President Signs Government Funding Bill with Health Spending/Policy Provisions

On December 16, 2014, President Obama signed a $1.1 trillion spending bill that funds most government agencies through the end of the fiscal year on September 30, 2015 (funding for the Department of Homeland Security is funded through February 27, 2015). With regard to HHS funding, the bill, among other things: holds CMS funding at FY 2014 levels; provides no new funding for Affordable Care Act implementation and blocks the use of CMS program management funds to support risk corridor payments; provides emergency funding to address the Ebola crisis; increases National Institutes of Health funding by $150 million over FY 2014 levels; provides funds to FDA to investigate counterfeit drugs within the United States and internationally; and reduces funding for the Independent Payment Advisory Board (IPAB) by $10 million.  The explanatory statement also includes a number of health policy provisions. For instance, the report: expresses concerns about a CMS proposal to eliminate critical access hospital status for certain rural facilities; requests CMS to report on the impact of competitive bidding on treatment patterns of enteral nutrition patients residing in LTC facilities; directs CMS to review billing rules regarding implantable pain pump drugs; requests that CMS develop proposals to encourage short-cycle dispensing of outpatient prescription drugs in LTC facilities; directs CMS to educate providers on how to reduce Medicare claims errors, develop procedures to reduce the Office of Medicare Hearings and Appeals (OMHA) appeals backlog, and improve the appeals and audit processes; requests that CMS reconsider changes to payment for surgical procedures included in the annual Medicare physician fee schedule rule; and directs HRSA to work with covered entities under the 340B drug program “to better understand the way these entities support direct patient benefits from 340B discounted sales.”

Congress Approves "ABLE Act" with Medicare Offsets

On December 16, 2014, Congress gave final approval to H.R. 5771, a tax extender bill that includes the “Achieving a Better Life Experience (ABLE) Act of 2014.” The ABLE Act provisions allow individuals with disabilities to establish tax free savings accounts to pay for qualified expenses (e.g. medical, post-secondary education, housing, and transportation expenses). Prior to House consideration, three Medicare “offsets” were added to help pay for the bill – despite the concerns among a number of lawmakers about the need to reserve such offsets for helping to pay for future Medicare physician fee schedule (MPFS) sustainable growth rate formula reform legislation. The three Medicare provisions would: (1) accelerate the start date for payment adjustments for MPFS misvalued services to 2016 and revise the annual targets (saving $365 million); (2) prohibit Medicare coverage of vacuum erection systems until such time as Medicare covers erectile dysfunction drugs under Part D (saving $444 million); and (3) delay implementation of oral-only end stage renal disease (ESRD)-related drugs in the ESRD PPS until January 1, 2025. The bill is now awaiting the President’s signature.

Congressional Panels Seek Input on Medicare Fraud & Abuse, LDT, GME Legislation

In preparation for legislative activity early next year, various lawmakers have issued open requests for feedback on several health policy initiatives. For instance:

  • The House Ways and Means Health Subcommittee chairman and ranking member have released a bipartisan bill including a variety of Medicare fraud/abuse provisions, covering such issues as recovery audit contractors, prevention of Medicare Part D prescription drug abuse, elimination of civil monetary penalties for inducements to physicians to limit services that are not medically necessary, and others.
  • The House Energy and Commerce Committee is seeking feedback on the regulation of in vitro diagnostic test kits and laboratory developed tests (LTDs); comments are due by January 5, 2015.
  • The Energy and Commerce Committee also is requesting comments on graduate medical education (GME) financing, federal program governance and structure, and how it might be improved or restructured. Feedback is due by January 16.

Extension of Enforcement Moratorium on Rural Hospital Supervision Requirements

On December 4, 2014, President Obama signed into law H.R. 4067, which requires the Secretary of HHS to continue to instruct Medicare contractors not to enforce requirements for direct physician supervision of outpatient therapeutic services in critical access and small rural hospitals through 2014.

Congressional Health Policy Hearings

Recent Congressional health policy hearings have addressed the following issues:

Looking ahead to 2015, House Energy and Commerce Committee Chairman Fred Upton has indicated that his panel will hold a hearing on preparation for ICD-10 implementation

Congress Approves Bill to Incentivize Ebola Treatment/Vaccine Developments; Congressional Hearings Address Ebola Response

In light of the recent Ebola outbreak and concerns over health safety, Congress has approved a bill (S. 2917) that would add Ebola to the Food and Drug Administration’s (FDA) priority review voucher program, which is designed to incentivize the development of treatments and vaccines for neglected tropical diseases. The legislation was approved by the Senate on December 2, 2014, followed by the House on December 3, and is now awaiting the President’s signature.

