Legislative Activity

House Republicans Take Aim At Affordable Care Act

On Tuesday, February 3, the House of Representatives will consider 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 for other purposes. The bill, introduced by Bradley Byrne (R-AL), also carries instructions to the House committees of jurisdiction to consider replacement plans for Obamacare. The Congressional Budget Office has stated that it will be unable to score the bill for budgetary impacts before the House vote, however, due to the tight timeline for analysis of “hundreds of provisions.” President Barack Obama has vowed to veto the bill.

Similarly, last week, House Committee on Energy and Commerce Chairman Fred Upton (R-MI), House Committee on Ways and Means Chairman Paul Ryan (R-WI), and House Committee on Education and Workforce Chairman John Kline (R-MN) formed a working group to develop a replacement plan for the Affordable Care Act, as well as a strategy in the event the Supreme Court will invalidate the Exchange subsidies after hearing oral arguments on March 4. It remains to be seen whether these members will obtain party-wide support for their plan.

Lawmakers Focus On Medical Innovation: 21st Century Cures, Innovation for Healthier Americans, And Precision Medicine Initiative

On Tuesday, January 27, the House Committee on Energy and Commerce released draft legislation titled the “21st Century Cures Act” and announced that it is accepting comments on the draft from the stakeholder community. This discussion language is the long-awaited follow-up to the 21st Century Cures Initiative, a broad bipartisan effort that, through hearings, roundtables, and white papers, explored such topics as: innovating public health agencies, incorporating patient perspectives into the regulatory process, meeting unmet patient needs, improving medicine, and modernizing medical product regulation. The 393-page draft, which was not endorsed by the Democrats on the Committee, is separated into five titles: (I) Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs; (II) Building The Foundation For 21st Century Medicine, Including Helping Young Scientists; (III) Modernizing Clinical Trials; (IV) Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At The National Institutes Of Health (NIH), Food And Drug Administration (FDA), Centers For Disease Control And Prevention (CDC), And Centers For Medicare And Medicaid Services (CMS); and (V) Modernizing Medical Product Regulation.

On Thursday, January 29, the Senate Committee on Health, Education, Labor, and Pensions (HELP) Chairman Lamar Alexander (R-TN) and Sen. Richard Burr (R-NC) released a report titled “Innovation for Healthier Americans.” The report examines and identifies inefficiencies in the current drug and device development process at the NIH and FDA. The report parallels the 21st Century Cures discussion draft; however, unlike the discussion draft released by the House members, the Senate report identifies challenges without putting forth recommendations. Stakeholders are encouraged to submit feedback on how to best address the challenges by February 23, 2015. Chairman Alexander has reportedly stated that he is working with HELP Ranking Member Patty Murray (D-WA) on the Senate version of the initiative, which is to include hearings and a bipartisan staff working group. The Senators aim to draft bipartisan legislation that can be signed into law this year.

After President Obama announced a Precision Medicine Initiative during his State of the Union address, he unveiled the details on Friday: a $215 million program to study human genes at various stages of illness and health to gain knowledge on more tailored and personalized approaches towards cures. Specifically, the White House identified the following objectives of the Initiative: provide more and better treatments for cancer, create a voluntary national research cohort, continue a commitment towards protecting privacy, modernize regulations, and forge strong public-private partnerships. The Initiative is to provide $200 million in new spending to the National Institutes of Health, $70 million of which is to be designated to the National Cancer Institute; $10 million to the Food and Drug Administration; and $5 million to the Office of the National Coordinator for Health Information Technology (ONC). Chairman Upton and Chairman Alexander have both signaled their support of bipartisan initiatives regarding cutting-edge medicine and treatments.

This Week’s Hearings:

  • Monday, February 2: The House Committee on Rules will hold a hearing on 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 for other purposes.
  • Tuesday, February 3: The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations will hold a hearing titled “Examining the U.S. Public Health Response to Seasonal Influenza.” The Senate Committee on Armed Services will hold a hearing titled “Findings of the Military Compensation and Retirement Modernization Commission.”
  • Wednesday, February 4: The Senate Committee on Finance will hold a hearing titled “The President’s Budget for Fiscal Year 2016.” The Honorable Sylvia Mathews Burwell, Secretary, Department of Health and Human Services, is to testify.

Regulatory Activity

CMS Indicates New Rulemaking On Electronic Health Record Incentive Program

On Thursday, January 29, the Centers for Medicare and Medicaid Services (CMS) announced that it would soon initiate rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program so as to support the long-term goals of the program while reducing the reporting burden on health care providers. CMS has stated that it is considering proposals to: realign hospital EHR reporting periods by the calendar year; modify the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens; and shorten the EHR reporting period by 90 days. The new rule, expected this spring, would be separate from the Stage 3 meaningful use rules that are currently under Office of Management and Budget review.

Office of National Coordinator Releases IT Interoperability Roadmap And Standards Advisory

On Friday, January 30, the Department of Health and Human Services’ ONC released a draft roadmap titled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0.” The draft focuses on the goal of safe and secure exchanges and uses of electronic health information, so as to provide better care and healthier patients. This document is a follow-up to a vision paper titled “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure,” which was released by ONC in June 2014 and spurred comments and feedback from stakeholders and other experts. The draft Roadmap focuses on five building blocks that have been identified to achieve interoperability: (1) core technical standards and functions; (2) certification to support adoption and optimization of health information technology products and services; (3) privacy and security protections for health information; (4) supportive business, clinical, cultural, and regulatory environments; and (5) rules of engagement and governance.

ONC also released the “Draft 2015 Interoperability Advisory: The Best Available Standards and Implementation Specifications for Interoperability of Clinical Health Information” (known as the “Standards Advisory”). The Standards Advisory is ONC’s assessment of the best available standards and implementation specifications for clinical health information interoperability as of the end of 2014.

ONC is accepting comments on the draft Roadmap until April 3, 2015 and on the Standards Advisory until May 1, 2015