Legislative Developments

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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

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 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

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

California’s new law, SB 1120, set to take effect on January 1, 2025, regulates how health care service plans (HCSPs) and disability insurers use automated decision-making tools, such as artificial intelligence, to analyze medical necessity in utilization reviews affecting California enrollees. Compared to federal guidelines, this law is more prescriptive, requiring HCSPs and disability…

In the two years since the Dobbs v. Jackson Women’s Health decision from the Supreme Court, state legislatures and courts have attempted to define the new post-Roe landscape in health care. That effort includes actions by states to enact health data privacy laws or to amend existing privacy laws to protect consumer health data…

Not a question that we thought we would be asking more than a year after the large omnibus package was signed into law by President Biden. But here we are, with a federal judge in Texas ruling on Feb. 27 that the House’s passage of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (CAA, 2023) violated the “quorum clause” of Article I, Section 5 of the U.S. Constitution.

The court’s ruling puts in jeopardy a number of substantive health policy provisions if it is allowed to stand. Many of the provisions of the act that could be overturned were designed to sunset at the end of 2024 and some have since been reauthorized. But some, like the FDA’s new cosmetic regulatory regime that was included in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are more permanent and are now under threat.

The court’s decision limited its impact to only one aspect of the law and enjoined that provision only as applied to public employees in Texas, but the court’s analysis of the way that the law was passed calls into question the entire appropriations act. The Department of Justice (DOJ) has 60 days from the court’s decision to appeal to the U.S. Court of Appeals for the Fifth Circuit. The agency has filed a notice of compliance with the court indicating that neither the DOJ or Equal Employment Opportunity Commission will enforce the law against the state or its agencies.Continue Reading Was the Consolidated Appropriations Act, 2023 Legitimately Passed by the House?

On Nov. 8, 2023, the Senate Finance Committee voted 26-0 to approve the Better Mental Health, Lower Cost Drugs, and Extenders Act. Among its other provisions, the bill, for which final legislative text has not yet been released, would, for the first time, mandate minimum prices that Medicare Part D plans, and the pharmacy…

New minimum wage requirements have been signed into law by Governor Gavin Newsom, establishing five comprehensive minimum wage schedules for “covered health care employees,” which includes both contracted and subcontracted employees. Effective June 1, 2024, “covered health care facilities” will be required to implement the applicable minimum wage schedule, as set forth by the law.…

UPDATE: Late in the evening of September 28, the House defeated H.R. 4368 by a vote of 191-237, with 27 Republicans voting against the bill. It was the only one of the four appropriations bills to fail.

Editor’s Note: This post was originally published at 11:15 PM EST on September 27, 2023 while the House of Representatives was still voting on amendments to other appropriations bills.

A group of conservative Republicans in the House of Representatives’ proposed Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368) would rescind the Food and Drug Administration (FDA)’s January 2023 change to the Risk Evaluation and Mitigation Strategy (REMS) program to allow certified retail pharmacies to dispense mifepristone as part of a medication abortion regimen. The proposal would effectively limit retail pharmacy dispensing of the only medication that is labeled for medication abortion.Continue Reading GOP House Bill Proposes Repeal of Retail Pharmacy Dispensing of Mifepristone

On April 27, 2023, Washington Governor Jay Inslee signed into law House Bill 1155, otherwise known as the My Health My Data Act.  Certain “geofencing” portions of the law became effective July 23, 2023.  Other provisions will become effective for “small businesses” on June 30, 2024, and for all other regulated entities on March 31, 2024. Below is a brief summary of the law’s following core components: (1) covered individuals and entities, (2) covered data, and (3) data collection and sharing requirements.Continue Reading Implementation Underway for Washington’s New Wide-Reaching Consumer Health Data Law

Shortly after Connecticut’s 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at reducing health care costs and undertaken in collaboration with the Connecticut Hospital Association. “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (“the Act”), which was passed by the Connecticut Legislature in early June and signed into law by Governor Lamont in late June, implements some of those initiatives. Among other things, the Act targets pharmaceutical marketing practices and imposes extensive reporting requirements. These provisions apply to “pharmaceutical manufacturers” and come into effect on October 1, 2023.

