Weekly Legislative & Regulatory Round-up

Week of July 31 - August 6, 2010

GAO reports

Medicaid Managed Care: CMS's Oversight of States' Rate Setting Needs Improvement GAO-10-810

OIG reports

No relevant reports.

Bills introduced

Number/ Title	Date Introduced	Sponsor	Description
S. 3668	07/29/10	Harkin, Tom (D-IA)	A bill to require the Secretary of Health and Human Services to establish a demonstration program to award grants to, and enter into contracts with, medical--legal partnerships to assist patients and their families to navigate health--related programs and activities; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3673	07/29/10	Hutchison, Kay Bailey (R-TX)	A bill to amend the Patient Protection and Affordable Care Act to repeal certain limitations on tax health care benefits; Referred to the Committee on Finance.
S. 3674	07/29/10	Stabenow, Debbie (D-MI)	A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of comprehensive Alzheimer's disease and other dementia diagnosis and services in order to improve care and outcomes for Americans living with Alzheimer's disease by increasing detection, diagnosis, care, and planning; Referred to the Committee on Finance.
H.R. 5923	07/29/10	Paulsen, Erik (R-MN)	A bill to amend the Patient Protection and Affordable Care Act to repeal certain limitations on tax health care benefits; Referred to the Committee on Ways and Means.
H.R. 5926	07/29/10	Markey, Ed (D-MA)	A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of comprehensive Alzheimer's disease and other dementia diagnosis and services in order to improve care and outcomes for Americans living with Alzheimer's disease by increasing detection, diagnosis, care, and planning; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 5936	07/29/10	Reichert, Dave (R-WA)	A bill to repeal limitations imposed by the Patient Protection and Affordable Care Act on health-related tax benefits under the Internal Revenue Code of 1986 and to treat high deductible health plans as qualified health plans under such Act; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H.R. 5950	07/29/2010	Courtney, Joe (D-CT)	A bill to amend title XVIII of the Social Security Act to count a period of observation status in a hospital exceeding 24 hours toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce.
H.R. 5961	07/29/2010	Maffei, Dan (D-NY)	A bill to require the Secretary of Health and Human Services to establish a demonstration project to award grants to, and enter into contracts with, medical-legal partnerships to assist patients and their families to navigate health-related programs and activities; Referred to the Committee on Energy and Commerce.
H.R. 5986	07/30/2010	Johnson, Hank (D-GA)	A bill to require the submission of a report to the Congress on parasitic disease among poor Americans; Referred to the Committee on Energy and Commerce.
H.R. 5987.	07/30/2010	Pomeroy, Earl (D-ND)	A bill to ensure that seniors, veterans, and people with disabilities who receive Social Security and certain other Federal benefits receive a one-time $250 payment in the event that no cost-of-living adjustment is payable in 2011; Referred to the Committee on Ways and Means, and in addition to the Committees on Transportation and Infrastructure, and Veterans' Affairs.
H.R. 6000	07/30/2010	Grayson, Alan (D-FL)	A bill to provide for criminal liability for the denial of health care coverage of a treatment or an individual, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary.
H.R. 6002	07/30/2010	Costello, Jerry (D-IL)	A bill to amend title II of the Social Security Act to provide that the waiting period for disability insurance benefits shall not be applicable in the case of a disabled individual suffering from a terminal illness; Referred to the Committee on Ways and Means.
H.R. 6005	07/30/2010	Burgess, Michael (R-TX)	A bill to amend titles XVIII and XIX of the Social Security Act to provide for the temporary treatment of certain electronic health records as certified EHR technology for purposes of health information technology payment incentives under the Medicare and Medicaid Programs; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.
H.R. 6012	07/30/2010	Space, Zack (D-OH)	A bill to direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes; Referred to the Committee on Energy and Commerce.
H.R. 6032	07/30/2010	Green, Gene (D-TX)	A bill to amend the Public Health Service Act to authorize appointment of Doctors of Chiropractic to regular and reserve corps of the Public Health Service Commissioned Corps, and for other purposes; Referred to the Committee on Energy and Commerce.
S. 3683	08/02/2010	Udall, Tom (D-NM)	A bill to support and encourage the health and well-being of elementary school and secondary school students by enhancing school physical education and health education; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3686	08/02/2010	Harkin, Tom (D-IA)	An original bill making appropriations for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2011, and for other purposes; Referred to the Committee on Appropriations.
S. 3684	08/02/2010	Udall, Tom (D-NM)	A bill to establish the Cavernous Angioma CARE Center (Clinical Care, Advocacy, Research and Education) at the University of New Mexico, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3690	08/03/2010	Bennet, Michael (D-CO)	A bill to provide for additional quality control of drugs; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3697	08/04/2010	Brownback, Sam (R-KS)	A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the priority review voucher incentive program relating to tropical and rare pediatric diseases; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3698	08/04/2010	Collins, Susan (R-ME)	A bill to amend the Public Health Services Act to provide for integration of mental health services and mental health treatment outreach teams, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3703	08/04/2010	Murray, Patty (D-WA)	A bill to expand the research, prevention, and awareness activities of the Centers for Disease Control and Prevention and the National Institutes of Health with respect to pulmonary fibrosis, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3708	08/05/2010	Schumer, Charles (D-NY)	A bill to amend titles XVIII and XIX of the Social Security Act to clarify the application of EHR payment incentives in cases of multi-campus hospitals; Referred to the Committee on Finance.
S. 3709	08/05/2010	Whitehouse, Sheldon (D-RI)	A bill to amend the Public Health Services Act and the Social Security Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Referred to the Committee on Finance.
S. 3711	08/05/2010	Kerry, John (D-MA)	A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish, promote, and support a comprehensive prevention, education, research, and medical management referral program for viral hepatitis infection that will lead to a marked reduction in the disease burden associated with chronic viral hepatitis and liver cancer; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3723	08/05/2010	Coburn, Tom (R-OK)	A bill to prohibit taxpayer funding of insurance plans or health care programs that cover abortion; Referred to the Committee on Health, Education, Labor, and Pensions.
S. 3737	08/05/2010	Enzi, Mike (R-WY)	A bill to amend the Public Health Service Act and title XVIII of the Social Security Act to make the provision of technical services for medical imaging examinations and radiation therapy treatments safer, more accurate, and less costly; Referred to the Committee on Health, Education, Labor, and Pensions.

