The House Energy and Commerce Subcommittee on Health will hold a hearing on Thursday, March 5, 2015 on “Examining the 340B Drug Pricing Program,” focusing on the functionality of the program and the extent to which it meets its goal of improving access to prescription drugs for needy patients at facilities serving these populations. Scheduled witnesses include officials from the Health Resources and Services Administration, the Government Accountability Office, and the Office of the Inspector General.
Ways and Means Committee to Markup Medicare Fraud, Competitive Bidding, and other Medicare Policy Bills
On February 26, 2015, the House Ways and Means Committee is scheduled to vote on the following bills:
- H.R. 1021, “Protecting the Integrity of Medicare Act of 2015” – a sweeping bill to promote Medicare program integrity and efficiency. Among many other things, the bill would: eliminate civil money penalties for inducements to physicians to limit services that are not medically necessary; create a Part D drug management program for beneficiaries at risk of prescription drug abuse; require MACs to establish improper payment outreach and education programs for providers; expand the Senior Medicare Patrol program; require the HHS Secretary to issue guidance on the application of the “Common Rule” protecting individuals involved in research; and require the Secretary to issue a report on how to establish a permanent physician-hospital gainsharing program.
- H.R. 284, “Medicare DMEPOS Competitive Bidding Improvement Act of 2015” -- which would require Medicare suppliers that bid under a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to submit binding bids or risk forfeiture of a surety bond.
- H.R. 876, “NOTICE Act” – which would require hospitals to provide certain notifications to individuals classified as being under observation status rather than admitted as inpatients.
- H.R. 887, “Electronic Health Fairness Act of 2015” -- which addresses the treatment of patient encounters in ambulatory surgical centers in determining meaningful electronic health record use.
On February 11, 2015, the House Energy and Commerce Committee approved the following bipartisan public health bills:
- H.R. 471, Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse);
- H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, as amended (to amend the Controlled Substances Act to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs);
- H.R. 647, Access to Life-Saving Trauma Care for All Americans Act (to reauthorize language from the Public Health Service Act to fund trauma care centers); and
- H.R. 648, Trauma Systems and Regionalization of Emergency Care Reauthorization Act (to reauthorize grants supporting state and rural development of trauma systems and authorize new regionalized emergency care model pilot projects).
The following Congressional panels have held hearings recently on various health policy issues:
- The House Science, Space, and Technology Committee held a hearing entitled, “Can Americans Trust the Privacy and Security of their Information on HealthCare.gov?”;
- The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the reemergence of vaccine-preventable diseases; and
- The Energy & Commerce Committee held hearings on ICD-10 implementation and federal mental health programs.
Earlier this month, the House of Representatives approved H.R. 596, a bill to repeal the Patient Protection and Affordable Care Act (PPACA) and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 and restore the laws as if the health reform provisions had never been enacted. The bill also directs the House Committees on Education and the Workforce, Energy and Commerce, Judiciary, and Ways and Means to develop alternative legislation to, among other things, lower health care premiums, ensure access to affordable health coverage for people with pre-existing conditions, and reform. The President has promised to veto the bill if it reaches his desk.
Three health policy hearings are scheduled for February 26, 2015:
- The Energy and Commerce Committee is holding a hearing on the Obama Administration’s proposed FY 2016 budget for the Department of Health and Human Services (HHS);
- The Senate HELP Committee is holding a hearing entitled “Medical and Public Health Preparedness and Response: Are We Ready for Future Threats?”; and
- The House Oversight and Government Reform Committee is holding a hearing entitled “From Health Care Enrollment to Tax Filing: A PPACA (Patient Protection and Affordable Care Act) Update."
On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) during expected debate in the coming months on Medicare physician fee schedule (MPFS) reform legislation or during future budget negotiations.
The following is a summary of the major Medicare, Medicaid, and related policy proposals contained in the FY 2016 budget proposal.Continue Reading...
Next week, the House is expected to take up H.R. 596, a bill to repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010 and restore the laws as if the health reform provisions had never been enacted. The bill also directs the House Committees on Education and the Workforce, Energy and Commerce, Judiciary, and Ways and Means to develop alternative legislation that meets various policy goals, including, among others: lowering health care premiums through increased competition and choice; preserving a patient's ability to keep his or her health plan if he or she likes it; providing people with pre-existing conditions access to affordable health coverage; reforming the medical liability system; increasing the number of insured Americans; expanding state flexibility to administer the Medicaid program; and expanding incentives to encourage personal responsibility for health care coverage and costs.
