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As individuals continue to live longer beyond retirement and the U.S. population size of those 65 years and older continues to increase, the demand for long-term services and supports (“LTSS”) is also expected to increase.[1] LTSS represents the wide-ranging health and social services that individuals require over an extended period of time, including assistive services.[2] The increasing demand for these services will also likely proportionally increase health care expenditures of LTSS. According to the Congressional Research Service, which analyzed data from the Centers for Medicare & Medicaid Services (“CMS”) National Health Expenditure Accounts (“NHEA”) on the personal health
Continue Reading The PACE Solution to Increasing Demands for Long-Term Services and Supports in the U.S.

Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing
Continue Reading Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

As we anticipated in our previous blog article, the Office of Health Care Affordability (OHCA) made revisions to its proposed regulations following the public workshop hosted by the California Department of Health Care Access and Information (HCAI) in August. On October 9, 2023, HCAI and OHCA published a revised draft of the regulations. Our August blog article outlined the substance of the original draft regulations; this article summarizes the critical takeaways regarding the revisions.
Continue Reading OHCA’s Revised Regulations Following Comments from Industry Stakeholders

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

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

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”) from November 11, 2023 until December 31, 2024. Under the Second Temporary Rule, practitioners may continue to prescribe schedule II-V controlled medications via telemedicine for new and existing patients without conducting a prior in-person medical evaluation through 2024. 
Continue Reading Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the bona fide employee exception and safe harbor to the federal Anti-Kickback Statute (the “AKS”). The opinion highlights flexibility for healthcare providers seeking to compensate employees in ways that align incentives with their employers, and particularly for physician practices to align employed physicians with use of the practices’ ambulatory surgery center (“ASC”) capabilities.
Continue Reading OIG Confirms the Broad Protection of Employee Safe Harbor

The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as well as organizations focused on increasing consumer access to various types of healthcare. Despite the growth of data analytics and interoperability, the constellation of companies and points of access are decentralized and disconnected. While the abundance of choice and options enhancing accessibility for healthcare consumers are positive indicators of progress in this space, the lack of holistic care coordination across this fragmented landscape affects patient outcomes, causes
Continue Reading At HLTH 2023: The Digital Health Symphony, A Care Coordination Orchestra with No Maestro

At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be vastly improved while the costs to the system of unnecessary care can be dramatically reduced. Here at HLTH, venture capital firm General Catalyst announced it is seeking to change that paradigm with the launch of its Health Assurance Transformation Corporation (HATCo), seeking to transform healthcare with global risk arrangements while leveraging data and technology. 
Continue Reading At HLTH 2023: General Catalyst’s HATCo Introduces a Radically Ambitious and Transformative Model for Healthcare

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
Continue Reading California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications

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
Continue Reading Medicare Advantage RADV Audit Final Rule Challenged in Court

On August 14, 2023, the Centers for Medicare & Medicaid Services (CMS) released guidance on changes to the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model starting in performance year 2024 (PY2024). The changes came about in response to stakeholder and participant feedback. All ACO REACH participants should familiarize themselves with the upcoming changes.
Continue Reading CMS Announces Changes to ACO REACH Model

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

The status of the independent dispute resolution (IDR) process under the No Surprises Act (NSA) is ever-evolving. Providers are waiting on the sidelines as cases weave their way through the court system. While the IDR process is currently on hold, it is incumbent on providers, payors, and individuals to remain vigilant and stay abreast of the forthcoming changes.
Continue Reading Sheppard Mullin Webinar – No Surprises Act: Litigation Update and Recent Guidance

On September 1, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a long-awaited proposal to establish new federal minimum staffing standards for long-term care facilities.[1] If the proposed rule is finalized, CMS estimates that approximately 75% of all nursing homes would have to “strengthen staffing in their facilities” in order to meet the new requirements.[2]
Continue Reading Long Term Care Facilities Face Mandatory Minimum Staffing Requirements