21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

This post was written by Katie Pawlitz and Jeremy Alexander.

As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, and other issues.

This blog post focuses on the bill’s proposed Sunshine Act (aka Open Payments) changes, which would broaden exclusions related to the provision of education-related payments or transfers of value.

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House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, and other issues  It also would exclude journals, reprints, and other education-related items and payments from Physician Payment Sunshine Act reporting.

During markup, the panel approved an amendment offered by Chairman Upton making a number of policy revisions and offsets, including, among other things, provisions that:

  • Limit Medicaid durable medical equipment reimbursement rates to Medicare fee-for-service rates applicable in the state, effective January 1, 2020;
  • Make various changes to Medicare imaging reimbursement policy, including modification of Medicare physician fee schedule and outpatient prospective payment system payments to incentivize the transition from traditional x-ray imaging to digital radiography (with payment reductions for the use of non-digital technology) and a requirement that the Secretary conduct an empirical analysis before applying the multiple procedure payment reduction to the professional component of imaging services;
  • Implement OIG recommendation to delay certain Medicare Part D prescription drug plan prepayments;
  • Establish a Cures Innovation Fund equal to $110 million for each of fiscal years 2016 through 2020; and
  • Exempt certain FDA user fees from sequestration.

The bill now moves on to the full House.

Action Continues on 21st Century Cures Act; Hearings on Medicare Competition, ACA Implementation, Opioid Abuse

Later today, the full House Energy and Commerce Committee is scheduled to begin markup of the 21st Century Cures Act, following Health Subcommittee approval on May 14. Votes are expected tomorrow (markup was subsequently delayed until May 21).  Also today, the House Ways and Means Subcommittee on Health is holding a hearing on "Improving Competition in Medicare: Removing Moratoria and Expanding Access.”

Tomorrow the House Ways and Means Committee has scheduled a hearing on the use of administrative actions in Affordable Care Act implementation. On May 21, the Energy and Commerce Oversight Subcommittee will address state government efforts to combat opioid abuse.

Upcoming 21st Century Cures Markup, Hearings on Medicare Chronic Care, Competition

Tomorrow the House Energy & Commerce Health Subcommittee is scheduled to mark up the 21st Century Cures Act; the Subcommittee has posted a substitute amendment that will be considered by the panel.  Also tomorrow, the Senate Finance Committee is holding a hearing on improving care for Medicare patients with chronic conditions.

Looking ahead to next week, the House Ways and Means Subcommittee on Health is holding a hearing on May 19 entitled “Improving Competition in Medicare: Removing Moratoria and Expanding Access.”

Congressional Health Policy Hearings

Congressional committees have held a number of hearings recently on health policy issues, include the following

Looking ahead, the following hearings are scheduled next week:

Congressional Health Policy Hearings

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program. Also on March 24, the House Ways and Means Subcommittee on Oversight examined CMS’s use of the Fraud Prevention System (FPS) to identify and stop Medicare fraud, and the Senate Health, Education, Labor and Pensions Committee held a hearing entitled “Continuing America's Leadership: Advancing Research and Development for Patients.” On March 25, the Senate Special Committee on Aging examined “The Fight Against Alzheimer's Disease: Are We on Track to a Treatment by 2025.” 

Ways & Means Committee Schedules March 24 Hearing on Use of Data Analysis to Stop Medicare Fraud

On March 24, the House Ways and Means Subcommittee on Oversight is holding a hearing on CMS’s use of the Fraud Prevention System (FPS) to identify and stop Medicare fraud. Government and non-governmental witnesses will discuss the progress that the FPS has made and how data analysis is being used to identify and stop Medicare fraud and waste.

March Congressional Health Policy Hearings

On March 10, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on “Continuing America’s Leadership in Medical Innovation for Patients,” featuring testimony from NIH Director Francis Collins, MD, PhD, and FDA Commissioner Margaret Hamburg, MD.  

On March 17, the HELP Committee has scheduled a hearing on “America’s Health IT Transformation: Translating the Promise of Electronic Health Records into Better Care.” The Senate Finance Committee is holding a hearing on the “Affordable Care Act at Five Years” on March 19. 

The Energy and Commerce has not yet rescheduled a previously-announced hearing on the 340B drug pricing program that was cancelled due to weather.

Upcoming House Hearing on 340B Program (March 25)

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. 

** Note: this hearing has been rescheduled for March 25.

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.

** These bills were approved with amendments

Energy & Commerce Committee Approves Bipartisan Public Health Bills

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).

Congressional Health Policy Hearings

The following Congressional panels have held hearings recently on various health policy issues:

Congressional Hearings to Focus on HHS Budget, Medical Preparedness, ACA Implementation

Three health policy hearings are scheduled for February 26, 2015:

House E&C Committee Schedules SGR Hearing (Jan. 21 & 22)

The House Energy and Commerce Subcommittee on Health has scheduled a two-day hearing for January 21 and 22 to discuss how to pass Sustainable Growth Rate (SGR) reform legislation before the current patch expires at the end of March 2015.

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

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.

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.”

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.

