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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
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Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses the duality of AI—its promising utility and disconcerting risks—across a range of public and private sectors, including healthcare. Below are five key takeaways from the EO for the healthcare industry.

Continue Reading AI’s Executive Order and Its Key Healthcare Implications 
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In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].

Continue Reading OIG General Compliance Program Guidance November 2023
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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
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At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our top 10 takeaways from what we heard, and did not hear, at HLTH 2023.

Continue Reading Sheppard Mullin’s Top 10 Takeaways from HLTH 2023
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California is taking steps through Assembly Bill 254 (the “Bill”), approved by the State’s Governor on September 27, 2023, to ensure that patient information collected through reproductive or sexual health applications enjoys protections under the Confidentiality of Medical Information Act (the “CMIA”).[1] In addition to applying to providers and plans, the CMIA applies to businesses that offer software or hardware to consumers, such as mobile applications, which maintain medical information for the purpose of enabling management of such medical information or to otherwise support diagnosis, treatment, or management of a medical condition.[2] As a result, software and application developers may need to consider the CMIA with respect to their obligations relating to this particular data. In addition to certain confidentiality requirements, the CMIA also prohibits certain marketing uses and disclosures and requires breach notification in certain qualifying instances.

Continue Reading California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications
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The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other changes, this Final Rule will allow CMS to audit a sample of an MA organization’s (“MAO”) diagnoses reported for risk adjustment purposes (from 2018 and later) and then use the audit findings to calculate an extrapolated improper payment amount for the MAO’s contract. This extrapolation technique is controversial for a number of reasons, including whether CMS has the authority to use it in the manner proposed in the Final Rule, and whether it is an actuarially sound method of auditing. As we predicted in February, this Final Rule is now being challenged in court.

Continue Reading Medicare Advantage RADV Audit Final Rule Challenged in Court
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As we previewed in our previous blog article, the California Department of Health Care Access and Information (HCAI) hosted a live public workshop on August 15, 2023 for in-person and virtual attendees to make comments and pose questions regarding the proposed regulations governing the Office of Health Care Affordability’s (OHCA) review authority for certain healthcare transactions.

Continue Reading Public Workshop for OHCA’s Proposed Regulations Sparks Lively Discussion Among Industry Stakeholders
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On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) announced updates to the Medicaid overpayment self-disclosure program, which now includes an abbreviated process for reporting and explaining overpayments that are considered routine or transactional in nature and have been already voided and adjusted.

Continue Reading New York Medicaid Providers Now Have Two Pathways to Self-Disclose Overpayments to the Office of the Medicaid Inspector General