On Feb. 6, the House Appropriations’ Labor-Health subcommittee held a hearing on the impact of the administration’s policies on the Affordable Care Act (ACA), specifically with regards to affordability, the increasing number of uninsured and the quality of the benefits available to people.
Find a link to witness testimonies, member statements and the hearing here.
Why this is important: The subcommittee’s new chairwoman, Rep. Rosa DeLauro (D-CT), said her intention with the hearing was to bring attention to the administration’s attempt to gut the Affordable Care Act (ACA) and to find ways to reverse the administration’s initiatives. Republicans on the panel invited as their witness Ed Haislmaier, senior fellow at the Heritage Foundation, a group that has pressed for the repeal of the ACA.
- Senate Health, Education, Labor and Pensions (HELP) Committee: How Primary Care Affects Health Care Costs and Outcomes
On Feb. 5, the Senate HELP Committee held a hearing on the importance of primary care in managing chronic conditions and preventing future health care costs.
Find a link to witness testimonies, member statements and the hearing here.
Why this is important: The hearing gave examples of various employer groups and primary care entrepreneurs that are bending the cost curve through the delivery of high-value care. Those testifying in front of the committee included primary care physicians and academics leading innovative primary care models such as Direct Primary Care (DPC) practices and an expert in employer health benefits.
House Democrats Introduce Legislation to Address Prohibition on CDC Gun Research
On Feb. 8, Rep. Robin Kelly (D-IL) introduced a bill to end a provision discouraging the Centers for Disease Control and Prevention (CDC) from researching gun violence, as part of a broader legislative package. The Recognizing Gun Violence as a Public Health Emergency Act requires the U.S. Surgeon General to provide an annual report to Congress on the public health impacts and cost of gun violence in America, and what the administration is doing as a response.
The move by House Democrats directly addresses the “Dickey Amendment,” a provision dating to the mid-1990s and written into annual congressional spending bills that bans the CDC from advocating for gun control, pausing federally funded research on the issue.
Monitor H.R. 114 here.
Doggett Introduces Bill for Medicare Drug Price Negotiations
On Feb. 7, House Ways and Means Health Subcommittee Chairman Lloyd Doggett (D-TX) introduced a bill requiring the Department of Health and Human Services (HHS) secretary to negotiate prices for drugs under Medicare Part D directly with drug manufacturers. If manufactures refuse to negotiate, the bill allows the HHS to issue competitive licenses to generic manufacturers whether or not the product in question has patent protection.
Under the bill, which mirrors parts of the Department of Veterans Affairs’ (VA) negotiation strategy, generic manufacturers would gain expedited review by the Food and Drug Administration (FDA). The bill has more than 100 House cosponsors. A companion bill is expected in the Senate.
Monitor H.R.1046 here.
Grassley, Leahy Reintroduce CREATES Act
On Feb. 5, Sens. Chuck Grassley (R-IA) and Patrick Leahy (D-VT) reintroduced the Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act, a bill to promote competition in the market for drugs and biological products. The bill allows a biosimilar or generic developer to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing. It also allows the Food and Drug Administration (FDA) to approve alternative Risk Evaluation and Mitigation Strategy, or REMS, programs if a generic or biosimilar developer and the innovator company are unable to arrive at a single shared system.
The bill is a response to brand-name drug manufacturers’ denying samples to generic companies, which need sometimes up to 5,000 samples of a drug to use for testing before they can gain regulatory approval from the FDA. The pharmaceutical industry expressed disapproval for the bill.
Monitor S.340 here.
Menendez, Boozman, and Schumer Introduce Legislation to add 15,000 Medicare-Funded Residency Slots
On Feb. 6, Sens. Bob Menendez (D-NJ), John Boozman (R-AR) and Senate Minority Leader Chuck Schumer (D-NY) reintroduced the Resident Physician Shortage Reduction Act, adding 15,000 additional Medicare-funded residency slots between 2021 and 2025. The legislation is a response to the Association of American Medical Colleges reporting the country is expected to face a physician shortage of more than 120,000 primary care doctors and specialists by 2030.
The bill also would require a Government Accountability Office (GAO) to study on strategies for increasing the health workforce diversity and requires hospitals to make sure at least 50 percent of the new graduate medical education (GME) supported spots are used for a shortage specialty residency program.
Pallone, Wyden Request GAO Determination on Administration’s Section 1332 Guidance
On Feb. 6, House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Senate Finance Ranking Member Ron Wyden (D-OR) sent a letter to the Government Accountability Office (GAO) seeking a determination on whether the Trump administration’s 2018 guidance on Section 1332 waivers is subject to the Congressional Review Act (CRA).
In Oct. 2018, the Trump administration issued new guidance on Section 1332 waivers, loosening the standards that states must meet to receive waiver approval. In the letter, Pallone and Wyden explained why they believe the 2018 guidance is a rule based upon the definition of the term “rule” as defined by the Administrative Procedure Act. If the GAO finds that the 2018 guidance qualifies as a rule then the guidance could be subject to the CRA, which allows Congress to overrule regulations issued by federal agencies through an expedited legislative process.
Read the letter here.
