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On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil…

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation…

The new Acting Director of Public Health in Connecticut, Deidre Gifford, recently rescinded a prior May 6, 2020, Department of Public Health (DPH) order that had eliminated the requirement that a request for collection or analysis of a COVID-19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 We previously wrote about the now rescinded DPH order and its relation to Governor Lamont’s Executive Order 7KK in a post, here. While the DPH order has been rescinded, Executive Order 7KK still remains in effect allowing pharmacists to order COVID-19 tests.
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Continue Reading Connecticut DPH Reinstates Requirement that COVID-19 Tests be Ordered by Physician or Other Authorized Practitioner and that Results be Reported to the Ordering Practitioner

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 Connecticut Governor Lamont Releases Guidance for Dentists Expanding Services Beyond Emergency-Only Care

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare Shared Savings Program regarding financial methodologies, and application and risk assumption deadlines for accountable care organizations, among other changes. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities, available here. Below are highlights from the Interim Rule.  Providers are encouraged to read all applicable sections of the Interim Rule in their entirety here. Comments may be submitted to CMS within 60 days of the date of publication in the Federal Register.…
Continue Reading CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On May 7, 2020 Connecticut Governor Ned Lamont issued Executive Order 7KK allowing pharmacists to order COVID-19 tests.

The order modifies Section 19a-36-D29 of the Regulations of Connecticut State Agencies to permit licensed pharmacists to order COVID-19 diagnostic tests consistent with the Clinical Laboratory Improvement Amendments. The modification also permits pharmacists to order any Food and Drug Administration (FDA) approved COVID-19 serology test that does not require venipuncture. Pharmacists are required to comply with all Department of Health testing reporting requirements. The Executive Order is effective immediately.…
Continue Reading Connecticut Governor Ned Lamont Issues Executive Order Allowing Pharmacists to Order COVID-19 Tests

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period published in the Federal Register on May 8, 2020 (the Interim Rule) which – among other things – makes changes to Medicare requirements for ordering COVID-19 laboratory tests, Medicare reimbursement for specimen collection and Medicaid reimbursement for laboratory services.…
Continue Reading CMS Interim Rule Makes Changes to COVID-19 Laboratory Test Ordering and Payment For Medicare and Medicaid Providers and Beneficiaries

On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that, effective immediately, it is temporarily postponing routine facility inspection and focusing on infection control and situations involving Immediate Jeopardy (where patient safety is placed in imminent danger). CMS is rolling out a new focused survey and inspection process to assess whether facilities are prepared for COVID-19, and has published a fact sheet describing the initiative. This will apply to inspections of all Medicare and Medicaid certified provider and supplier types across the country, such as long term care facilities (nursing homes), hospitals, and CLIA laboratories.…
Continue Reading CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

On March 18, 2020, the Connecticut Department of Public Health (DPH) issued an order requiring laboratories to report negative SARS-CoV-2 test results to DPH using the Electronic Laboratory Reporting System. DPH indicated the immediate reporting of such results is necessary for public health purposes.…
Continue Reading Connecticut DPH Updates List of Reportable Laboratory Findings to Include Negative SARS-CoV-2 Test Results

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic.  This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020.  The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.…
Continue Reading HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency