THIS WEEK’S DOSE
Congress was in session this week and legislative business was in full swing in the House, with committee hearings getting underway and the full House taking up a series of bills related to COVID-19. In related news, the Biden Administration announced its intention to end the COVID-19 public health emergency (PHE) and the related national emergency declaration on May 11.
House Votes on COVID-19 Bills. On January 31 and February 1, the House voted on a series of bills related to the COVID-19 pandemic:
- The Pandemic is Over Act (H.R. 382) – to terminate the COVID-19 PHE that was declared on January 31, 2020; passed the House on a party-line vote of 220–210 on January 31
- The Freedom for Health Care Workers Act (H.R. 497) – to nullify the requirement that healthcare providers, as a condition of Medicare and Medicaid participation, ensure that staff are fully vaccinated against COVID-19; passed the House by a vote of 227–203 on January 31, largely along party lines (seven Democrats joined Republicans in voting for the bill)
- H.J. Res. 7 – to terminate the national emergency concerning COVID-19 declared by the president on March 13, 2020; passed the House by a vote of 229–197 on February 1, largely along party lines (11 Democrats joined Republicans in voting for the bill)
- The SHOW UP Act (H.R. 139) – to require federal agencies to reinstate the telework policies that were in place on December 31, 2019, prior to the pandemic; passed the House by a vote of 221–206 on February 1, largely along party lines (three Democrats joined Republicans in voting for the bill, and one Republican joined Democrats in opposition).
These bills are largely messaging bills for the new Republican majority in the House, as they are not likely to be taken up in the Democrat-controlled Senate. To get in front of House consideration of these bills, the White House released a statement of administration policy (SAP) in opposition to H.R. 382 and H.J. Res. 7. The SAP included the announcement that the Biden Administration intends to end the COVID-19 PHE and related national emergency declaration on May 11, effectively nullifying the need for any legislative action and highlighting the importance of transitioning out of the PHE in an orderly way (see related story below).
House Committees Hold Health-Related Hearings. On February 1, the Energy and Commerce Health Subcommittee held a legislative hearing focused on the illicit fentanyl poisoning crisis, a cybersecurity breach of the 9-8-8 suicide lifeline, and Quality Adjusted Life Year (QALY) measures.
The Health Subcommittee examined the following bills:
- The Halt All Lethal Trafficking (HALT) of Fentanyl Act (H.R. 467), sponsored by Reps. Morgan Griffith (R-VA) and Bob Latta (R-OH), to place fentanyl-related substances (FRS) permanently into Schedule I of the Controlled Substances Act. The bill also would simplify the registration processes for certain research with Schedule I substances and exempt an individual FRS from Schedule I when evidence demonstrates it is appropriate.
- The Block Reporting, and Suspend Suspicious Shipments Act (H.R. 501), sponsored by Reps. Diana Harshbarger (R-TN) and Debbie Dingell (D-MI), to require drug manufacturers, distributors and other US Drug Enforcement Administration (DEA) registrants to practice due diligence when discovering suspicious orders of controlled substances.
- The 9-8-8 Lifeline Cybersecurity Responsibility Act (H.R. 498), sponsored by Reps. Jay Obernolte (R-CA) and Tony Cardenas (D-CA), to require internal coordination within the US Department of Health and Human Services (HHS) to protect the 9-8-8 lifeline from cybersecurity incidents and to require the comptroller general to conduct a study to evaluate cybersecurity risks and vulnerabilities associated with the 9-8-8 lifeline.
- The Protecting Health Care for All Patients Act (H.R. 485), sponsored by Energy and Commerce Chair Cathy McMorris Rodgers (R-WA), to prohibit the usage of QALYs by federal healthcare payers. QALYs are a metric used for determining the cost-effectiveness of a course of treatment that evaluates the merits of covering the costs of a drug or treatment relative to the quantity and so-called “quality” of years that will be gained from such a course of treatment. While healthcare cost management is important, the nature of defining an individual’s quality of life can pose ethical dilemmas.
The same day, the Energy and Commerce Oversight and Investigations Subcommittee held a hearing focused on a report by the US Government Accountability Office (GAO) examining the challenges of investigating the origins of infectious disease pandemics and biological outbreaks, as well as recommendations for future improvements.
The hearing’s panel of witnesses all agreed with the five recommendations provided in the GAO report:
- Improve access to samples and genetic sequence data
- Develop standard processes for database use
- Encourage the improvement of current or the development of new genetic sequence database tools
- Build a sufficient and skilled interdisciplinary workforce
- Create a national strategy that specifically addresses pandemic origins.
