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Articles by Nancy Halstead
CMS Finalizes Interim Payment Policy for Software as a Medical Service in Hospital Outpatient, Physician Fee Schedule Rules
In July, we reported on CMS’s proposed “interim payment policy” for software-based technologies that support clinical decision-making through algorithmic analyses.
ONC Finalizes HTI-5, De-regulating Less than Anticipated and Punting on Information Blocking Changes
On October 28, 2026, the Office of the National Coordinator for Health Information Technology (ONC) released its final rule on “Deregulatory Actions to Unleash Prosperity”. The rule, known as HTI-5, contains substantial changes to ONC’s Health IT certification program and continues the push toward Fast Healthcare Interoperability Resources (FHIR)-based interoperability. However, the final rule’s impact is narrower than ONC’s initial proposal.
New coordination of voluntary self-disclosure policies announced in criminal health care fraud matters
23 October 2026 / 4 min read Authors Selina P. Coleman, Nancy Bonifant Halstead, Scott L. Marrah, Adria L. Perez, Lesley C. Reynolds, Kristin B. Parker, Matthew K. Loughran Authors The new National Fraud Enforcement Division (Fraud Division) of the Department of Justice (DOJ) has issued another directive in its recent spate of memoranda and guidance for the newly established division.
Delegation of permissive Medicare and Medicaid exclusion authority raises questions and may further politicize fraud enforcement
The Trump Administration Secretary of the Department of Health and Human Services (HHS) has officially added the Administrator of the Centers for Medicare & Medicaid Services (CMS) to the list of individuals with the authority to exclude entities from participation in Medicare and Medicaid. This action is expected to further politicize fraud enforcement – a consistent theme of the Trump Administration.
Delegation of permissive Medicare and Medicaid exclusion authority raises numerous questions and undermines the HHS Office of Inspector General
The Trump Administration Secretary of the Department of Health and Human Services (HHS) has officially added the Administrator of the Centers for Medicare & Medicaid Services (CMS) to the list of individuals with the authority to exclude entities from participation in Medicare and Medicaid. This action is expected to further politicize fraud enforcement – a consistent theme of the Trump Administration.
DOJ’s National Fraud Enforcement Division: Potential Impact on False Claims Act and Other Corporate Fraud Cases
Since the April creation of the Department of Justice (DOJ) National Fraud Enforcement Division, the DOJ has issued memos operationalizing that Division, including setting forth its priorities and providing guidance on criminal enforcement.
Investigations and enforcement trends: top takeaways for Q3 2026
We recently gathered a group of regulatory attorneys from across Reed Smith to provide a rundown of the key trends to watch for in Q3 2026. If you missed the webinar, you can access the recording on demand.
Your Regulators Are Talking: FDA and SEC Enter into Three-Year Agreement to Share Nonpublic Information
The potential for FDA regulatory developments to impact a company’s financial prospects has always been keenly felt by the life sciences industry.
Remote Patient Monitoring at Risk: Could Qualified Third-Party Entities—like Remote Monitoring IDTFs—Preserve Patient Access Under CMS’s Proposed Rule?
On July 16, 2026, CMS published the CY 2027 Medicare Physician Fee Schedule Proposed Rule, which contains a proposal that could reshape how remote patient monitoring services are delivered to Medicare beneficiaries. Key Takeaways CMS is proposing to require that remote physiologic monitoring (RPM) and remote therapy monitoring (RTM) services be furnished only by direct employees of the billing practitioner’s practice.
CMS Proposes an Interim Payment Policy for Software as a Medical Service in Outpatient Rule
Isabelle Auble, a law student at the College of William & Mary and a member of the 2026 Reed Smith summer associate class, co-authored this post. On July 7, 2026, CMS published a proposed rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for CY 2027 (the Proposed Rule).
HTI 5 Proposal Signals Health IT Deregulation and FHIR-first Interoperability and Refines Information Blocking Rule
The new Health Data, Technology and Interoperability proposed rule (known as HTI-5) signals a significant deregulatory shift aimed at simplifying Health IT certification, accelerating FHIR‑based interoperability, and tightening information blocking rules to promote competitive, AI‑ready health data exchange.
HHS Announces Crackdown on Health Data Blocking
In the first week of September, the U.S. Department of Health and Human Services (HHS) announced a renewed enforcement focus on information blocking through a press release and joint enforcement alert issued by the Office of Inspector General (OIG) and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC).
