Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
Articles by Alexander Dworkowitz
5 Drug Pricing Policy Developments To Watch In 2026
By Alexander Dworkowitz and Michael Kolber ( January 26, 2026, 11:11 AM EST) -- 2025 was an eventful year in the world of drug pricing.... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.
Understanding The GENEROUS Model In Six Infographics
MP Manatt, Phelps & Phillips LLP More Manatt is a multidisciplinary, integrated national professional services firm known for quality and an extraordinary commitment to clients. We are keenly focused on specific industry sectors, providing legal and consulting capabilities at the very highest levels to achieve our clients’ business objectives. With the Centers for Medicare & Medicaid Services' (CMS) announcement of the GENEROUS Model, life science companies, states and other stakeholders...
HHS Previews Data Crackdown: Potential Impacts On Providers, EHRs And HIEs
Two recent announcements from the Trump Administration promise increased enforcement of two important health data laws: the federal substance use disorder confidentiality regulations and the information blocking rule. If the Trump Administration follows through, it could lead to more scrutiny of data practices of health care providers, electronic health record vendors, health information exchanges and others in the health care system.
Five Key Ways The Budget Reconciliation Bill Could Impact Life Sciences-and How To Prepare
On Tuesday, July 30, Manatt Health hosted a webinar on how the newly enacted budget reconciliation legislation (the One Big Beautiful Bill Act or OBBBA) will impact the life sciences industry. Below are some of the key points to help you prepare. Click here to watch the full webinar. On July 4, 2025, President Trump signed the OBBBA into law. The budget reconciliation package makes significant reforms to Medicaid and the Affordable Care Act (ACA) Marketplace.
CMS Releases Guidance On Interpretation Of Medicaid Covered Outpatient Drug
On July 24, the Centers for Medicare & Medicaid Services (CMS) released guidance to pharmaceutical manufacturers intended to clarify certain aspects of the Medicaid Drug Rebate Program (MDRP) final rule issued by the agency last year, particularly with respect to the modified definition of covered outpatient drugs (CODs) that are eligible for rebates under the MDRP.
CMS Announces 33 States Participating In CMMI CGT Access Model
On July 15, the Centers for Medicare & Medicaid Services (CMS) announced that 33 states, plus D.C. and Puerto Rico, will participate in the Center for Medicare and Medicaid Innovation (CMMI) Cell and Gene Therapy (CGT) Access Model for Medicaid enrollees seeking treatment for sickle cell disease (SCD).1 According to the press release, participating states represent approximately 84 percent of Medicaid beneficiaries with the condition.
HIPAA Reproductive Health Privacy Rule Protections Struck Down
MP Manatt, Phelps & Phillips LLP More Manatt is a multidisciplinary, integrated national professional services firm known for quality and an extraordinary commitment to clients. We are keenly focused on specific industry sectors, providing legal and consulting capabilities at the very highest levels to achieve our clients’ business objectives. On June 18, 2025, in the case Purl v.
CMS Approves 35 States To Participate In Its Cell And Gene Therapy Model
On April 25, HHS Secretary Robert F. Kennedy Jr. said that 35 states have agreed to participate in the Center for Medicare & Medicaid Services (CMS) Innovation Center's Cell and Gene Therapy (CGT) Access Model. One of these states, California, announced on April 14 that CMS approved its application to participate—marking the first public announcement of a state being selected to join the model.
Senate Finance Committee Ranking Member Releases Report On MA Plans' Marketing Practices.
MP Manatt, Phelps & Phillips LLP More Manatt is a multidisciplinary, integrated national professional services firm known for quality and an extraordinary commitment to clients. We are keenly focused on specific industry sectors, providing legal and consulting capabilities at the very highest levels to achieve our clients’ business objectives.
CGT Access For Medicaid Enrollees: Insights, Solutions And A Way Forward
Below is an excerpt from a recent Manatt Health white paper. Click here to read the full report. Thanks to breakthroughs in precision medicine, leading scientists have developed a growing number of cell and gene therapies (CGTs) for serious and life-threatening diseases. By addressing the root causes of disease, these transformative therapies can slow, stop, or even reverse disease progression, achieving life-changing results for patients who previously had no hope of effective treatment.