Federal Register notices

August 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Agency Information Collection Activities; Submission for Office

of Management and Budget Review; Comment Request; Human Tissue Intended

for Transplantation

ACTION: Notice.

Food and Drug Administration

Guidance for Industry and Researchers on the Radioactive Drug

Research Committee: Human Research Without an Investigational New Drug

Application; Availability

ACTION: Notice.

August 3

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Changes to the Hospital Outpatient Prospective

Payment System and Ambulatory Surgical Center Payment System for CY

2010, and Extension of Part B Payment for Services Furnished by

Hospitals or Clinics Operated by the Indian Health Service, Indian

Tribes, or Tribal Organizations Made by the Affordable Care Act

ACTION: Notice.

SUMMARY: This Notice contains the final wage indices, hospital

reclassifications, payment rates, impacts and addenda for payments made

under the Medicare hospital outpatient payment system (OPPS) for CY

2010. This Notice also contains the payment rates and addenda for

payments made under the Medicare Ambulatory Surgical Center (ASC)

payment system for CY 2010. The final rates, wage indices, addenda and

impacts for the OPPS and as applicable for the ASC payment system

contained in this Notice reflect the provisions of the Affordable Care

Act. It also announces the extension of payment under Medicare Part B

to hospitals and ambulatory care clinics operated by the Indian Health

Service, Indian Tribes, or Tribal Organizations.

