On June 30, 2020 the Connecticut Office of Health Strategy (OHS) announced in a newsletter that the agency will prepare to resume the Certificate of Need (CON) application review process. This includes transitioning to virtual hearings, as Connecticut’s COVID-19 restrictions still prevent any in-person hearings. While OHS has yet to announce a specific date for resumption of CON hearings, “OHS officials expect the first of these virtual CON public hearings to be held sometime this summer.” Continue Reading
On June 24, 2020 the New York State Department of Health (DOH) published formal notice of its June 5th emergency rule “necessary to clarify and strengthen the Department’s authority and that of the local health departments to take specific actions to control the spread of disease, including actions related to investigation and response to a disease outbreak, as well as the issuance of isolation and quarantine orders.” Though the emergency regulations are issued in the midst of the COVID-19 pandemic, DOH indicates it intends to adopt the emergency rule as a permanent rule and will publish a notice of proposed rulemaking in the State Register at some future date.
The emergency rule amends Title 10 of the New York Codes, Rules and Regulations in parts 2, 58, and 405. The emergency changes are effective as of June 5th until September 2nd. Below are some highlights of the changes made by the emergency rule.
Amendments to 10 NYCRR part 2 include:
- Amending existing definitions and adding new defined terms such as “quarantine,” “contact,” and “isolation.”
- Clarifying local health department authority to investigate a case, suspect case, outbreak, or unusual disease, and requires individuals and entities subject to a public health investigation to cooperate with the DOH and local health department.
- Adding new language to make clear that the DOH has the authority to issue isolation and quarantine orders, as do local departments of health, and the process for such orders and penalties for any violation.
- Relocating and updating existing regulations that require the attending physician to report cases and suspected cases to the local health authority, and require physicians to provide instructions concerning how to protect others.
Amendments to 10 NYCRR 58 include:
- Requiring DOH to designate communicable diseases that require prompt action, and to make available a list of such diseases on the DOH website.
- Requiring clinical laboratories to immediately report positive test results for communicable diseases identified as requiring prompt attention.
- Requiring clinical laboratories to report all test results, including negative and indeterminate results, for communicable diseases identified as requiring prompt attention.
Amendments to 10 NYCRR 405 include:
- Mandating hospitals to report syndromic surveillance data during an outbreak of a highly contagious communicable disease.
- Permitting DOH to direct hospitals to take patients during an outbreak of a highly contagious communicable disease.
This post was co-authored by Michael Lisitano, legal intern at Robinson+Cole. Michael is not yet admitted to practice law.
On June 12, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued timely HIPAA guidance (Guidance) regarding solicitations of blood and plasma donations from recovered COVID-19 patients.
In the Guidance, OCR affirms that health care providers can use patient information to identify patients that have recovered from COVID-19 to provide information about how they may donate plasma or blood with COVID-19 antibodies to support treatment of other patients with COVID-19. OCR explains that this use of protected health information would be permissible as part of a provider’s health care operations to enable case management of COVID-19 patient populations. OCR also reminds providers that because the activity is a health care operation and not for treatment purposes, HIPAA’s minimum necessary standard applies to any use or disclosure of protected health information in connection with the solicitation of blood or plasma donations. Continue Reading
On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced that it would distribute up to $25 billion of CARES Act Provider Relief Funds to safety net hospitals and state Medicaid and Children’s Health Insurance Program (CHIP) providers. Continue Reading
On June 9, 2020 the Health and Human Services Office for Civil Rights (OCR) announced it had reached an Early Case Resolution (ECR) with the State of Connecticut and a separate ECR with Hartford Hospital. Both ECRs involve the rights of patients with disabilities to have reasonable access to support persons in hospital settings during COVID-19. OCR had received complaints that the COVID-19 hospital visitor policies of the State and the hospital violated the Americans with Disabilities Act (ADA) by failing to make exceptions for patients needing support persons for their care. Continue Reading
The Joint Commission (JC) announced yesterday that it will resume its regular surveying and reviews beginning in June. The JC will identify and prioritize low-risk organizations, and organizations due for a survey can expect to be contacted by the JC for an assessment of the impact that COVID-19 has had on the organization. Although surveying will resume, the JC announced there will be changes to the process to maintain social distancing and protect all parties involved. Those changes include:
- Limited number of individuals in meetings and increased use of audio and/or video conferencing.
- Use of masks by all surveyors. The JC expects the organization being surveyed to provide appropriate protective equipment for the JC surveyors.
- Use of technology to avoid extended periods of contact with an organization’s employees or to avoid entering high-risk areas. Examples include using screen-sharing to review electronic medical records and interviewing patients and staff by phone.
On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions attached to such payments. Providers now have up to 90 days from the date a payment is received to accept the Terms and Conditions or return the funds to HHS. In its announcement, HHS reiterated its prior position that “Providers that do not accept the Terms and Conditions after 90 days of receipt will be deemed to have accepted the Terms and Conditions.” Continue Reading
The new Acting Director of Public Health in Connecticut, Deidre Gifford, recently rescinded a prior May 6, 2020, Department of Public Health (DPH) order that had eliminated the requirement that a request for collection or analysis of a COVID-19 specimen be made by a licensed physician or other licensed person authorized by law to make diagnoses, and eliminated the obligation to report the COVID-19 results to the licensed provider who ordered the testing. We previously wrote about the now rescinded DPH order and its relation to Governor Lamont’s Executive Order 7KK in a post, here. While the DPH order has been rescinded, Executive Order 7KK still remains in effect allowing pharmacists to order COVID-19 tests.
On May 17, 2020 Connecticut Governor Ned Lamont – in conjunction with the Department of Public Health (DPH) – released a guidance document for resuming non-emergency dental procedures (the “Guidance”). The Guidance notes that while dental practices were never subject to an executive order to close, the governor’s office and DPH had both strongly encouraged the suspension of all elective procedures and routine non-emergency care. Accordingly, as certain businesses in the state begin to reopen starting on May 20th, the Guidance is designed to inform dental practitioners on preparation and policies for expanding services beyond emergency-only care to include elective procedures and routine hygiene and health exams. The document details policies for expanding offered procedures and notes that dental practices that cannot meet the guidelines “are strongly advised to delay expansion of their operations beyond urgent care until they are able to meet these guidelines.” Continue Reading
On May 11, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for FY 2021 (the “Rule”). IPPS and LTCH PPS proposed rules are released on a fiscal year cycle to define payment and policies for inpatient hospitals, long-term care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, skilled nursing facilities, and hospices. CMS also released a fact sheet highlighting certain major provisions in the Rule. Continue Reading