Although the Congressional Budget Office (CBO) typically releases a budget estimate for legislation scheduled for a floor vote, CBO announced today that it is unable to do so in this case. CBO explains that estimating the budget impact of this legislation would take weeks of CBO and Joint Committee on Taxation staff time “because there are hundreds of provisions in the laws that would be repealed and those provisions are in various stages of implementation.” The CBO did not point out that President Obama would undoubtedly veto the legislation if it were to reach his desk.
On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the drug and device approval processes; clinical trials; Medicare coverage, payment, and coding; drug safety; and other proposals intended to streamline medical technology regulations across government. The Committee invites interested stakeholders to submit specific suggestions about how to improve the legislation; no deadline is specified.
In a related development, on January 29, the Senate Health, Education, Labor and Pensions (HELP) Committee launched its own initiative to examine and reform public policies in order to speed patient access to safe and effective medical products and treatments. To kick off this effort, the HELP Committee released a report entitled “Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development.” The report seeks feedback on a series of questions on ways to decrease the time and costs associated with bringing medical products to patients, including questions related to: more effectively targeting government resources; evaluating public-private partnerships; promoting biomedical research; streamlining clinical trial requirements; modernizing Food and Drug Administration medical product approval processes; and harmonizing US regulations with international standards. Feedback is requested by February 23, 2015. The Committee also intends to hold a series of hearings on issues raised in the report.
On January 27, 2015, the House Energy and Commerce Subcommittee on Health held a hearing on bipartisan public health legislation, including:
- Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse);
- Improving Regulatory Transparency for New Medical Therapies Act (to amend the Controlled Substances Act to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs);
- Veteran Emergency Medical Technician Support Act (to provide demonstration grants to states with a shortage of emergency medical technicians (EMTs) to streamline licensing requirements for military veteran EMTs);
- Trauma Systems and Regionalization of Emergency Care Reauthorization Act (to reauthorize grants supporting state and rural development of trauma systems and authorize new regionalized emergency care model pilot projects); a bill to reauthorize language from the Public Health Service Act to fund trauma care centers; and
- National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act (to reauthorize programs to support state prescription drug monitoring programs).
On January 28, 2015, the Senate Finance Committee unanimously approved H.R. 22, the “Hire More Heroes Act," which is intended to allow businesses to hire veterans without them counting as a full-time employee under the Affordable Care Act (ACA) if the veteran already has medical coverage through the TRICARE program or the Veterans Administration. The House approved the legislation earlier this month.
Looking ahead, the following hearings are scheduled next week:
- A February 3 Energy and Commerce Oversight and Investigations Subcommittee hearing entitled “Examining the U.S. Public Health Response to Seasonal Influenza”; and
- A February 4 Senate Finance Committee hearing to consider the HHS budget request and review the Department’s operations, including ACA implementation. HHS Secretary Sylvia Burwell is scheduled to testify.
On January 8, 2015, the House of Representatives approved H.R. 30, the “Save American Workers Act.” The legislation would amend the ACA’s definition of “full-time employee” for purposes of the requirement that certain employers provide health care coverage for their full-time employees. Specifically, the bill, which was approved on a 252 to 172 vote, would define full-time employee as an employee who is employed on average at least 40 hours of service a week, rather than the ACA’s 30 hours. The Administration has promised to veto the legislation if it reaches the President’s desk.
This vote followed unanimous House passage of a separate bill, H.R. 22, the “Hire More Heroes Act of 2015.” H.R. 22 is intended to encourage businesses to hire veterans by permitting an employer, for purposes of determining whether the employer is an applicable large employer and thus required to provide health care coverage to its employees under the ACA, to exclude employees who have health coverage under TRICARE or the Veterans Administration.
Both bills are awaiting Senate consideration.
In December 2014, President Obama signed into a law H.R. 5771, a tax extender bill that includes the “Achieving a Better Life Experience (ABLE) Act of 2014.” As discussed in a previous post, the law, P.L. 113-295, includes three Medicare provisions to finance the ABLE Act: revisions to payment adjustments for Medicare physician fee schedule misvalued services, limits on Medicare coverage of vacuum erection systems, and an additional delay in implementation of oral-only end stage renal disease (ESRD)-related drugs in the ESRD PPS. President Obama also has signed into law S. 2917/P.L. 113-233, which adds Ebola to the FDA’s priority review voucher program.
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.