CMS Releases Additional Blanket Waivers in Response to COVID-19 Pandemic

On May 11, 2020 the Centers for Medicare and Medicaid Services (CMS) announced additional blanket waivers for hospitals and other facilities in response to the COVID-19 pandemic. According to CMS, the new waivers “provide the flexibilities needed to take care of patients during the COVID-19 public health emergency.” The blanket waivers have a retroactive effective date of March 1, 2020 and do not require a waiver request or notice to CMS to apply. Continue Reading

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 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

Connecticut Governor Ned Lamont Issues Executive Order Allowing Pharmacists to Order COVID-19 Tests

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

OCR Issues Guidance About Media Access to Health Care Facilities

These days, news stations are frequently running stories concerning people being treated for COVID-19, the providers working tirelessly to care for them, and politicians visiting health care facilities for a first-hand look at the crisis. In response to the media interest, the Office for Civil Rights (OCR) issued guidance on May 5, 2020 to healthcare providers answering the question “Does the COVID-19 Public Health Emergency alter the HIPAA Privacy Rule’s restrictions on disclosures of protected health information to the media?” The guidance reminds them “that the HIPAA Privacy Rule does not permit them to give media and film crews access to facilities” in which patient health information may be accessible without the patients’ authorization. This includes any areas of the facility where patients’ protected health information (PHI) may be accessible in any form (e.g., written, electronic, oral, or other visual or audio form). Continue Reading

CMS Interim Rule Makes Changes to COVID-19 Laboratory Test Ordering and Payment For Medicare and Medicaid Providers and Beneficiaries

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 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 increases reimbursement for some of these services. Highlights of these changes and pertinent background are provided below. Continue Reading

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. Continue Reading

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 level, the changes encompass 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, and changes to the Medicare Shared Savings Program regarding financial methodologies and application and risk assumption deadlines for accountable care organizations. While we are still reviewing the Rule in its entirety and its implications, those who are interested should read the Rule in its full form linked above. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities which are available here. Individuals wishing to submit comments to CMS may do so by email or mail for 60 days following the date of publication in the Federal Register, which has not yet occurred as of today.

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.  A summary of particularly significant changes contained in those Orders follows. Continue Reading

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 data to Medicare. A clinician’s Medicare reimbursement may be reduced if the clinician does not meet certain quality and performance measures. Continue Reading

LexBlog