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Weekly Legislative & Regulatory Round-up

Week of June 12 - 18, 2010

GAO reports

Medicare Fraud, Waste, and Abuse: Challenges and Strategies for Preventing Improper Payments GAO-10-844T

Home Infusion Therapy: Differences between Medicare and Private Insurers' Coverage GAO-10-426

OIG reports

Advisory Opinion 10-08 (PDF) (concerning two affiliated corporate entities that each own and operate a freestanding radiation oncology center proposing to provide the services of a dietitian and social worker at no additional charge to each center’s Medicare cancer patients as part of the patients’ treatment)

Testimony of Lewis Morris (PDF), Chief Counsel to the Inspector General, before the Subcommittees on Health and Oversight of the U.S. House Ways and Means Committee on Reducing Fraud, Waste and Abuse in Medicare

Semiannual Report to Congress: Spring Fiscal Year 2010 (PDF)

OIG Reports More Than $3 Billion in Expected Recoveries from Fighting Fraud, Waste, and Abuse for the First Half of FY 2010: Press Release (PDF)

Medicare Part D – Prescription Drug Event Reconciliation Process (A-18-08-30102)

Review of the Centers for Disease Control and Prevention’s Resolution of Audit Recommendations (A-07-09-03131)

Bills introduced
Number/
Title
Date Introduced Sponsor Description

H. Res. 1438

06/14/2010

Paulsen, Erik (R-MN)

A resolution promoting increased awareness and diagnosis of peripheral arterial disease (PAD) to address the high mortality rate of this treatable disease; Referred to the Committee on Energy and Commerce.

S. 3491

06/15/2010

Inouye, Daniel (D-HI)

A bill to amend title XVIII of the Social Security Act to provide for patient protection by establishing safe nurse staffing levels at certain Medicare providers, and for other purposes; Referred to the Committee on Finance.

S. 3493

06/15/2010

Specter, Arlen (R-PA)

A bill to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers; Referred to the Committee on Health, Education, Labor, and Pensions.

H.R. 5527

06/15/2010

Capps, Lois (D-CA)

A bill to amend title XVIII of the Social Security Act to provide for patient protection by establishing safe nurse staffing levels at certain Medicare providers, and for other purposes; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H. Res. 1444.

06/15/2010

Pallone, Frank (D-NJ)

A resolution recognizing the 60th anniversary of the National Institute of Diabetes and Digestive and Kidney Diseases; Referred to the Committee on Energy and Commerce.

H. Res. 1445

06/15/2010

Rooney, Tom (R-FL)

A resolution expressing support for designation of July 17, 2010, as ``National Bladder Cancer Awareness Day''; Referred to the Committee on Oversight and Government Reform.

H.R. 5546

06/16/2010

Roskam, Peter (R-IL)

A bill to provide for the establishment of a fraud, waste, and abuse detection and mitigation program for the Medicare Program under title XVIII of the Social Security Act; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means.

H. Res. 1449

06/16/2010

MYRICK, Sue (R-NC)

A resolution supporting the observance of Thyroid Cancer Awareness Month and recognizing and applauding the work of national and community thyroid cancer organizations; Referred to the Committee on Energy and Commerce.

S. 3504

06/17/2010

Murray, Patty (D-WA)

A bill to establish a public education and awareness program relating to emergency contraception; Referred to the Committee on Health, Education, Labor, and Pensions.

H.R. 5560

06/17/2010

Moore, Dennis (D-KS)

A bill to amend the Public Health Service Act to improve quality of cancer care and quality of life for patients and survivors by coordinating development and distribution of information about relieving pain, symptoms, side effects, and stress; increasing awareness of treatment and post-treatment health risks for survivors; enhancing research into symptom management and survivorship; increasing health care professional education and training; reducing health disparities in cancer treatment, symptom management, and survivorship care; and expanding and enhancing cancer registries; and for other purposes; Referred to the Committee on Energy and Commerce.

H.R. 5561

06/17/2010

Slaughter, Louise (D-NY)

A bill to establish a public education and awareness program relating to emergency contraception; Referred to the Committee on Energy and Commerce.

 

Federal Register notices

June 14

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Developing Guidance on Naming, Labeling, and Packaging Practices

to Reduce Medication Errors; Public Workshop; Change of Meeting

Location

ACTION: Notice.

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

in location for the upcoming public workshop entitled ``Developing

Guidance on Naming, Labeling, and Packaging Practices to Reduce

Medication Errors.'' A new address is given for those attending the

workshop.

DATES: The public workshop will be held on Thursday and Friday, June 24

and 25, 2010, from 8:30 a.m. to 5 p.m. each day.

ADDRESSES: The public workshop will be held at the Holiday Inn College

Park, 10000 Baltimore Ave., College Park, MD 20740.

 

June 15

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

Agency Information Collection Activities; Submission for Office

of Management and Budget Review; Comment Request; The Mammography

Quality Standards Act Requirements

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.

 

Office of the National Coordinator for Health Information

Technology

Office of the National Coordinator for Health Information

Technology; HIT Policy Committee's Privacy & Security Tiger Team

Meeting; Notice of Meeting

ACTION: Notice of meeting.

Date and Time: The meeting will be held on June 29, 2010, from 8

a.m. to 5:15 p.m./Eastern Time.

Location: Grand Hyatt Washington Hotel, 1000 H Street, NW.,

Washington, DC 20001 (telephone: 202-582-1234).

 

June 16

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Disease Control and Prevention

Draft Guideline for the Prevention and Control of Norovirus

Gastroenteritis Outbreaks in Healthcare Settings

ACTION: Notice of availability and request for public comment.

SUMMARY: This notice is a request for review of and comment on the

Draft Guideline for the Prevention and Control of Norovirus

Gastroenteritis Outbreaks in Healthcare Settings, available on the

following Web site: http://www.cdc.gov/publiccomments/.

DATES: Comments must be received on or before July 16, 2010.

 

Food and Drug Administration

Agency Information Collection Activities; Proposed Collection;

Comment Request; Study of Clinical Efficacy Information in Professional

Labeling and Direct-to-Consumer Print Advertisements for Prescription

Drugs

ACTION: Notice.

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Establishment of the Personal Care Attendants Workforce Advisory

Panel

AGENCY: Community Living Assistance Services and Supports (CLASS)

Office, Department of Health and Human Services.

ACTION: Notice.

 

Office of the National Coordinator for Health Information

Technology

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 additional public meetings during June 2010: June 22nd

Privacy & Security Tiger Team, 10 a.m. to 1 p.m./ET; June 25th

Enrollment Workgroup, 9 a.m. to 10 a.m./ET; June 28th Enrollment

Workgroup, 10 a.m. to 1 p.m./ET and Privacy & Security Tiger Team, 2

p.m. to 4 p.m./ET. In addition, the June 28th Privacy & Security Policy

Workgroup, 2 p.m. to 4 p.m./ET, has been cancelled.

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

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

healthit.hhs.gov.

 

June 17

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

Medicare Program; Supplemental Proposed Changes to the Hospital

Inpatient Prospective Payment Systems for Acute Care Hospitals and the

Long-Term Care Hospital Prospective Payment System and Supplemental

Proposed Fiscal Year 2011 Rates; Corrections

ACTION: Correction of proposed rule.

SUMMARY: This document corrects technical and typographical errors in

the supplementary proposed rule entitled ``Medicare Program;

Supplemental Proposed Changes to the Hospital Inpatient Prospective

Payment Systems for Acute Care Hospitals and the Long-Term Care

Hospital Prospective Payment System and Supplemental Proposed Fiscal

Year 2011 Rates'' which appeared in the June 2, 2010 Federal Register.

 

Centers for Medicare & Medicaid Services

Medicare Program; Hospital Inpatient Prospective Payment Systems

for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-

Term Care Hospital Prospective Payment System and Rate Year 2010 Rates:

Final Fiscal Year 2010 Wage Indices and Payment Rates Implementing the

Affordable Care Act; Corrections

ACTION: Correction of notice.

SUMMARY: This document corrects technical errors in the notice entitled

``Medicare Program; Hospital Inpatient Prospective Payment Systems for

Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term

Care Hospital Prospective Payment System and Rate Year 2010 Rates:

Final Fiscal Year 2010 Wage Indices and Payment Rates Implementing the

Affordable Care Act'' which appeared in the June 2, 2010 Federal

Register.

DATES: Effective Date: This document corrects technical errors that

appeared in a notice that described revised standard Federal rates

effective for payment years beginning October 1, 2009. Hospitals are

paid based on the rates published in that notice, as corrected by this

document, for discharges on or after April 1, 2010.

 

Food and Drug Administration

Center for Drug Evaluation and Research Data Standards Plan;

Availability for Comment

ACTION: Notice.

