On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) revised and finalized draft guidance first issued on May 3, 2019, for co-location of hospitals with other hospitals or healthcare providers[1] (the “Finalized Guidance”). The Finalized Guidance is intended to guide CMS Surveyors in evaluation of such hospitals’ compliance with Medicare Conditions of Participation related to shared space, services, and staff.
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Continue Reading CMS Loosens Restrictions on Co-Located Healthcare Providers; Enforcement Interpretation Still to Be Determined

The United States Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a report concerning the use of telehealth to render behavioral health services to Medicaid enrollees, calling for greater evaluation and oversight in the hopes of encouraging states to implement changes to improve how their Medicaid programs use telehealth for behavioral health services, including mental health assessments, individual therapy, and medication management.
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Continue Reading HHS OIG Studies State Medicaid Programs’ Use of Telehealth

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will be taking actions to advance its strategic commitment to drive innovation to support health equity and high quality, person centered care. CMS’ 2022 Physician Fee Schedule final rule (the “Final Rule”), will focus on, amongst other things:
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Continue Reading Health Equity Remains a Priority for the Center for Medicare and Medicaid Services in 2022

This post originally appeared as an article in the Daily Journal on October 29, 2021.

As of January 1, 2022, patients will no longer be at risk for one of the most detested practices in healthcare: surprise out-of-network bills.

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Continue Reading Relief from Surprise Bills – Congress Passes the No Surprises Act What Providers and Insurers Need to Know

Six months ago, we cautioned health plans and plan sponsors that states, the federal government, and private litigants were laser focused on Mental Health Parity and Addiction Equity Act (“MHPAEA”) compliance. The United States Department of Labor (“DOL”) investigated and closed 127 health plan investigations related to MHPAEA in FY 2020. Given the changes announced in the Consolidated Appropriations Act, 2021 (“CAA”), and subsequent guidance, we expect heightened scrutiny of MHPAEA compliance from states, the federal government, and private parties.
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Continue Reading State, Federal, and Private Enforcement of Mental Health Parity Compliance

On October 20, 2021, the Centers for Medicare and Medicaid (“CMS”) Innovation Center (“Innovation Center”) published a white paper detailing its vision for the next ten years: a health system that achieves equitable outcomes through high quality, affordable, person-centered care.  The white paper first recounts the last ten years of testing and learning that laid the foundation for the Innovation Center’s future strategy.  The future strategy is organized around five strategic objectives that will guide the Innovation’s Center’s models and priorities for the next ten years.  The five strategic objectives for advancing this systemwide transformation include (1) Drive Accountable Care, (2) Advance Health Equity, (3) Support Innovation, (4) Address Affordability, and (5) Partner to Achieve System Transformation.  These strategic objectives aim to guide the Innovation Center’s models which will seek to reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries.  Finally, the white paper emphasizes its approach to measuring the progress of each of these objectives and assessing the impact the objectives have on beneficiaries, providers, and the market as a whole.
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Continue Reading Centers for Medicare and Medicaid Innovation Center: Equity and Vision

“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”[1]

On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule (“Privacy Rule”) to disclosures and requests for information regarding COVID-19 vaccination status. In a frequently-asked-questions format, the Guidance sets forth a series of workplace-related scenarios involving the confidentiality of an employee’s vaccination status, an employer’s ability to obtain vaccination information from its employees, and the confidentiality of such information.

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Continue Reading HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance

On October 4, 2021, the California Senate Bill 650 (“SB 650”), also known as the Corporate Transparency in Elder Care Act of 2021, was signed by Governor Gavin Newsom. As described below, SB 650 is designed to provide the public with greater transparency as to skilled nursing facility (“SNF”) ownership and finances.
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Continue Reading What Price Transparency? California SB 650 Shines Light on Skilled Nursing Facility Ownership while Creating New Reporting Burdens for California Skilled Nursing Facilities

On October 4, 2021, California Governor Gavin Newsom signed California bill SB-664 “Hospice licensure: moratorium on new licenses” (the “Bill”) into law.  The Bill, which passed the California Assembly on September 8, 2021 and the California Senate on September 9, 2021, imposes a moratorium on the California Department of Public Health (the “Department”) issuing new hospice licenses on or after January 1, 2022.  Under the California Hospice Licensure Act of 1990, a person, political subdivision of the state, or other governmental agency must obtain a license from the Department to provide hospice services to an individual who is experiencing the last phase of life due to a terminal disease.  The moratorium will end either three hundred and sixty five (365) days from the date the California State Auditor publishes a report on hospice licensure or when the provisions of the Bill are repealed on January 1, 2027, whichever is sooner.  The Department may grant an exception to the moratorium upon making a written finding that an applicant for a new license, or with a license application pending on January 1, 2022, has shown a ‘demonstrable need’ for hospice services in the area.  However, the Bill does not affect the Department’s ability to renew existing licenses.
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Continue Reading New California Law Imposes Moratorium on New Hospice Licenses

As the world continues to shift and adapt to the ongoing COVID-19 pandemic, the digital health sector has experienced tremendous growth and the momentum has only accelerated in 2021.
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Continue Reading Trends in Digital Health Funding and Transactions: A Tremendous Year So Far

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower Drug Costs Now Act, proposes to grant the U.S. Department of Health and Human Services (“HHS”) the authority to negotiate directly with pharmaceutical companies in order to lower drug prices in Medicare Part B and Medicare Part D (the “Proposal”).  The Proposal would require that 125 brand-name drugs that cost Medicare the most to be subject to negotiation by Medicare, with a cap on the price for each drug set at 120% of the average price paid in six other countries.  The Proposal is part of a $3.5 trillion budget proposal that, as of this writing, faces an uncertain future in Congress.  While not a novel idea, the Proposal is controversial and faces strong opposition from pharmaceutical companies in particular.
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Continue Reading Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform