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The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

December 29, 2020

The 340B Program, named after its section within the 1992 Public Health Service Act, allows covered entities to stretch their scarce federal resources as far as possible, by setting a ceiling price on the sale of covered outpatient drugs from participating pharmaceutical manufactures to covered entities. With the passage of the Patient Protection and Affordable Care Act in 2010, 340B’s oversight agency, the Health Resources and Services Administration (“HRSA”) within the Department of Health and…

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HHS Final Rules Modernize the Stark Law and Anti-Kickback Statute to Usher in Value-Based Care

By Eric S. Klein & David R. Padalino

December 11, 2020

On November 20, 2020, the U.S. Department of Health and Human Services (“HHS”) released final rules seeking to modernize the Physician Self-Referral Law (“Stark Law”) and the federal Anti-Kickback Statute (“AKS”). The final rules, released by HHS’ Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”), are part of The Regulatory Sprint to Coordinated Care—an effort launched by HHS in 2018 aimed at removing barriers to value-based care. Among other changes,…

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The CDC’s New Definition of “Close Contact”: What You Need To Know

By Bonnie Mayfield

November 25, 2020

The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (including transportation and logistics, health care, automotive, manufacturing, and educational industries) and different…

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U.S. Department of Labor Issues Revised Regulations Implementing FFCRA Leaves Following New York Court’s Decision

By James F. Hermon

September 14, 2020

We reported last month on a decision by a New York federal court that rejected portions of the Department of Labor regulations implementing the Families First Coronavirus Response Act (“FFCRA”) leaves signed into law earlier this year. The FFCRA created rights for employees of employers with fewer than 500 employees, and all public employers, to take up to 10 days of paid sick leave under the Emergency Paid Sick Leave Act (“EPSLA”) for various COVID-19…

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Michigan Reinstitutes Pre-COVID Scope of Practice, Licensure, and Liability Standards

By Eric S. Klein

July 16, 2020

On July 13, 2020, Michigan Governor Gretchen Whitmer issued Executive Order 2020-150 to rescind a previous order (Executive Order 2020-61) that had permitted certain health care professionals to temporarily practice beyond the scope of their license. Governor Whitmer cited Michigan’s progress in slowing the spread of COVID-19 and the reduced pressure on hospitals as reasons for rescinding the prior expansion of scope. Read More › Tags:…

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DHHS Issues Terms and Conditions for Relief Funds

By Kathrin E. Kudner

April 14, 2020

On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act or “CARES Act” which includes $100 billion in relief funds for hospitals and other healthcare providers to be used to provide support for healthcare-related expenses or lost revenue attributable to COVID-19. Funding is also available to providers to assist uninsured individuals to obtain testing and treatment for COVID-19. Read More › Tags:…

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Nursing Home Compliance Under the COVID-19 Microscope

By Jonathan S. Feld & David R. Padalino

April 8, 2020

Nursing homes have been on the front lines throughout the COVID-19 pandemic as they care for the persons most at risk. In an effort to improve safety and curb the spread of COVID-19, federal and state authorities are relaxing certain compliance obligations. Despite this regulatory latitude, nursing facilities should remain aware that federal and state agencies continue to closely monitor nursing home compliance. Read More › Tags:…

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OCR Guidance During the COVID-19 Public Health Emergency

By Kathrin E. Kudner

April 6, 2020

Telehealth On March 17, 2020, OCR issued guidance indicating that it would exercise enforcement discretion and waive penalties for entities that provide services to individuals using “everyday communication technologies.” On March 20, 2020, OCR provided additional more detailed guidance on telehealth services applicable to all health care providers covered by HIPAA who provide telehealth services during the COVID -19 public health emergency. Read More › Tags:…

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Michigan Governor’s Executive Order 2020-30 Expands Health Care Professionals’ Scope of Practice and Lifts Certain Licensure Restrictions

By Kathleen A. Reed

March 30, 2020

On March 29, 2020, Michigan Governor Gretchen Whitmer issued Executive Order 2020-30 (“E.O. 2020-30”) temporarily lifting certain licensure and scope of practice restrictions for health care professionals practicing at health care facilities in response to the COVID-19 public health emergency. E.O. 2020-30 contains the following provisions, which are effective immediately through the end of the COVID-19 public health emergency. Read More › Tags:…

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Medicare Telemedicine Reimbursement Updates in Response to COVID-19

By Serj Mooradian

March 30, 2020

On March 17, 2020, the Centers for Medicare and Medicaid Services (“CMS”) implemented a telehealth waiver (the “Waiver”) under the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020, which allows the U.S. Department of Health and Human Services (“HHS”) to temporarily waive certain Medicare restrictions and requirements regarding the delivery of telehealth services during the coronavirus public health emergency (the “Emergency”). Under the Waiver, CMS is expanding Medicare coverage for telehealth visits. CMS has…

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Blog Authors

The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

HHS Final Rules Modernize the Stark Law and Anti-Kickback Statute to Usher in Value-Based Care

The CDC’s New Definition of “Close Contact”: What You Need To Know

U.S. Department of Labor Issues Revised Regulations Implementing FFCRA Leaves Following New York Court’s Decision

Michigan Reinstitutes Pre-COVID Scope of Practice, Licensure, and Liability Standards

DHHS Issues Terms and Conditions for Relief Funds

Nursing Home Compliance Under the COVID-19 Microscope

OCR Guidance During the COVID-19 Public Health Emergency

Michigan Governor’s Executive Order 2020-30 Expands Health Care Professionals’ Scope of Practice and Lifts Certain Licensure Restrictions

Medicare Telemedicine Reimbursement Updates in Response to COVID-19

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