 

Food and Drug Administration

Converged Communications and Health Care Devices Impact on

Regulation; Public Meeting; Request for Comments

ACTION: Notice of public meeting; request for comments.

 

Food and Drug Administration

Oversight of Laboratory Developed Tests; Public Meeting; Request

for Comments

ACTION:  Notice of public meeting; request for comments.

 

Food and Drug Administration

Risk Evaluation and Mitigation Strategies; Notice of Public

Meeting; Reopening of Comment Period

ACTION: Notice of public meeting; reopening of comment period.

 

Food and Drug Administration

Memorandum of Understanding Between the Food and Drug

Administration and Drugs.Com; Correction of Effective Date

ACTION: Notice; correction.

 

DEPARTMENT OF THE TREASURY

Internal Revenue Service

DEPARTMENT OF LABOR

Employee Benefits Security Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Interim Final Rules for Group Health Plans and Health Insurance

Coverage Relating to Status as a Grandfathered Health Plan Under the

Patient Protection and Affordable Care Act

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 status as a grandfathered health

plan.

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

June 14, 2010, except that the amendments to 26 CFR 54.9815-2714T, 29

CFR 2590.715-2714, and 45 CFR 147.120 are effective July 12, 2010.

    Comment date. Comments are due on or before August 16, 2010.

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Meeting of the Presidential Commission for the Study of

Bioethical Issues

AGENCY: Department of Health and Human Services, Office of Public

Health and Science, The Presidential Commission for the Study of

Bioethical Issues.

ACTION: Notice.

SUMMARY: The Presidential Commission for the Study of Bioethical Issues

(Amy Gutmann, PhD, Chair, and James Wagner, PhD, Vice Chair), will

conduct its first meeting to discuss the implications of synthetic

biology.

DATES: The meeting will take place Thursday, July 8, 2010, from 8:30

a.m. to 5 p.m., ET; and Friday, July 9, 2010, from 8:30 a.m. to 11:45

a.m., ET.

 

June 18

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

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

approved collection; Title of Information Collection: Healthcare

Effectiveness Data and Information Set (HEDIS[supreg]) Data Collection

for Medicare Advantage

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

Information Collection: The Medicare Acute Care Episode Demonstration

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

approved collection; Title of Information Collection: Medicare Waiver

Demonstration Application

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

approved collection; Title of Information Collection: Medicaid Drug

Program Monthly and Quarterly Drug Reporting Format

5. Type of Information Collection Request: Reinstatement with

change of a previously approved collection; Title of Information

Collection: Beneficiary Customer Service Feedback Survey

6. Type of Information Collection Request: Reinstatement with

change of a previously approved collection; Title of Information

Collection: Conditions of Coverage for Organ Procurement Organizations

and Supporting Regulations in 42 CFR, Sections 486.301-.348

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

approved collection; Title of Information Collection: End Stage Renal

Disease Medical Evidence Report Medicare Entitlement and/or Patient

Registration.

 

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Extension without change

of a currently approved collection; Title of Information Collection:

Requests by Hospitals for an Alternative Cost-to-Charge Ratio.

2. Type of Information Collection Request: Extension without change

of a currently approved collection; Title of Information Collection:

Subpart D--Private Contracts and Supporting Regulations contained in 42

CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455.

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

approved collection; Title of Information Collection: Skilled Nursing

Facility Health Care Complex Cost Report.

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

approved collection; Title of Information Collection: Medicaid Managed

Care Regulations for 42 CFR 438.6, 438.8, 438.10, 438.12, 438.50,

438.56, 438.102, 438.114, 438.202, 438.204, 438.206, 438.207, 438.240,

438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416,

438.604, 437.710, 438.722, 438.724, and 438.810.

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

Information Collection: Patient Safety Survey Under the 9th Scope of

Work: Nursing Home in Need (NHIN).

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

approved collection; Title of Information Collection: Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen.

7. Type of Information Collection Request: Reinstatement without

change of a previously approved collection; Title of Information

Collection: End Stage Renal Disease (ESRD) Medical Information Facility

Survey; Form Number: CMS-2744 (OMB: 0938-0447.)

8. Type of Information Collection Request: Reinstatement without

change of a previously approved collection; Title of Information

Collection: End Stage Renal Disease Death Notification P.L. 95-292; 42

CFR 405.2133, 45 CFR 5-5b; 20 CFR Parts 401 and 422E.

 

 

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