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Mintz IRA Update — Inaugural Edition
September 20, 2023 | Blog | By Theresa Carnegie, Tara E. Dwyer, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh
Mintz IRA Update — A Timeline of the IRA’s Major Milestones
September 20, 2023 | Blog
Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review
September 20, 2023 | Blog
Mintz IRA Update — Legal Challenges to the Medicare Drug Price Negotiation Program
September 20, 2023 | Blog
New York’s Office of the Medicaid Inspector General Creates Abbreviated Self-Disclosure Process
September 13, 2023 | Blog | By Jean D. Mancheno
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) issued updated guidance regarding its Self-Disclosure Program (Updated Guidance). In the final days of 2022, New York’s Department of Social Services adopted revised regulations that set forth the requirements for participation in OMIG’s Self-Disclosure Program, as well as regulations regarding Medicaid fraud, waste, and abuse prevention, and Medicaid compliance programs. Since the enactment of these regulations, OMIG has promulgated several guidance documents, including in January 2023, when it first published guidance (Original Guidance) regarding the Self-Disclosure Program. In the Updated Guidance, which replaced the Original Guidance, OMIG announced its new Abbreviated Self-Disclosure Process (ASDP).
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CMS Announces Drug List for Inflation Reduction Act Price Negotiations
August 29, 2023| Alert|
OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers
August 23, 2023 | Blog | By Rachel Yount, Karen Lovitch
On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider of intraoperative neuromonitoring (IONM) services. In reaching its determination, the OIG stated that Newco and its arrangements with the IONM Company would present a significant risk under the federal Anti-Kickback Statute (AKS) primarily because it exhibits many indicia of a suspect contractual joint venture.
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Health Law Diagnosed – CA Proposes Regs for Pre-Closing Review of Health Care Deals: What You Need to Know
August 21, 2023 | Podcast | By Lara Compton, Deborah Daccord, Bridgette Keller, Daria Niewenhous
Mintz Health Law attorneys discuss regulations recently proposed by California’s newly established Office of Health Care Affordability, which call for advance regulatory review of certain health care entity mergers, acquisitions, affiliations, and other arrangements.
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FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Cosmetic Product Listing
August 9, 2023 | Blog | By Benjamin Zegarelli, Jean D. Mancheno
On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed clarifications to the registration and listing requirements that will soon apply to cosmetics companies under the Modernization of Cosmetics Regulation Act (MoCRA), for review and public comment. MoCRA was signed into law in December 2022 (see our prior post here) and added significant new provisions on cosmetic products to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 607 of the amended FD&C Act, facilities that manufacture or process a cosmetic product for distribution in the United States must register with FDA and submit a cosmetic product listing, and the Draft Guidance answers basic and essential questions about who must register and list, what information must be included, and how to submit information to FDA. This post summarizes key takeaways from the Draft Guidance and discusses its implications as the December 29, 2023 initial registration and listing deadline approaches.
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Transforming Primary Care: CMS Launches Making Care Primary (MCP) Model
August 8, 2023 | Blog | By Rachel Yount, David Gilboa, Stephnie John
The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate independently in value-based care initiatives. The MCP Model will be tested in eight states - Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, New York, North Carolina, and Washington.
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California Publishes Proposed Regulations for the Pre-Closing Review of Health Care Transactions: What You Need To Know Before January 1, 2024
August 7, 2023 | Blog | By Lara Compton, Daniel Cody, Kathryn Edgerton
January 1, 2024 is rapidly approaching, which is when California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care mergers, acquisitions, affiliations, and other arrangements that result in material changes of assets, control, or governance. The law establishing OHCA left many details regarding the types of transactions that would be subject to review to be established by emergency regulations, which have been proposed and are available here. A public workshop will be held on August 15, 2023 (more information here), allowing for public comment and the written comment period will be open until August 31, 2023. The final emergency rulemaking package is expected to be submitted in October 2023.
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CMS Announces GUIDE – a New Dementia Care Model Designed for Participation by a Range of Providers
August 2, 2023 | Blog | By Rachel Yount
Health care providers furnishing dementia care should take note of a new payment model announced by the Centers for Medicare & Medicaid Services on July 31, 2023, called Guiding an Improved Dementia Experience (GUIDE). GUIDE is designed to improve dementia care, reduce strain on unpaid caregivers, and help people with dementia remain in their homes and communities. Providers participating in GUIDE receive monthly per-beneficiary per-month payments, can bill for respite care services, and are eligible for one-time payments to support infrastructure.
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FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter
August 1, 2023| Blog|
OCR and FTC Issue Joint Statement Warning Health Care Providers and App Developers About Use of Third Party Online Tracking Technologies
July 21, 2023 | Blog | By Kathryn Edgerton, Lara Compton, Kate Stewart
Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.
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New York and Connecticut Increase Regulation Over Hospital and Health System Facility Fees
July 20, 2023 | Blog | By Jean D. Mancheno, Sophia Temis
Since the federal No Surprises Act took effect in January 2022, many pieces of legislation have been, and continue to be, geared toward promoting price transparency in health care. One such example is seen in the momentum of state legislative activity surrounding the billing of facility fees. These fees are typically charged to cover the overhead costs associated with the operation of a health care facility, such as payment of staff, maintenance of the facilities, and administrative costs. Patients, however, are often unaware that such costs will be factored into their medical bills. In response, New York and Connecticut, among other states, have recently enacted and expanded laws regulating facility fee billing.
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