Access To Transformative Therapies For Medicaid Enrollees Current Barriers And Proposed Policy Solutions
Thanks to breakthroughs in precision medicine, leading scientists have developed a growing number of cell and gene therapies (CGTs) for serious and life-threatening diseases. By addressing the root causes of disease, these transformative therapies can slow, stop, or even reverse disease progression, achieving life-changing results for patients who previously had no hope of effective treatment. Troublingly, these breakthroughs are not accessible to all.
IRS Proposes Rule For Calculation Of The Tax Imposed On Drug Manufacturers Under IRA
On December 31, the Internal Revenue Service (IRS) issued a proposed rule for the calculation of the excise tax under the Medicare Drug Price Negotiation Program, as enacted under the Inflation Reduction Act (IRA). Under the IRA, a manufacturer, producer, or importer is subject to an excise tax for sales of a designated drug if that entity fails to reach agreement with CMS on a maximum fair price for the drug and the entity does not exit from the Medicare and Medicaid programs.
Your IT Security Budget May Need To Increase: Proposed Updates To The HIPAA Security Rule
Key Takeaways: Over the past five years, documented large-scale data breaches increased by 102 percent, and the number of individuals affected by such breaches increased by 1,002 percent. The Office of Civil Rights (OCR) recently issued a proposed rule that would substantially modify the Health Insurance Portability and Accountability Act (HIPAA ) security rule and require significant investment in informational technology (IT) security from providers and payors (the Proposed Rule).
HIPAA Reproductive Privacy Protections at Risk By Texas Lawsuit | JD Supra
Summary Points: The Texas Attorney General filed suit against the Department of Health and Human Services (HHS) to block new privacy protections under the Health Insurance Portability and Accountability Act of 1995 (HIPAA) aimed at protecting patient reproductive health care information from going into effect later this year.
CMS Opens Funding Opportunity for States to Participate in Cell and Gene Therapy Model | JD Supra
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. On August 15, the Centers for Medicare & Medicaid Services (CMS) released a Notice of Funding Opportunity (NOFO) for states participating in the Cell and Gene Therapy (CGT) Access Model.
CMS and ONC Issue Final Rule on E-Prescribing | JD Supra
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D.
[Webinar] Understanding Recent Developments in Health Care Privacy Laws - July 24th, 10:00 am - 11:00 am PST | JD Supra
This year, the federal government has made significant changes to longstanding health care privacy rules, while state lawmakers continue to enact privacy restrictions on consumer health data. These reforms modify legal obligations for providers, payers, and health tech companies, and reflect federal and state governments’ increasing concern regarding the privacy and security of health care data.
CMS Issues Update On Stacking Provision In Medicaid Drug Rebate Program Rule
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. On May 15, the Centers for Medicare & Medicaid Services (CMS) issued a statement saying that it would not finalize the “stacking” proposal in its Medicaid Drug Rebate Program proposed rule—the remaining provisions are expected to be finalized soon.
Marketing Organizations File Suit Over Medicare Advantage Final Rule
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. On May 13, an association of Medicare Advantage field marketing organizations (FMOs) filed suit against CMS, challenging new marketing restrictions in the 2025 Medicare Advantage final rule.
Changes To The Substance Use Disorder Confidentiality Regulation: Implications For Stakeholders
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the Confidentiality of Substance Use Disorder Patient Records regulations under 42 CFR Part 2 with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.
Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders | JD Supra
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the Confidentiality of Substance Use Disorder Patient Records regulations under 42 CFR Part 2 with the regulatory requirements under the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.
CMS Final Rule Requires Payers To Modify Prior Authorization, Create New APIs
In the federal government's latest effort to promote interoperability in the health care sector, on January 17 the Centers for Medicare & Medicaid Services (CMS) released a final rule that expands the requirements for electronic exchange of information between federally funded health plans, providers, and plan enrollees through application programming interfaces (APIs).
