POLICY BRIEFINGS


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.


THIS WEEK'S BRIEFING - SEPTEMBER 30, 2019


CR Extending Funding Through Nov. 21 Signed Into Law


The Senate passed a stopgap spending measure (H.R. 4378) last week by a vote of 81-16 to prevent a government shutdown at the end of the fiscal year (FY) on September 30. The continuing resolution (CR) would fund the government at current levels through Thursday, November 21. The CR includes a package of health extenders that would temporarily extend current funding for several public health programs that have expired or are set to expire at the end of the month. The package also includes the bipartisan Fair and Accurate Medicaid Pricing (AMP) Act (H.R. 3276). This bill would repeal the requirement that drug manufacturers include the prices of certain authorized generics when calculating the average manufacturer price (AMP) of brand drugs and would exclude manufacturers from the definition of wholesalers in the calculation of Medicaid drug rebates. Estimates indicate that such changes will produce savings of $3.1 billion over the next decade. The CR, which passed the House last week, was signed into law by the President on Friday. Lawmakers, however, are no closer to reaching an agreement on the passage of FY 2020 appropriations legislation and continue to grapple with negotiations surrounding abortion policy, funding for a wall along the southern border, and overall top-line spending figures. Lawmakers have departed Washington for the next two weeks, leaving five legislative weeks before the November 21 deadline to fund the federal government.


Status of Drug Pricing Reforms Remains Unclear


Leadership of the Senate Finance Committee officially introduced the bill previously advanced by the panel that aims to lower the cost of prescription drugs. The text of the Prescription Drug Pricing Reduction Act (S. 2543) follows the committee’s consideration of a conceptual document in July and includes inflationary caps on price increases and requirements for pharmacy benefit managers (PBM) to disclose rebate information. While Chairman Chuck Grassley (R-Iowa) has stressed that this is the only bipartisan drug pricing bill in Congress to be advanced through the committee process, he has also acknowledged the possibility that drug pricing reform will be delayed until next year. Senate Majority Leader Mitch McConnell (R-Ky.) has not yet committed to bringing the bill to the floor for a vote. Grassley is reportedly working with Democrats in the House to see if any common ground on the issue of drug prices can be reached.

There is much speculation around the potential for the impeachment inquiry against President Trump to negatively impact bipartisanship in Congress and overshadow the congressional agenda for the rest of the year. House Speaker Nancy Pelosi (D-Calif.) announced the official opening of an impeachment inquiry last week. While the White House stated that the move “destroyed any chances of legislative progress,” Pelosi still appeared optimistic about working with the President to lower drug prices. Her senior health advisor Wendell Primus said that the Speaker’s drug pricing legislation could be considered on the House floor before the end of October. The Lower Drug Costs Now Act (H.R. 3) would direct the Secretary of the U.S. Department of Health and Human Services (HHS) to negotiate the price of as many as 250 drugs that lack marketed competition and would enact price caps of 1.2 times the average price in six other countries, named in the bill. Two of the committees of jurisdiction – Energy and Commerce as well as Education and Labor – held hearings on the bill last week. The Ways and Means Committee is expected to hold its hearing on H.R. 3 the first week following the return of Congress from its two-week October recess; the Energy and Commerce Committee may schedule its markup of the legislation for that week as well.

The House Ways and Means Committee has released a new report examining drug prices in the U.S. compared to the prices paid by other similar countries. The report finds that costs in the U.S. are nearly four times higher than the combined average of 11 other comparable nations, and that patients themselves are paying as much as 67 percent more for prescription drugs than the patients in other countries. Monthly average per capita spending on prescriptions in the U.S. is almost double the next closest country. The report analyzes 2018 data for 79 products sold in Australia, Canada, Denmark, France, Germany, Japan, the Netherlands, Portugal, Sweden, Switzerland, the U.K., and the U.S. The Committee asserts that the U.S. could save $49 billion annually in Medicare Part D through the use of these countries’ average prices for the 79 drugs examined alone.


Civica Rx to Make First Vancomycin Delivery


Civica Rx recently announced that it is preparing the delivery of its first batches of newly manufactured generic antibiotics to its member health care systems nationwide. Civica Rx is a nonprofit drug manufacturing and distribution company that was launched last year to stabilize both the supply and price of essential generics. There are currently 39 health system members of Civica representing more than 1,000 U.S. hospitals.



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