DATES: Effective Date: The revised CY 2010 national unadjusted OPPS and

ASC payment rates described in this Notice are effective for payments

for services furnished on or after January 1, 2010.

Centers for Medicare & Medicaid Services

Medicare Program: Changes to the Hospital Outpatient Prospective

Payment System and CY 2010 Payment Rates; Changes to the Ambulatory

Surgical Center Payment System and CY 2010 Payment Rates; Corrections

Book 2 of 3 books

ACTION: Correction of final rule with comment period.

SUMMARY: This document corrects technical errors that appeared in the

final rule with comment period found in the Federal Register (FR) on

November 20, 2009, entitled ``Medicare Program: Changes to the Hospital

Outpatient Prospective Payment System and CY 2010 Payment Rates;

Changes to the Ambulatory Surgical Center Payment System and CY 2010

Payment Rates'' and in the correction document found in the Federal

the Hospital Outpatient Prospective Payment System and CY 2010 Payment

Rates; Changes to the Ambulatory Surgical Center Payment System and CY

2010 Payment Rates.''

DATES: Effective Date: This document is effective on August 3, 2010.

Applicability Date: The corrections in this document are applicable

on and after January 1, 2010.

Centers for Medicare & Medicaid Services

Medicare Program; Proposed Changes to the Hospital Outpatient

Prospective Payment System and CY 2011 Payment Rates; Proposed Changes

to the Ambulatory Surgical Center Payment System and CY 2011 Payment

Rates; Proposed Changes to Payments to Hospitals for Certain Inpatient

Hospital Services and for Graduate Medical Education Costs; and

Proposed Changes to Physician Self-Referral Rules and Related Changes

to Provider Agreement Regulations

ACTION: Proposed rule.

Book 3 of 3 books

SUMMARY: This proposed rule would revise the Medicare hospital

outpatient prospective payment system (OPPS) to implement applicable

statutory requirements and changes arising from our continuing

experience with this system and to implement certain provisions of the

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

Care and Education Reconciliation Act of 2010 (Affordable Care Act). In

this proposed rule, we describe the proposed changes to the amounts and

factors used to determine the payment rates for Medicare hospital

outpatient services paid under the prospective payment system. These

proposed changes would be applicable to services furnished on or after

January 1, 2011.

Food and Drug Administration

Draft Guidance for Industry on Residual Drug in Transdermal and

Related Drug Delivery Systems; Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a draft guidance for industry entitled ``Residual Drug

in Transdermal and Related Drug Delivery Systems.'' This draft guidance

provides recommendations to developers and manufacturers of transdermal

drug delivery systems (TDDS), transmucosal drug delivery systems

(TMDS), and topical patch products regarding use of an appropriate

scientific approach during product design and development--as well as

during manufacturing and product lifecycle management--to ensure that

the amount of residual drug substance at the end of the labeled use

period is minimized. The draft guidance is applicable to

investigational new drug applications (INDs), new drug applications

(NDAs), abbreviated new drug applications (ANDAs), and supplemental new

drug applications (sNDAs) for TDDS, TMDS, and topical patch products.

Food and Drug Administration

Guidance for Industry on Label Comprehension Studies for

Nonprescription Drug Products; Availability

ACTION: Notice.

Food and Drug Administration

Medical Device User Fee Rates for Fiscal Year 2011

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

fee rates and payment procedures for medical device user fees for

fiscal year (FY) 2011.

Food and Drug Administration

Design of Clinical Trials of Aerosolized Antimicrobials for the

Treatment of Cystic Fibrosis; Public Workshop

ACTION: Notice of public workshop.

Office of Consumer Information and Insurance Oversight

Planning and Establishment of State-Level Exchanges; Request for

Comments Regarding Exchange-Related Provisions in Title I of the

Patient Protection and Affordable Care Act

ACTION: Request for comments.

