On April 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued recommendations for Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I. The recommendations apply to areas with a low, or relatively low and stable incidence of COVID-19, in states or regions that have passed Phase I gating criteria that were previously announced by the Administration on April 16, 2020. Initially, the recommendations apply to non-emergent care that is currently on hold, such as chronic disease care, surgery and other procedures, and, eventually, preventive care. CMS is strongly urging maximum use of telehealth.  For healthcare systems and facilities that are considering resuming in-person care, CMS recommends careful planning with state public health authorities. The recommendations also caution that all facilities should continually evaluate whether their area continues to have a low incidence of COVID-19 and be prepared to cease non-essential procedures if there is a surge.
Continue Reading CMS Issues Phase-In Recommendations for Non-COVID Non-Emergent Care

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.
Continue Reading Massachusetts Issues COVID-19 Orders and Guidance 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 issued FAQs for behavioral health providers utilizing telehealth to provide services.
Continue Reading Massachusetts Issues Further COVID-19 Updates for Providers

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 provides a brief overview of some of the major pieces of the CARES Act, and the firm will provide additional updates on key aspects of the Act.
Continue Reading CARES Act Provides Vital Financial Support for Health Care Providers on COVID-19 Front Lines

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 pandemic.  HHS has emphasized, however, that the Notification does not allow the use of public-facing communications products, such as Facebook live or other livestreaming applications.
Continue Reading COVID-19: HHS Issues FAQs on HIPAA and Telehealth to Help Providers Maintain Access to Care During the Pandemic

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 General (OIG) announced it will allow healthcare providers to reduce or waive cost-sharing for telehealth visits.
Continue Reading Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

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

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against an EHR company, and the “unique” deferred prosecution agreement (DPA) imposed by the DOJ against Practice Fusion that seeks “to ensure acceptance of responsibility and transparency as to” underlying conduct may reflect a new approach to settlements with corporate health care defendants.
Continue Reading DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

The U.S. Department of Health and Human Services’s (HHS) Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020.  In the Notice, OCR addressed the recent memorandum Opinion issued in Ciox Health v. Azar, et al, No. 18-cv-00040 (D.D.C. January 23, 2020).

In that case, Ciox Health, LLC, a specialized medical records provider, had challenged certain provisions of the 2013 Omnibus Rule, including provisions pertaining to what can be charged for delivering records containing protected health information (PHI). One cited issue was whether the limitations on fees for these services applied only to requests for PHI that are made by the patient, for use by the patient (the Patient Rate), or whether the limitations also applied to PHI to be delivered to third parties.
Continue Reading OCR Comments on Recent Ciox Case Vacating Certain Omnibus Rule Regulations and Guidance Relating to Fees for Providing Patient Records

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known commonly as the Stark Law (AKS proposed rule available here; PSR proposed rule available here). In an earlier blog post, we described each of the proposed rules. Among the proposed changes are a new safe harbor/exception that would generally permit entities to donate certain cybersecurity technology and related services to physicians, subject to compliance with the conditions described below. In the preamble to each proposed rule, the HHS Office of Inspector General (OIG) (which published the AKS proposed rule) and the Centers for Medicare and Medicaid Services (CMS) (which published the PSR proposed rule) noted that cyber-attacks in the health care industry are on the rise and cybersecurity technology can be cost-prohibitive for some providers. Both OIG and CMS stated their hope that the proposed rules will improve overall cybersecurity in the health care industry and reduce instances of data breaches resulting from cyber-attacks.
Continue Reading HHS Proposes Changes to Permit Donation of Cybersecurity Technology