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 prepare their operational, administrative, and clinical teams for the reinstatement of previously waived requirements.Continue Reading Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

Have you been working out recently? We hope so, for today, Day Three of the 40th Annual J.P. Morgan Healthcare Conference, was definitely a day for heavy lifting.  Got a challenge that seems overwhelming? A problem that’s big enough to totally scare other folks? Do you eat triathlons for lunch? Well, then you’re going to like the Day Three companies. Let’s talk about fixing the huge American diabetes problem, providing better healthcare for Medicaid and dual eligible beneficiaries, and helping people beat cancer.  All that, plus a COVID-19 thought exercise…
Continue Reading Day Three Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

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 annual!), I was lamenting the bland, boring backgrounds of the presenters who were using low-quality stock shots or empty office views until I realized that I was looking at the wrong thing. I really had to look at the shadows and not the backgrounds. There are a LOT of shadows over this year’s J.P. Morgan Conference – COVID-19, the jittery stock market, the future of Medicare Advantage and recent industry changes.
Continue Reading Day One Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

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 of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule  published on November 4, 2021, which requires staff working in Medicare or Medicaid certified providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) to have the shots necessary to be fully vaccinated against COVID-19 by January 4, 2022, and receive their first shot prior to December 6, 2021 (the “Rule”).
Continue Reading CMS Suspends Vaccine Mandate Enforcement for Healthcare Workers

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

On February 4, 2021, the Department of Justice (“DOJ”), Office of Public Affairs, issued a Press Release (the “DOJ Press Release”) announcing that Kelly Wolfe, President of Regency, Inc., a medical billing company located in Florida, pleaded guilty to conspiracy to commit healthcare fraud through a “pernicious telefraud scheme”[1] involving fraudulent Medicare and CHAMPVA (Civilian Health and Medical Program of the Department of Veterans Affairs) claims for medically unnecessary durable medical equipment (“DME”) supplies.  As a result of Wolfe’s criminal plea, Wolfe could face up to 13 years in federal prison. 
Continue Reading OIG Warns Telehealth Industry: “With Great Power Comes Great Responsibility”

In a February 10, 2021 ruling (the “Garcia Ruling”) out of the District Court for the Central District of California (the “CDCA Court”) in the case of Gilbert Garcia et al v. Welltower OpCo Group LLC, et. al., 20-02250JVS (C.D. Ca. Feb. 10, 2021), the CDCA Court held that the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d–6d) (the “PREP Act”) provides senior living facilities with an exemption from civil liability for actions taken by such facilities to protect facility residents from COVID-19.
Continue Reading Senior Living Communities, Liability for COVID-19 Countermeasures, and the PREP Act: Is the Tide Turning for Providers?

On February 26, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury issued Frequently Asked Questions (FAQs) on the implementation of the Families First Coronavirus Response Act (“FFCRA”), the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), and other health coverage issuesrelated to COVID-19.
Continue Reading New Guidance on Health Plans’ COVID-19 Coverage Obligations

In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a temporary basis during the PHE, the range of healthcare professionals who can provide Medicare-covered telehealth services to include physical therapists, occupational therapists, speech language pathologists, and other non-physician practitioners.  (See also, CMS Fact Sheet, “Medicare Telemedicine Health Care Provider Fact Sheet” (March 17, 2020) and CMS’s “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” (December 1, 2020)).
Continue Reading The Other Shoe Drops: OIG To Audit COVID-19 Telehealth Home Health Services