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 …
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Subscribe to Academic Medical Centers RSS FeedCMS 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 …
Massachusetts Issues COVID-19 Orders and Guidance for Providers
Massachusetts continues to issue directives and guidance for health care providers in response to COVID-19. In this post we highlight Orders and Guidance issued by Massachusetts Governor Baker and the Massachusetts Department of Public Health (DPH). The guidance addresses topics including collection of COVID-19 demographic information, use of alternative space for provision of health care treatment, health professional licensing, EMS transport of patients, hospital policies for returning exposed health care personnel to work, use of PPE and equipment, and updates for pharmacies.…
HHS Waives HIPAA Penalties for Operation of a Community-Based COVID-19 Testing Site
On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection with good faith participation in the operation of COVID-19 testing sites during the COVID-19 emergency.…
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).…
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.…
OCR Issues Additional Guidance on HIPAA for Providers and First Responders on COVID-19 Front Lines
On March 24, 2020, the U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued new HIPAA guidance to help providers and first responders in efforts to combat the COVID-19 pandemic. …
DOJ and FTC Issue Joint Statement on Antitrust Enforcement and the COVID-19 Pandemic
On March 24, 2020, the Department of Justice (DOJ) and Federal Trade Commission (FTC) issued a joint statement on COVID-19-related antitrust enforcement highlighting ways “firms, including competitors, can engage in procompetitive collaboration that does not violate the antitrust laws” to protect public health and safety. The DOJ and FTC emphasized their commitment to facilitating antitrust compliance for businesses that are responding to the national emergency. In furtherance of this position, the agencies gave examples of collaborative activities designed to improve health and safety during the COVID-19 pandemic that are unlikely …
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 …
COVID-19: HHS Issues FAQs on HIPAA and Telehealth to Help Providers Maintain Access to Care During the Pandemic
On March 20, the U.S. Department of Health and Human Services (HHS) issued additional guidance in the form of Frequently Asked Questions (FAQs) on HIPAA and telehealth services to help providers furnish care during the COVID-19 pandemic.
The FAQs follow and provide further information on the Notification of Enforcement Discretion issued by HHS on March 17 (Notification), in which HHS indicated that it would not penalize providers for using popular video chat applications, such as FaceTime and Skype, in good faith to provide telehealth services amid the COVID-19 …
Massachusetts Issues New COVID-19 Guidance and Updates
Massachusetts government agencies have issued recent guidance and updates concerning the COVID-19 emergency. A summary is provided below.
Allowing Health Care Personnel with Potential Exposure to COVID-19 to Continue to Work
On March 19, the Massachusetts Department of Public Health issued the following Guidance for Health Care Personnel with Potential Exposure to Patients with COVID-19.
Healthcare facilities must take the following procedures in order that health care personnel (HCP) who have had exposure to COVID-19, but are asymptomatic, may continue to work. Under the guidance, exposed HCP may continue …
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. …
COVID-19: Connecticut Issues Expedited CON Review Guidelines and Provider Guidance to Help Response Efforts
On March 16, Connecticut agencies released two important guidance documents for state health care providers and organizations confronting the COVID-19 pandemic:
- The Connecticut Office of Health Strategy (OHS) – the entity responsible for overseeing Certificate of Need reviews and approvals – issued new CON Guidance that allows OHS to temporarily waive CON review requirements of transactions intended to promote the State’s response and management of COVID-19. The Guidance also mandates that all public hearings related to pending CON projects will be conducted remotely until further notice, with further guidance to
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 …
CMS Issues Final Regulations for Hospital Price Transparency
On November 15, 2019, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) announced final regulations implementing greater price transparency requirements for hospitals. Issued on the heels of a Trump Administration Executive Order directing HHS to propose regulations on increased price transparency, the new regulations modify and finalize CMS’ earlier guidance implementing section 2718(e) of the Public Health Service Act, to further expand price transparency requirements for hospitals. (See our previous analysis of the Executive Order here.) Effective January 1, 2021, the …
Massachusetts Board of Registration in Medicine Adds New Physician Credentials Verification Requirement for First Time Licensure
On October 11, 2019, the Massachusetts Board of Registration in Medicine (BORIM) announced a new requirement for initial physician licensure in the state. Effective January 1, 2020, all first-time applicants in Massachusetts will be required to also complete an application through the Federation Credentials Verification Service (FCVS). FRVS’s website indicates it is “a Lifetime Repository of Verified Core Credentials … that can be used for multiple state medical boards.” The new BORIM requirement will require first-time applicants to apply for a verified profile with FCVS that designates BORIM as …
Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …
CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers
The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce burdensome regulations in order to improve the patient and provider experience, and the health care system as a whole. On September 26, 2019, CMS passed the Omnibus Burden Reduction (Conditions of Participation) Final Rule (Final Rule), with the goal of removing CMS regulations that have become extraneous or burdensome on health care providers, allowing providers to increase and …