The Ebola outbreak has also been the subject of several recent Congressional hearings. For instance, the Senate Homeland Security and Governmental Affairs Committee recently held a hearing entitled "Preparedness and Response to Public Health Threats: How Ready Are We?”  In addition, the House Energy and Commerce Committee has held hearings on medical product development in the wake of the Ebola epidemic and the U.S. public health response to the Ebola outbreak.

Congressional Hearing on Government Response to Ebola Crisis (Nov. 6)

On November 6, 2014, the Senate Appropriations Committee is holding a hearing on the U.S. government response to the Ebola outbreak. This follows an October 24 House Oversight Committee hearing on coordination of a multi-agency response to the Ebola crisis, along with an October 16 House Energy and Commerce Committee hearing on the U.S. public health response to the Ebola outbreak.

President Obama Signs Post-Acute Care Transformation Act and Other Health Policy Bills

On October 6, 2014, President Obama signed into law H.R. 4994, the Improving Medicare Post-Acute Care Transformation Act of 2014 (the “IMPACT Act”). The IMPACT Act’s provisions will affect a broad range of post-acute care (PAC) providers: home health agencies (HHAs), skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), and long-term acute care hospitals (LTCHs). Various facets of daily operations of these PAC providers will change as a result of the Act and ensuing regulations: what information PAC providers must collect and report, the information the public will receive about PAC providers, and the method of determining future Medicare payments to PAC providers, among others. The IMPACT Act also increases survey frequency for Medicare-certified hospice programs. A Reed Smith client alert summarizing the Impact Act is available here.

Separately, President Obama also signed into law a number of other health policy bills approved by Congress, including the following:

  • H.R. 594, Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of 2014, which revises and expands research, surveillance, and education activities relating to muscular dystrophy at the National Institutes of Health and the Centers for Disease Control and Prevention, and expands the federal agencies comprising the Muscular Dystrophy Coordinating Committee;
  • S. 2154, Emergency Medical Services for Children Reauthorization Act of 2014, which reauthorizes appropriations through fiscal year 2019 for a program to provide highquality emergency medical care to children; and
  • H.R. 4631, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2014, which reauthorizes Combating Autism Act funding for autism research, screening, intervention, and education activities, as well as an HHS coordinating committee.

Upcoming House Hearings to Address ACA Implementation, Accelerating Medical Innovation

On September 9, 2014, the House Energy and Commerce Subcommittee on Health is holding a hearing entitled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests.” The hearing will focus on the FDA’s recent guidance on the regulation of lab developed tests and its “impact on innovation and the practice of precision medicine.” The panel will also host a “roundtable” discussion September 10 at which HHS Secretary Burwell, NIH Director Collins, FDA Commissioner Hamburg, and other experts will address opportunities to accelerate the discovery, development, and delivery of new cures and treatments. In addition, two hearings are scheduled on ACA implementation. On September 10, the House Ways and Means Subcommittee on Health will review ACA Marketplace administration, including verification of tax credit eligibility. On September 18, the House Oversight and Government Reform Committee will address Healthcare.gov transparency, accountability, and information security.

House Panel to Examine FDA Lab-Developed Test Policy

On September 9, 2014, the House Energy and Commerce Subcommittee on Health is holding a hearing entitled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests.” The hearing will focus on the FDA’s recent guidance on the regulation of lab developed tests and its “impact on innovation and the practice of precision medicine.”

Two Health Policy Laws Enacted, Additional Bills Advance

On August 8, 2014, President Obama signed into law the following two bills approved by the Senate in July:

  • H.R. 4631, the Autism CARES Act, to continue federal research, early identification and intervention, and education related to autism; and
  • H.R. 3548, the Improving Trauma Care Act, to include in the Public Health Service Act definition of trauma injuries caused by thermal, electrical, chemical, or radioactive force.