FDA Guidance: The Least Burdensome Provisions — Concept and Principles
On Feb. 4, the Food and Drug Administration (FDA) released final guidance on how it will apply least burdensome provisions of medical device review to a device’s total product life cycle, rather than just the premarket phase, while still ensuring devices meet safety and efficacy standards.
The final guidance is largely similar to the draft. Differences include new initiatives within FDA and industry relating to “just-in-time testing,” the use of FDA-recognized voluntary consensus standards, device submission efficiencies and FDA feedback regarding inspectional observations from device manufacturing facilities.
Read the full report here.
HHS Proposal Calls for Reforming Drug-Rebate System
Published on Feb. 6, a proposal by the Department of Health and Human Services (HHS) called for a ban on drug rebates, unless shared directly with seniors at the pharmacy counter, significantly lowering out-of-pocket retail drug spending for the minority of seniors on expensive drugs. The proposal would raise premiums for all Medicare beneficiaries. Part of the administration’s plan is set to take effect in a year and an anticipated legal challenge by pharmacy benefit managers (PBMs) could delay implementation.
The proposal cuts rebates tied to a percentage of list price that drug manufacturers pay to Part D plans, Medicaid managed care and PBMs by taking away the long-standing exemption for rebates in anti-kickback law. The administration proposed two new safe harbor protections: one that would allow rebates that are shared with patients at the point of sale, and another that would let PBMs charge flat fees for their services.
Comment period ends on April 8, 2019.
CMS Proposes Innovations in Technology to Promote Patient Access; Make Health Data Exchange a Reality
On Feb. 11, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) released proposed rules to support secure access, exchange, and use of electronic health information. The Interoperability and Patient Access Proposed Rule from CMS outlines opportunities to make patient data more useful and transferable through open, secure, standardized, and machine-readable formats while reducing restrictions on healthcare providers. The ONC rule calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will allow individuals to securely and easily access structured electronic health information (EHI) using smartphone applications.
In addition to the policy proposals, CMS released two Requests for Information (RFIs) to obtain feedback on interoperability and health information technology (health IT) adoption in Post-Acute Care (PAC) settings, and the role of patient matching in interoperability and improved patient care.
Comment period for the proposed rules and the RFIs closes in early April - exact date will be updated when the rules are posted to the Federal Register.
Find the proposed rules here.
CMS Proposes Medicare Advantage and Part D Payment and Policy Updates to Maximize Competition and Coverage
On Jan. 30, the Centers for Medicare & Medicaid Services (CMS) released Part II of the 2020 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part D Payment Policies (the Advance Notice), and the Draft Call Letter. CMS released Part I of the Advance Notice on Dec. 20. The proposed updates will continue to modernize and maximize competition among Medicare Advantage and Part D plans, as well as include actions to address the nation’s opioid crisis. The final 2020 Rate Announcement and final Call Letter will be published by April 1, 2019.
The proposed regulation topics include:
- 2020 Part C Risk Adjustment Model Proposals
- Encouraging plans to take advantage of the new flexibilities to offer targeted benefits and cost-sharing reductions for patients with chronic pain or undergoing addiction treatment
- Encouraging Part D sponsors to provide lower cost sharing for opioid-reversal agents
- Proposing steps to advance opioid-related measures through the Star Ratings development process
Comment period for Part I and Part II ends on March 1, 2019.
Find the proposed regulation for Part II here.
GAO: Medicaid — CMS Action Needed to Ensure Compliance with Abortion Coverage Requirements
On Feb. 4, the Government Accountability Office (GAO) released a report with three recommendations to the Centers for Medicaid and Medicare Services (CMS) to ensure compliance with federal requirements for abortion coverage. To receive federal funding, state Medicaid programs are supposed to meet federal health care coverage requirements. The GAO found state-reported practices that did not comply with federal requirements, including one state that did not cover abortion in cases of rape or incest and 14 states that did not cover the drug used in non-surgical abortions, even when the abortion was eligible for federal funding.
The Department of Health and Human Services (HHS) concurred with the following GAO recommendations:
- Ensure South Dakota’s Medicaid state plan provides coverage for abortions in cases of rape and in cases of incest, in addition to life endangerment.
- Determine the extent to which state Medicaid programs are in compliance with federal requirements regarding coverage of Mifeprex and take actions to ensure compliance.
- Determine the extent to which state Medicaid programs are accurately reporting fee-for-service abortions on line 14 of the CMS-64 and take actions to ensure accuracy.
Find the full report here.
White House Council of Economic Advisers: Deregulating Health Insurance Markets – Value to Market Participants
On Feb. 8, the White House Council of Economic Advisers released an analysis on the administration’s health care policies, including the elimination of the Affordable Care Act’s (ACA) individual mandate penalty and new rules around short-term and association health plans.
The report concluded that dropping the ACA’s mandate penalty is worth $14 billion in benefits per year. The advisers conclude that expanding access to short-term and association health plans is creating $16 billion in annual benefits. The report projects that the administration will generate another $15 billion in benefits per year through changes to labor taxation burdens.
Read the full report here.
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Mariam Eatedali, Research Associate
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