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.”
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.
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.
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.
Recent Congressional health policy hearings have addressed the following issues:
- The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on generic drug pricing;
- The House Oversight and Government Reform Committee focused on its concerns associated with transparency in passage and implementation of the Affordable Care Act in a hearing featuring CMS Administrator Marilyn Tavenner and Massachusetts Institute of Technology Professor Dr. Jonathan Gruber (); and
- The House Energy and Commerce Committee addressed fiscal challenges and opportunities for savings within the federal health care budget, and the future of the Children’s Health Insurance Program.
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.
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.
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 high‑quality 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.
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.
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.”
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:Continue Reading...
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:Continue Reading...
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.
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.
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.
Recent Congressional hearings on health policy issues include the following:
- A House Energy and Commerce Health Subcommittee “21st Century Cures Roundtable” discussed steps Congress can take to bridge the gap between medical advances and the regulatory policies that govern them, and ultimately advance digital and personalized health care. The panel also released a related white paper on digital health care and is seeking feedback on this topic through July 22, 2014.
- The Energy and Commerce Oversight Subcommittee held a hearing on “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse.” The Committee also held hearings on health care access under the ACA.
- The Senate Special Committee on Aging held a hearing entitled “State of Play: Brain Injuries and Diseases of Aging.”
- The Ways and Means Health Subcommittee held a hearing on MedPAC's June Report to the Congress on Medicare delivery reforms.
- The House Oversight and Government Reform Committee held a hearing on health insurance company profits under the ACA.
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.
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.