Weekly Roundup: July 15, 2022

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HHS Renews Public Health Emergency Determination for COVID-19 Pandemic

Today, Secretary Xavier Becerra of the Department of Health and Human Services (HHS) announced his renewal of the public health emergency (PHE) determination due to the ongoing consequences of the COVID-19 pandemic. Assuming that HHS issues the maximum 90-day renewal in line with the length of past renewals, such a renewal would extend the PHE through October 13, 2022.

The PHE status has been in place nationwide since January 27, 2020.

CMS Proposes Rule Relating to Health Equity and Improved Access to Care

Today, the Centers for Medicare & Medicaid Services (CMS) released its annual Medicare OPPS / ASC / QRP rule related to payment for outpatient and ambulatory services. CMS’ fact sheet outlines the major policies included within the proposed changes, included important policies related to health equity and the newly-created Rural Emergency Hospital (REH) designation. Highlights from the rule include:

Rural Emergency Hospitals (REHs): As part of its broader efforts to address health equity CMS, CMS recently released the first Conditions of Participation for the newly-created REH provider facility type. In today’s rule CMS outlines the payment for such facilities under Medicare. REHs are intended to include emergency department services and observation care and may include other outpatient medical and health services. The rule proposes to set the payment for services provided in REHs as the same as those offered under Medicare plus 5%. They will also receive a monthly facility payment that will increase annually at an indexed rate.

The rule also outlines provider enrollment, quality requirements, and self-referral policies specific to REHs. CMS seeks input on all of these components as well as the conditions of participation introduced in June.

Extension of Remote Behavioral Health Services: CMS is proposing to extend the payment for the provision of certain telehealth behavioral health services beyond the conclusion of the PHE.

RFI on Competition: CMS has included an RFI on enhancing transparency and competition in the health care system more broadly. Specifically, CMS is seeking feedback on how data can be further utilized to promote competition and quality improvement, and whether CMS should consider releasing data on mergers, acquisitions, consolidations, and changes in ownership for other provider types. In addition to the highlighted changes, CMS increasing qualified hospital and ASC payment amounts by 2.7%.

Healthsperien will continue to review the rule and provider further details on its proposed changes.

Senator Manchin Expresses Preferences for Narrow Budget Reconciliation Package

On Thursday evening, Senator Joe Manchin (D-WV) reportedly announced that he would only support a budget reconciliation package that includes a two-year extension of enhanced ACA tax credits for individuals up to 150% of FPL (originally passed in 2021 as part of the American Rescue Plan Act) as well as drug pricing reform legislation. The announcement severely limits the intended scope of the reconciliation package, which Democrats hope would also include broader reforms such as climate change policies, tax reforms meant to ensure Medicare trust fund solvency, and the closure of the Medicaid gap (solutions to expand coverage to individuals in non-Medicaid expansion states). Moreover, if accepted as the final compromise position, it would only delay the current “benefit cliff” associated with the enhanced ACA subsidies to 2024 instead of making them permanent, the latter of which is the more broadly preferred option by Congressional Democrats.

While the announcement by Senator Manchin represents a setback for health care-related reconciliation efforts, it still leaves sufficient room for the consistently bipartisan drug pricing reform legislation. It also does not directly impact ongoing negotiations related to the developing bipartisan mental health package, which is not expected to move through the budget reconciliation process and instead should be introduced and voted on in normal order.

988 Mental Health Crisis Hotline Launches Saturday

On Saturday, the United States will transition from the 10-digit National Suicide Prevention Lifeline to 988, an easy-to-remember number where callers can access 24/7 crisis care.

This initiative reflects a collaboration between the Department of Health and Human Security (HHS), Federal Communications Commission (FCC), and Veterans Affairs (VA), and aligns with President Biden’s commitment to addressing the nation’s mental health crisis. The Biden-Harris administration has increased federal investments in the Lifeline to $432 million to build crisis center capacity.

The Lifeline received 3.6 million calls, chats, and texts in 2021—that figure is expected to double within the first year of transition to 988. This action represents cross-government collaboration to support the needs of at-risk communities in crisis, including young people, individuals with disabilities, and veterans.

House Takes Up Abortion Bills For First Time Since Dobbs Decisions

Today, the House of Representatives will vote on two abortion-related bills (subscription required), after the Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization created a policy priority for many Democrats.

One bill, H.R. 8296 would codify the federal abortion protections overturned with Roe v Wade. The second bill, H.R. 8297, seeks to pre-empt any state laws that may try to limit an individual’s right to travel across state lines to obtain an abortion. The bills are likely to pass the House but would not have sufficient Senate support to overcome a filibuster.