In addition, prior to beginning the August recess, the House of Representatives approved the following bills:

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Ways and Means Committee Seeks Comments on Medicare Program Integrity Bill

The Chairman of the House Ways and Means Subcommittee on Health is seeking comments on a draft bill, the Protecting Integrity in Medicare Act of 2014, that is “aimed at combating fraud, waste and abuse in the Medicare program.” The bill covers a range of Medicare and Medicaid policies, from establishing new alternative sanctions for technical physician self-referral violations to providing more flexibility in meeting durable medical equipment (DME) documentation requirements. Among other things, the bill would: 

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Senate Aging Committee Calls for Medicare Audit, Local Coverage Policy Reforms

The Senate Aging Committee has released a staff report entitled “Improving Audits: How We Can Strengthen the Medicare Program for Future Generations.”  The report describes the burden audits can impose on providers, and raises concerns that CMS’s current efforts are “aimed more at identifying and recovering improper payments that have already occurred, rather than a proactive strategy to ensure that those errors are not made in the first place.” For instance, the Recovery Audit Contractor (RAC) contingency fee structure “could be viewed as providing an incentive to keep improper payment rates high.” The report also notes that inconsistent local coverage determinations (LCDs) can increase the burden on providers and contractors, since different rules apply depending on the location of the service provided. Moreover LCDs have not been targeted to the most costly, highly-utilized services in a consistent way and may lead to discrepancies in access to care based on the beneficiary’s location. The report includes a series of recommendations for reforms of the audit and local coverage decision processes, including consolidating post-payment review activities; revising the RAC incentive structure to focus on reduced improper payment rates; assessing the effectiveness of pre-payment review processes; improving provider education; and ensuring that LCDs are targeted and do not create inconsistent access to care. The report was issued in connection with a hearing on improving the Medicare audit program.

July Congressional Health Policy Hearings

Congressional panels have held numerous hearings on health policy issues this month, including the following:

  • The House Energy and Commerce Committee held a series of hearings on its “21st Century Cures” initiative, focusing on personalized medicine, barriers to evidence development and communication, technological innovations, the patient perspective, and modernizing clinical trials. A separate hearing focused on ACA’s insurance eligibility verification system. Coming up, the Committee will examine plan “bailouts” and cancellations under the ACA (July 28) and the status of ACA payment and verification systems (July 31).
  • The Ways and Means Committee held hearings on the integrity of the ACA’s premium tax credit verification system and the future of Medicare Advantage health plans.
  • The House Oversight Committee held a hearing on Medicare appeals reform.
  • The House Science, Space, and Technology Committee examined “Policies to Spur Innovative Medical Breakthroughs from Laboratories to Patients.” 
  • A Senate Finance Committee hearing focused on chronic illness and patients’ unmet needs.
  • The Senate Health, Education, Labor and Pensions Committee examined preventable deaths and improving patient safety. The Committee also approved a number of bipartisan bills, including S. 315, the "Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments; S 2154, the Emergency Medical Services for Children Reauthorization Act; S. 2405, the Trauma Systems and Regionalization of Emergency Care Reauthorization Act; S. 2406, the Improving Trauma Care Act; and S. 2539, the Traumatic Brain Injury Reauthorization Act.

Finance Committee Invites Comments on Health Care Data Transparency

Senate Finance Committee Chairman Ron Wyden and Ranking Member Chuck Grassley are asking providers, patients, insurers, entrepreneurs, and other stakeholders for ideas on ways to improve the availability and utility of health care data, while protecting patient privacy. In particular, the Senators are requesting information on: the data sources that should be made more broadly available; the form such data should be conveyed; ways to reduce the unnecessary fragmentation of health care data; and reforms to overcome barriers that stand in the way of effective use of existing data sources. Comments will be accepted until August 12, 2014.

Congressional Hearings Examine Medicare Fraud, ACA, Digital Health, MedPAC Report, Brain Injuries

Recent Congressional hearings on health policy issues include the following:

Bipartisan Health Bills Advance

This week the House is scheduled to consider five bipartisan public health bills addressing traumatic brain injuries, newborns, trauma patients, and individuals with autism. Specifically, the House is expected to vote on the following:

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Full Energy and Commerce Committee Approves Three Bipartisan Health Bills

On June 10, 2014, the full House Energy and Commerce Committee approved by voice vote three bipartisan public health bills:

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HHS Secretary Nominee Burwell Confirmed by Senate

The Senate has confirmed Sylvia Mathews Burwell to be Secretary of Health and Human Services on a bipartisan vote of 78 to 17.  Secretary Burwell was sworn in on June 9, 2014.

House Energy and Commerce Subcommittee Approves Health Bills

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:

  • H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for the use of controlled substances in clinical trials to allow treatments to get to patients in a more timely and predictable manner.
  • H.R. 4709, “Ensuring Patient Access and Effective Drug Enforcement Act,” which would amend the Controlled Substances Act to clarify definitions, allow parties to submit a corrective action plan prior to revocation or suspension of a registration, and require a report identifying how collaboration between agencies and stakeholders can benefit patient access to medications and prevent diversion and abuse of controlled substances.
  • H.R. 4631, “Combating Autism Reauthorization Act of 2014,” which would continue autism-related federal research, early identification and intervention, education, and activities of the Interagency Autism Coordinating Committee.

