On July 4, President Trump got his wish and was able to hold a signing ceremony for the Reconciliation Bill that put into effect many of his policy priorities.

The “One Big Beautiful Bill Act”, H.R. 1, was thus made law after the House of Representatives underwent hours of holding open votes, and a marathon speech from Democratic leader Hakeem Jeffries (D. N.Y.), to concur in the Senate amendment to the bill. That amendment was substantially different from the version that was sent over from the House at the end of May. We covered the basics of the initial House version in an earlier blog post.

We will have more in depth explorations of what changes this law will bring on the health law universe, and they are going be extensive. However, here is a quick highlight of the areas of health care law that were included (and those that were left out).

Continue Reading Senate Version of Reconciliation Bill Becomes Law

On July 2, 2024, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the formation of a new False Claims Act (FCA) Working Group.  The creation of the group, especially in the wake of record-breaking FCA recoveries in 2024, underscores the government’s ongoing commitment to combating health care fraud and makes clear that FCA enforcement is here to stay.

Continue Reading DOJ and HHS Launch Joint False Claims Act Working Group

The U.S. Department of Health and Human Services (HHS) is still looking for stakeholders to comment on what regulations should be modified. The HHS deregulation request for information (RFI), issued on May 14, has a public comment period that closes on July 14 at midnight.

At the American Health Law Association Annual Meeting on Wednesday, Elizabeth Kelley, the acting deputy general counsel at the HHS Office of General Counsel indicated that the overarching theme of the Trump Administration is to take a market-based approach to a number of issues, deregulation among them. Kelley said that with the RFI, HHS is seeking information about regulations that are either an extreme burden or may not be consistent with the enabling statute.

Additionally, Kelley indicated that HHS was interested in potentially addressing regulations that would have been approved by a court under the deference standard of the defunct Chevron doctrine. That doctrine required a court to defer to an agency’s interpretation of its enabling statute when crafting a regulation if that interpretation was reasonable and the statute was sufficiently ambiguous as to require interpretation.

Continue Reading HHS Still Seeking Public Input on Deregulation Efforts

On June 26, 2025, the U.S. Supreme Court held that Medicaid beneficiaries have no recourse under 42 U.S.C. § 1983 (Section 1983) to enforce their right under the Medicaid Act to receive care from any qualified provider of their choice. The decision in Medina v. Planned Parenthood South Atlantic, No. 23-1275, 606 U.S. ___ (2025) resolves a circuit split and has broad implications for private enforcement of federal spending statutes, particularly in the Medicaid context.

Case Background

In July 2018, South Carolina’s governor issued an executive order prohibiting clinics that render abortion services from participating in the state’s Medicaid program, even if they provide other types of covered services in addition to abortions. Planned Parenthood, along with patient Julie Edwards, sued the state, claiming that the exclusion violates the “any-qualified-provider” provision in the Medicaid statute. That provision requires states to ensure that “any individual eligible for medical assistance . . . may obtain” it “from any [provider] qualified to perform the service . . . who undertakes to provide” it. 42 U.S.C. § 1396a(a)(23)(A). The plaintiffs brought a class action under Section 1983, which allows private parties to sue state actors who violate their “rights” under the federal “Constitution and laws.” The state argued that federal statutes, like Medicaid, do not automatically confer enforceable “rights” under Section 1983.

Continue Reading Supreme Court Says Beneficiaries Have No Section 1983 Private Right of Action to Enforce Medicaid Provider Choice Provisions

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) released Advisory Opinion 25-03, offering a favorable review of a proposed telehealth arrangement involving a management support organization (MSO) and a professional corporation (PC). These parties (Requestors) proposed to enter into agreements with third-party telehealth platforms consisting of MSOs providing management services to telehealth providers (Platform MSOs) and affiliated professional telehealth entities that employ clinicians (Platform PCs).

Under the proposal, Requestors would lease clinicians from the Platform PCs and obtain certain administrative services from the Platform MSOs, including marketing, accounting, administrative support, and IT services. The Requestors sought OIG’s review of the proposed structure with the aim to expand access to in-network telehealth services, particularly for patients in underserved and rural areas. The Requestor PC would credential the leased clinicians and enroll them under its existing payor contracts. These clinicians would then provide services to Platform patients under Requestor PC’s in-network plans.