SUMMARY: This document is a request for comments regarding the

Exchange-related provisions of the Patient Protection and Affordable

Care Act (the Affordable Care Act), enacted on March 23, 2010. The

Department of Health and Human Services (HHS) invites public comments

in advance of future rulemaking and grant solicitations.

DATES: Submit written or electronic comments by October 4, 2010.

Office of the Secretary

Delayed Update of the HHS Poverty Guidelines for the Remainder of

2010

ACTION: Notice.

SUMMARY: This notice provides a delayed update of the Department of

Health and Human Services (HHS) poverty guidelines for the remainder of

2010, and until the 2011 poverty guidelines are published, which is

expected to occur in late January 2011. HHS is issuing this delayed

update due to recent legislation that prohibited the Secretary of HHS

from publishing 2010 poverty guidelines before May 31, 2010, and

required that the 2009 poverty guidelines remain in effect until the

Secretary of HHS published updated guidelines.

Office of the Secretary, Office of Public Health and Science

Solicitation of Nomination for Appointment to the Chronic Fatigue

Syndrome Advisory Committee

ACTION: Notice.

The President

Proclamation 8544--45th Anniversary of Medicare and Medicaid

August 4

Centers for Medicare & Medicaid Services

Medicare Program; Listening Session Regarding Confidential

Feedback Reports and the Implementation of a Value-Based Payment

Modifier for Physicians, September 24, 2010

ACTION: Notice of meeting.

SUMMARY: This notice announces a listening session being conducted as

part of the transition to a value-based purchasing program for services

of physicians and certain other professionals, as well as other related

provisions under the Patient Protection and Affordable Care Act (known

as the Affordable Care Act (ACA)). This public law contains provisions

that continue and expand the Physician Feedback Program and also

require implementation of a value-based payment modifier to the fee-

for-service physician fee schedule. The purpose of the listening

session is to solicit comments on approaches being considered as we

implement these provisions. Physicians, physician associations, and all

others interested in the use of confidential feedback reports as one

means of enhancing quality and efficiency are invited to participate,

in person or by calling in to the teleconference. The meeting is open

to the public, but attendance is limited to space and teleconference

lines available. Background information, including the relevant

preamble language from calendar year (CY) 2011 Physician Fee Schedule

proposed rule will be posted on the CMS Web site at http://

www.cms.hhs.gov/center/physician.asp approximately 1 week prior to the

session.

DATES: Meeting Date: The listening session will be held on Friday,

September 24th from 10 a.m. until 4 p.m. Eastern Daylight Time (e.d.t.)

Deadline for Meeting Registration and Request for Special

Health Resources and Services Administration

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

Proposed Project: Scholarships for Disadvantaged Students (SDS) Program

(OMB No. 0915-0149)--Extension

The Scholarships for Disadvantaged Students (SDS) Program has as

its purpose, the provision of funds to eligible schools to provide

scholarships to full-time, financially needy students from

disadvantaged backgrounds enrolled in health professions and nursing

programs.

August 5

Agency for Healthcare Research and Quality

Solicitation for Nominations for New Clinical Preventive Health

Topics To Be Considered for Review by the United States Preventive

Services Task Force

ACTION: Solicit for new topic nominations.

Food and Drug Administration

Center for Devices and Radiological Health 510(k) Working Group

Preliminary Report and Recommendations, and Task Force on the

Utilization of Science in Regulatory Decision Making Preliminary Report

and Recommendations; Availability; Request for Comments

ACTION: Notice; request for comment.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability for public comment of a two-volume set of documents

entitled ``Center for Devices and Radiological Health Preliminary

Internal Evaluations,'' which is comprised of the preliminary reports

of two internal committees: The 510(k) Working Group and the Task Force

on the Utilization of Science in Regulatory Decision Making.

DATES: Submit either electronic or written comments on the preliminary

report by October 4, 2010.

August 6

No relevant notices.