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 - DECEMBER 14, 2020


Pfizer COVID Vaccine Receives EUA


Pfizer Inc.’s coronavirus vaccine has received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). Operation Warp Speed official Army Gen. Gustave F. Perna stated over the weekend that the first vaccines will be distributed today, echoing earlier remarks by U.S. Department of Health and Human Services (HHS) Secretary Alex Azar.

The FDA’s advisory panel voted to back the Pfizer shot by a vote of 17 to 4, with one abstention, earlier in the week – signaling that the benefits of the product outweigh the risks for individuals age 16 and older. Much of the panel’s discussion centered on whether there was enough evidence to support the vaccine’s use in 16 and 17 year olds. The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted during an emergency meeting on Saturday to recommend that people age 16 and older receive the Pfizer vaccine. ACIP recommended that care providers monitor people with a history of anaphylaxis for 30 minutes after giving them a shot. The group also recommended letting pregnant women, lactating women, and immunocomprised people decide whether to get a vaccine given the lack of specific data on how it performs in these populations.

Defense officials announced that a group of senior leaders, including Defense Secretary Chris Miller, will be the first in the military to receive a COVID-19 vaccine as a part of an effort to build confidence in a vaccine and encourage other personnel to get the shot. The Pentagon is currently preparing to accept the first doses of the Pfizer vaccine and to distribute it to high-priority officials, who are likely to include Deputy Defense Secretary David Norquist, Joint Chiefs Chairman Gen. Mark Milley, Vice Chairman Gen. John Hyten, and Senior Enlisted Adviser Ramón Colón-López. While the vaccine will initially be voluntary while it is under EUA, Pentagon officials have stated that once full approval is granted by the FDA that the department may require mandatory vaccination.

The FDA’s advisory panel will meet on December 17 to evaluate Moderna’s vaccine, and ACIP will next meet on December 18 and 20 to discuss vaccine distribution.


Compromise Reached on Surprise Billing Fix


On Friday, key congressional lawmakers released legislative text and a summary of their negotiated agreement to protect patients from surprise insurance gaps and end surprise medical billing. All four health care committees of jurisdiction – led by House Ways and Means Chair Richard Neal (D-Mass.), House Energy and Commerce Chair Frank Pallone (D-N.J.), House Education and Labor Chair Bobby Scott (D-Va.), and Senate Health, Education, Labor, and Pensions (HELP) Chair Lamar Alexander (R-Tenn.) – have agreed to the proposal, which would use an independent dispute resolution (IDR) process without benchmark pay rates to resolve disputes over out-of-network bills between providers and payers. The arbiter would be directed to consider the median in-network payment rate for the service in question, information related to the providers’ experience, the complexity of the service, and the market share of the parties and their previous contracting history. The IDR would be binding, and there would be no monetary threshold for seeking arbitration. Patients would be held harmless from surprise medical bills and only be responsible for the in- network payment rate, unless they are notified about receiving out-of-network services 72 hours before receiving care. The agreement includes provisions to improve the accuracy of provider directory information. Also, a ban on air ambulance surprise bills is included in the deal. The legislation would extend mandatory funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education Program at current levels through fiscal year (FY) 2024. House Speaker Nancy Pelosi (D-Calif.) has said she will push for the measure’s passage before the end of the year, but it remains unclear whether Senate Majority Leader Mitch McConnell (R-Ky.) will support the inclusion of the measure in a year-end legislative package.



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