OIG ultimately concluded that while the arrangement implicates the federal Anti-Kickback Statute (AKS), it falls within a safe harbor protection. Thus, the payments between the parties do not constitute prohibited remuneration. The opinion offers important insight into how OIG continues to evaluate evolving telehealth and care coordination models under federal fraud and abuse laws.

Continue Reading OIG Issues Favorable Advisory Opinion 25-03 Regarding Telehealth Arrangement

Well, that was quite a week. Even with a federal holiday right in the middle, there were a number of developments in health care law that could reshape the very nature of the industry in the coming years.

Here is a summary of what happened last week and what we could foresee happening in the coming weeks.

Continue Reading A Week that Changed Health Care Law

On June 18, 2025, in a decision with multiple concurrences and dissents, the U.S. Supreme Court held that Tennessee’s SB1, which prohibits the provision of gender-affirming care to minors, does not violate the Equal Protection Clause of the Fourteenth Amendment. United States v. Skrmetti, No. 23-477, 605 U.S. ___ (June 18, 2025). This decision will have broad implications for gender-affirming care throughout the United States, given the Supreme Court’s holding that SB1 classifies based on age and medical condition, rather than sex, resulting in the Court’s application of rational basis review instead of heightened scrutiny.

Continue Reading Supreme Court Upholds Tennessee Ban on Gender-Affirming Care for Minors

Late on Wednesday June 18, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas issued an order vacating almost the entirety of HHS’s 2024 amendments to the HIPAA Privacy Rule that created special protections for reproductive health care information (the “Reproductive Health Privacy Rule”). The order was issued in a case brought by a Texas health care provider challenging the Reproductive Health Privacy Rule on the bases that the Rule unlawfully limited mandatory child abuse reporting, impermissibly redefined key statutory terms such as “person” and “public health,” and exceeded HHS’s statutory authority by using HIPAA to impose special rules for reproductive health care information. Purl, M.D. et al, v. United States Department of Health and Human Services et al., 2:24-cv-00228-Z (N.D. Tex.).  

Continue Reading Federal Court Vacates 2024 Reproductive Health Privacy Rule

On June 9, 2025, Oregon updated its Corporate Practice of Medicine (“CPOM”) doctrine by passing SB 951, to, among other things, prohibit workarounds to the doctrine by management services organizations (MSOs) and their owners and employees. According to one of the sponsors of the law, it was designed to prevent private equity or corporate owners from exploiting loopholes and exerting control over clinic operations through MSOs, which she argued violates the spirit and intent of Oregon’s CPOM law. The new law is effective on January 1, 2026 for new MSO arrangements, and its requirements apply on January 1, 2029 for those MSO arrangements in existence prior to its passing.

Continue Reading New Oregon Law Targets MSO Involvement in Medical Practices

Judge Kathryn Kimball Mizelle in the Middle District of Florida has once again ruled that the qui tam relator provisions of the False Claims Act (FCA) violated the Appointments Clause of the U.S. Constitution. In a May 29, 2025 order in United States ex rel. Gose v. Native American Services Corp., Judge Mizelle followed the same logic that led to her ruling last fall in United States ex rel. Zafirov v. Florida Medical Associates, LLC.   

In Zafirov, Judge Mizelle ruled that the FCA’s provisions that permit a private citizen to bring a claim in the absence of intervention by the federal government are unconstitutional because they established a mechanism whereby “unaccountable, unsworn, private actors” are permitted “to exercise core executive power with substantial consequences to members of the public.”  In reaching this conclusion, Judge Mizelle, who clerked for Justice Thomas, followed reasoning in a dissent by Justice Thomas in the decision United States ex rel. Polansky v. Executive Health Resources, Inc. (599 U.S. 419).

Zafirov has been appealed to the U.S. Court of Appeals for the Eleventh Circuit. The parties have completed briefing in the case, but the court has not yet scheduled oral argument. In the absence of an appellate ruling to the contrary, Judge Mizelle continues to apply her analysis to FCA cases before her.

