Health Law Advisor

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to the OTP regulations in over 20 years, and significantly increases access to lifesaving medication while easing operational restrictions.

The agency eased admission requirements and cemented some of the telehealth and take-home dose flexibilities put in place during the COVID-19 pandemic. Other changes streamline OTP operations, reduce restrictions on ...

On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November ...

When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal Physician Self-Referral Law (the “Stark Law”), which has draconian penalties, such as clawback of Medicare payments plus additional stiff monetary penalties and possible exclusion from participation in federal health care programs. 

During the COVID-19 PHE, CMS issued temporary waivers, including a waiver of the “location requirement” of the In-Office Ancillary Services (“IOAS”) exception. That waiver allowed physician groups that furnish certain durable medical equipment, orthotics, prosthetic devices – including intermittent urinary catheters (“IUCs”) – and other medical supplies (collectively referred to here as “DME”) to provide home delivery of such DME to their Medicare patients without facing sanctions for violating the Stark Law.[1] With the end of the PHE having occurred over three months ago, that temporary waiver of sanctions ended and can no longer be relied upon for legal compliance with the Stark Law.[2]     

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.

Interest in and acceptance of telehealth services continues to grow. Recent events, like the COVID-19 pandemic and the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women's Health Organization, have put more pressure than ever on federal and state legislators to promote access to telehealth services.

However, the greater use of telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while staying compliant with applicable laws.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. We are pleased to release our latest compilation of state telehealth laws, regulations, and policies within the mental/behavioral health practice disciplines.

In this episode of the Diagnosing Health Care Podcast:  What challenges are providers likely to face as the Occupational Safety and Health Administration (OSHA) prepares its permanent COVID-19 standard for health care workers?

Attorneys Denise Dadika, Bob O’Hara, and Tim Murphy review the provisions of OSHA’s temporary COVID-19 standard for health care workers and what’s expected to change under the permanent rules. They also discuss how the agency’s current enforcement push is impacting health care providers.

On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.

On the evening of Wednesday, December 22, 2021, the Supreme Court of the United States announced that it will hold a special session on January 7, 2022, to hear oral argument in cases concerning whether two Biden administration vaccine mandates should be stayed. One is an interim final rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”); the other is an Emergency Temporary Standard (“ETS”) issued by the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”). The CMS interim final rule, presently stayed in 24 states, would require COVID-19 vaccination for staff employed at Medicare and Medicaid certified providers and suppliers. The OSHA ETS, which requires businesses with 100 or more employees to ensure that workers are vaccinated against the coronavirus or otherwise to undergo weekly COVID-19 testing, was allowed to take effect when a divided panel of the United States Court of Appeals for the Sixth Circuit, to which the consolidated challenges had been assigned by the Judicial Panel on Multidistrict Litigation issued a ruling, on December 17, 2021, lifting a stay that had been previously entered by the Fifth Circuit. Multiple private sector litigants and states immediately challenged the decision.

As we previously reported, the Centers for Medicare & Medicaid Services' (CMS's) interim final rule (the “Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) was effectively stayed nationwide on November 30, 2021, by the U.S. District Court for the Western District of Louisiana (the “Louisiana Court”).  In yet another twist to the ongoing legal battles, the U.S. Court of Appeals for the Fifth Circuit lifted the nationwide stay and held that the Louisiana Court only had authority to block the vaccine mandate in the fourteen plaintiff states that brought suit in that court. Those states are Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.

Due to the litigation in the Eastern District of Missouri, as reported here, enforcement of the vaccine mandate is also blocked in ten other states:  Alaska, Arkansas, Kansas, Iowa, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.  In total, the vaccine mandate under the Rule is now stayed in twenty-four states, but is now in effect in the remaining twenty-six states.

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.

As featured in #WorkforceWednesday: The Centers for Medicare & Medicaid Services (CMS) issued an interim final rule outlining vaccine requirements for staff at Medicare- and Medicaid-certified providers and suppliers.

Attorney Frank Morris discusses the next steps for health care providers. In addition, covered employers should continue to monitor the recent litigation filed in the Eastern District of Missouri and the Western District of Louisiana seeking to permanently enjoin the CMS interim final rule.

See below for the video and podcast links. Visit ...

Our colleague Robert O'Hara of Epstein Becker Green has a new post on the Workforce Bulletin blog that will be of interest to our readers: "OSHA Launches New COVID-19 Initiatives: With More to Come".

The following is an excerpt:

President Biden’s January 21, 2021 Executive Order (EO) on COVID-19 tasked the Occupational Safety and Health Administration (OSHA) to: launch a national enforcement program, review and correct any shortcomings in their prior enforcement strategies and to determine whether any Emergency Temporary Standards (ETS) were necessary and, if so, to issue an ...

Our colleagues Susan Gross Sholinsky, Nancy Guzenhauser Popper, Eric Emanuelson, and Christopher Shur of Epstein Becker Green have a new post on the Workforce Bulletin blog that will be of interest to our readers: "New York City Council Establishes Board to Assess Employers’ COVID-19 Workplace Health and Safety Protocols and Training."

The following is an excerpt:

The New York City Council is planning to evaluate how effectively both the City, as an employer, and private employers disseminated and implemented COVID-19 workplace guidance over the past year with the goal of ...

