This week in Washington: Congress moves towards budget reconciliation.

Congress

Hearings/Markups

• House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States
• House Committee on Energy and Commerce, Subcommittee on Health: Road to Recovery – Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain

House

• Energy and Commerce Committee Investigates COVID-19 Vaccine Misinformation Online

Senate

• Senate Approves Amendment on Provider Relief Fund
• Cassidy, Baldwin, Shaheen Introduce Bill to Close Orphan Drug Loophole
• Markey Introduces Bill that Gives NIAID $1B to Research Universal Coronavirus Vaccine

Administration

• CBO Releases Model of Drug Price Negotiations under the Elijah Cummings Lower Drug Costs Now Act

Proposed Rules

• FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs

Courts

• SCOTUS to Hear Medicaid Work Requirement Case March 29

Reports

• GAO: Medicaid - CMS Needs to Implement Risk-Based Oversight of Puerto Rico’s Procurement Process
• GAO: Veterans Community Care Program - Immediate Actions Needed to Ensure Health Providers Associated with Poor-Quality Care Are Excluded

Congress

Hearings/Markups

House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations: No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States

Tuesday, February 2: The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations held a hearing on COVID-19 vaccine distribution and administration. The subcommittee heard from medical officials from West Virginia, Illinois, Michigan, Louisiana and Colorado about the vaccine administration, methods to maintain transparency and an overall lack of supply.

The state health officials told the subcommittee they need better predictability around how many COVID-19 vaccine doses they will receive each week, and some said until they know for sure of the supply available, they will continue holding back doses to make sure everyone who got their first dose is able to get their second shot.

Find more details here.

House Committee on Energy and Commerce, Subcommittee on Health: Road to Recovery – Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain

Wednesday, February 3: The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on the federal government’s handling of COVID-19 vaccine development, testing and the medical supply chain. The subcommittee and witnesses went through the responses, including congressional efforts, and recommendations on how better to fund and regulate the response moving forward.

Find more details here.

House

Energy and Commerce Committee Investigates COVID-19 Vaccine Misinformation Online

On Feb. 2, House Energy and Commerce Committee Chairman Frank Pallone (D-NJ) and subcommittee leaders Anna Eshoo (D-CA), Diana DeGette (D-CO), Mike Doyle (D-PA) and Jan Schakowsky (D-IL) sent letters to Facebook, Twitter and Google concerning the COVID-19 pandemic. The letters were in response to reports that COVID-19 vaccine misinformation is escalating on their platforms, and are part of an ongoing investigation by the committee. The letters ask for details of all actions the companies have taken to limit false or misleading vaccine misinformation, as well as a layout of all policies and responses to the problem.

Find the letters and more information here.

Senate

Senate Approves Amendment on Provider Relief Fund

On Feb. 4, the Senate agreed to add to the budget resolution an amendment (#546) sponsored by Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) that adds to the Provider Relief Fund $35 billion, with 20 percent set aside for rural hospitals. As congressional committee draft legislation for the COVID-19 package, a Provider Relief Fund may be included.

Cassidy, Baldwin, Shaheen Introduce Bill to Close Orphan Drug Loophole

On Feb. 4, Sens. Bill Cassidy (R-LA), Tammy Baldwin (D-WI) and Jeanne Shaheen (D-NH) introduced S.250, bipartisan legislation to close the orphan drug loophole that drug manufacturers allegedly use to lead competition off the market. The bill allows the Food and Drug Administration (FDA) to remove market exclusivity if the drug manufacturer cannot continue to prove that the drug would be economically unviable when facing competition.

Find more information here.

Find the full legislation here.

Markey Introduces Bill that Gives NIAID $1B to Research Universal Coronavirus Vaccine

On Feb. 4, Sen. Edward Markey (D-MA) reintroduced legislation that calls for a total investment of $1 billion for the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The funds would include $250 million for each of fiscal years 2021 through 2024.

Find the full legislation here.

Administration

CBO Releases Model of Drug Price Negotiations under the Elijah Cummings Lower Drug Costs Now Act

On Feb. 4, the Congressional Budget Office (CBO) released an estimation of the budgetary effects of the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3) with a simulation model of price negotiations. In CBO’s analysis, the average resulting drug price would be close to the specified upper bound of 120 percent of the index of international drug prices. Negotiations would reduce prices by 57 percent to 75 percent, relative to current prices, depending on the data and parameters that were used in the calculations. H.R. 3 specified upper and lower bounds on the prices resulting from the negotiations; in CBO’s estimation, changes to the upper bound would significantly affect the prices of the drugs CBO examined.

Find the full report here.

Proposed Rules

FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs

On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.

Find the draft guidance here. Public comments are due by Feb. 8, 2021.

Courts

Find a comprehensive look at “The Courts and Healthcare Policy” here.

SCOTUS to Hear Medicaid Work Requirement Case March 29

On Feb. 1, the Supreme Court docket showed that the justices will hear oral arguments in the case over the validity of the Trump administration’s 1115 Medicaid work requirement waivers on March 29, 2021. President Biden recently signed an executive order directing the Department of Health and Human Services (HHS) to review the work requirement waivers, but the Biden administration does not appear to have weighed in with a new position in the case and CMS is still reviewing 1115 demonstration protections former CMS Administrator Seema Verma put in place before leaving her position.

Reports

GAO: Medicaid - CMS Needs to Implement Risk-Based Oversight of Puerto Rico’s Procurement Process

On Feb. 4, the Government Accountability Office (GAO) issued a report on how states and U.S. territories paid contractors about half of their Medicaid spending for health care and other services in 2018. In the same year, Puerto Rico paid contractors almost all of its Medicaid spending—97 percent of $2.5 billion.

GAO found that the Centers for Medicare & Medicaid Services (CMS) does not oversee contracting in Puerto Rico, where former officials face allegations of contract fraud. GAO also found that Puerto Rico did not always take steps to ensure competition or to lower the risk of fraud, waste and abuse.

GAO recommended CMS begin risk-based oversight of contracting in Puerto Rico.

Find the full report here.

GAO: Veterans Community Care Program - Immediate Actions Needed to Ensure Health Providers Associated with Poor-Quality Care Are Excluded

On Feb. 1, the Government Accountability Office (GAO) issued a report analyzing the Veterans Community Care Program, established in 2019, which allows eligible veterans to receive care from non-Veterans Affairs (VA) health care providers. The VA excludes providers from participating in the program who have been disciplined for poor-quality care.

GAO reported that VA’s processes may not prevent excluded providers from participating. For example, the VA may not always verify whether providers have lost licenses over care quality. In addition, while the VA excludes providers who have been removed from VA facilities over care quality, providers removed before 2019 may still participate.

GAO made recommendations to ensure credential policies are followed here.

Find the full report here.