The Ethical Roundabout
Healthcare News and Ethical Issues for June 30 to July 11
Federal:
AMCP: The President has signed the "One Big, Beautiful Bill", which includes significant health provisions aimed at reducing the budget deficit. H.R. 1 is estimated to save nearly a trillion dollars over a decade, primarily targeting Medicaid by introducing community engagement requirements for able-bodied adults without dependents and mandating more frequent eligibility redeterminations. Additionally, the bill addresses drug pricing by expanding the orphan drug exclusion and establishing a new definition for Pharmacy Benefit Managers (PBMs), requiring greater transparency and de-linking PBM compensation from drug prices.
Justice.gov: The Department of Justice has filed a civil complaint against medical provider Dr. Shayasta S. Mufti under the False Claims Act. This legal action alleges that Dr. Mufti caused the submission of false claims to Medicare for medically unnecessary genetic laboratory tests between April and November 2019. The complaint asserts that Dr. Mufti referred over 100 Medicare beneficiaries for expensive genetic tests without establishing a proper medical relationship, conducting examinations, or using the results for patient management, often based on brief or no telemedicine consultations.
National Law Review: The District Court for the Northern District of Texas has vacated portions of the HIPAA final rule concerning reproductive health care information, impacting privacy protections. Purl, et al. v. U.S. Department of Health and Human Services, et al., effectively prevents the implementation of the Final Rule, which aimed to narrow the permitted uses and disclosures of protected health information related to lawful reproductive health care. As a result of the court's decision, group health plans are expected to revert to their previous HIPAA compliance programs, pending a potential appeal by the U.S. Department of Health and Human Services (HHS) by August 17, 2025.
National Law Review: The Supreme Court has upheld the Affordable Care Act's (ACA) preventive services mandate in a recent judicial decision. This court case, Kennedy v. Braidwood Management, Inc., centered on a challenge to the constitutionality of the U.S. Preventive Services Task Force's (USPSTF) appointment process. The Supreme Court ruled that USPSTF members are inferior officers whose appointment by the Secretary of Health and Human Services is constitutionally valid, thereby ensuring that non-grandfathered group health plans and issuers must continue to cover USPSTF-recommended preventive services without cost sharing.
State:
Capital News Illinois: The Governor of Illinois signed two significant health care bills aimed at controlling costs and expanding insurance coverage. The first, House Bill 1697, known as the Prescription Drug Affordability Act, places new controls on pharmacy benefit managers (PBMs), prohibiting practices like "spread pricing" and steering patients to affiliated pharmacies, while also establishing a grant program for independent pharmacies. The second, House Bill 3019, the Healthcare Protection Expansion Act, notably prohibits state-regulated health plans from requiring prior authorization for outpatient mental health services and mandates coverage for patients' travel expenses when seeking long-distance in-network care, particularly benefiting rural residents.
WUSF: The Florida Governor has signed into law a bill extending the ban on discrimination based on mRNA vaccination status. House Bill 1299 maintains the legal definition of mRNA vaccines and prohibits government agencies, certain businesses, and schools from discriminating against individuals based on their vaccination status, including for COVID-19. Beyond vaccination discrimination, the new law also introduces provisions requiring state medical marijuana treatment centers to report theft or loss of cannabis, mandating criminal history checks for their employees, specifying licensing criteria for physician assistants in critical need areas, and revising rules for out-of-state healthcare workers seeking licenses under the Act.
Journal Record: In Oklahoma, the state legislature overrode a veto from the Governor to pass a bill to address prescription drug pricing. House Bill 2048 aims to protect the federal 340B Drug Pricing Program, which allows certain healthcare organizations to purchase outpatient drugs at discounted prices, from practices by pharmacy benefit managers (PBMs) and pharmaceutical companies that reduce the benefit to these entities. Specifically, the Act prohibits health insurance issuers, PBMs, and third-party payors from reimbursing 340B entities at lower rates or imposing different terms based on their participation in the program, or interfering with patient choice.
Glances Abroad:
ChosunBiz: In South Korea, the Lee Jae-myung government is actively promoting legislation to institutionalize non-face-to-face medical consultations. This executive and legislative push seeks to formalize remote medical care, which had previously only operated on a pilot project basis, largely initiated due to the COVID-19 pandemic. The government's moves are seen as a critical step toward establishing non-face-to-face medical consultations as a permanent part of the healthcare system.
Euractiv: In Bulgaria, a proposed drug procurement bill, supported by factions within parliament, has been consistently blocked by the country's parliamentary majority, defying an ongoing EU infringement process. This legislation aims to mandate public tenders for medicine purchases by private hospitals, seeking to reduce inflated prices and potential corruption in the use of state health funds. The European Commission initiated infringement proceedings in 2018 due to Bulgaria's prior removal of such tender requirements, and the continued blockage of the bill by parties like GERB, influenced by private medical institutions, risks financial sanctions from the EU. However, some argue that private hospitals should be exempt from EU procurement directives, citing practices in other European countries.
AP: The Finance Ministry of China announced that European medical device companies will be barred from selling to the Chinese government. This countermeasure responds to the EU’s restrictions on similar products from China, applying to procurements over 45 million yuan ($6.28 million) but exempting European companies manufacturing in China. The EU had previously announced in June that Chinese companies would be excluded from its government purchases above 5 million euros ($5.89 million), citing China's alleged discrimination against EU firms in its procurement market.