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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

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

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

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?

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…

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) will start to enforce compliance later this month with new special protections for individuals’ reproductive health information as required by a recently finalized HIPAA Privacy Rule, as we noted in an earlier blog post. While the incoming Trump Administration may change enforcement priorities or even rescind that rule, a settlement from OCR that pre-dated implementation of that rule indicates that OCR already affords this information protection.

The settlement marks OCR’s first enforcement action and settlement against a health care provider centered around, and specific to, an impermissible disclosure of an individual’s reproductive health information under the existing Privacy Rule standards. In other words, regardless of whether the incoming administration rescinds or revises the new protections for reproductive health information, OCR has demonstrated that it considers reproductive health information as highly sensitive and will take enforcement action accordingly under the HIPAA Privacy Rule as it is today.

Organizations would be well advised to take the remaining time before the December 23 compliance date to update existing policies to define the scope of reproductive health care-related protected health information (PHI) within the organization and set forth standards and procedures for how the organization will implement compliance with the new requirements including, for example, how the organization will assess and respond to third-party requests for reproductive health care-related PHI, including situations in which an attestation is required.Continue Reading OCR Sets Precedent with Settlement Over Impermissible Disclosure of Reproductive Health Information

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice.  The planned initiatives, which would require further policy development…

President Trump has signed an executive order entitled “Reducing Regulation and Controlling Regulatory Costs,” also known informally as the “2-for-1 Order,” that directs agencies to take a number of actions aimed at deregulating a variety of industries.  The Order is considerably vague, relying instead on the Office of Management and Budget (OMB) to issue additional implementation guidance.  As a result, it remains unclear how this new regulatory approach will operate in practice.

2-for-1 Regulatory Identification Process

The Executive Order, signed January 30, 2017, directs each department or agency to identify two regulations to be repealed any time it proposes or finalizes a new regulation. It is worth noting that the Executive Order never expressly requires these regulations to actually be repealed; rather, merely identified.  Importantly, the Order provides that this 2-for-1 regulatory identification process need only be followed if it is permitted by law.  That is, Congress often passes laws that require certain administrative agencies to promulgate implementing regulations.  To this end, the Order cannot and does not block regulations required by statute.  Instead, only discretionary regulations would be eligible for elimination.

Critics of the Executive Order view this 2-for-1 regulatory identification process as an illogical approach to industry deregulation, arguing that this approach demonstrates a dearth of understanding about how and why regulations are actually issued. For example, in its examination of costs, the Executive Order ignores expected long-term cost savings, and only focuses on annualized regulatory costs.  Accordingly, agencies might be required to eliminate regulations whose benefits greatly outweigh their regulatory costs, simply to meet this arbitrary regulatory standard.  Supporters contend, however, that a requirement to eliminate regulations in order to promulgate new ones forces agencies to review and update existing regulations.  This perceived lack of periodic of review and update is something that has long troubled many in regulated industries.
Continue Reading The Fine Print of the Trump Administration “2-for-1” Regulatory Reduction Executive Order

Observers are digesting what the Trump Administration will mean for the health care and life sciences industry.  Forecasting is more challenging for this incoming Administration than most given the relatively sparse policy details released during the campaign and the lack of a government service record to examine for clues.  Today President-elect Trump’s transition team released a one-page statement on health care policy, but many questions remain.  Nevertheless, we offer below our initial observations and issues to watch in the months to come.

  • Potential Sea Change. Uncertainty is, as some like to say, the “obvious comment” that characterizes the whole prospective Trump Administration.  Other than an intended “repeal and replacement” of the Affordable Care Act (ACA), President-elect Trump has provided relatively few details on a proposed health care agenda.  Until these policies are fleshed-out, expect an environment where some business decisions and investments may be delayed, with a resulting impact on merger and acquisition activity. That said, other transactions may become more likely, as the threat of new restrictions under a Clinton administration are removed, along with the prospect of potential regulatory relief under a Republican-controlled federal government.
  • Affordable Care Act Repeal and Replacement.  Trump has repeatedly indicated his desire to repeal and replace the ACA, including a vow to summon Congress into a special session for this task.  If the law is repealed, however, what would take its place, and how would Congress address the roughly 20 million Americans currently covered in some way under the ACA (and the potential rise in uncompensated care costs that also would result)?  Despite the call for repeal, certain parts of the law are popular. For instance, President-elect Trump noted on the campaign trail that he was in support of the ACA’s prohibition against the use of pre-existing health conditions to deny coverage (or as a basis for premium-setting).  Other proposals offered by Trump as candidate include allowing for the sale of health insurance across state lines as long as plans comply with state requirements, various tax benefits, and more transparency in health care pricing.  In today’s policy statement, President-elect Trump added support for high-risk pools, which he characterizes as “a proven approach to ensuring access to health insurance coverage for individuals who have significant medical expenses and who have not maintained continuous coverage.”  Congressional Republicans have offered a number of alternatives that are likely to be a springboard for reform, most notably the “Better Way” plan proposed by House Speaker Paul Ryan.  In fact, according to the Speaker’s office, “in the 114th Congress alone, House Republicans have introduced more than 400 individual bills that would improve our nation’s health care system” – demonstrating that Congress is not reticent about legislating on health care issues.  The new Senate’s Republican majority will not have the 60 votes required to override a potential Democratic filibuster of legislation to fully repeal the law. While Congress could use budget reconciliation authority (which requires only 50 votes in the Senate) to make significant changes, the drawn-out pace of the budget process may not satisfy those who want quick action in this area.  Regardless of the legislative vehicle, after years of calling for Obamacare repeal while President Obama was in office, the Republican Congress will be under tremendous pressure to act quickly – even if it is a “down-payment” on reform — now that Republicans will control the presidency and the Congress.

Continue Reading Looking Ahead to a Trump Administration: Health Care and Life Sciences Industry Perspectives