On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider so long as they demonstrate independent compliance with the Medicare Conditions of Participation (CoPs). This Guidance, which finalizes the prior draft guidance issued on May 3, 2019, explains how CMS and state agency surveyors will evaluate a hospital’s space sharing or contracted staff arrangements when assessing the hospital’s compliance with the Medicare CoPs.  The Guidance took effect immediately upon publication on November 12, 2021.

As relayed by CMS, hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services. Continue Reading CMS Finalizes Guidance on Hospital Co-Location

To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to provide services (in person or via telemedicine) to patients in Massachusetts. Order 2021-13 extends prior DPH orders which authorized issuance of temporary licenses for certain health care providers and renewal or reactivation of certain temporary licenses. Continue Reading Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review. Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests

On November 4, 2021, the Department of Justice (DOJ) announced the conviction of several South Florida addiction treatment facility operators following a seven-week trial. The initial indictment was filed in September 2020, charging ten defendants for their alleged conduct in committing health care fraud, wire fraud, violations of the Eliminating Kickbacks in Recovery Act (EKRA), the Anti-Kickback Statute, and money laundering. The defendants included the co-owners of two entities providing treatment and therapy for substance use disorder, several other management level individuals, a referring chiropractor, and several marketing employees. Continue Reading DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.

Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff: Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers

The Office for Civil Rights (OCR) recently announced that it has entered into the 20th settlement under its Right of Access Initiative. The settlement with Children’s Hospital and Medical Center in Nebraska includes an $80,000 payment by the hospital for failing to provide a mother with timely access to her daughter’s medical records.

According to OCR, after the mother first requested the records, the hospital provided her with some of the records, but failed to provide her with missing records after repeated requests. Once OCR intervened, the hospital provided all of the records to the mother.

In addition to the monetary penalty of $80,000, the hospital entered into a Corrective Action Plan with OCR.

This post is also being shared on our Data Privacy + Cybersecurity Insider blog. If you’re interested in getting updates on developments affecting data privacy and security, we invite you to subscribe to the blog.

On September 9, 2021 President Biden announced a COVID-19 Action Plan entitled “Path out of the Pandemic” (the “Plan”) which comprises a six-pronged national strategy aimed at combatting COVID-19. The Plan includes a number of important provisions related to health care, including implementation of COVID-19 vaccine requirements and an expansion of resources available for treatment of COVID-19. The Plan signals significant changes upcoming for health care organizations, their employees, and their patients.

The following summary addresses certain parts of the Plan with specific implications for health care, but please continue to check R+C blogs and legal updates for follow-up analysis of the specific guidance and rules that are released in furtherance of the Plan. Continue Reading Biden COVID-19 Action Plan Expands Vaccine Mandates, Testing, and Treatment to Combat Spread of Virus

On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations for vaccine booster shots, and as schools adopt COVID-19 control measures for returning students and staff. The Order modifies Connecticut law to allow the Commissioner of Public Health to disclose information reported to the Department of Public Health regarding a COVID-19 vaccine recipient’s immunization information– i.e., information in the state COVID-19 immunization registry – to:

  • a health care provider of a vaccine recipient or potential vaccine recipient;
  • each school nurse at a public or private school in any town, city or school district; and
  • local health directors and other public health authorities to support COVID-19 vaccination efforts within their jurisdictions.

The Order defines “health care provider” to include physicians, advanced practice registered nurses, and physician assistants licensed by the Department of Public Health, as well as any health care organization that is providing COVID-19 vaccines under a Center for Disease Control and Prevention COVID-19 Vaccination Program Provider Agreement or any officer, employee or agent thereof acting in the course and scope of his or her employment. The release of this COVID-19 immunization information must be for the purposes of reducing the spread of COVID-19 and increasing access, use, and the provision of COVID-19 vaccines. The Order also grants the Commissioner authority to issue policies and procedures necessary to administer the disclosure of COVID-19 immunization information in accordance with the Order, including the way in which such information will be disclosed to vaccine recipients.

According to a press release issued by Governor Lamont announcing the Order, the changes are intended to align access to vaccine information in Connecticut with approaches taken in at least 37 other states, including New Jersey, New York, and Rhode Island. The press release also states that the Order “will allow individuals to easily and securely access their own COVID-19 vaccine record” and suggests that the Order will remove current barriers for patients seeking to access their own COVID-19 vaccination record.

Notably, the Order takes effect immediately but will only remain in effect through September 30, 2021 unless it is earlier modified or terminated.

*This post was co-authored by Erin Howard, legal intern at Robinson+Cole. Erin is not yet admitted to practice law.

On June 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-26 “An Act Concerning Various Revisions to the Public Health Statutes” (the “Act”). This Act makes notable changes to laws affecting hospital and health system practices, including the following:

Hospitals Required to Give Patients Option to Contact Family or other Support Personnel Upon Admission

Existing law requires that. upon admitting a patient to a hospital, hospital personnel shall promptly ask the patient if he or she wants the hospital to notify his or her physician.  The Act expands this obligation for hospitals by also requiring them to ask if there is any family member, caregiver, or support person who should be notified about the admission. If the patient requests, the hospital personnel must then make reasonable efforts to contact the family member, caregiver, or support person as soon as practicable, but within 24 hours after the request. This requirement takes effect October 1, 2021.

Donation of Blood by 16-Year Olds

Under existing law, an individual seventeen years or older is deemed to have the capacity to consent to donate blood or any component thereof. The Act now allows any person sixteen years of age to consent to donate blood or any component thereof, with written authorization of a parent or guardian. This section became effective July 1, 2021.

Hospital Discharge Plans Can be Provided Electronically

Also effective July 1, 2021, The Act newly allows a hospital to electronically provide a discharge summary and any related materials to a patient upon discharge from the hospital, and to document acknowledgment of receipt of such materials electronically, as long as the patient agrees to electronic-only delivery.

*This post was co-authored by Erin Howard, legal intern at Robinson+Cole. Erin is not yet admitted to practice law.

In June 2021, the Centers for Medicare and Medicaid Services (CMS) issued a notable interpretation of the Physician Self-Referral Law (aka the Stark Law) in Advisory Opinion No. CMS-AO-2021-01 (Advisory Opinion) regarding whether a physician practice can furnish designated health services (DHS) through a wholly-owned subsidiary and still qualify as a group practice (as defined under the Physician Self-Referral Law) for purposes of compliance with various Physician Self-Referral Law exceptions. Continue Reading CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice Structure