THIS WEEK’S DOSE
Congress was in session this week, as President Biden’s annual State of the Union address took center stage. The House Energy and Commerce Committee held a hearing to examine the Administration’s COVID-19 response. Meanwhile, the Centers for Medicare & Medicaid Services (CMS) released updated fact sheets on various aspects of the unwinding of the COVID-19 public health emergency (PHE) and the related national emergency declaration, which are scheduled to end on May 11.
President Gives State of the Union Address to Joint Session of Congress. The House and Senate met in a joint session of Congress the evening of February 7 to receive President Biden’s State of the Union address.
The health-related portions of the speech focused on provisions in the Inflation Reduction Act, including controlling the costs of prescription drugs through Medicare price negotiation, and capping the cost of insulin for Medicare beneficiaries at $35. The president called for an expansion of that $35 cap on insulin to all Americans and called on non-Medicaid expansion states to expand Medicaid coverage. He also urged Congress to make permanent the healthcare premium tax credits that will expire after 2025 without congressional action and touted this year’s record enrollment numbers under the Affordable Care Act.
With respect to negotiations on the debt limit, President Biden remarked that some Republicans have proposed cuts to Social Security and Medicare as part of the debate. This remark resulted in several outbursts on the Republican side of the aisle, giving the President an opportunity to capitalize on the public moment to assure Americans that cuts to Social Security and Medicare would not be on the table. The entire chamber—Democrats and Republicans alike—stood and applauded in agreement.
Other noteworthy passages during the speech included calls for a crackdown on fentanyl to avoid more opioid-related deaths, improving mental health services and access, preventing veteran suicides, and reigniting the cancer moonshot that aims to dramatically cut the cancer death rate in coming years. The president also called on Congress to restore the full child tax credit, provide access to preschool for three- and four-year-olds, and codify Roe v. Wade. He also made clear that while COVID-19 is not over, the United States has significantly moved passed the pandemic.
House Energy and Commerce Committee Holds Hearing on COVID-19 Response. On February 8, the House Energy and Commerce Subcommittees on Health and Oversight and Investigations held a joint hearing on the federal response to COVID-19.
The subcommittees heard testimony from a panel of senior government officials representing the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and the US Food and Drug Administration (FDA). According to a briefing memo from majority committee staff, the hearing sought to explore past, present and any necessary future actions by each of the agencies related to the response to the COVID-19 pandemic and the transition out of the PHE.
During the hearing, the agency leaders discussed their successes and weaknesses over the past three years and outlined how they are learning from these actions. They fielded questions from committee members, many related to issues of public trust, vaccine hesitancy and the need for improved transparency.
The next day, the full Energy and Commerce Committee met to consider the committee’s authorization and oversight plan for the 118th Congress. The healthcare section of the plan, found on pages 2-5, includes priorities related to examining the origins of COVID-19 and pandemic prevention efforts, responding to the fentanyl crisis, addressing healthcare costs, reviewing Medicare and Medicaid entitlements, reviewing FDA matters and addressing the mental health crisis. The resolution to adopt the authorization and oversight plan was approved by a majority voice vote.
Administration Begins Providing Guidance on PHE’s End. Following the Administration’s January 30 announcement that it intends to end COVID-19 PHE and national emergency on May 11, CMS began releasing updated information on the winding down of certain temporary waivers and flexibilities.
CMS updated more than a dozen provider-specific fact sheets, providing guidance and information on certain waiver end dates to physicians, hospitals, long-term care facilities, inpatient rehabilitation facilities, federally qualified health centers, laboratories, and Medicare Advantage and Part D plans, among others. The updated fact sheets can all be found in the link above.
Our team is closely monitoring the PHE unwinding and will continue to provide updates and key takeaways as additional documents are updated and announcement are made.
District Court Vacates Provisions of No Surprises Act Final Rule. On February 6, a US district court in Texas vacated provisions of the No Surprises Act final rule related to the independent dispute resolution (IDR) process for determining payment for out-of-network services.
The district court granted summary judgment to the Texas Medical Association, which had brought suit against the US Departments of Health and Human Services (HHS), Labor and the Treasury over the IDR process. The district court held that provisions of the final rule were contrary to law and therefore in violation of the Administrative Procedure Act. The order vacated the provisions of the final rule that require IDR entities to look at the qualifying payment amount first and consider other factors only if those other factors are not already accounted for in the qualifying payment amount.
The departments have not yet filed a notice of appeal or amended their sub-regulatory guidance to align with the district court’s order.
- CMS released guidance on implementation of the Inflation Reduction Act’s prescription drug rebate program for Medicare Parts B and D. The program will require rebates to the Medicare Trust Fund in cases of price increases that exceed inflation, particularly brand name drugs. CMS released a fact sheet, the Part B guidance and the Part D Guidance, and also has a website dedicated to the implementation of the Inflation Reduction Act as it relates to Medicare.
- The HHS Office of Inspector General (OIG) released a technical assistance brief on the implementation of inflation-indexed rebates for Part B drugs, as set forth in the Inflation Reduction Act. OIG anticipates that unless CMS takes action to remedy administrative issues, it will face challenges in implementing inflation-indexed rebates for Part B drugs related to identifying products subject to Part B rebates and excluding claims from Part B rebate calculations that were already subject to rebates under the Medicaid Drug Rebate Program and discounts under the 340B Drug Discount Program.
- In related news, Senate Finance Committee Chair Ron Wyden (D-OR) sent a letter to CMS asking that information be shared with the public regarding implementation of the Inflation Reduction Act’s drug pricing provisions, specifically the inflation rebates that apply to Medicare Parts B and D.
- The House approved a bill to terminate the CDC’s COVID-19 vaccine requirement for foreign air travelers arriving in the United States (H.R. 185) by a largely party-line vote of 227–201, with seven Democrats joining Republicans in voting for the bill.
- The Office of Management and Budget is requesting feedback on proposed revisions to federal race and ethnicity collection statistical standards. Initial proposals for comment can be found here, and feedback is due by April 12 through the Federal Register.
- The Senate Judiciary Committee held an executive session during which it advanced five bipartisan drug patent reform bills by voice vote.
NEXT WEEK’S DIAGNOSIS
The House is in recess the next two weeks. The Senate is scheduled to be in session next week, and committee work is expected to get underway now that Senate committees have been formally organized.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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