POLICY BRIEFINGS


House Passes Second Minibus Appropriations Bill


The House of Representatives has passed its second minibus spending bill for fiscal year (FY) 2020. H.R. 3055, which provides funding for Agriculture-Food and Drug Administration (FDA), Commerce-Justice-Science, Interior-Enviornment, Military Construction-VA, and Transportation-Housing and Urban Development, passed by a vote of 227-194, largely along party lines. It includes a total of $383 billion in spending. The White House has threatened to veto the measure in opposition to overall spending levels, arguing that it is unnecessary for non-defense spending to match or exceed defense spending. The House has now passed 10 of the 12 total appropriations bills for the coming fiscal year. The Senate has yet to begin work on FY 2020 appropriations. Senate leadership is still stuck on budget deal negotiations around top-line defense and non-defense spending figures and a debt ceiling increase. Appropriations Chairman Richard Shelby (R-Ala.) has stated that staff is already working on back-up appropriations bills if leadership provides clearance to move forward with their own top-line spending levels. The Senate will return from the Fourth of July recess on July 8, and the House will reconvene on July 9.


PAHPAI Signed Into Law


President Trump has signed the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act into law. The legislation would reauthorize programs related to emergency preparedness and public health response efforts. Most of these programs expired last September but were funded under fiscal year (FY) 2019 appropriations legislation.


Update on Congressional Drug Pricing Negotiations


The Senate Judiciary Committee advanced four pieces of drug pricing legislation to the full Senate for consideration last week. The Affordable Prescriptions for Patients Act of 2019 (S. 1416) would cap the number of patents manufacturers can file for brand products. S. 1227 would require the Federal Trade Commission (FTC) to review the role of intermediaries in the pharmaceutical supply chain and provide Congress with relevant policy recommendations. S. 1224 would allow the FTC to revise the citizen petition process to prevent it from being used for delaying generic or biosimilar competition. S. 440 would prevent a patent owner from asserting sovereign immunity as a defense before the U.S. Patent and Trademark Office. The panel hopes the bills will receive a full Senate vote before the August recess.

The bipartisan House Problem Solvers Caucus laid out a set of principles last week for assessing drug pricing proposals brought before Congress this year. The lawmakers support a clean vote on drug pricing legislation passed by the House earlier this year. The bills were previously coupled with fixes to shore up the Affordable Care Act (ACA) and the individual market. The Caucus was joined by Sens. Bill Cassidy (R-La.), Susan Collins (R-Maine), and Joe Manchin (D-W.Va.) in announcing the principles. The group hopes to convince House leadership to consider legislation that has the best chance of also passing the Senate and being signed into law by President Trump.

Democrats on the House Committee on Oversight and Reform have written to Gilead Sciences Inc. to request documents related to the pricing and patents for the HIV drug Truvada. Chairman Elijah Cummings (D-Md.) and Reps. Alexandria Ocasio-Cortez (D-N.Y.), Ro Khanna (D-Calif.), and Ayanna Pressley (D-Ill.) ask for information on any communications with federal agencies about donations of Truvada to the U.S. government, patents related to Truvada, how much it costs to make Truvada, and Truvada price increases since 2012. The letter requests a response by the end of July. It is a part Cummings’ larger investigation into prescription drug pricing. The Chairman has said that he has received “fairly decent compliance” from companies so far, but that he would not rule out the use of subpoenas if necessary.

The Congressional Budget Office (CBO) has released its score of the Prescription Drug STAR Act (H.R. 2113), which was reported out of the House Ways and Means Committee earlier this year. The budget office found that the bill would save $1.7 billion over the next decade. The savings would primarily stem from requiring manufacturers to report the prices used to calculate Medicare payment rates for products administered in physicians’ offices and hospital outpatient departments.


Johnson Requests Info on Medicaid Fraud and Abuse


Chairman of the Senate Committee on Homeland Security and Governmental Affairs Ron Johnson (R-Wis.) has asked Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma for an update on the one-year anniversary of the agency’s announcement of new efforts to combat fraud, waste, and abuse in the Medicaid program. CMS’ initiative was intended to help states more accurately determine Medicaid benefit eligibility. Sen. Johnson asks which states have been audited, what the audits found, whether any further actions have been taken to improve program integrity based on the results of the audits, and what analytics and solutions are being used to improve Medicaid eligibility and payment data.


E&C Requests Opioid Briefings, Details on Drug Supply Chain Safety


Leadership of the House Energy and Commerce Committee have written to Acting Commissioner of Food and Drugs Ned Sharpless asking for two briefings related to the opioid epidemic. The panel is seeking information related to the Food and Drug Administration’s (FDA) management of safeguards surrounding the prescription of certain fentanyl products as well as more details about the agency’s 2001 decision to expand the label for Oxycontin to cover chronic, long-term pain. The letter was signed by Chairman Frank Pallone, Jr. (D-N.J.), Ranking Member Greg Walden (R-Ore.), Health Subcommittee Chair Anna Eshoo (D-Calif.), Ranking Member Michael Burgess (R-Texas), Oversight and Investigations Subcommittee Chair Diana DeGette (D-Colo.), and Ranking Member Brett Guthrie (R-Ky.).

Chairman Pallone and Ranking Member Walden are also questioning the FDA’s ability to ensure the safety of the U.S. drug supply chain in light of recent recalls of generic blood-pressure medication tainted with possible carcinogens. The lawmakers have asked the agency for information about the FDA’s inspections of foreign and domestic pharmaceutical manufacturing facilities, specifically as it relates to the Chinese firm Zhejiang Huahai Pharmaceutical Co. Ltd. They have also written to the Government Accountability Office (GAO) asking for an investigation into the number of inspections that FDA conducts of foreign and domestic facilities, what resources the agency dedicates to its foreign offices, and how it chooses which facilities to inspect.


Pallone Questions Legality of Medicaid Block Grants


Chairman of the House Energy and Commerce Committee Frank Pallone (D-N.J.) has written to Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar, warning that any decision by the administration to place a spending limit on the Medicaid program would be illegal. There have been recent reports that the Department is considering approving waivers to allow states to receive their federal Medicaid money through block grants. Rep. Pallone requests further details from the Secretary regarding the administration’s plans for the waivers, which he argues would be outside the authority of HHS, no later than July 15.



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