OIG Approves Free Companion Diagnostic Testing Program for Enzyme Inhibitor Drug
The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion 25-07) regarding a pharmaceutical manufacturer’s program to sponsor free companion diagnostic testing for certain oncology patients.
OIG Issues Unfavorable Opinion to Device Manufacturer
The Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion 25-04, concluding that a medical device manufacturer’s proposal to pay for third-party compliance screening and monitoring services required or requested by its hospital and surgery center customers could violate the federal Anti-Kickback Statute (AKS) if the requisite intent were present.
Information blocking victory in favor of access to health data
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.
Final 2025 CMS Physician Fee Schedule Rule Includes Changes To Medicare Overpayment Standard
Changes to regulations bring identification of overpayment into line with False Claims Act statutory requirements. Medicare Parts A and B providers will now have a six-month timeline to investigate and quantify payments. Despite new administration, nature of changes and reasons for changes make a roll-back unlikely. Included in the final 2025 Medicare Physician Fee Schedule ("MPFS") Rule are modifications to the overpayment refund rule that impact all four parts of the Medicare program.
AI Explained: AI In Clinical Research And Life Sciences (Video)
Life science professionals are grappling with questions related to integrating AI into clinical trials, patient care and other processes. How can we ensure that AI models consistently deliver accurate and reliable results? What steps should organizations take to guarantee the quality of data used to train and refine AI models? How will AI affect the interactions between drug developers on the one hand and the FDA, IRBs and ethics boards on the other?
AI explained: AI in clinical research and life sciences
Click here to watch the video. Life science professionals are grappling with questions related to integrating AI into clinical trials, patient care and other processes. How can we ensure that AI models consistently deliver accurate and reliable results? What steps should organizations take to guarantee the quality of data used to train and refine AI models? How will AI affect the interactions between drug developers on the one hand and the FDA, IRBs and ethics boards on the other?
CMS Revisits Medicare Overpayment Standards In 2025 Physician Fee Schedule
In its recently released 2025 proposed Medicare Physician Fee Schedule ("MPFS"), the Centers for Medicare & Medicaid Services ("CMS") proposed two important modifications to the Medicare 60-day overpayment refund rule—a new "identified overpayment" standard and codification of a 6-month timeframe to investigate and quantify an overpayment. A product of the Affordable Care Act, the 60-day rule requires a person to report and return Part A and B overpayments within 60 days of identification.
HHS Finalizes Rule On Health Care Provider Information Blocking Penalties
The Centers for Medicare & Medicaid Services ("CMS") and the Office of the National Coordinator for Health Information Technology ("ONC") have released a final rule establishing "disincentives" (i.e., penalties) for health care providers that participate in certain Medicare payment programs who have engaged in information blocking, as determined by the HHS Office of Inspector General ("OIG").
States’ legislative reaction to Dobbs impacts consumer health data privacy
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 that may not be covered by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations.
States’ legislative reaction to Dobbs impacts consumer health data privacy
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 that may not be covered by the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations.
2024 brings novel compliance challenges from state health data privacy laws
Key takeaways Several states have proposed bills, enacted health data privacy laws, or amended existing privacy laws to protect “consumer health data” (a term that encompasses more than businesses and individuals might expect); the laws broadly apply to many types of businesses that would not normally be expected to have obligations under a health-related law.
ONC Finalizes Information Sharing and Algorithm Transparency Rule
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) has published its first final rule on Health Data, Technology and Interoperability. The rule, known as the HTI-1 rule, takes effect on February 8, and governs updates to the ONC’s Health IT Certification Program, as well as regulations on information blocking.
OIG Finalizes Information Blocking Penalties
Three years after the Department of Health and Human Services’ (HHS) Office of the National Coordinator of Health Information Technology (ONC) issued a final rule that defined and clarified the scope of the information blocking provisions of the 21st Century Cures Act (the Information Blocking Rule), the HHS Office of Inspector General (OIG) has now published its own final rule implementing penalties for violations of the Information Blocking Rule by certain regulated actors (the OIG Final...
Health Care Websites And Mobile Apps: Are Your Third-party Trackers Compliant? Energized Regulators And Class Actions Plaintiffs May Force You To Find Out - Data Protection - United States
Health care and health care-adjacent organizations face materially increased regulatory and class action risk from commonly used third-party analytics and advertising services (ad/analytics services) on their websites, patient portals, mobile applications, and other Internet-connected services.
