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This is the second in a series of blog posts designed to provide a deeper dive into the provisions of the 2025 Reconciliation Law (Informally called the One Big Beautiful Bill Act). An earlier installment discussed the impact of the law on reproductive rights and gender affirming care. This installment discusses the impact on the Medicare program.

Of the two primary Federal health care programs, Medicaid experienced the most significant changes in the final version of H.R. 1, the 2025 Reconciliation Law. But Medicare did not go unscathed. In fact, the impact to Medicare will be substantial—both in terms of the law’s express provisions and the broader implications regarding future Medicare payment levels.

What was carved out of the law during the Senate amendment process may be just as important as what was left in, as that Senate carve-out process reflects legislative changes to the Medicare program that were a high enough priority to make it into a House bill that passed by only a single vote, but were omitted from the Senate version for procedural reasons. The Reconciliation Law’s changes are designed to offset increased government costs associated with the Administration’s tax agenda. As a result, the cuts associated with those changes will result in reduced access to certain Medicare services.

In this post, the second in our series that dives deeply into the terms and impact of the Reconciliation Law, we will discuss both the textual and contextual impacts of the law on Medicare, starting with the provisions that actually made it into the law.Continue Reading Medicare Changes as a Result of 2025 Reconciliation Law Could Be Substantial

This is the first in a series of blog posts designed to provide a deeper dive into the provisions of the 2025 Reconciliation Law (Informally called the One Big Beautiful Bill Act). This installment discusses the impact of the law on reproductive rights and gender affirming care. See the note at the end of this post for a listing of further parts.

The 2025 Reconciliation Law (informally known as the “One Big Beautiful Bill Act”), signed into law on July 4, 2025 transformed dramatically from the version that was introduced in the House Rules Committee’s 22-hour meeting on May 21-22. Between that committee meeting and the law’s eventual signing ceremony, nearly all of the restrictions on abortion care and gender-affirming care were removed. What remains is a Medicaid funding provision designed to defund health care providers who provide family planning and related services. Shortly after the law’s passage, even the remaining provision quickly faced legal challenge, with a federal judge blocking its enforcement.

In this post, we explore the law, from inception to enactment, and examine how what remains will impact reproductive health care going forward.Continue Reading Reconciliation Bill Blocks Funding For Family Planning Services, Reproductive Health, and Related Medical Care

In an advisory opinion released June 30th, the U.S. Department of Health and Human Services Office of Inspector General (OIG) confirmed that it would not seek to impose monetary sanctions on a medical device manufacturer for its efforts to reimburse purchasers of its device for accidental needle stick injuries caused by a failure of the device’s safety mechanism.

According to the OIG, the manufacturer’s plan fits under the federal Anti-Kickback Statute’s regulatory safe harbor for warranties and does not generate prohibited remuneration under that statute, despite the offer to pay purchasers for failure of the device which might induce purchasers to choose the manufacturer’s product.Continue Reading OIG Advisory Opinion Supports Plan to Reimburse for Needle Stick Injuries

The U.S. Department of Health and Human Services (HHS) has announced a new general policy on what factors the agency will take into account when considering whether to make a criminal referral to the Department of Justice (DOJ) for individuals and entities who violate HHS regulations.

The notice, published on June 24, is in response to Executive Order 14294, which was issued by President Trump on May 9, 2025 and is designed to fight “overcriminalization in federal regulations.” That executive order pointed to the Code of Federal Regulations and its reams of pages in which lurk regulations that could result in criminal liability.

Under the executive order, agencies were required to issue guidance in the Federal Register (so, more pages to read) to identify their plan to address criminal regulatory offenses. In addition to this policy guidance, the agencies are required to submit a report within a year to the Office of Management and Budget (OMB) detailing all potentially criminal regulatory offenses as well as the potential punishment for violation of those regulations.Continue Reading HHS Announces Policy on Criminal Referrals for Regulatory Violations

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

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 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

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

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

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?

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

On January 15, the Department of Justice (DOJ) reported that False Claims Act (FCA) recoveries for civil cases in fiscal year 2024 totaled approximately $2.9 billion, representing about a $200 million increase from 2023. And these numbers do not account for two major settlements that were reached shortly after the close of the fiscal year that would have added an additional $830 million to the total. Of the total recovered by DOJ in 2024, approximately $1.67 billion (58%) related to matters involving the health care sector. Although a lower percentage of these recoveries related to health care than prior years, the health care sector remains the primary industry under scrutiny.  

For the second year in a row, the total number of qui tam lawsuits increased, demonstrating continued fraud enforcement by the agency and an active environment for private whistleblowers. The 979 qui tam cases filed in 2024 is a new record, blowing past the prior record of 757 cases in 2013 and far exceeding last year’s total of 713. And while the number of government-initiated cases dropped from last year’s record pace, the 423 non qui tam cases filed in 2024 is an order of magnitude higher than any other year since 1986.

This increase in FCA activity comes at a time of uncertainty for the law. As Reed Smith covered last fall, a federal judge in Florida ruled that the qui tam provisions of the FCA violated the Appointments Clause of the Constitution by investing core executive powers into unappointed whistleblowers. That decision followed reasoning in a Supreme Court dissent and is on appeal to the U.S. Court of Appeals for the Eleventh Circuit. Incoming Attorney General Pam Bondi assured senators during her confirmation hearing that she would defend the constitutionality of the provisions.Continue Reading DOJ exceeds $2.9 billion in FCA recoveries in 2024 and reports a record number of qui tams

In the final 2025 Medicare Physician Fee Schedule, which is set to be published in the Federal Register on December 9, the Centers for Medicare and Medicaid Services (CMS) included substantive changes to the regulations governing when a provider must report and return a Medicare overpayment in order to avoid liability under the False Claims…

The 2024 elections created a bit of a mixed result for reproductive rights in the United States. A number of states passed ballot initiatives designed to increase access to abortion and reproductive health services. However, at the same time, Donald Trump was elected back into the office of the President and Republicans appear to have…

This month, the Centers for Medicare & Medicaid Services (CMS) has begun an off-cycle revalidation process directed at all Medicare-participating skilled nursing facilities (SNFs). The process is designed to implement provisions of the Affordable Care Act (ACA) that require facilities to detail their ownership structures and key managerial personnel.

CMS is seeking information about ownership of SNFs by private equity firms and real estate investment trusts (REITs). In September, CMS revised Form 855A to require a SNF to report those types of ownership interests. The agency has also released a guidance document detailing the requirements and how a SNF should go about filling out the form.

CMS indicated that it would seek this off-cycle revalidation process as part of its effort to implement the disclosure requirements of Section 1124(c) of the Social Security Act (42 U.S.C. § 1320a-3(c)) in a Final Rule issued in November 2023 (88 Fed. Reg. 80,141).Continue Reading CMS Ramps up Process for Identifying Private-Equity Ownership of SNFs