Department of Health and Human Services

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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 2024amendments 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…

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…

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

On January 17, 2025, the Drug Enforcement Administration (DEA) announced a proposed rule to establish a special registration framework for prescribing controlled substance medications via telemedicine in the post-COVID era (the 2025 Proposed Rule).  The DEA  had, in an earlier proposed rule from March 2023 (the 2023 Proposed Rule), rejected the same framework as too burdensome for both prospective telemedicine providers and patients.

In its simplest form, the 2025 Proposed Rule seeks to impose separate special registrations with highlighted regulations on both clinician and platform practitioners who prescribe or dispense Schedule II-V narcotic and non-narcotic controlled substances via telemedicine without an in-person medical evaluation.  The rule is complex, more restrictive than the telemedicine flexibilities allowed during the COVID-19 era, and, more importantly, presents a significant departure from the regulations put forth in the 2023 Proposed Rule.

Considering the uncertainty surrounding the priorities and perspectives of the Trump administration regarding telemedicine prescribing of controlled substances, it remains unclear whether the 2025 Proposed Rule will be finalized as-is or if a different overhaul is forthcoming.Continue Reading What Does DEA’s Proposed Special Registration Framework for Tele-prescribing Controlled Substances Mean?

In its first advisory opinion of the year, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on January 15, 2025 that addressed an arrangement by a pharmaceutical manufacturer to offer certain patients free access to a pharmaceutical product that has limited coverage by Federal health care programs.

The opinion, offers guidance to pharmaceutical companies and administering providers about the mechanics of free or discount programs for their products or services that present low risk of fraud and abuse. The opinion aligns with the OIG’s recent assessment of a supplier’s loyalty program issued in December 2024.Continue Reading OIG Issues Favorable Opinion on Free Access to Pharmaceutical Products

Hospitals and large healthcare organizations have increasingly become prime targets for cybercriminals. In response, the Department of Health and Human Services (HHS) has established a new initiative within the National Institutes of Health (NIH) aimed at enhancing cybersecurity measures for hospitals.

This initiative, called “Universal Patching and Remediation for Autonomous Defense” (UPGRADE), was launched on May 20. UPGRADE’s mission is to develop a tailored and scalable suite of software tools that will enable hospital IT teams to effectively combat ransomware attacks and reduce the time needed to patch vulnerable healthcare products from months to just days or weeks.Continue Reading HHS Pledges $50 million to Empower Hospitals in the Battle Against Cyberattacks

Last week, on April 18, several federal agencies jointly launched a “one-stop shop” to facilitate reporting of allegedly anticompetitive behavior in the health care sector. While there has always been a complaint portal for the antitrust agencies, the Federal Trade Commission (FTC), the U.S. Department of Health and Human Services (HHS), and the Antitrust Division…

The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. We have put together this alert to summarize the provisions of the rule and what you…

Building on prior requests for information and an increased focus on Medicare Advantage oversight, the Centers for Medicare and Medicaid Services (CMS) has issued another request for information (RFI) seeking input on data needed for Medicare Part C, also known as the Medicare Advantage (MA) program. The goal of this RFI, which was published in the Federal Register on January 30, 2024, is to provide CMS with feedback on both the format and types of data that will allow CMS to have better insight into MA organizations and their operations and to consider future rulemaking. Responses to the RFI are due by May 29, 2024.

This RFI is an extension of CMS’s General MA RFI published in August 2022, which generated over 4,000 responses from various stakeholders. The 2024 RFI broadly seeks input on “all aspects of data related to the MA program—both data not currently collected as well as data currently collected.” The eventual goal is to make MA data commensurate with data available from Medicare Parts A and B to ensure appropriate transparency into MA organizations and to address perceived shortcomings through additional rulemaking.Continue Reading CMS Issues RFI for Medicare Advantage Data

The Department of Health and Human Services (HHS) has issued a notice of proposed rulemaking that removes an exception to the definition of “lawfully present” that would then serve to include in that term individuals who have obtained temporary immigration status under the Deferred Action for Childhood Arrivals (DACA) program.

The expansion of the the definition of “lawfully present” would allow DACA recipients as of November 1, 2023 to enroll in a qualified health plan (QHP) from a health insurance exchange as established by the Affordable Care Act. Additionally, the definition change would open up eligibility for DACA recipients to enroll in a Basic Health Program, or Medicaid and the Children’s Health Insurance Program (CHIP) in states that have elected to cover “lawfully residing” pregnant individuals and children.Continue Reading DACA Recipients Can Enroll in Qualified Health Plans under Proposed HHS Rule

On March 27, 2023, two United States Senators, Bill Cassidy, MD (R-LA) and Jeff Merkley (D-OR) introduced the bipartisan No Unreasonable Payments, Coding, or Diagnoses for the Elderly (“No UPCODE”) Act to address perceived financial incentives inherent in the Medicare Advantage patient risk scoring reimbursement methodology. Senator Merkley alleges that the current reimbursement…

As the September 1, 2023 deadline for Centers for Medicare & Medicaid Services (CMS) to publish the first 10 “selected drugs” subject to negotiation of “maximum fair prices” under Medicare Parts B and D fast approaches, CMS has recently specified information that manufacturers must submit in order for their drugs to qualify for the “Small Biotech Exception” to being included on the list. The information is to be submitted during the summer of 2023; the specific deadline has not yet been announced.

