On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path
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Day One Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022
By Eric Klein & Aytan Dahukey
For those of you who know me, I like to have fun with my Zoom backgrounds – choosing photos of interesting scenery or changing them mid-call to reflect my mood or negotiating strategy. Sitting in front of my computer this year for the first day of the 2022 J.P. Morgan Annual Healthcare Conference (the 40th…
Tri-Agencies Release Guidance on Coverage of OTC COVID-19 Tests
By Xavier Baker
On January 10, 2022, the U.S. Department of Health & Human Services, Department of Labor, and the Treasury (“Tri-Agencies”) published guidance about how health plans and health insurance issuers must reimburse OTC COVID-19 tests. As first announced by President Biden on December 2, 2021, the Biden Administration explained that health plans and health insurance…
CMS’ Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs
On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). Per CMS, the Proposed Rule will reduce out-of-pocket prescription drug costs, improve price transparency and market competition…
COVID-19 Impacts and Outcomes on Hospital Margins in 2021: Increased Activity in Hospital Transactions in 2022?
In its December Hospital Flash Report, Kaufman Hall identified and reviewed the continued, negative impact of COVID-19 on hospital operating margins. After a dramatic drop in hospital margins during the height of the pandemic in 2020 and early 2021, hospitals experienced a fluctuation of decreasing and increasing margins in the latter-half of the year.…
Debate Continues Around Scope of Practice Expansion for APPs
Scope of practice expansion has been a hot-button issue within medical communities and state legislatures for more than thirty years. The debate is centered on what services advanced practice providers (“APPs”) who hold Master’s Degrees (e.g., Physician Assistants, Nurse Practitioners, Pharmacists, Dental Hygienists, etc.) should or should not be able to furnish in their professional…
Health Law Policy Heading Into 2022 At The ABA Health Law Summit
The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues. But, as always at this conference, there are the issues selected by the conference chairs and formally on the agenda – and then there are issues…
News Flash: Last Minute Congressional Action Saves Physicians from a Nearly 10% Cut to Medicare Payments
Physicians and other providers can take a deep breath as Congress has acted to prevent the trio of Medicare payment cuts that were set to take effect at the beginning of 2022—a 3.75% cut due to scheduled changes in the Medicare Physician Fee Schedule (“PFS”), a 2% cut for Medicare sequestration, and a 4% Statutory…
CMS Suspends Vaccine Mandate Enforcement for Healthcare Workers
On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement…
HHS OIG Studies State Medicaid Programs’ Use of Telehealth
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…
Health Equity Remains a Priority for the Center for Medicare and Medicaid Services in 2022
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:
- promoting greater
…
HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance
“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…
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, 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.
Currently, an organization…
Trends in Digital Health Funding and Transactions: A Tremendous Year So Far
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.
According to the Digital Health Funding and M&A 2021 First Half Report released by Mercom Capital, the first half of 2021 closed with $14.7 billion invested…
The Infrastructure Investment and Jobs Act: Potential Impact on Healthcare Policy and Spending
On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure purposes. Notably, the Infrastructure Bill is paid for in part through changes to several healthcare policies, including delaying a Medicare Part D rebate rule…
Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While Keeping the “Most Favored Nations” Drug Reimbursement Program on the Sidelines
On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020 (“Interim Final Rule”). As described in our December 2020 blog post, the Interim Final Rule established seven-year nationwide,…