Reform and Affordability 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.
H.R. 5425	05/27/2010	FLEMING, JOHN (R-LA)	A bill to amend the Patient Protection and Affordable Care Act to permit a State to elect not to establish an American Health Benefit Exchange; Referred to the Committee on Energy and Commerce.
H.R. 5433	05/27/2010	HASTINGS, DOC (R-WA)	A bill to repeal certain provisions of the Patient Protection and Affordable Care Act relating to the limitation on the Medicare exception to the prohibition on certain physician referrals for hospitals and to transparency reports and reporting of physician ownership or investment interests; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5440	05/27/2010	KENNEDY, PATRICK (D-RI)	A bill to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments, and for other purposes; Referred to the Committee on Energy and Commerce.
H.R. 5444	05/27/2010	PAUL, RON (R-TX)	A bill to amend the Internal Revenue Code of 1986 to repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 and to replace it with provisions reforming the health care system by putting patients back in charge of health care; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Appropriations, House Administration, Ways and Means, Education and Labor, Natural Resources, the Judiciary, and Rules.

Federal Register notices

May 24

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Notice of Request for Public Comment

SUMMARY: The Secretary's Advisory Committee on Genetics, Health, and

Society (SACGHS) is requesting public comment on a draft report to the

Secretary of Health and Human Services (HHS) on genetics education and

training of health care professionals, public health providers, and

consumers. A copy of the draft report is available electronically at

http://oba.od.nih.gov/SACGHS/sacghs_public_comments.html. A copy may

also be obtained by contacting Kathryn Camp at campkm@od.nih.gov or

301-496-9838.

DATES: Please submit all public comments by June 30, 2010, for

consideration by SACGHS as it finalizes its report to the Secretary.

May 25

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: Healthcare Integrity and Protection Data Bank for

Final Adverse Information on Health Care Providers, Suppliers and

Practitioners (45 CFR 61) (OMB No. 0915-0239)--[Extension]

May 26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs: Proposed Changes Affecting

Hospital and Critical Access Hospital (CAH) Conditions of Participation

(CoPs): Credentialing and Privileging of Telemedicine Physicians and

Practitioners

ACTION: Proposed rule.

SUMMARY: This proposed rule would revise the conditions of

participation (CoPs) for both hospitals and critical access hospitals

(CAHs). These revisions would allow for a new credentialing and

privileging process for physicians and practitioners providing

telemedicine services.

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

the addresses provided below, no later than 5 p.m. on July 26, 2010.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs: Proposed Changes Affecting

Hospital and Critical Access Hospital (CAH) Conditions of Participation

(CoPs): Credentialing and Privileging of Telemedicine Physicians and

Practitioners

ACTION: Proposed rule.

SUMMARY: This proposed rule would revise the conditions of

participation (CoPs) for both hospitals and critical access hospitals

(CAHs). These revisions would allow for a new credentialing and

privileging process for physicians and practitioners providing

telemedicine services.

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

the addresses provided below, no later than 5 p.m. on July 26, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; Medicare Coverage Gap Discount Program Model

Manufacturer Agreement and Announcement of the June 1, 2010 Public

Meeting

ACTION: Notice with comment period.

SUMMARY: This notice with comment period contains a draft model

agreement for use by the Secretary and manufacturers under the Medicare

Coverage Gap Discount Program established by section 3301 of the

Patient Protection and Affordable Care Act, as amended by section 1101

of the Health Care and Education Reconciliation Act of 2010. Under the

agreement, manufacturers of applicable covered Part D drugs must

provide applicable discounts to applicable Medicare beneficiaries for

applicable covered Part D drugs while in the coverage gap beginning in

2011. It also announces the June 1, 2010 public meeting regarding the

draft model agreement.

DATES: Meeting Date: Tuesday, June 1, 2010, 9 a.m. to 5:30 p.m.,

eastern daylight time (e.d.t.).