Broadly, the provisions require “pharmaceutical manufacturers” that employ “pharmaceutical representatives” to register annually with the Department of Consumer Protection (“DCP”) as “pharmaceutical marketing firms” and provide annual reports to DCP containing various information about their employed “pharmaceutical representatives.” The provisions also require “pharmaceutical representatives” to disclose specific information to prescribing practitioners and pharmacists and provides DCP with the authority to impose penalties for non-compliance.

The nuance lives in the Act’s definitions, and several key questions remain open, including to what extent the Act applies to medical device and technology manufacturers.Continue Reading New Connecticut Law Targets Drug and Device Manufacturers who Employ Sales Representatives for Additional Scrutiny

On May 3, New York Governor Kathy Hochul signed into law provisions that will require health care entities to submit a notification to the state Department of Health (DOH) providing information about any material transaction involving that health care entity.

The law, passed as part of the state’s budget, was originally crafted to give the DOH authority to review and approve those transactions. Ultimately, following several iterations during the legislative process, that approval power was stripped out by the state general assembly and replaced with the current notice requirement.

The law will take effect on August 1, 2023 and states on its face that it will apply to all “material transactions” involving health care entities that close on or after that date. That said, the requirements for transactions that close between August 1 and August 31 are a somewhat open question, given the 30-day notice requirement in the law. The DOH is tasked by the law with creating regulations that may address this situation.Continue Reading New York Passes Health Care Transaction Notice Requirements

[Note, this is Part 3 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA). Earlier parts covered Medicare Payments and the PIE Act]

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is Subtitle E of the Food and Drug Administration Title of the 2023 CAA. The subtitle itself is a major change for the cosmetics industry, bringing almost all manufacturers and distributors into a regulatory and reporting structure similar to that currently used by the FDA to govern drugs and medical devices.

The Senate and House committee markups for both versions of the FDA User Fee legislation included a version of this law. However, the final version of that legislation had almost all policy riders stripped from it. But, it reappeared in the 2023 CAA and is now law.

So, what is MoCRA and what does it do? As with the previous posts on the 2023 CAA, we will go a little deeper on this than a regular blog post. That approach is particularly warranted here since this is an entirely new regulatory structure.Continue Reading Health Provisions of the Consolidated Appropriations Act, 2023: Part 3 Cosmetics Regulation

In December 2022, the New York City Council introduced the Secure Jobs Act. The Act attempts to redefine the long-established system of at-will employment by requiring New York City employers to provide “just cause” before firing an employee. The Act builds on December 2020 legislation that imposed similar restrictions within the fast food industry…

[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA). Part 1, available here, covered changes in Medicare payment rates.]

Buried in the “Miscellaneous” chapter of Subtitle F (“Cross-Cutting Provisions”) of the Food and Drug Administration Title (Title III) of the 2023 CAA is Section 3630, a provision without a short title called “Facilitating exchange of product information prior to approval.”

This provision was originally proposed as the Pre-approval Information Exchange Act (or PIE Act) in March 2022 and was included in the House version of the Food and Drug Administration user fee legislation before being dropped from that legislation along with almost all other policy riders in a deal to get the FDA User Fee program approved before it expired.

But the same language was included in the 2023 CAA that was signed into law on Dec. 29, 2022. And again, while it was not directly entitled as such in the law, it is the PIE Act and that is how this post will refer to it. So, exactly what is the PIE Act and what does it do?  Before assuming there is “PIE” for everyone, read more for important content on the boundaries of this law, and remaining challenges for companies seeking to exchange information under this statutory authority.Continue Reading Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act

The Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA) runs more than 1,600 pages long in the official PDF version, so you would be excused if you missed a few key substantive health provisions that were included in the law.

Many of the substantive provisions of the law had been proposed as parts of other packages throughout the year, including the Infrastructure law, the FDA User Fee legislation and the Inflation Reduction Act. However, for one reason or another, these provisions were eliminated from the final versions of the laws that were passed.

The 2023 CAA included, among other aspects, changes to the Medicare payment program and sequestration requirements, additions to the accelerated approval process for drugs, a regulatory regime for cosmetics, and changes related to pre-approval communication of health care economic information to payors, formularies and similar entities.

This is the first in a series of posts exploring some of the more important policy aspects of the law. With part 1, we will explore the changes to Medicare payment rules.Continue Reading Health Provisions of the Consolidated Appropriations Act, 2023: Part 1 Medicare Payments