Health care websites and mobile apps: Are your third-party trackers compliant? Energized regulators and class actions plaintiffs may force you to find out | Reed Smith - JDSupra
OCR bulletin. OCR’s bulletin focuses on educating HIPAA-regulated entities on whether the use of third-party trackers is an impermissible disclosure of protected health information (PHI) under HIPAA. The applicability of HIPAA to certain online activities has been a question with which HIPAA-regulated entities have wrestled for years.
MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization | JD Supra
On February 28, 2023, six of the seven Medicare Administrative Contractors (MACs), who administer Medicare reimbursement on behalf of the Centers for Medicare and Medicaid Services (CMS), came together for a multijurisdictional contractor advisory committee (CAC) meeting. The purpose of the CAC meeting was to discuss remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) for non-implantable devices.
MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization
On February 28, 2023, six of the seven Medicare Administrative Contractors (MACs), who administer Medicare reimbursement on behalf of the Centers for Medicare and Medicaid Services (CMS), came together for a multijurisdictional contractor advisory committee (CAC) meeting. The purpose of the CAC meeting was to discuss remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) for non-implantable devices.
Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act | JD Supra
[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).
Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act
[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).
Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act
[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).
Telehealth Under Scrutiny: OIG Special Fraud Alert and DOJ Enforcement Highlights Suspect Characteristics Associated with High-Risk Telemedicine Arrangements
The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently published a Special Fraud Alert warning health care providers (e.g., prescribers, pharmacies, durable medical equipment providers, clinical laboratories) to steer clear of certain telemedicine arrangements and outlining seven “suspect” characteristics that may present heightened risk of fraud and abuse.
ONC’s Trusted Exchange Framework and Common Agreement (TEFCA): Impacts on Health Information Networks and Health Care Organizations
The U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) released earlier this year the Trusted Exchange Framework and Common Agreement (TEFCA), which is intended to improve electronic interoperability among health information networks (HINs) and facilitate the exchange of health information among connected organizations.
OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers
The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders.
Consensus among HHS agencies on addressing social determinants of Health Through Better Data Capture, Interoperability
Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1] In the past year or so, U.S. federal government policy has made a fundamental shift to align with this notion, focusing in part on better integration of...
HHS Proposes Important Changes To Key Aspects Of HIPAA Privacy Rule
United States: HHS Proposes Important Changes To Key Aspects Of HIPAA Privacy Rule 16 December 2020 by Nancy B. Halstead , Brad Rostolsky and Vicki Tankle Reed Smith Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
HHS proposes important changes to key aspects of HIPAA Privacy Rule
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes to key standards, definitions, and patient rights under the HIPAA Privacy Rule, which are geared toward promoting care coordination and...
HHS further delays compliance for Interoperability and Information Blocking Rule
Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) issued an interim final rule with comment period (the “Interim Final Rule”) extending the compliance dates and timeframes necessary to comply with the...
Patient Access To Health Information At The Forefront Of Government Initiatives And Scrutiny
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
Patient access to health information at the forefront of government initiatives and scrutiny
Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information. In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.
Regulatory framework for haircuts on non-centrally cleared securities financing transactions – FSB extends implementation deadlines | LexBlog
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HHS Delays Compliance For Sweeping Interoperability And Information Blocking Rules
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
HHS Delays Compliance for Sweeping Interoperability and Information Blocking Rules
Following more than a month of silence from the U.S. Department of Health and Human Services (HHS) on the publication of its widely anticipated companion interoperability and information blocking final rules to the Federal Register, HHS’s Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the Office of the Inspector General (OIG), issued a joint statement announcing a policy of enforcement...
HHS Finalizes Healthcare Interoperability And Information Blocking Rules
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
U.S. Department of Health and Human Services issues final rules expected to transform how certain stakeholders share patient information
The U.S. Department of Health and Human Services (HHS) released companion interoperability and information blocking final rules that will significantly impact the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information. For a discussion on major provisions of these rules, please read our post on our Health Industry Washington Watch blog.
HHS Finalizes Healthcare Interoperability and Information Blocking Rules
The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information.
HHS Sustains Digital Health Momentum And Continues Publishing Policy Initiatives To Kick-Off 2020
To print this article, all you need is to be registered or login on Mondaq.com. The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan).
HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020 | Lexology
The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan).
HHS Sustains Digital Health Momentum and Continues Publishing Policy Initiatives to Kick-off 2020
The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health by releasing proposed rules and policy initiatives. On January 15, 2020, the HHS Office for the National Coordinator for Health Informational Technology (ONC) released a draft of its 2020-2025 Federal Health IT Strategic Plan (Plan).
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