On February 10, 2021, the Centers for Disease Control and Prevention (“CDC”) issued  updated guidance and a report emphasizing the importance of a wearing a mask that fits tightly over the face to slow the spread of COVID-19.  The report, which provides the basis for the CDC’s updated guidance, is based on CDC experiments that showed “substantially improved source control and reduced wearer exposure” when worn properly. The publications recommend two specific ways to ensure a mask works the best it can: (1) make sure the mask fits snugly against the face and (2) pick a mask with ...

Recently, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), the agency enforcing the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, obtained two large breach-related settlements: one from a HIPAA Covered Entity and one from a HIPAA Business Associate.  These enforcement actions signal that despite COVID-19 related challenges, organizations continue to face rampant data breaches and ensuing HIPAA enforcement.

On September 25, 2020, OCR settled an investigation into a breach suffered by a large health insurer by obtaining the second-largest resolution payment in HIPAA enforcement history ($6.85 million).  This enforcement action resolved an investigation concerning potential violations of HIPAA Privacy and Security Rules related to a breach affecting the electronic protected health information (ePHI) of more than 10.4 million people.  The breach resulted from a phishing attack that introduced malware into the insurer’s IT systems and allowed unauthorized actors to gain access and remain undetected for nearly nine months.  Similarly on September 23, 2020, a business associate providing IT and health information management services to hospitals and physicians clinics entered a settlement ($2.3 million) with OCR for potential violations of HIPAA Privacy and Security Rules related to a breach affecting over 6 million people.  Essentially, these cyberattacks were advanced persistent threats that compromised the privacy and security of ePHI and PHI and revealed longstanding gaps in the companies’ cybersecurity controls.

Our colleagues David M. Prager, Jennifer L. Nutter, Alice Kwak, and Mary T. Vu at Epstein Becker Green recently published an Act Now Advisory that will be of interest to our readers in the health care industry: “Annual California Employment Law Update: New Laws for 2021 Provide COVID-19 Protections and Expand Family Leave.” This year, Governor Gavin Newsom signed numerous employment-related bills passed by the California Legislature. Major changes affecting employers with California operations in the coming year include:

• requiring COVID-19 supplemental paid sick ...

To limit exposure and reduce the spread of COVID-19, New York and New Jersey are requiring long-term care facilities to implement testing for staff.

New York

On May 11, 2020, New York Governor Andrew Cuomo issued Executive Order 202.30 requiring nursing homes and adult care facilities, including all adult homes, enriched housing programs and assisted living residences (“facilities”), to test all staff for COVID-19 twice per week.  Staff who refuse to be tested will be deemed to have incomplete health assessment and will be prohibited from providing services until the test has ...

To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[1], Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.[2]

As of May 7, 2020, HHS identified $50 billion for general distribution to Medicare providers. HHS distributed to Medicare providers the Relief Fund’s initial $45 billion tranche in April 2020, and is distributing the Relief Fund’s second $20 billion tranche. Also, HHS allocated Relief Funds to: hospitals in COVID-19 high impact areas ($10 billion); rural providers ($10 billion); Indian Health Services ($400 million), and skilled nursing facilities, dentists, and providers that take solely Medicaid (unidentified amounts).[3]

As the number of COVID-19 cases in the State of New Jersey continues to grow, Governor Murphy has issued various executive orders aimed at combatting COVID-19.  On April 1, 2020 the Governor signed Executive Order 112 (“EO 112”), which focuses on the health care industry with a goal of increasing the number of health care workers responding to COVID-19 in New Jersey.  EO 112, among others things:

• Allows the Department of Law and Public Safety, Division of Consumer Affairs (DCA) to reactivate the license of any health care professional previously licensed in New Jersey who retired ...

Notwithstanding numerous restrictions limiting access to many resources during the ongoing coronavirus (COVID-19) pandemic, marijuana users in states where medicinal and adult use is legal may still have access to cannabinoid supplies. Even as states, counties, and municipalities increasingly restrict or shut down business activities to stem the spread of the virus, many jurisdictions will keep medical marijuana dispensaries open as “essential” businesses like pharmacies and grocery stores.

Medical Marijuana Dispensaries Deemed “Essential” Businesses

Our colleague Nancy Gunzenhauser Popper at Epstein Becker Green has recently published a post on the Workforce Bulletin blog that will be of interest to our readers in the health care industry: “Colorado Mandates 4 Days of Paid Leave for COVID-19 Testing.”

Following is an excerpt:

On March 10, 2020, Colorado Governor Jared Polis issued an executive order directing he Colorado Department of Labor and Employment (“DLE”) to create emergency rules to “ensure workers in food handling, hospitality, child care, health care, and education can get paid sick leave to ...

On March 11, 2020, the World Health Organization declared that the 2019 novel coronavirus (known as “COVID-19”) is now a pandemic. The effects continue to be felt in the United States, which currently has well over 1,000 cases of COVID-19. As of March 12, 2020, 19 states have declared a state of emergency to ensure there are resources to address the coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020, which was extended to the United Kingdom and Ireland on March 15^th. Additionally, on March 13, 2020 President ...