Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Lawmakers Continue Negotiations on Next COVID Package

Senate Republicans remain at work on the next round of aid to strengthen the economy and support the country’s health care infrastructure in response to the COVID-19 pandemic. Senate Majority Leader Mitch McConnell (R-Ky.) has previewed the Republican proposal, highlighting jobs, health care, schools, and liability protections as the four major themes of the forthcoming stimulus package. McConnell has said that the bill will include another round of loans for the Paycheck Protection Program (PPP), another round of stimulus checks for individual Americans, and provisions to protect seniors from a potential increase in their health insurance premiums. Congressional Republicans and the White House, however, are still at odds on several policies, including stimulus check eligibility and a possible payroll tax cut. The White House has expressed reservations about including additional resources for testing and contact tracing, which McConnell has indicated will be included in the legislation. Despite these reservations, the White House announced the award of $7.6 million to expand the availability of high-capacity testing machines made by Hologic. The House New Democrat Coalition has also characterized new funding for testing and contact tracing as essential for the next pandemic package. Senate Democrats have raised concerns that the Republican proposal does not include hazard pay for workers, adequate support for state and local governments, or maintain enhanced unemployment benefits. House Speaker Nancy Pelosi (D-Calif.) has stated she would like to reach an agreement by the end of the week, although Treasury Secretary Steven Mnuchin intimated that expiring provisions, such as unemployment insurance may pass this week while other parts of the legislation will continue to be negotiated through the August recess.

President Signs New EOs on Drug Pricing

On Friday, President Trump released several new executive orders to lower drug prices. He also previewed a most favored nations order, which would cap the price Medicare pays for Part B drugs based on the costs charged in comparable foreign countries. The policy goes into effect on August 25 if the pharmaceutical industry does not reach an alternative agreement with the administration in the meantime. The Executive Order on Access to Affordable Lifesaving Medications provides for the U.S. Department of Health and Human Services (HHS) Secretary to take action to ensure that future grants to federally-qualified health centers (FQHCs) are conditioned on the FQHC having established practices to make insulin and injectable epinephrine available at the 340B discounted price to individuals with low incomes who (1) have cost-sharing for insulin or injectable epinephrine; (2) have a high unmet deductible; or (3) have no health insurance. Further detail on who would qualify is to be established by the Secretary. The Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen directs the HHS Secretary to complete the rulemaking process he commenced to eliminate safe harbor protection from antikickback law for payments from manufacturers to insurers, pharmacy benefit managers (PBMs), and pharmacies in Part D and establish new safe harbors for discounts to the patient at the point-of-sale. The HHS Secretary, prior to taking this action, must publicly confirm that “the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.” The Executive Order on Increasing Drug Importation to Lower Prices for American Patients instructs the HHS Secretary to take action to complete the previous importation rulemaking process to allow importation of certain drugs from Canada. Additionally, he must facilitate the granting of waivers of the current prohibition on importation of drugs, “provided such importation poses no additional risk to public safety and results in lower costs to American patients[.]” Finally, he must take action to authorize the re-importation of insulin products upon a finding that it is required for emergency medical care.

House Passes First Set of FY21 Spending Bills

The House of Representatives approved a $259.5 billion spending package last week to fund Agriculture-Food and Drug Administration (FDA), Interior-Environment, Military Construction-Veterans Affairs, and State-Foreign Operations for fiscal year 2021 (FY21). The four-bill minibus (H.R.7608) was approved by a 224-189 vote. It is the first appropriations measure passed by either chamber of Congress this year. Prior to passage, lawmakers added a package of amendments that included changes to prevent the U.S. from withdrawing from the World Health Organization (WHO) and to emphasize the need for a binational COVID-19 testing strategy with Mexico. The House plans to vote on a seven-bill spending package (H.R.7617) this week that includes Defense, Commerce-Justice-Science, Energy and Water, Financial Services, Homeland Security, Labor-Health and Human Services-Education, and Transportation-Housing and Urban Development FY21 appropriations. These programs are currently funded through September 30, 2020.

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