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.


House to Vote on E-Cig Legislation This Week

The House of Representatives plans to vote this week on legislation (H.R. 2339) that would ban the sale of flavored tobacco products, including e-cigarettes, while providing for a narrow pathway for the Food and Drug Administration (FDA) to approve such products if they reduce smoking rates. It would also ban the online sale of e-cigarettes and tobacco products. The bill, sponsored by House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) and Rep. Donna Shalala (D-Fla.), aims to reduce youth vaping rates. The Reversing the Youth Tobacco Epidemic Act may combined with legislation (H.R. 4742) to assess an excise tax on tobacco alternatives equal to that of the $1.01 federal levy per cigarette pack. It is not clear whether the legislation will be brought for a vote in the Republican-controlled Senate.

Grassley Continues to Push Drug Pricing Bill Among GOP Colleagues

Sen. Joni Ernst (R-Iowa) has announced her support for the Senate Finance Committee’s bipartisan drug pricing legislation, making her the 12th GOP senator to endorse the bill. Chairman Chuck Grassley (R-Iowa) has stated that he needs 25 Republican members to convince Senate leadership to allow a vote on the Prescription Drug Pricing Reduction Act, which already has the support of President Trump. Sen. Grassley has also said that he expects other Senate Republicans to announce their support for the bill in the coming days. The fate of the legislation remains uncertain, given the opposition from many Republicans to a provision that would limit drug price increases in the Medicare program to the rate of inflation. Majority Leader Mitch McConnell (R-Ky.) has declined to say whether the bill will get a vote on the Senate floor.

Lawmakers Consider Potential Drug Shortages Stemming from Coronavirus

Several House lawmakers have highlighted the need to expand domestic manufacturing of prescription drugs in response to the coronavirus outbreak and concerns about resulting drug shortages among Chinese manufacturers. Reps. John Garamendi (D-Calif.) and Vicky Hartzler (R-Mo.) are pushing to include their legislation, the Pharmaceutical Independence Long-Term Readiness Reform Act (H.R. 4710) in the fiscal year (FY) 2021 defense authorization bill. It would require the Pentagon to purchase only American-made active pharmaceutical ingredients (APIs), medicines, and vaccines for members of the military. House Energy and Commerce Subcommittee on Health Chairwoman Anna Eshoo (D-Calif.) also supports advancing a measure to expand U.S. manufacturing of pharmaceutical products, though the panel is reportedly only in the early stages of drafting legislation.

In related news, the World Health Organization (WHO) is calling on nations around to world to increase funding to combat the coronavirus outbreak despite the virus still being largely confined to China. WHO Director-General Tedros Adhanom Ghebreyesus expressed concerns that countries are not taking the outbreak seriously enough, arguing that now is the time to halt the spread of the virus while it is still “manageable.”

Lawmakers Request CAR T-Cell MS-DRG

A group of House lawmakers have written to the Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma praising the administration’s recently finalized National Coverage Determination (NCD) for chimeric antigen receptor (CAR) T-cell therapy and urging the agency to establish a Medicare Severity-Diagnosis Related Group (MS-DRG) specific to CAR T-cell therapy in the fiscal year (FY) 2021 Inpatient prospective payment system (IPPS). The lawmakers explain how reimbursement remains a barrier to inpatient hospitals treating Medicare beneficiaries with CAR T-cell therapy, exacerbating the access challenges already faced by patients in rural areas. The letter, which was signed by 76 bipartisan members of Congress, argues that the establishment of an MS-DRG would help improve access for Medicare patients in need of cancer treatment, regardless of where they live.

February 24, 2020: | Page 1 Page 2



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