HHS Finalizes Regulation Of Certain AI - Healthcare - United States
This week, the U.S. Department of Health and Human Services (HHS) took its first step in actually regulating the use of artificial intelligence (AI) in health care.
California Enacts Laws To Further Protect Reproductive Health Data - Healthcare - United States
Last week, California Governor Gavin Newsom signed a package of legislation intended to strengthen the state's shield laws, which provide protections to patients receiving and providers rendering reproductive health services, including abortions, in the state.
Information Blocking Penalties To Take Effect September 1
More than three years after the federal government issued rules to prohibit "information blocking," penalties for violating those rules are taking effect. September 1 marks the first day on which certain entities may face civil monetary penalties (CMPs) for engaging in conduct deemed to be information blocking.
Accessing Cell And Gene Therapies: Insights On Coverage, Reimbursement And Emerging Models
Editor's Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage, including separate payment policies, value-based payment (VBP) arrangements and reinsurance programs. Click here to download a free copy of the full white paper.
Health IT Organizations Soon To Face Enforcement Under Final OIG Information Blocking Rule
After a COVID-19-related delay, on June 27, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a long-awaited final rule that establishes monetary penalties for violations of health information technology (IT) information blocking rules.
Accessing Cell And Gene Therapies: Insights On Coverage, Reimbursement And Emerging Models
Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients' reach. Over ten cell and gene therapies have been approved by the FDA in the past five years and over 500 gene-based therapies are in clinical development as of 2022.
Provider Obligations For Patient Portals Under The 21st Century Cures Act
When Congress prohibited “information blocking” under the 21st Century Cures Act in 2016, it made no reference to patient portals, the websites through which many health care providers share clinical information with their patients. Similarly, the word “portal” does not appear once in the 6,000-word information blocking regulation, issued by the Office of the National Coordinator for Health Information Technology (ONC) in 2020.
Provider Obligations For Patient Portals Under The 21st Century Cures Act
When Congress prohibited “information blocking” under the 21st Century Cures Act in 2016, it made no reference to patient portals, the websites through which many health care providers share clinical information with their patients. Similarly, the word “portal” does not appear once in the 6,000-word information blocking regulation, issued by the Office of the National Coordinator for Health Information Technology (ONC) in 2020.
Texting: An Important Outreach Strategy As States Unwind Medicaid Continuous Coverage
Manatt, Phelps & Phillips LLP United States: Texting: An Important Outreach Strategy As States Unwind Medicaid Continuous Coverage 08 February 2022 by Kinda Serafi , Alexander Dworkowitz and Michael Budros Manatt, Phelps & Phillips LLP To print this article, all you need is to be registered or login on Mondaq.com. Currently, states are maintaining continuous enrollment of all Medicaid enrollees as a condition of receiving enhanced federal funding under the Families First Coronavirus Response Act.
Medicare Advantage
Manatt, Phelps & Phillips LLP To print this article, all you need is to be registered or login on Mondaq.com. The Big Picture On January 12, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs proposed rule, representing CMS' first major policy proposals for these programs in the Biden Administration. The changes proposed are, overall, modest in scope.
Delivering Breakthrough Treatments Affordably
Manatt, Phelps & Phillips LLP United States: Delivering Breakthrough Treatments Affordably 01 November 2021 by Alexander Dworkowitz , Anthony J. Fiori and Jonathan DiBello Manatt, Phelps & Phillips LLP To print this article, all you need is to be registered or login on Mondaq.com.
Now on Demand: “Evolving Pharmaceutical Benefit Trends and Medicaid Managed Care’s Role” | Lexology
Click Here to View Manatt’s Recent Webinar Free, on Demand. Click Here to Download a Free Copy of the Presentation. State Medicaid programs continue to balance serving eligible beneficiaries and controlling costs. In an environment sharply focused on the cost of drugs, it is increasingly critical to understand the Medicaid pharmacy benefit and the part health plans play in managing that benefit.
Show More
loading
Actions
Is this you?
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.Get in touch with Alexander
Contact Alexander, search articles and posts on X, monitor coverage, and track replies from one place.
Learn more about Muck Rack