Legal and Regulatory Compliance

Supreme Court ruling on Chevron makes regulations in healthcare (and other industries) more vulnerable to legal challenges

The U.S. Supreme Court issued a decision Friday that has dramatic implications for the regulatory infrastructure in healthcare, among many other industries. Since it was established in a 1984 case, Chevron deference has served as guidance to courts that regulatory authorities such as CMS and dozens of others across the federal government have license to…

Nick Hut June 28, 2024

Preventive-services coverage mandate for Affordable Care Act plans remains intact following appeals court ruling

In a decision that could have been consequential for health insurance coverage offered through the Affordable Care Act (ACA) marketplaces, an appeals court limited the immediate impact. The U.S. Court of Appeals for the Fifth Circuit upheld a lower-court ruling that preventive-care mandates for ACA health plans are unconstitutional. But the appeals court said the…

Nick Hut June 24, 2024

Hospitals can bring their case on disproportionate share hospital payments to the Supreme Court

The Supreme Court granted hospitals’ request that it hear their appeal about the formula for determining Medicare disproportionate share hospital (DSH) payments, landing the case on the docket for the 2024-25 term. More than 200 hospitals are plaintiffs in the case. A federal district court ruled for HHS and against the hospitals in 2022, and…

Nick Hut June 12, 2024

340B providers are at a disadvantage after the latest court ruling on contract pharmacies

A decision issued by an appeals court represents the latest setback for 340B providers hoping to secure widespread access to price discounts on Medicare Part B drugs. The U.S. Court of Appeals for the District of Columbia Circuit on May 21 upheld a district-court ruling that drug manufacturers can impose restrictions on the 340B discounts…

Nick Hut May 24, 2024

Healthcare Blame Game: What media and lawmakers don’t understand about hospital finances

In this episode, HFMA policy director Andrew Donahue discusses margins, investments and M&A and what measure tells the real story of hospital finance.

Erika Grotto May 23, 2024

Optimizing 340B participation compliantly while “waiting and watching” new developments

Since 1992, the 340B program has required drug manufacturers to provide eligible healthcare organizations and other covered entities with drugs to be used for these organizations’ outpatients at significantly reduced prices, with the intent of helping safety net organizations improve their financial stability. In turn, hospitals are expected to demonstrate that the savings they receive…

Lauren Gorski May 22, 2024

HHS issues regulations to strengthen anti-discriminatory protections in healthcare (updated)

July 3 update A judge with the Southern District of Mississippi federal court granted an injunction preventing the Biden administration from enforcing regulations expanding anti-discrimination protections in the Affordable Care Act (ACA). Issued two days before the new rule was to take effect, the order applies to the provisions concerning gender identity. The move came…

Nick Hut May 14, 2024

Seeking to improve healthcare for Medicaid beneficiaries, CMS issues a flurry of regulations

CMS over the last month published a trio of final rules intended to make the Medicaid program work better for beneficiaries, with implications for healthcare providers. The three rules address eligibility and enrollment, access and Medicaid managed care. Streamlining eligibility and enrollment The first rule addresses administrative barriers in an effort to simplify enrollment processes…

Nick Hut May 1, 2024

A new 340B dispute resolution process could create more opportunities for providers

Regulatory updates to the administrative dispute resolution (ADR) process in the 340B Drug Pricing Program seem likely to expedite the filing of claims over manufacturers’ refusal to offer discounts on drugs distributed at contract pharmacies. HHS and the Health Resources and Services Administration (HRSA), which administers the 340B program, published a final rule that modifies…

Nick Hut April 26, 2024

The FTC’s new non-compete regulations will affect hospital agreements with physicians, unless courts intervene

Hospital advocates expressed concern about the implications of new federal regulations that prohibit employers from including non-compete clauses in employment agreements. Although tax-exempt hospitals largely fall outside the jurisdiction of the Federal Trade Commission (FTC), which will enforce the regulations, the newly issued final rule stands to affect clinical staffing. Non-compete agreements apply to between…

Nick Hut April 24, 2024
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