Also on February 1, the House Committee on Oversight and Accountability held a hearing titled Federal Pandemic Spending: A Prescription for Waste, Fraud and Abuse. The hearing explored incidences of fraud, waste and abuse seen in COVID-19 programs, such as the paycheck protection program and unemployment insurance. Of note to healthcare providers, the Provider Relief Fund was not mentioned as a source of fraud, waste and abuse, and in fact one witness identified it as a successful COVID-19 relief program.
Additional Committee Assignments Announced. News on committee assignments continued to be released this week. In the Senate, Majority Leader Chuck Schumer (D-NY) announced his party’s committee assignments, and Minority Leader Mitch McConnell (R-KY) announced his as well. Of note to healthcare stakeholders:
- Senate Finance Committee Republicans welcomed three new members: Sens. Ron Johnson (R-WI), Thom Tillis (R-NC) and Marsha Blackburn (R-TN).
- New members of the Senate Appropriations Committee include Sens. Gary Peters (D-MI), Deb Fischer (R-NE) and Katie Britt (R-AL).
Across the Capitol, House Minority Leader Hakeem Jeffries (D-NY) announced Democratic members of select committees this week, including the Subcommittee on the Coronavirus Pandemic. Democratic members include Ranking Member Raul Ruiz (D-CA) and Reps. Debbie Dingell (D-MI), Kweisi Mfume (D-MD), Deborah Ross (D-NC) and Robert Garcia (D-CA).
Administration Announces PHE End Date. On January 30, the Biden Administration announced its intent to end the COVID-19 PHE and national emergency on May 11. As noted above, it did so through an SAP in response to the COVID-19 bills being considered on the House floor this week.
The SAP stated: “At present, the Administration’s plan is to extend the emergency declarations to May 11, and then end both emergencies on that date. This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE.” The SAP went on to express opposition to the abrupt manner in which the House bills (H.R. 382 and H.J. Res. 7) would end the PHE and national emergency, citing potential chaos and uncertainty throughout the healthcare system.
This PHE end date announcement will kick off a flurry of activity from the Administration to address and clarify how to transition temporary policy changes that were put in place during the PHE and are set to expire with it. For example, while many Medicare telehealth flexibilities were untied from the PHE with the enactment of the Consolidated Appropriations Act, 2023, other telehealth provisions are still tied to the PHE’s end date. One example is a waiver for the prescribing of controlled substances via telehealth without an in-person visit. On that front, the DEA indicated on January 31 that it will release long-awaited rules to address this issue before the end of the emergency declarations.
Our team is closely monitoring the PHE unwinding and will continue to report updates as additional administrative announcement are made.
CMS Releases Final Rule on Medicare Advantage Risk Adjustment Data Validation. On January 30, the Centers for Medicare & Medicaid Services (CMS) released a final rule regarding the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program that CMS uses to recover improper risk adjustment payments made to MA plans.
According to a CMS fact sheet, the RADV final rule will address instances where Medicare paid MA organizations more than they otherwise should have received because the medical diagnoses submitted for risk adjustment payment were not supported in the beneficiary’s medical record. The final rule codifies in regulation that, as part of the RADV audit methodology, CMS will extrapolate RADV audit findings beginning with payment year 2018.
The effective date of the final rule is April 3.
- CMS sent a letter to state health officials and issued a corresponding FAQ document detailing the temporary special enrollment period for consumers losing Medicaid or Children’s Health Insurance Program coverage because of the unwinding of the Medicaid continuous enrollment condition under the PHE.
- HHS, together with the US Departments of Labor and the Treasury, issued proposed rules to expand access to birth control coverage under the Affordable Care Act. A fact sheet on the proposals can be found here.
- House Energy and Commerce Democrats sent a letter to HHS and the Departments of Labor and the Treasury, asking for immediate action to roll back the previous Administration’s expansion of short-term, limited duration health insurance plans. Regulations on this subject have long been anticipated from the agency.
- GAO released a report on nursing homes, finding that CMS should make ownership information more transparent for consumers by fully aligning nursing home ownership information on Care Compare with relevant characteristics of effective transparency tools.
- GAO released a report on MA plans’ supplemental benefit offerings and CMS’s limited data on utilization. The report made two recommendations to CMS related to guidance for MA plans on data submissions.
- GAO released a report on pediatric cancer studies, including early results of the Research to Accelerate Cures and Equity for Children Act.
- The Texas Medical Association filed a lawsuit against the Biden Administration over the implementation of the No Surprises Act, specifically challenging the increase in administrative fees for seeking federal dispute resolution.
- The Biden Administration is expected to release its FY 2024 budget proposal on March 9, according to a White House memo. Although nonbinding, this annual budget blueprint offers details on the Administration’s funding and policy priorities for the coming year.
NEXT WEEK’S DIAGNOSIS
Congress will be in session next week, and the House and Senate will meet in a joint session the evening of February 7 for President Biden’s annual State of the Union address.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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