Capitol Hill Update
House lawmakers will meet for “Committee Work Days” this week as key committees of jurisdiction are scheduled to begin crafting legislative language that conforms to the fiscal year (FY) 2022 budget resolution’s instructions. Members will kick off markups of their respective portions of the reconciliation package next week — starting with the Natural Resources and Oversight & Reform Committees on Thursday. While a formal announcement from each committee is still forthcoming, the currently anticipated markup schedule is as follows:
- Thursday, September 2: Natural Resources; Oversight & Reform.
- Thursday, September 9: Education and Labor; Science, Space, and Technology; Small Business; Veterans’ Affairs; Ways and Means.
- Friday, September 10: Ways and Means; Agriculture; Homeland Security
- Monday, September 13: Ways and Means; Energy and Commerce; Financial Services; Judiciary.
- Tuesday, September 14: Ways and Means; Transportation and Infrastructure.
Meanwhile, the Senate remains away from Washington for its August state work period, and will return on Monday, September 13. The next scheduled votes in the House are slated for Monday, September 20.
FDA to Pave New Path for Rare Disease Treatments
The Food and Drug Administration (FDA) and the drug industry reached an agreement this past week to furnish new pilot programs for rare disease drug approvals. The agreement is part of FDA’s goal letter for the Prescription Drug User Fee Amendments (PDUFA VII) for fiscal years (FY) 2023-2027 reauthorization. While FDA often expresses its desire to speed up the drug approval process, this new language focuses specifically on rare diseases. Pressure from patient advocates spurred this approach, for example, a hearing held last month featured rare disease patients and providers who raised this very topic. Drug companies’ application fees will pay for the new initiatives, though Congress must ratify the FDA’s goal letter outlining the program before the agency can implement changes. FDA also announced a public meeting regarding the PDUFA VII reauthorization for September 28.
In the goal letter for PDUFA VII, FDA outlined a new Split Real Time Application Review (STAR) Pilot Program, which would speed the agency’s review of new drugs by allowing drugmakers to submit their application data in two stages. FDA review panels would get a head start on reviewing data before the application is finalized, cutting down on the final review process once the entirety of an application is submitted. The option would be available starting in 2023 and fully implemented in 2024.
Another pilot program, the Rare Disease Endpoint Advancement Pilot Program, would promote manufacturers’ collaboration with FDA to design new clinical endpoints for rare disease therapies. The agency explained that a narrowly identified set of endpoints has sometimes kept FDA from approving drugs for untreatable conditions. Under the pilot, FDA would accept one proposal from this program in 2023 and expand to three proposals a year in 2024, through 2027. FDA also said that it will give drugmakers more notice on when it will require post-marketing studies. This would provide manufacturers with a total of eight weeks’ notice and six weeks for drugs operating under the FDA’s priority pathway.
Biden Administration Pushes Back Insurer Transparency, Surprise Billing Regulations
In recent guidance from August 20, entitled “FAQs About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 49,” the Biden administration delayed the implementation of two policies affecting health insurers. One of the targeted regulations is a Trump-era transparency rule from October of 2020 that obligated insurers to digitally disclose certain pricing data, including drug pricing, starting in 2022. The Biden administration announced that it will delay enforcement of the machine-readable formatting stipulation for the transparency regulation until July 1, 2022. The guidance also outlines the administration’s reconsideration of its drug pricing transparency policy due to concerns of new reporting requirements passed in the 2021 omnibus spending package last December. As such, the interim final rule requiring drug pricing transparency is delayed indefinitely. However, some policy experts expect the administration to request 2020 and 2021 drug pricing data in December of 2022.
Since the initial publication of new requirements, experts have been doubtful that insurers would be able to stand up the necessary technical components to comply with the rule by the 2022 enforcement date. Recently, the U.S. Chamber of Commerce and the Tyler (Texas) Area Chamber of Commerce filed a suit against the Department of Health and Human Services (HHS) in a federal district court regarding the rule. The U.S. Chamber asserted that HHS’s transparency rule would compel the disclosure of confidential information and the local Texas Chamber argued that the rule violates the Administrative Procedure Act. The Chamber is concerned with the regulation calling for machine-readable delivery of information as well requirements that would compel the disclosure of trade secrets and other commercially sensitive information that they claim will reduce competition and raise prices for consumers.
The other rule delayed by the Biden administration is on surprise billing from July of 2021. The administration’s interim final rule would ban surprise billing for emergency services and high out-of-network cost-sharing. However, the August 20 guidance has placed an indefinite hold on its enforcement of new advanced explanation of benefits requirements. Additionally, regulators will not immediately sanction providers that do not provide good faith estimates at the time or scheduling services.
ICER to Evaluate Five COVID-19 Therapies
Last Thursday, the Institute for Clinical and Economic Review (ICER) announced that it will compare the clinical efficacy and value of five COVID-19 treatments and evaluate the therapies’ projected impact on health care costs over five years. ICER is taking public comment regarding the scope of its investigation through September 15, and the final assessment is set for public discussion during a Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) meeting in April 2022. The five therapies for evaluation are:
- casirivimab/imdevimab (REGEN-COV, Regeneron);
- sotrovimab (GlaxoSmithKline and Vir Biotechnology);
- molnupiravir (Merck);
- PF-07321332/ritonavir (Pfizer); and
- fluvoxamine (Investigator initiated).
Each treatment is set to be compared to outpatient care for symptomatic treatments only. Specifically, ICER announced its interest in analyzing patient-centered outcomes including the pace of symptoms resolution, ability to return to work and regular life activities, symptom and illness severity, hospitalization factors, and Long-COVID, among other factors. While ICER plans to focus on the U.S., some international data regarding clinical outcomes may be included. Additionally, ICER will develop an economic model to assess the cost-efficacy of each treatment relative to supportive care. The review will include direct costs, though changes in productivity and more general indirect costs may be evaluated separately.
HHS to Maintain Provider Relief Fund Reporting Deadline
This past Thursday, HHS held two brief stakeholder calls in which the agency announced that provider relief recipients have 35 days to submit documentation detailing how they used their funding to cover lost revenue during the pandemic. A group of medical practices recently asked HHS to extend the reporting deadline until 2023, noting that resurgences of COVID-19 cases are preoccupying providers. Stakeholders on the HHS calls echoed this concern, explaining that complex reporting requirements are exacerbated by provider shortages.
Providers who received a minimum of $10,000 before June 30, 2020 have a reporting deadline of September 30, 2021, and they will have to return unspent funds by October 30. However, Health Resources and Services Administration (HRSA) said as of Thursday that the bulk of providers have not yet signed up for the reporting portal. To help push providers along, HRSA laid out three new resources focusing on clarifying previous guidance and condensing frequently asked questions to help providers comply with these deadlines. While HRSA is trying to help providers, the resources do not include new information. Analysts and accountants are still waiting on further guidance to calculate lost 2021 revenues, since providers’ budgets were set before March 2020.