Food and Drug Administration

The 13th Annual Food and Drug Administration-Orange County

Regulatory Affairs Educational Conference in Irvine, California:

``Regulatory Affairs: The Business of Regulatory Affairs''

ACTION: Notice of conference.

Food and Drug Administration

Identifying Unmet Public Health Needs and Facilitating Innovation

in Medical Device Development; Notice of Public Workshop; Request for

Comments

ACTION: Notice of public workshop; request for comments.

Dates and Times: This workshop will be held on June 24, 2010, from

8 a.m. to 5 p.m. Persons interested in attending the meeting must

comments by July 23, 2010.

Food and Drug Administration

Memorandum of Understanding Between the Food and Drug

Administration and Drugs.Com

ACTION: Notice.

Health Resources and Services Administration

Public Health Service Act, Rural Physician Training Grant

Program, Definition of ``Underserved Rural Community''

ACTION: Interim final rule with request for comment.

SUMMARY: This interim final rule (IFR) with request for comment is

meant to comply with the statutory directive to issue a regulation

defining ``underserved rural community'' for purposes of the Rural

Physician Training Grant Program in section 749B of the Public Health

Service Act, as amended by the Patient Protection and Affordable Care

Act of 2010. This IFR is technical in nature. It will not change grant

or funding eligibility for any other grant program currently available

through the Office of Rural Health Policy (ORHP) or HRSA. For purposes

of the Rural Physician Training Grant Program only, HRSA has combined

existing definitions of ``underserved'' and ``rural'' by using the

definition of rural utilized by the ORHP Rural Health Grant programs

and the definition of ``underserved'' established by HRSA's Office of

Shortage Designation (OSD) in the Bureau of Health Professions (BHPr).

DATES: Effective Date: This interim final rule is effective 30 days

after May 26, 2010.

Comment Date: To be assured consideration, written or electronic

comments must be received at one of the addresses provided below, no

later than 5 p.m. on July 26, 2010.

Office of Public Health and Science, Office of the Secretary

Solicitation of Nominations for Membership on the Secretary's

Advisory Committee on Human Research Protections

ACTION: Notice.

May 27

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Healthcare Infection Control Practices Advisory Committee,

(HICPAC); Notice of meeting

Times and Dates: 9 a.m.-5 p.m., June 17, 2010; 9 a.m.-12 p.m., June

18, 2010.

Place: CDC, Global Communications Center, Building 19, Auditorium

B3, 1600 Clifton Road, NE., Atlanta, Georgia 30333.

Status: This meeting is open to the public, limited only by the

space available. Please register for the meeting online at http://

www.cdc.gov/hicpac or by sending an e-mail to hicpac@cdc.gov.

Office of the National Coordinator for Health Information

Technology

HIT Policy Committee's Workgroup Meetings; Notice of Meetings

ACTION: Notice of meetings.

Name of Committees: HIT Policy Committee's Workgroups:

Meaningful Use, Privacy & Security Policy, Adoption/Certification,

and Nationwide Health Information Infrastructure (NHIN) workgroups.

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

following public meetings during June 2010: June 4th Meaningful Use

Workgroup hearing on disparities, 10 a.m. to 4 p.m./ET (location:

TBD); June 10th Privacy & Security Policy Workgroup, 2 p.m. to 4

p.m./ET; June 15th NHIN Workgroup, 10 a.m. to 1 p.m./ET; June 18th

Certification/Adoption Workgroup, 10 a.m. to 12 p.m./ET; and June

28th Privacy & Security Policy Workgroup, 2 p.m. to 4 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 Advisory

ACTION: Notice of meeting.

Date and Time: The meeting will be held on June 30, 2010, from 9

a.m. to 3 p.m./Eastern Time.

Location: The location is TBD. Please check the ONC Web site for

additional information.

HIT Standards Committee's Workgroup Meetings

ACTION: Notice of meetings.