Administrative Action

The Department of Health and Human Services (HHS) announced new guidance and communication to ensure all patients have access to the full rights and protections for emergency medical care afforded under the law. The announcement comes after President Joe Biden issued an executive order on reproductive health last Friday. Through the Centers for Medicare & Medicaid Services (CMS), HHS issued clarifying guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA) and reaffirmed that it protects providers when offering legally-mandated, life or health-saving abortion services in emergency situations. Secretary Xavier Becerra also sent a letter to providers, making it clear that this federal law preempts state law restricting abortion access in emergency situations.
Drug manufacturers Danco Laboratories and GenBioPro have submitted (subscription required) a detailed proposal to the Food and Drug Administration (FDA) laying out ways to expand access to medication abortion, particularly in states that allow telemedicine care. The companies hope to modify the risk-mitigation strategy for the abortion pill, mifepristone, but declined to provide details. In December, the FDA stopped restricting the types of facilities that can dispense mifepristone and allowed certified pharmacies to dispense the drug. These changes to the mifepristone risk evaluation and mitigation strategy (REMS) allow the drug to be delivered through the mail via telehealth. Legal scholars argue the FDA should further loosen or remove REMS restrictions for mifepristone to facilitate access to abortion care.
The Department of Health and Human Services (HHS) issued guidance to roughly 60,000 U.S. retail pharmacies on Wednesday, reminding them of their federal anti-discrimination obligations. As recipients of federal financial assistance (including Medicare and Medicaid payments), civil rights laws prohibit discrimination on the basis of race, sex, age, and disability in all programs and activities, including supplying prescriptions, determining patient eligibility for medications, and advising patients on medication use. The guidance states that pharmacies, therefore, may not discriminate against pharmacy customers on the bases prohibited by Section 1557 of the Affordable Care Act and Section 504 of the Rehabilitation Act of 1973—including with regard to supplying medications; making determinations regarding the suitability of a prescribed medication for a patient; or advising patients about medications and how to take them.
The Patent and Trademark Office (PTO) will work (subscription required) with the Food and Drug Administration (FDA) to increase scrutiny of drug patents. The organizations will commit more resources to ensuring that drug companies are not allowed to patent trivial changes to their products to delay generic competition. The collaboration follows an executive order President Biden signed last year, ordering Health and Human Services (HHS) to control drug prices. HHS Secretary Xavier Becerra released a plan to improve coordination between the agency and other departments, prompting a partnership between the FDA and PTO. In May, Sens. Maggie Hassan (D-NH) and Bill Cassidy (R-LA) called on the organizations to improve coordination on drug patents.
HRA Pharma submitted an application to the Food & Drug Administration (FDA) on Monday to sell its birth control pill, Opill, over the counter (OTC). The company has applied for an Rx-to-OTC switch for the progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). If approved, this would be the first daily birth control pill available OTC without a prescription in the U.S. This precedent-setting move seeks to expand contraceptive access in the wake of the Supreme Court’s controversial Dobbs v Jackson Women’s Health Organization decision. Nearly one third of women who have tried to obtain a prescription for contraceptive services reported difficulty doing so.

Litigation

The Texas attorney general filed a lawsuit against the Biden administration on Thursday challenging the recent Emergency Medical Treatment and Active Labor Act (EMTALA) guidance which informed health care providers that they can perform certain abortions in emergency situations regardless of any statewide bans in place. The lawsuit argues that EMTALA does not protect abortions and that HHS is exceeding its authority by claiming that it does.

Congressional Action

Senator Richard Burr (R-NC), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), introduced the Food and Drug Administration Simple Reauthorization Act today. The bill would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements to ensure Americans continue to have access to innovative treatments and therapies. The legislation follows concerns over the Senate’s ability to pass the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act on time.
The Congressional Budget Office (CBO) projects Democrats’ updated drug pricing legislation would reduce the federal deficit by $288 billion over a decade. The bill is part of the reconciliation package that Senate Majority Leader Chuck Schumer (D-NY) is working on with Sen. Joe Manchin (D-WV) to ensure the legislation has universal support from the Democratic party. The previous version of the legislation from last November received a projected savings estimate of $297 billion from the CBO. The largest block of savings, $122 billion, comes from repealing a Trump-era drug rebate ban.

Regulatory Action

The Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Physician Fee Schedule proposed rule that outlines the Agency’s policy proposals for Medicare payments under the physician fee schedule. Significant policies addressed in this rule include changes to the Medicare Shared Savings Program, behavioral health integration, evaluation and management visits, telehealth services, updates to the Medicare Economic Index, and a new provision for accessing audiology services. Healthsperien has provided a detailed summary of the proposed rule, including relevant background information and areas where CMS is seeking comments, which can be accessed here.

Medicare

The Commonwealth Fund released a report titled “Approaches to Improving Medicare’s Home Health Benefit: Lessons from Medicaid.” The Medicare Home Health Benefit is designed to provide care to beneficiaries in their homes following acute events, or for ongoing conditions. In practice, the report notes that the benefit is underutilized, and home health agencies do not provide the full range of services. Access to these services has splintered along racial and ethnic lines, and when Medicare does not cover these services, the burden of payment falls to family members.
USC-Brookings Schaeffer on Health Policy released an analysis of profits in the Medicare Advantage (MA) program, including highlighting the extent of incomplete MA plan/payment data and the subsequent limitations to derive conclusions about market performance. The authors examined sources of earnings and profits by MA plans, focusing on potential sources, measurement challenges, and the role of Medical Loss Ratio (MLR) regulations in constraining the potential for overpayments.

Research

According to a new study, methadone-related overdose deaths declined relative to all drug overdose deaths during the COVID-era treatment expansion. Access to the opioid use disorder treatment was expanded at the start of the pandemic to allow more patients to take home doses without requiring a clinic visit. In 2020, the Substance Abuse and Mental Health Services Administration under the U.S. Department of Health and Human Services allowed states to request exceptions to provide up to 28 days and 14 days of take-home methadone for stable and less stable patients, respectively. The data indicates that broader access to treatment was not associated with greater harms. Only about 18% of substance use disorder patients receive medication for their illness, and methadone is currently restricted through federally certified opioid treatment programs.