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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. …

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 …

CMS Proposes IPPS and LTCH PPS Payment and Policy Changes for FY 2021

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 …

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.…

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 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.…

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 …

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 …

CMS Updates and Revises COVID-19 FAQs on Medicare FFS Billing

On April 9 and 10, 2020, the Centers for Medicare and Medicaid Services (CMS) updated and revised their COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing. The updates were intended to bring the FAQs up to date in light of new section 1135 waivers, provisions from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the interim final rule for Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. The extensive new FAQs are marked in the document as “New: …

OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law

On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).…

CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts

On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to health care providers’ response to the COVID-19 pandemic. The Blanket Waivers were issued under the Department of Health and Human Services Secretary’s authority in Section 1135 of the Social Security Act to ensure that (i) sufficient health care items and services are available to federal health care program beneficiaries, and (ii)  health care providers are reimbursed for providing …

Massachusetts Issues Further COVID-19 Updates for Providers

Massachusetts continues to issue additional directives and guidance for the health care provider community in response to COVID-19. In this post we highlight new orders by Massachusetts Governor Baker, the Massachusetts Department of Public Health (DPH), and MassHealth. Updates include expanded license reciprocity for non-physicians, independent practice of certain Advanced Practice Registered Nurses (APRNs), waiver of certain MassHealth requirements in the discharge and transfer of long-term care patients, and authorization for EOHHS to establish temporary rates, supplemental payments, or alternative rates and payment methodologies for certain providers. MassHealth has also …

CARES Act Provides Vital Financial Support for Health Care Providers on COVID-19 Front Lines

On March 27, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, or the Act), Public Law 116-136, a trillion-dollar stimulus bill intended to provide financial assistance to individuals and business affected by the COVID-19 pandemic.  The Act contains a broad range of measures intended to bolster the economy in the midst of the COVID-19 pandemic.  Unsurprisingly, a central focus of the Act is the provision of relief and support for hospitals and health care providers on the front lines of the COVID-19 pandemic.  This article …

CMS grants Massachusetts Section 1135 Waiver, DPH issues Guidance regarding Determination of Need and Nurse Staffing Requirements, and MassHealth Issues Provider and Pharmacy Guidance

In this article, we highlight additional updates issued by state and federal government authorities for the health care community in Massachusetts related to COVID-19. This post addresses the Section 1135 waivers granted by the Centers for Medicare and Medicaid Services (CMS) related to MassHealth and CHIP, Massachusetts Department of Public Health (DPH) orders and guidance regarding Determination of Need and nurse staffing ratios, and MassHealth guidance for providers and pharmacies.…

CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

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 …

Rhode Island Issues Emergency Regulations on Off-Label Prescribing for COVID-19, and Guidance on Telehealth and Reciprocal Licensure

Rhode Island has issued important updates for health care providers related to COVID-19, available at https://health.ri.gov/diseases/ncov2019/for/providers/.  Providers should be aware of these updates including, among others, the following described below.…

OIG Warns of COVID-19 Fraud Schemes

The US Department of Health and Human Services Office of Inspector General (OIG) released a fraud alert warning Medicare beneficiaries of potentially fraudulent schemes that take advantage of the fears surrounding the COVID-19 public health emergency. The OIG warns that fraudsters are targeting Medicare beneficiaries through telemarketing, social media and even in-person, door-to-door contact. According to the OIG, the fraudulent schemes often involve an offer of a COVID-19 test in exchange for an individual providing personal information.…

Connecticut Governor Lamont Expands Access to Telehealth Services In Response to COVID-19 Pandemic

On March 19, Connecticut Governor Ned Lamont issued Executive Order No. 7G, which is intended to expand access to telehealth services for Connecticut residents amidst the COVID-19 pandemic.  Notably for health care providers, the Order waives or modifies provisions of Conn. Gen. Stat. § 19a-906 and any associated regulations, rules and policies regarding the delivery of telehealth services as follows:

  • Allows telehealth providers enrolled in Medicaid or in-network in fully-insured commercial plans to provide covered telehealth services via audio-only telephone to established patients (i.e., those with an existing provider-patient

COVID-19: Lamont Authorizes DSS to Expand Access to Telehealth Services for Medicaid Beneficiaries in Response to Coronavirus Pandemic

As part of Executive Order No. 7F issued on March 18, Connecticut Governor Ned Lamont authorized the Commissioner of the Department Social Services (DSS) to “temporarily waive any requirements” set forth in state law, regulations, rules, policies or other directives concerning telehealth as is necessary to enable the Medicaid program “to cover applicable services provided through audio-only telehealth services.”  As a result, DSS will be able to expand Medicaid coverage for telehealth services that are provided by phone, and not just audio-video technology.…

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector …

Massachusetts COVID-19 Guidance for Health Care Providers, Payors and Laboratories on Issues Including Telehealth, Elective Procedures, COVID-19 Testing, and Provider Licensure

Massachusetts executive agencies have been issuing an array of further guidance to the healthcare provider community regarding COVID-19.  All orders and guidance are available at https://www.mass.gov/2019coronavirus. Review of this website and CDC websites for periodic updates is strongly encouraged, as the situation is fluid and continually evolving. …

HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency

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 …

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