Date and Time: The HIT Standards Committee Workgroups will hold

the following public meetings during June 2010: June 9th Clinical

Operations Workgroup/Vocabulary Task Force, 10 a.m. to 11 a.m./ET;

June 11th Implementation Workgroup, 3 p.m. to 4 p.m./ET; June 17th

Privacy & Security Workgroup, 10 a.m. to 12 p.m./ET; June 18th

Clinical Quality Workgroup, 2 p.m. to 4 p.m./ET; and June 29th

Clinical Operations/Vocabulary Task Force, 9 a.m. to 4 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.

HIT Policy Committee Advisory Meeting

ACTION: Notice of meeting.

Date and Time: The meeting will be held on June 25, 2010, from

10 a.m. to 4 p.m./Eastern Time.

Location: TBD. Please check ONC Web site for information on

location.

May 28

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicaid Program; Premiums and Cost Sharing

ACTION: Final rule with comment period.

SUMMARY: This final rule revises the November 25, 2008 final rule

entitled, ``Medicaid Programs; Premiums and Cost Sharing (73 FR

71828),'' to address public comments received during reopened comment

periods, and to reflect relevant statutory changes made in section

5006(a) of the American Recovery and Reinvestment Act of 2009 (the

Recovery Act). This revised final rule implements and interprets

section 1916A of the Social Security Act (the Act), which was added by

sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005

(DRA), amended by section 405(a)(1) of the Tax Relief and Health Care

Act of 2006 (TRHCA) and further amended by section 5006(a) of the

American Recovery and Reinvestment Act of 2009 (the Recovery Act).

These provisions increase State flexibility to impose premiums and cost

sharing for coverage of certain individuals whose family income exceeds

specified levels. This revised rule also provides a further opportunity

for public comment on revisions made to implement and interpret section

5006(a) of the Recovery Act. The Recovery Act prohibits States from

charging premiums and cost sharing under Medicaid to Indians furnished

items or services directly by the Indian Health Service, Indian Tribes,

Tribal Organizations, or Urban Indian Organizations or through referral

under contract health services.

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

Comment Date: To be assured of consideration, comments limited to

the implementation of section 5006(a) of the Recovery Act must be

received at one of the addresses provided below, no later than 5 p.m.

on July 27, 2010.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: New collection; Title of

Information Collection: Medicare Savings Program Protection from

Medicaid Estate Recovery--State Plan Pre-print under Title XIX. Form

No: CMS-10314 (OMB 0938-New).

2. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Independent Renal

Dialysis Facility Cost Report.

3. Type of Information Collection Request: Extension of a currently

approved collection; Title of Information Collection: Home Health

Agency Cost Report.

4. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Data Collection

for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration.

26.)

5. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Medicare Current

Beneficiary Survey.

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Advisory Panel on Medicare

Education

June 22, 2010.

ACTION: Notice of meeting.

DATES: Meeting Date: Tuesday, June 22, 2010 from 8:30 a.m. to 3 p.m.,

eastern daylight time (e.d.t.).

Centers for Medicare & Medicaid Services

Medicare Program; Public Meeting in Calendar Year 2010 for New

Clinical Laboratory Tests Payment Determinations

ACTION: Notice.

DATES: Meeting Date: The public meeting is scheduled for Thursday, July

22, 2010 from 9 a.m. to 2 p.m., Eastern Standard Time (E.S.T.).

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

DEPARTMENT OF LABOR

Employee Benefits Security Administration

Medicaid and CHIP Programs; Meeting of the CHIP Working Group--

June 14, 2010

ACTION: Notice.

DATES: Meeting Date: Monday, June 14, 2010 from 9 a.m. to 5 p.m.,

Eastern Standard Time (e.s.t.).

Deadline for Registration without Oral Presentation: June 12, 2010,

12 p.m., e.s.t.

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: Organ Procurement and Transplantation Network and

Scientific Registry of Transplant Recipients Data System (OMB No. 0915-

0157)—Extension