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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.…

Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy Professionals

On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies. The Order as well as supplemental guidance issued by the Board of Registration in Pharmacy (Board) is effective as of March 24. …

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 …

OIG Issues FAQs on its Policy for Waiver of Patient Cost Sharing Obligations for Telehealth During COVID-19 Public Health Emergency

On March 25, 2020, the Office of Inspector General, Health and Human Services (OIG) issued two frequently asked questions (FAQs), clarifying its March 17th Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak (Policy Statement).…

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 …

OHS Streamlines Application Process for CON Waivers to Respond to COVID-19

On March 20, the Connecticut Office of Health Strategy (OHS) issued new guidance (Guidance) on the process for requesting a certificate of need (CON) waiver for projects related to the COVID-19 response. See our analysis of the initial OHS guidance on CON waivers here.…

New York Further Expands Facility Capacity and Practitioner Capacity in New Executive Order

On March 23, 2020, New York Governor Andrew Cuomo issued an executive order (Executive Order) related to the COVID-19 public health emergency to ease regulatory requirements and expand the resources available to address the emergency.

Significant provisions of the Executive Order are as follows:

Provisions to Expand Facility Capacity

  • Orders the Commissioner of Health to direct all general hospitals, ambulatory surgery centers, office-based surgery practices and diagnostic and treatment centers to increase the number of beds available to patients, including by canceling all elective surgeries and procedures, as determined by

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 …

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.…

Connecticut DPH Updates List of Reportable Laboratory Findings to Include Negative SARS-CoV-2 Test Results

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.…

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:

  1. 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 …

HHS Finalizes Joint Rules on Electronic Health Record Interoperability and Access

On March 9, 2020, the Department of Health and Human Services (HHS) announced final rules seeking to give patients more access to, and control of, their health data. The final rules were issued by the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare and Medicaid Services (CMS). The ONC rule is available here and the CMS rule here. Both rules implement interoperability and patient access provisions from the 21st Century Cures Act and the Trump administration’s MyHealthEData initiative.…

FTC and Commonwealth of Pennsylvania Challenge Proposed Hospital Merger

On February 27, 2020, the Federal Trade Commission (FTC) announced an action to block a proposed transaction between Thomas Jefferson University d/b/a Jefferson Health (Jefferson) and Albert Einstein Healthcare Network (Einstein). Jefferson and Einstein entered into a “System Integration Agreement” in late 2018 under which Jefferson would become the sole member (i.e., owner) of Einstein and oversee a 14-hospital system (11 of which would be located in Pennsylvania). According to the FTC, Jefferson and Einstein are leading providers of inpatient general acute care (GAC) hospital services and inpatient acute rehabilitation …

DOJ and FTC Announce Draft Vertical Merger Guidelines

On January 10, 2020, The Department of Justice (DOJ) and Federal Trade Commission (FTC) announced new draft vertical merger guidelines for public comment. Once finalized, the draft guidelines will replace the DOJ’s 1984 Non-Horizontal Merger Guidelines and describe how the FTC and the DOJ will analyze and enforce vertical mergers for compliance with the antitrust laws. Vertical mergers combine two or more companies operating at different levels of the same supply chain, e.g., a combination between a hospital and independent physician group, or a health system and a skilled nursing …

Connecticut Governor Lamont Issues Executive Orders Aiming to Contain Health Care Cost Growth and Improve Transparency

On January 22, 2020, Connecticut Governor Ned Lamont issued two health care-related executive orders, Executive Order No. 5 and Executive Order No. 6, (the Executive Orders) to address the increasing cost of health care in Connecticut. The Executive Orders build upon the state’s Office of Health Strategy’s (OHS) obligation to create a health care cost-containment strategy for Connecticut.…

CMS to Repay Hospitals Millions After Court Finds Reduction in Rates Improper

On December 12, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will automatically reprocess claims which had been reimbursed at a reduced rate in 2019 under the site-neutral payment policy and pay hospitals monies that were withheld due to the policy.

In November 2018, CMS promulgated a Final Outpatient Prospective Payment System (OPPS) Rule and implemented its site-neutral payment policy, which cut Medicare reimbursement rates for outpatient hospital services provided at certain off-campus, provider-based departments (PBDs) to the lower Physician Fee Schedule (PFS) rate for the …

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.…

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