In light of the increasing demand for mental health treatment and simultaneous provider shortages, the private insurance industry is rolling out targeted initiatives to increase mental health support for members by mitigating many of the barriers to entry facing the mental health industry today.
Continue Reading Payor-Led Initiatives to Strengthen Mental Health Resources

The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the guidance documents issued by the Centers for Medicare and Medicaid Services (“CMS”) detailing the proposed implementation of the Medicare Part B and Medicare Part D Prescription Drug Inflation Rebate Programs.
Continue Reading CMS Releases First Set of Part B Rebatable Drugs for Coinsurance Adjustment Under IRA

Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers and agencies.
Continue Reading PBM Practices Receive Increased Federal Scrutiny

According to the White House, the end of the COVID-19 national emergency and public health emergency (PHE) declarations is now barely two months away, as they are scheduled to end on May 11, 2023. These declarations provided the federal government with flexibility to waive or modify certain regulatory requirements applicable to the healthcare industry. Once the declarations end, so will the vast majority of these flexibilities and waivers. Accordingly, a relatively short and closing window remains for the healthcare industry – including but not limited to health plans, hospitals, home health agencies, clinics, and entities that offer telehealth services – to…
Continue Reading Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

California has a new regulatory review process that could have implications for healthcare mergers and acquisitions and similar transactions in the state. By way of background, after nearly two years of negotiations with state legislators, Governor Gavin Newsom signed into law healthcare omnibus bill SB 184 on June 30, 2022, which created the new Office of Health Care Affordability (OHCA). With this new law and state agency, California joins several other states, including Massachusetts, New Jersey, Oregon, Washington and Nevada in implementing oversight and funding measures geared towards healthcare cost growth targets and containment. While the goal of the law…
Continue Reading California Office of Health Care Affordability: Another Regulatory Hurdle for California Healthcare M&A Transactions?

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug manufacturer to provide financial assistance for transportation, lodging, meals, and other out-of-pocket expenses to eligible patients receiving the manufacturer’s drug (the “Arrangement”). Overall, OIG concluded that: (1) the risk of fraud and abuse presented by the manufacturer’s Arrangement was sufficiently low under the Federal anti-kickback statute; and (2) the remuneration offered under the Arrangement was not likely to influence a beneficiary to…
Continue Reading OIG Advisory Opinion Alert: Medical Flights for Patient Access

Since its launch in November 2022, ChatGPT (“GPT” stands for Generative Pre-trained Transformer), a type of artificial intelligence model, has gained over a million users. ChatGPT is used by entities in a wide variety of industries. On March 1, 2023, OpenAI, the developer of ChatGPT, updated its data usage policies[1] noting that (i) OpenAI will not use data submitted by customers to train or improve its models unless customers expressly opt-in to share such data, and (ii) OpenAI also will enter into business associate agreements in support of applicable customers’ compliance with the Health Insurance Portability and Accountability Act (“HIPAA”).
Continue Reading ChatGPT And Healthcare Privacy Risks

The Centers for Medicare & Medicaid Services (“CMS”), on behalf of the U.S. Department of Health and Human Services (“HHS”), recently issued a proposed rule to adopt standards under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) for “health care attachment” transactions (the “Proposed Rule”). The Proposed Rule would implement requirements of HIPAA’s administrative simplification regulations, which are intended to support healthcare claims and prior authorization transactions while also introducing a standard format for electronic signatures to be used in conjunction with health care attachments.
Continue Reading CMS’s Administrative Simplification Rule Aims to Increase Efficiency and Standardization for Health Care Attachments

This blog is the third installment of our Digital Health Trends Series, see previous blog posts here and here.

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008 (“RHA”) after the COVID-19 Public Health Emergency (“PHE”) terminates on May 11, 2023. The proposed rule extends certain flexibilities beyond the PHE and proposes to make permanent certain scenarios, in which a practitioner may prescribe controlled substances without a prior in-person medical evaluation.
Continue Reading DEA Proposes Rule for Post-PHE Telemedicine

The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid Services in its response to the public health emergency (“PHE”) declared in March of 2020 and which was repeatedly renewed until now. On January 30, 2023, President Joe Biden announced that the PHE would end on May 11, 2023. As the curtains are drawn on the PHE, there can be no doubt that telehealth is here to stay. In light of that reality, it is…
Continue Reading Telehealth in a Post-PHE World

Effective March 1st, certain providers choosing to self-disclose Stark Law violations must use forms updated by the Centers for Medicare & Medicaid Services (“CMS”).
Continue Reading CMS Streamlines Stark Law Self-Referral Disclosure Protocol (SRDP)

On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the Medicare Physician Fee Schedule when furnished via telehealth.
Continue Reading CMS Updates List of Telehealth Services for CY 2023

On February 15, 2023, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require nursing homes enrolled in Medicare and Medicaid to disclose new information about their ownership and management structures. If finalized, the rule would require nursing homes to disclose any ties to private equity companies or real estate investment trusts (REITs) (defined below), as well as the names and information of individuals and entities that provide certain administrative, management or consulting services.
Continue Reading CMS Issues Proposed Rule Requiring Nursing Homes to Disclose Additional Ownership Information, Including Ties to Private Equity and REITS