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In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:…

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

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 Monetary Penalty (CMP) Rules related to beneficiary inducements. Most of the changes are effective January 19, 2021.

Together with the new physician self-referral law (also known as Stark) regulations published by the Centers for Medicare …

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

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 of cybersecurity technology and services and limited remuneration to physicians; introduced new definitions and updated key terms, including “commercial reasonableness,” the “volume and value” standard and “fair market value”; and updated several existing exceptions, including …

Massachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to documents requested in discovery as part of a qui tam False Claims Act (FCA) case. In United States ex rel. Wollman v. Massachusetts General Hospital, Inc. et al., Case Number 1:15-cv-11890-ADB, the court reviewed the purpose of the peer review privilege and precedent addressing the applicability of state privileges under the Federal Rules of …

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving …

REMINDER: November 6 Deadline for New CARES Act Funding Approaches

Health care providers interested in applying for additional CARES Act Provider Relief funding from the Phase 3 General Distribution have until November 6, 2020 to submit an application to the Department of Health & Human Services (HHS).…

CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here.…

CMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance

On October 14, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded the list of telehealth services covered by Medicare during the COVID-19 Public Health Emergency. CMS also announced it would be providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in delivering telehealth services. CMS added the telehealth services using, for the first time, an expedited process that does not involve rulemaking which had been established by CMS in May 2020.…

CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.…

Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic

On July 14, 2020 Connecticut Governor Lamont issued Executive Order No. 7HHH, in which the Governor modified state law to enable the Commissioner of the Department of Public Health (DPH) to temporarily suspend licensure, registration and certification requirements for certain DPH-regulated practitioners for the duration of the state public health and civil preparedness emergency.  Notably, in that Executive Order, the Governor stated that “healthcare providers from outside Connecticut have greatly enhanced the provision of healthcare services in Connecticut during the COVID-19 pandemic and thereby fundamentally improved the state’s ability …

CMS Releases Guidance on the Allowance of Telehealth Encounters in eCQMs

On July 2, 2020, the Centers for Medicare and Medicaid Services (CMS) released guidance documents on the allowance of telehealth encounters for the Eligible Professional and Eligible Clinician electronic clinical quality measures (eCQMs) used in CMS quality reporting programs for the 2020 and 2021 performance periods. The guidance applies to eCQMs used in the:

  • Quality Payment Program: The Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (Advanced APMs)
  • APM: Comprehensive Primary Care Plus (CPC+)
  • APM: Primary Care First (PCF)
  • Medicaid Promoting Interoperability Program for Eligible Professionals

CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

On July 6, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) rule. ESRD PPS rules are promulgated on an annual basis, providing updates to payment policies and rates for renal dialysis services furnished to beneficiaries. The 2021 proposed rule also proposes to update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI, and proposes changes to the ESRD Quality Incentive Program. In addition to the …

HHS Issues Guidance for Providers on Soliciting COVID-19 Blood and Plasma Donations

On June 12, 2020, 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 …

HHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General Distribution

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. …

OCR Reaches Early Case Resolutions with the State of Connecticut and a Private Hospital Regarding Rights of Persons with Disabilities to Have Reasonable Access to Support Persons in Hospital Settings During COVID-19

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 …

HHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

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 …

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

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 …

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

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 …

CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

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 …

CMS Broadens Telehealth Access Across the Board, Including Audio-Only Telephone Services

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 April 30 Interim Rule) building on previous regulatory waivers and other revisions to regulations issued March 31, 2020 in an interim final rule (March 31 Interim Rule) in response to the COVID-19 public health emergency (PHE). Among other changes, the April 30 Interim Rule further broadens access to patient care provided via telehealth and other communication technology-based services and …

CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback

Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.…

CMS Issues New Interim Final Rule With Sweeping Regulatory Changes in Response to the COVID-19 Pandemic

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (the “Rule”) which sets forth additional regulatory waivers and other changes to healthcare regulations in response to the COVID-19 pandemic. “Today’s actions are informed by requests from healthcare providers as well as by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act” states CMS in its press release. Spanning 279 pages, the Rule makes sweeping changes for the full spectrum of health care providers. On a high …

Connecticut Governor Expands Health Care Workforce, Access to Telehealth Services and Issues Other Important Health Care Updates in New Executive Orders

Connecticut Governor Ned Lamont recently issued four new executive orders to address the COVID-19 state of emergency (Executive Orders 7CC – 7FF) that contain provisions relevant to health care providers and facilities in the state.  Among other things, the Executive Orders (i) expand access to telehealth services, (ii) expand the available health care workforce, (iii) increase current reporting requirements for long-term care facilities, (iv) allow the Commissioner of the Department of Social Services (DSS) to scale back certain Medicaid program requirements, and (v) update requirements related to out-of-network emergency billing.  …

CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by attesting to a new COVID-19 Clinical Trials improvement activity based on participation in a clinical trial and reporting information. Clinicians who may earn this MIPS credit include physicians, physician assistants, nurse practitioners and others. MIPS is one of two options for clinicians to participate in Medicare’s QPP, and requires clinicians to report certain quality, cost and other …

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