POLICY BRIEFINGS


Trump Touts Health Care Accomplishments in SOTU


During his 83-minute address to Congress on Tuesday night, President Trump spent roughly 15 minutes discussing his administration’s work on health care-related issues. He underscored White House efforts to increase health transparency. He also touted the administration’s success in combatting the opioid epidemic and reducing overdose deaths. The President pledged to protect Medicare against proposals like “Medicare for All” and noted his administration’s efforts to uphold protections for patients with preexisting conditions and to expand the availability of low-cost health insurance options. He called on Congress to pass legislation barring undocumented immigrants from receiving public benefits such as health care, announced a new $50 million request for neonatal research, and mentioned investments to improve kidney care and fight HIV. During his speech, President Trump urged Congress to act to eliminate surprise medical billing. He also pushed for unity on the issue of drug pricing, saying that he was in talks with Senate Finance Committee Chairman Chuck Grassley (R-Iowa) on legislation to lower the cost of prescription drugs. Without endorsing a particular bill, President Trump stated that if drug pricing legislation is sent to his desk that he “will sign it into law immediately.”

The State of the Union was widely criticized by Democrats for the campaign-style tone in which it was delivered. In the Democrats’ official response, Michigan Governor Gretchen Whitmer criticized Republicans for undermining the Affordable Care Act (ACA). She highlighted Democratic support for the ACA’s coverage expansions in contrast to the administration’s support for the lawsuit to strike down the law.


FDA Commissioner Hahn: Coronavirus Situation Remains Fluid


House and Senate lawmakers have been briefed on the government’s response to the coronavirus outbreak situation for at least the third time in recent weeks. The administration’s coronavirus task force is meeting at least twice daily and continues to request permission from the Chinese government to send experts to assist on the ground. During his State of the Union address on Tuesday, the President said that the U.S. in coordinating with China on the outbreak, and that his “administration will take all necessary steps to safeguard our citizens from this threat.”

The Food and Drug Administration (FDA) has said that no shortages of drugs or devices in the U.S. have been reported as a result of the coronavirus, but Commissioner Stephen Hahn acknowledged that “the situation is fluid.” Concerns about shortages have been voiced by both the White House and lawmakers on both sides of the aisle. China provides active pharmaceutical ingredients (APIs) for 13 percent of U.S. drugs and is home to 400 drug manufacturing facilities. Sens. Marco Rubio (R-Fla.) and Chris Murphy (D-Conn.) have requested information from Dr. Hahn about how the coronavirus has impacted the agency’s ability to oversee the safety of imported drugs and devices from China. They ask whether the FDA has the resources necessary to ensure that the coronavirus outbreak does not affect the U.S. supply of drugs and devices, and what steps the agency is taking to ensure that there are no shortages due to manufacturing disruptions stemming from the outbreak. The FDA has pulled its inspectors from China as a result of the coronavirus epidemic.

The World Health Organization (WHO) is warning of potential shortages of protective medical gear stemming from the coronavirus. Demand for such products is up 100 times higher than normal, while prices have increased by a factor of 20. Assistant Secretary for Preparedness and Response Robert Kadlec has urged people to avoid using masks when they are not necessary.

The U.S. Department of Health and Human Services (HHS) has notified Congress that it may transfer an additional $136 million to combat the coronavirus outbreak. The Centers for Disease Control and Prevention (CDC) has already begun to deplete the $105 million set aside through the Infectious Diseases Rapid Response Reserve Fund, using the money for immediate planning and response, enhancing laboratory capacity, communication and education efforts, and medical screening and monitoring of citizens returning from China. The additional funding would support the CDC ($75 million), the Office of the Assistant Secretary for Preparedness and Response (ASPR) ($52 million), and the Office of Global Affairs ($8 million). By law, HHS must wait 15 days after providing Congress with notice before shifting appropriated funds from one account to another. HHS did not indicate which accounts from which it would be transferring the money.

Lawmakers have repeatedly stressed that they are ready to provide additional resources if it becomes necessary, with House Democrats writing to HHS Secretary Alex Azar urging him to request an emergency supplemental funding package from Congress to aid with coronavirus response. The letter was sent by House Appropriations Chairwoman Nita Lowey (D-N.Y.) and Labor, Health and Human Services Subcommittee Chairwoman Rosa DeLauro (D-Conn.). They ask that the emergency supplemental request to cover enhanced screening, quarantines, and vaccine research be submitted no later than February 10, alongside the submission of the President’s fiscal year (FY) 2021 budget. They also request details on how HHS anticipates spending the coronavirus response money. The lawmakers are pushing for the additional funding to avoid dollars being transferred from other public health priorities, such as the National Institutes of Health (NIH). A senior administration official has responded that the administration does not require a supplemental coronavirus spending bill.

Rep. Derek Kilmer (D-Wash.) and Sen. Patty Murray (D-Wash.) have led a bipartisan letter calling on CDC to distribute rapid diagnostic tests for the coronavirus as quickly as possible. The letter, signed by 48 lawmakers, asks that states with confirmed cases of the virus receive available test kits first. On Thursday, CDC announced that an initial 200 test kits would be made available, with additional kits scheduled to be released.


Moderate Dems Endorse Bills to Strengthen Health Care System


The New Democrat Coalition has endorsed several pieces of legislation that aim to improve the way the health care system functions. The bills include H.R. 3107, Improving Seniors’ Timely Access to Care Act; H.R. 2061, Pathway to Universal Coverage Act; H.R. 4336, Easy Enrollment Act; H.R. 1763, Resident Physician Shortage Reduction Act; H.R. 2564, Medicare Enrollment Protection Act; H.R. 4575, Improving Provider Directories Act; and H.R. 4576, Health Savings for Families Act. The coalition is a group of more than 100 centrist Democrats in the House of Representatives. They hope the measures will be included in a health reform package that Democratic leadership plans to unveil around the 10th anniversary of the Affordable Care Act (ACA) being signed into law on March 23.


LDT Legislation Expected Later this Month


House Energy and Commerce Oversight Subcommittee Chair Diana DeGette (D-Colo.) and Larry Bucshon, MD (R-Ind.) are expected to introduce legislation to overhaul the regulation of laboratory-developed tests (LDTs) before the end of February, according to House staff. The bill would give the Food and Drug Administration (FDA) new authority over diagnostics by creating a category of medical products called “in vitro clinical tests.” LDTs are currently considered under medical device regulations.



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