Photo of Stephanie Awanyai-Ufondu

Stephanie Awanyai-Ufondu

Subscribe to Stephanie Awanyai-Ufondu's Posts

Stephanie Awanyai-Ufondu is an associate in the Corporate Practice Group in the firm's Century City office.

Contact:Read more about Stephanie Awanyai-Ufondu

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

The expanded use of artificial intelligence (AI) in the delivery of health care continues to receive increased attention from lawmakers across the country. Although AI regulation is still in its early developmental stages, there are various efforts underway to address the unintended negative consequences stirred by AI technology, particularly in health care and other key sectors.[1] Of particular interest are regulatory efforts to restrict discrimination through AI and related technologies.Continue Reading At a Glance: Legal Efforts to Limit Discrimination Through AI

Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to dispute the issue of whether drug manufacturers are required to give 340B Participants discounts on drugs dispensed through contract pharmacies.  The most recent point of contention involves the U.S. Health Resources and Services Administration’s (“HRSA”) May 17, 2021 letters sent to six drug manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for 340B Participants who dispense drugs through contract pharmacies is in direct violation of Section 340B of the Public Health Service Act (also referred to as the “340B Statute”).  The letters also included HRSA’s demand that the manufacturers immediately begin offering their drugs at discounted prices to these 340B Participants as well as credit or refund all 340B Participants for overcharges that resulted from the limiting policies, or be subject to civil monetary penalties.  As anticipated, certain drug manufacturers, including Eli Lilly, have filed motions in federal court to stop the HRSA from placing monetary penalties based on their refusal to provide 340B discounts to contract pharmacies.
Continue Reading 340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation

On May 21, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that the Next Generation Accountable Care Organization (“ACO”) Model (“NGACO Model” or “Model”), set to end December 31, 2021, will not be extended after receiving a one-year extension due to COVID-19.  The decision comes as a surprise to NGACO participants and other industry groups who have been calling on CMS to revisit its decision and closely consider the Model’s merits and potential as a permanent program option.  Industry stakeholders, such as the National Association of ACOs (“NAACOS”), expressed initial disappointment with CMS’ decision to end the program, but were later able to find some reprieve with CMS’ decision to “allow Next Gen ACOs a limited opportunity to apply for Direct Contracting . . . . starting next year.”
Continue Reading CMS’ Next Generation Accountable Care Organization (NGACO) Model Set To End in December 2021

On April 27, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released the Hospital Inpatient Prospective Payment System (“IPPS”) and Long-Term Care Hospital (“LTCH”) unpublished Proposed Rule for 2022 (“Proposed Rule”). The Proposed Rule, if enacted, would eliminate the requirement from the Hospital IPPS and LTCH Final Rule for 2021 (“IPPS Final Rule for 2021”), as discussed in our September 11, 2020 blog post, that hospitals report the median payer-specific negotiated charge with Medicare Advantage (“MA”) payers, by MS-DRG, on its Medicare cost reports for cost reporting periods ending on or after January 1, 2021. CMS estimates that this will reduce the administrative burden on hospitals by approximately 64,000 hours.
Continue Reading CMS Proposes Repeal of Certain Cost Reporting Requirements from the IPPS Final Rule for 2021

N.B.  Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech.  It is being reported that the FDA may formally approve the applications as soon as tomorrow, Friday, December 11, 2020.  More detail regarding the recommendation and the FDA’s decision will be discussed in a follow-up article.

On Monday, December 7, 2020, California Governor Gavin Newsom announced that, “Hope is on the horizon with the [COVID-19] vaccination. We continue to accelerate our planning and preparedness for a safe and equitable vaccine distribution.”  As noted by the Governor, California expects to receive a little more than two million doses of the vaccine this month including 327,000 doses from pharmaceutical company, Pfizer, and 2.6 million doses from biotechnology maker, Moderna.
Continue Reading “Hope Is On The Horizon”: California Governor Gavin Newsom Announces COVID-19 Vaccine Distribution Plan

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by applicable manufacturers and group purchasing organizations about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.
Continue Reading On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data Collection And Reporting Requirements

In July 2020, the Centers for Medicare & Medicaid Services (“CMS”) released part three of its ongoing Accountable Care Organization (“ACO”) Learning System and Toolkit Series: Provider Engagement Toolkit (the “Toolkit”), focusing on strategies to effectively engage healthcare providers in the ACO and in quality improvement activities.  In particular, the Toolkit showcases the various effective strategies Medicare ACOs are currently using to help primary care and specialty providers in the ambulatory setting to improve health care quality and overall patient outcomes.
Continue Reading CMS Launches New ACO Toolkit Highlighting Effective Strategies For Achieving Provider Engagement

On June 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced its proposed Home Health Prospective Payment System Rule, for calendar year 2021 (the “Rule”), which aims to increase home health agency Medicare payment rates.  This Rule also includes a provision to make permanent the regulatory changes related to telecommunication technologies in providing care under the Medicare home health benefit beyond the expiration of the COVID-19 public health emergency (“PHE”), which is set to time out at the end of July 2020.
Continue Reading CMS Issues Proposed Home Health Agency Rule On Making Certain Telehealth Flexibilities Permanent, Increasing Medicare Payment Rates And Home Infusion Therapy Service Payment Rates For CY 2021

According to an April 13, 2020 Press Release issued by the National Association of ACOs (“NAACOS”),  a recent NAACOS survey shows that 56% of the survey-participating at-risk accountable care organizations (“ACOs”) – i.e., ACOs participating in a Center for Medicare and Medicaid Innovation (“CMMI”) alternative payment model (“APM”) and assuming financial risk thereunder – said that they were likely to drop out of their APM because of their fear of having to cover massive losses resulting from the COVID-19 pandemic.  In addition, the survey revealed that, as a result of swings in unpredictability and spikes in expensive hospitalizations, 21% of at-risk ACOs were “very likely” to leave the Medicare ACO program, 14% said they were “likely,” and another 21% said they were “somewhat likely” to leave.  Almost 80% of responding at-risk ACOs said they were “very concerned” about their 2020 financial performance in general and how their financial performance compared to their applicable annual APM benchmarks.
Continue Reading More Help Is On The Way For Accountable Care Organizations: CMS Announces New Relief For ACOs Struggling With The COVID-19 Crisis