Older Entries

June 2, 2014 — Congressional Health Policy Hearings

June 2, 2014 — Finance Committee Endorses Burwell Nomination

May 19, 2014 — House Panel to Consider Bundled Post-Acute Care, Cancer Care Payment Parity Bills

May 14, 2014 — House Panel to Examine Medicare Hospital Issues (May 20)

May 13, 2014 — Senate Finance Committee Schedules Hearing on Burwell HHS Nomination

May 6, 2014 — Congressional Committees to Consider HHS Secretary Nomination, HHS Budget, ACA Implementation, Cancer Research

April 28, 2014 — Congressional Hearings this Week to Focus on Medicare Fraud, Telehealth

April 8, 2014 — April Congressional Hearings

April 8, 2014 — Children's Hospital GME Reauthorization Act Signed

April 4, 2014 — President Signs Medicare Physician Fee Schedule/SGR Patch with Numerous Health Policy Provisions

March 25, 2014 — As End of 3-Month SGR Patch Approaches, Hope Fading for Permanent Fix This Month

March 24, 2014 — March Congressional Health Policy Hearings

March 5, 2014 — Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

March 4, 2014 — Congressional Health Policy Hearings

February 13, 2014 — Bipartisan/Bicameral SGR Reform Bill Released; Offsets Not Yet Identified

February 13, 2014 — House Panel, GAO Examine Drug Shortages

February 12, 2014 — Congress Approves 1-Year Extension of Medicare Sequestration

January 30, 2014 — Omnibus Government Spending Signed to Fund HHS, Other Departments

January 30, 2014 — Congressional Health Policy Hearings

January 29, 2014 — SGR Reform/IPAB Connection - Will Medicare Physician Fee Schedule Fix Trigger IPAB Provider Cuts?

January 6, 2014 — House Panel to Examine Medicare "Extenders" Policy

December 30, 2013 — President Signs 2-Year Funding Bill with Medicare SGR Patch, Sequestration Extension for Medicare Providers

December 10, 2013 — Drug Distribution Security Legislation Signed into Law

December 10, 2013 — Senate Finance Committee Schedules SGR Markup

December 10, 2013 — Congressional Hearings Examine ACA Insurance Developments and Other Health Policies

December 10, 2013 — HIV Organ Policy Equity, PREEMIE Reauthorization Acts Signed into Law

December 3, 2013 — House Approves "Keep Your Health Plan Act"

November 25, 2013 — Congressional Panels Continue Focus on ACA Insurance Enrollment, Security, and Cost Issues, and Other Health Policy Topics

November 14, 2013 — House Schedules Vote on "Keep Your Health Plan Act"

November 14, 2013 — CBO Offers Deficit Reduction Options

November 14, 2013 — Congressional Hearings Focus on HealthCare.gov Enrollment, Other Policy Issues

November 14, 2013 — Health Policy Bills Advance

November 5, 2013 — Key House and Senate Panels Invite Comments on SGR Reform Plan (Due Nov. 12)

October 30, 2013 — Congressional Hearings Focus on Rocky HealthCare.gov Rollout

October 30, 2013 — Continuing Resolution for FY 2014 Adopted; Budget Panel Could Take Up Medicare Issues

September 17, 2013 — House Approves Bill to Require Verification of ACA Individual Subsidy Eligibility

September 16, 2013 — Upcoming House Hearings on ACA Implementation (Sept. 18 & 19)

September 16, 2013 — Congressional Health Policy Hearings

August 12, 2013 — Ways and Means Committee Releases Draft Medicare Post-Acute Care Reform Legislation

August 6, 2013 — Bill Introduced to Narrow Stark Exception for In-Office Services

July 29, 2013 — House Approves Legislation to Amend ACA to Delay Insurance Mandates

July 29, 2013 — House Panel Approves Bipartisan SGR Reform Bill

July 29, 2013 — Ways and Means Committee Invites Public Comment on Medicare Cost Sharing Proposals