Continue Reading Florida judge once again rules against constitutionality of False Claims Act relators

The California Senate has approved SB 41, a bill now under consideration in the Assembly, that would impose new licensing, transparency, and pricing regulations on pharmacy benefit managers (PBMs). Proponents argue the legislation would curb anti-competitive practices, enhance transparency, and ensure fairer pricing in the administration of prescription drug benefits by health insurers and health care service plans. Opponents of the legislation argue that, among other things, the bill would result in significant premium increases and that banning so-called performance-based contracts would not lower costs to patients.

Continue Reading California Senate Passes Bill Regulating Pharmacy Benefit Managers

After 28 hours of deliberation including a marathon Rules Committee meeting that saw more than 500 proposed Democratic amendments, the House of Representatives, early in the morning of May 22, passed the One Big Beautiful Bill Act (H.R. 1) (the Reconciliation bill).

The bill in its final form is certainly big, clocking in at over 1000 pages long and including a 42 page “manager’s amendment” with detailed editing instructions for changes that were needed to pass the bill both through the Rules Committee and through the full House. But is it beautiful? That, as the say, is in the eye of the beholder.

Continue Reading Breaking down the Health Care Impacts of the One Big [Reconciliation] Bill

On May 12, 2025, the Trump Administration released Executive Order 14297, entitled “Delivering Most-Favored-Nation Drug Pricing to American Patients” (the Order).  The Order seeks to make available to American consumers the “most-favored nation lowest price” to end “global freeloading.”

The Order and a related fact sheet released on the same day assert that the prices Americans pay for brand-name drugs are more than three times the prices other OECD nations pay, even after accounting for discounts that manufacturers provide in the U.S.  They state that this has resulted from “a purposeful scheme in which drug manufacturers deeply discount their products to access foreign markets, and subsidize that decrease through enormously high prices in the United States.” They further assert that “[t]he inflated prices in the United States fuel global innovation while foreign health systems get a free ride.”

The Order states that, within 30 days (i.e., by June 11, 2025), the Secretary of the Department of Health and Human Services (HHS) will “communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.”  The Order and fact sheet indicate that if drug manufacturers fail to offer most-favored nation (MFN) pricing in the U.S., the administration will take a series of additional steps.

Continue Reading MFN Drug Pricing Executive Order: New HHS release adds details on prices manufacturers expected to offer

Last week, on May 15, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if adopted, will change the standards by which states obtain waivers for health care-related provider taxes used to finance Medicaid. The proposal is aimed at closing a regulatory “loophole” that CMS believes allows states to shift Medicaid financing burdens to the federal government without meeting the statutory intent of redistributive tax structures.

CMS will be accepting public comments on the proposed rule until July 14, 2025.

Continue Reading CMS Proposes Rule to Tighten Medicaid Provider Tax Requirements

On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health research efforts in the United States. The orders, in part, direct federal agencies to take actions by this fall to curtail certain pharmaceutical manufacturing and health research activities performed outside the United States. The orders are among the first of many that are anticipated to initiate federal restrictions on offshore health care and life sciences activities and incentivize domestic operations in the industry.

Executive Order 14293 Regulatory Relief To Promote Domestic Production of Critical Medicines (E.O. 14293) restores an effort that was started during the first Trump administration and continued under the Biden administration to attempt to assist companies to bring pharmaceutical manufacturing capacity back to the United States. As with E.O. 14292, this order directs federal agencies to take the next 90 to 180 days to review and offer changes to regulations and subregulatory guidance to help increase American manufacturing capacity for pharmaceuticals.

Executive Order 14292, Improving the Safety and Security of Biological Research (E.O. 14292) seeks to regulate and eliminate “gain of function research” which has been identified by some as the genesis of the novel coronavirus responsible for COVID-19. On top of suspending federal funding for gain-of-function research both in and outside of the United States, the order broadly suspends funding for “other life-science research” that is occurring in countries of concern or foreign countries where there is not adequate oversight. The order also directs federal agencies to revise the framework for oversight and managing risks in biological research.

Both of these executive orders could signal massive changes to the production and importation of drugs as well as the research process behind those drugs. As a result, pharmaceutical manufacturers, research institutions, and health care institutions that dispense, distribute, or otherwise rely on these offshore activities should carefully watch upcoming actions by the various elements of the Department of Health and Human Services (HHS) as well as the Environmental Protection Agency (EPA) for guidance on how these changes will be implemented.