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA). Among other provisions, the IRA provides for the CMS to negotiate “maximum fair prices” with manufacturers of “selected drugs” covered under Medicare Parts B and D. The price negotiation process begins on September 1, 2023, when CMS is required to publish the list of the first 10 selected drugs subject to negotiation, for maximum fair prices which will take effect beginning January 1, 2026.

The IRA provides that the selected drugs will be the 10 “negotiation-eligible drugs” having the highest total expenditures under Medicare Part D during the period June 1, 2022 through May 31, 2023. Negotiation-eligible drugs generally consist of “qualifying single-source drugs”, which are generally defined as branded drugs and biologicals approved by the Food and Drug Administration (FDA) at least 7 years (with respect to drugs) or 11 years (with respect to biologicals) before the date the list is published, and which do not have a marketed generic equivalent or biosimilar. However, for 2026 through 2028, the IRA provides that negotiation-eligible drugs exclude certain drugs under what CMS refers to as the “Small Biotech Exception”.Continue Reading CMS Specifies Info Needed for Small Biotech Exception to Medicare Drug Price Negotiation

The Department of Health and Human Services recently issued a proposed rule that would streamline the federal regulations governing the confidentiality of substance use disorder (SUD) patient records at 42 CFR Part 2 (Part 2) with the Health Insurance Portability and Accountability Act and its implementing regulations (HIPAA). Comments on the proposed rule are due to HHS by January 31, 2023

For years, health care providers regulated by both Part 2 and HIPAA and their patients, have wrestled with the inconsistencies across these two privacy frameworks. Part 2, for example, currently imposes different patient consent requirements and disclosure restrictions on Part 2-protected SUD treatment records (Part 2 Records) than HIPAA, even though such records often constitute protected health information (PHI) as well. The inconsistencies (and in some cases, conflicts) between HIPAA and Part 2 requirements have created barriers to information sharing and confusion and compliance challenges for entities regulated under both frameworks, which in turn have unnecessarily impeded treatment access and care coordination.

As noted in the HHS fact sheet and the press release issued by the Substance Abuse and Mental Health Services Administration (SAMHSA), the proposed rule would, if finalized, enhance care coordination, afford patients a formal right of access to their SUD records, and extend HIPAA’s breach notification standards to Part 2-regulated providers and information. The proposed rule would also allow health care providers to align internal privacy compliance programs, the importance of which is underscored by another proposal to impose the same HIPAA civil and criminal penalties on regulated providers for noncompliance with Part 2 regulations. Continue Reading HHS proposes update to Part 2 confidentiality regulations to align with HIPAA

The Department of Health and Human Services (“HHS”) has proposed a rule that updates retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  There is a 60-day public comment period for this rule, which closes on January 9, 2023.  This proposed rule, if finalized, would modify the currently adopted National Council for Prescription Drug Programs (“NCPDP”) Telecommunications Standard Implementation Guide (“TSIG”) and its equivalent batch standards. 

Specifically, the proposed rule would adopt TSIG version F6, and its equivalent batch standards NCPDP Batch Standard Implementation Guide, Version 15, and Batch Standard Pharmacy Subrogation Implementation Guide Version 10 (for non-Medicaid health plans).

The new standards will allow retail pharmacies with multiple locations to send one batch mode transaction that meets the F6 standard.  Among the changes from version to version are new data fields, new data segments, and new functionality.Continue Reading HHS Proposes Rule to Update Retail Pharmacy Standards for Electronic Transactions under HIPAA

On August 26, 2022, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) issued the highly anticipated Requirements Related to Surprise Billing (“August 2022 Final Rule”) and associated guidance materials concerning the independent dispute resolution (“IDR”) process established by the No Surprises Act. The August 2022 Final Rule is narrow in scope and responds to two recent decisions by the Eastern District of Texas vacating portions of the October 2021 Interim Final Rule, Requirements Related to Surprise Billing: Part II (“IFR II”), and incorporates stakeholder comments solicited by the Departments.

Importantly, as discussed more below, the August 2022 Final Rule removes the qualifying payment amount (“QPA”) as the presumptive factor in IDR payment decisions and requires health plans to submit additional information in the IDR process for cases where a claim at issue was “downcoded” by the plan.   

The August 2022 Final Rule will take effect October 25, 2022, 60 days after its publication in the Federal RegisterContinue Reading Departments issue new Final Rule and guidance materials for No Surprises Act IDR process

On June 29, 2022, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) issued two pieces of guidance clarifying the applicability of the Health Insurance Portability and Accountability Act (“HIPAA”) related to privacy of information connected to an individual’s reproductive health. 

Through this guidance, HIPAA addresses both protected health information (“PHI”), which is subject to HIPAA’s rules, as well as general, personal information that is not directly protected by HIPAA.Continue Reading New Guidance by OCR addresses HIPAA and Disclosures of Information relating to Reproductive Health