Policy & Politics

Study Could Help Policymakers Set Fair Reimbursement Rate for Ground Ambulances

Ground ambulance services are exempt from the federal ban on balance billing, also known as surprise billing, and a new study published in the journal Health Affairs found that privately owned ambulances are more likely to balance bill than their public sector counterparts. The study’s findings will doubtless be considered by a new federal panel convened to recommend solutions to the complexities of ground ambulance balance billing, which could shape potential legislation to fix the problem in the current Congress — legislation that could find the federal government setting rates for ambulance reimbursement.

A key reason that ground ambulance services were not included in the No Surprises Act (NSA) — the 2020 law that bans medical balance billing — is the ownership structure of ambulance services. About 60% of ground ambulance providers are funded by local governments as part of their fire departments or as a quasi-utility, according to Loren Adler, a coauthor of the study and an economist and associate director of the USC-Brookings Schaeffer Initiative for Health Policy. That arrangement is somewhat unique in the U.S. health care system.

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News Briefs: Public Health Emergency Is Slated to End in May

The COVID-19 public health emergency (PHE) will end on May 11, the Biden administration said. Emergency authorities flowing from the PHE have required insurers to make certain COVID-19 testing and treatment available to plan members at no additional cost; expanded access to telehealth in Medicare, Medicaid and CHIP; increased funding to states for Medicaid; and barred states from disenrolling Medicaid members. In December, Congress authorized states to begin disenrolling Medicaid members starting in April, with enhanced funding declining and zeroing out on a set schedule starting then. The Biden administration’s announcement comes as Republicans, newly in control of the House of Representatives, have introduced bills that would end the PHE much sooner. The May 11 end date “align[s] with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the PHE,” according to a White House statement.

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New Law Could Make Accelerated Approval Stricter, If FDA Enforces It

The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.

Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.

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Even With Split Congress, Some Experts Predict Heightened Health Care Oversight

Although there’s a divided Congress this year — with Republicans controlling the House and Democrats in charge of the Senate — there are still a variety of health care policy issues that federal and state legislators alike have in their crosshairs, experts said during a recent webinar hosted by the Alliance for Health Policy. And some of those agenda items could be of considerable interest to health insurance companies.

Paul Edattel, principal of Todd Strategy Group, LLC, a federal government affairs firm, said he expects the newly Republican-controlled House to zero in on budgetary issues. “Budgetary issues are top-of-mind for House Republicans and some Senate Republicans,” he remarked during the Jan. 25 webinar. “Things like the operating budget for the Department of Health and Human Services...will be under really heightened scrutiny relative to prior Congresses.”

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New Law Could Make Accelerated Approval Stricter, If FDA Enforces It

The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.

Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.

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Federal Funding Law Introduces New Compliance Challenges in Telehealth, Mental Health, Medicaid

The Consolidated Appropriations Act, 2023 (2023 CAA) — the latest edition of the annual bill that funds the federal government — includes notable new policies that will touch on telehealth, behavioral health and Medicaid enrollment, among other areas. According to policy experts, because of the law, health plans have a great deal of new compliance requirements to manage in plan year 2023 and beyond.

Congress discussed notable reforms to telehealth and mental health care over the course of 2022, and the 2023 CAA includes permanent changes to the latter — and temporary extensions of pandemic-era policies for the former. Meanwhile, the law sets out requirements for states and managed care organizations disenrolling Medicaid members as part of the return of Medicaid eligibility redeterminations.

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News Briefs: FDA Requests Withdrawal of Pepaxto Marketing Authorization

The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7. “We respect FDA´s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.

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2023 Outlook: Analysts Predict Another ‘Stable’ Year for Health Insurers

This year, a variety of headwinds and tailwinds are likely to buffet the health insurance industry, including inflation, a possible recession, the return of Medicaid eligibility checks, potential policy changes in Medicare Advantage, a split Congress, easing COVID costs and more. But the net effect of all those factors is likely to leave the sector on stable footing, analysts tell AIS Health.

“The tailwinds and headwinds change every year — that’s the case again for ’23. Overall, we think it’s balanced; that’s why we have a stable view,” says James Sung, associate director of insurance at S&P Global Ratings.

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Is Now the Time to Take All-Payer Claims Databases National? Some Policy Experts Say Yes

For years, all-payer claims databases (APCDs) have been popping up around the country, collecting claims and encounter data in order to help payers, providers, policymakers and others better understand and improve local health care markets. Currently, 18 states have an APCD and at least six are developing one, according to Manatt Health. But in a new report and during a recent virtual summit, the firm argues that the current patchwork of state APCDs isn’t up to the task of providing comprehensive, streamlined data that can help solve the pressing affordability, quality, equity and access issues facing the American health care system.

Instead, after engaging “more than 40 federal and state policymakers, regulators, researchers, and other health data leaders,” the Manatt report recommends building on the existing state-based APCD structure by creating a Federally Facilitated State Data Partnership model.

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Spending Bill Ends Uncertainty by Setting Start Date for Medicaid Redeterminations

While making their financial projections for 2023, health insurers have had to acknowledge that the timing of a major headwind — the resumption of Medicaid eligibility redeterminations — continued to be a question mark. Now, if a newly released draft of Congress’ year-end spending bill is passed as written, that uncertainty will be removed and replaced with a firm date: April 1.

Industry observers tell AIS Health, a division of MMIT, that it’s helpful for both state governments and managed care organizations to have a definite answer about when millions of people will start losing their Medicaid eligibility — although the event itself remains a net negative for MCOs.

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