July 29, 2013 — July Health Policy Hearings

July 29, 2013 — HIV Organ Policy Equity Act Advances

July 3, 2013 — House Panel Invites Comments on Draft SGR Reform Legislation

June 27, 2013 — Congressional Committees Seek Input on Post-Acute Care Reforms

June 27, 2013 — Health Policy Hearings

June 11, 2013 — Health Policy Hearings

June 11, 2013 — House Approves ACA Repeal Legislation

June 5, 2013 — House Approves Drug Distribution Security Plan

June 5, 2013 — House SGR Reform Efforts Continue - Hearing Today

May 11, 2013 — Senate Finance Members Seek Physician Input on SGR Reform

May 10, 2013 — Congressional Health Policy Hearings & Markups

April 24, 2013 — Lawmakers Float Draft Drug Distribution Security Plan; Comment Opportunity

April 15, 2013 — April Congressional Health Policy Hearings & Markups

April 11, 2013 — Updated House SGR Reform Proposal

April 10, 2013 — Obama Administration's Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

March 28, 2013 — President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

March 28, 2013 — Congressional Health Policy Hearings

March 27, 2013 — Senate HELP Committee Approves Organ Transplant, Animal Drug User Fee Bills

March 13, 2013 — Congress Clears Pandemic and All-Hazards Preparedness Reauthorization Act

March 12, 2013 — Congressional Hearings

March 4, 2013 — Medicare and Sequestration - What Happens Now?

February 18, 2013 — House Panels Invite Comments on Medicare SGR/Physician Fee Schedule Reform

February 18, 2013 — House Approves GME, Pediatric Research, and EMT Bills

February 18, 2013 — February Congressional Health Policy Hearings & Markups

February 18, 2013 — Finance Committee Compilation of Public Recommendations to Address Health Care Fraud and Abuse

February 11, 2013 — House Panel Hearing to Focus on Physician Payment/SGR Reform (Feb. 14)

January 30, 2013 — House Passes Pandemic and All-Hazards Preparedness Reauthorization Act

January 30, 2013 — House Energy and Commerce Committee Approves GME, Pediatric Research, and EMT Bills

January 30, 2013 — Senate HELP Committee Hold Hearings on Mental Health, Primary Care

January 28, 2013 — Reed Smith Analysis of Changes to Medicare Secondary Payer (MSP) Law

January 11, 2013 — New Law Establishes IVIG Demonstration/Makes MSP Policy Revisions

January 4, 2013 — Fiscal Cliff Deal Includes Medicare Cuts and Other Health Policy Changes

December 17, 2012 — December Congressional Hearings and Markups

December 5, 2012 — House Panel Schedules Hearing on Implementation of ACA's Exchanges and Medicaid Expansion (Dec. 13)

November 29, 2012 — GAO Assesses CMS Fraud Prevention System Implementation

November 12, 2012 — November Congressional Health Policy Hearings

October 15, 2012 — Short-Term Government Funding, FDA User Fee & Safe Doses Bills Signed into Law

September 28, 2012 — Congress Clears Short-Term Government Funding Bill

September 27, 2012 — Generic Drug User Fee Fix Cleared by Congress

September 27, 2012 — Senate Approves Legislation to Combat Medical Product Theft

September 27, 2012 — House Approves "Taking Essential Steps for Testing (TEST) Act"

September 27, 2012 — House, Senate Committee Votes on Health Research Measures

September 27, 2012 — House Panel Approves Changes to Medicare Secondary Payer (MSP), Medical Loss Ratio Rules

September 27, 2012 — Congressional Health Policy Hearings

September 17, 2012 — Budget Sequestration ("Fiscal Cliff") to Cost Medicare Providers $11 Billion in FY 2013, White House Reports

September 11, 2012 — Aging Committee Hearing on Physician Payments Sunshine Act (Sept. 12)

September 5, 2012 — Congressional Hearings

August 29, 2012 — Jumping Off The 'Fiscal Cliff'? What Can Happen When Congress Returns?

July 31, 2012 — Congressional Health Policy Hearings

July 19, 2012 — House Votes to Repeal ACA

July 19, 2012 — July Congressional Hearings

July 19, 2012 — House Appropriations Panel Votes to Defund ACA, AHRQ

July 6, 2012 — Congressional Panels Schedule Hearings on ACA Issues (Tax Policy, Physician/Economic Impact)

June 28, 2012 — Supreme Court Upholds ACA Insurance Mandate, Limits Withholding of Medicaid Funds to States

June 28, 2012 — Congress Clears FDA Safety & Innovation Act

June 27, 2012 — House Approves Medical Product Counterfeiting Act

June 18, 2012 — House Panel Clears Legislation to Address Medical Product Theft, Counterfeiting