Older Entries

June 25, 2014 — Congressional Hearings Examine Medicare Fraud, ACA, Digital Health, MedPAC Report, Brain Injuries

June 2, 2014 — House Energy and Commerce Subcommittee Approves Health Bills

June 2, 2014 — Congressional Health Policy Hearings

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

March 24, 2014 — March Congressional Health Policy Hearings

March 4, 2014 — Congressional Health Policy Hearings

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

January 30, 2014 — Congressional Health Policy Hearings

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

December 10, 2013 — Senate Finance Committee Schedules SGR Markup

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

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

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

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

September 16, 2013 — Congressional Health Policy Hearings

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 — Health Policy Hearings

June 11, 2013 — Health Policy Hearings

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

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

March 28, 2013 — Congressional Health Policy Hearings

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

March 12, 2013 — Congressional Hearings

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

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

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

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

September 27, 2012 — Congressional Health Policy Hearings

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

September 5, 2012 — Congressional Hearings

July 31, 2012 — Congressional Health Policy Hearings

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

June 18, 2012 — June Congressional Health Policy Hearings

June 8, 2012 — House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

May 31, 2012 — House Panel Takes Up ACA Medical Device Tax Repeal, Other Health Tax Policy Bills

May 31, 2012 — Congressional Health Policy Hearings

May 14, 2012 — Congressional Health Policy Hearings

May 11, 2012 — House Panel Unanimously Approves FDA User Fee Act

April 23, 2012 — Ways & Means Bill Would Recapture Additional ACA Subsidy Overpayments.

April 23, 2012 — April Congressional Health Policy Hearings and Markups

March 29, 2012 — Congressional Health Policy Hearings

March 14, 2012 — Two House Panels Approve IPAB Repeal Legislation

March 14, 2012 — Congressional Hearings on Drug Issues.

February 24, 2012 — Congressional Health Policy Hearings & Markups

February 10, 2012 — February Congressional Health Policy Hearings

January 25, 2012 — Second House Committee Votes to Repeal ACA CLASS Program

January 25, 2012 — E&C Health Subcommittee Plans FDA User Fee Hearings in February

January 23, 2012 — E&C Health Subcommittee Plans FDA User Fee Hearings in February

December 13, 2011 — December Congressional Health Policy Hearings

December 13, 2011 — Counterfeit Drug Penalties

December 13, 2011 — ACA CLASS Program Repeal Bill Advances

November 29, 2011 — House Panel Votes to Repeal ACA CLASS Program

November 29, 2011 — Congressional Health Policy Hearings

November 11, 2011 — Congressional Health Policy Hearings & Markups

October 28, 2011 — Energy & Commerce Hearings on ACA Policy Issues

October 12, 2011 — Hearings this Week on Medicare Reform, Chronic Care, Employer-Provided Insurance

September 29, 2011 — Congressional Hearings Examine Variety of Health Industry Issues

September 22, 2011 — Upcoming House Hearings on Drug Shortages, Device/Drug Regulations

September 8, 2011 — Upcoming Congressional Hearings on Health Care Industry Consolidation, Pharmaceutical Supply Chain Security

September 1, 2011 — Senate HELP Committee Markup of GME/Autism Bills.

July 29, 2011 — Congressional Panels Consider Generic Drug Promotion, Other Health Policy Legislation

July 29, 2011 — Congressional Health Policy Hearings

July 18, 2011 — July Congressional Health Policy Hearings/Markups

June 24, 2011 — Congressional Hearings on Health Policy Issues

June 24, 2011 — Upcoming Markup of GME, Autism Policy Legislation

June 13, 2011 — June Congressional Hearings on Health Policy Issues

May 31, 2011 — Senate Judiciary Committee Clears Anti-Fraud Legislation

May 31, 2011 — Congressional Hearings on Health Policy Issues

May 13, 2011 — House Panel Approves Bill to Repeal Medicaid/CHIP Maintenance of Eligibility Requirements

May 13, 2011 — Congressional Hearings on Health Policy Issues

May 13, 2011 — Health Care Liability Reform

April 13, 2011 — House Panel Approves Bills to Roll Back Certain ACA Funding

April 13, 2011 — Congressional Health Policy Hearings

April 12, 2011 — Congressional Hearings This Week on FDA Medical Device Approvals, Drug Imports/Diversion

March 29, 2011 — Congressional Hearings on ACA, Medicare & Other Health Policies

March 11, 2011 — Upcoming Congressional Hearings on the Affordable Care Act

March 7, 2011 — Congressional Hearings on the ACA, Health Care Fraud

February 24, 2011 — Upcoming Congressional Hearings on ACA and the States, Health Care Fraud

February 18, 2011 — House Committees Consider Medical Liability, Health Policy Bills

February 18, 2011 — Congressional Hearings

February 4, 2011 — Congressional Hearings on ACA Implementation Issues (Feb. 9-10)

January 28, 2011 — Congressional Hearings

January 11, 2011 — Upcoming Senate Hearings on ACA Implementation

December 15, 2010 — Health Policy Bills Approved