Continue Reading Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research

In February 1971, at the tail end of Richard Nixon’s first term, his Secretary of Health, Education and Welfare, Elliot Richardson, approved a directive that was printed in the Federal Register as a Statement of Policy on “Public Participation in Rulemaking”.

The statement asserted that the Department of Health Education and Welfare (the precursor to the current Department of Health and Human Services [HHS]) would NOT exempt from full notice and comment rulemaking any rules relating to public property, loans, grants, benefits or contracts. The Department made this decision even though it was permitted to exempt these rules by the text of the Administrative Procedure Act (APA). Additionally, the policy statement urged the agency to only sparingly use a “good cause” exemption from notice and comment that was also included in the text of the APA.

Continue Reading Elimination of the Richardson Waiver Means Changes . . . But To What End?

In a significant ruling among the first to analyze the application of information blocking regulations, the U.S. Court of Appeals for the Fourth Circuit affirmed a preliminary injunction against an EHR company in favor of a diagnostic analytics services company. The injunction grants the analytics company access to patient data, enabling the company to provide its analytics services to nursing facility customers who use the EHR vendor’s services.

The case, Real Time Medical Systems, Inc. v. PointClickCare Technologies, Inc., No. 24-1773 (4th Cir. 3/12/25), arises out of claims by Real Time Medical Systems, Inc. (“Real Time”) that PointClickCare Technologies, Inc. (“PCC”) implemented a technical protocol that cut-off Real Time’s appropriate access to its customers’ electronic health information (“EHI”) and that PCC did not implement this protocol for legitimate security or performance reasons as PCC claimed, but rather to interfere with Real Time’s business so that PCC could capture Real Time’s market share with its own competing analytics products.

Continue Reading Information blocking victory in favor of access to health data

Reed Smith has announced the dates and topics for it’s 11th annual health care conference from March 17-21, 2024. The conference will be conducted entirely virtually this year with CLE webinars offered throughout the week on important and timely topics for the health care industry.

The schedule of the sessions is below, all of the webinars are free and have each been presumptively approved for CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit will also be filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia.

Webinars can also be watched on-demand, but viewers who do so will only be able to obtain CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. They will also have to alert Reed Smith to their viewing of the program to obtain credit.

To register for any or all of the webinars, please click here.

Here is the schedule of webinars for the week: (all times are in EST)

Continue Reading Reed Smith’s 11th Annual (Virtual) Health Care Conference Coming March 17-21

California lawmakers are once again considering legislation targeting private equity’s influence in health care. Senate Bill 351 (SB 351), introduced on February 12, 2025, seeks to limit the influence of management service organizations (MSOs) and dental service organizations (DSOs) backed by private equity (PE) groups and hedge funds over medical and dental practices.

SB 351 adopts certain provisions of last year’s vetoed Assembly Bill 3129 (AB 3129), which would have required PE groups and hedge funds to obtain California Attorney General (AG) approval before entering into certain health care transactions. In September 2024, Governor Gavin Newsom vetoed that bill, citing redundancy with the California Office of Health Care Affordability’s (OHCA) existing oversight of health care transactions. Our discussion of OHCA’s health care transaction notice requirements is available in an earlier Reed Smith in-depth piece.

Continue Reading California to Reconsider Restrictions on Private Equity Influence in Medicine and Dentistry

At the Federal Bar Association’s (FBA) Annual Qui Tam Conference on February 20, 2025, Department of Justice (DOJ) representatives Michael Granston (Deputy Assistant Attorney General for Commercial Litigation) and Jamie Yavelberg (Director of the Fraud Section in the Civil Division) discussed enforcement priorities for the False Claims Act (FCA), including Medicare Advantage, cybersecurity, and pandemic fraud, and emphasized the continuing focus on FCA enforcement. Despite the Trump administration hitting “pause” on FCPA enforcement, FCA enforcement is here to stay.

We lay out the impacts of their comments at the conference and what it means for enforcement priorities by the DOJ in this Reed Smith Client Alert.