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Nathaniel Arden is a member of Robinson+Cole's Health Law Group. He advises hospitals, physician groups, community providers, and other health care entities on a wide variety of health law and business matters. He regularly assists clients with transactional and regulatory issues, including Medicare and Medicaid fraud and abuse, health information privacy and security, compliance, licensure, clinical trials and health care-related information technology issues. Read his full rc.com bio here.

On May 10, 2021, Connecticut Governor Ned Lamont signed into law “An Act Concerning Telehealth” (the “Act”). The Act extends, until June 30, 2023, many of the COVID-19 related telehealth expansions issued by Governor Lamont through executive orders. A press release from the Governor’s Office expressed the Act’s purpose to extend the duration

The Office of Civil Rights (OCR) issued a notice yesterday stating that it will not impose penalties for HIPAA non-compliance in connection with a covered entity health care provider’s or business associate’s good faith use of online or web-based scheduling applications (WBSAs) for the scheduling of appointments for COVID-19 vaccinations during the public health emergency.  The notice is retroactively effective to December 11, 2020. OCR highlights to covered health care providers and business associates that its temporary lifting of HIPAA penalties applies only to scheduling of COVID-19 vaccinations and to no other activities.
Continue Reading OCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling Apps

Excerpt of a contributed article published in Medical Economics on November 18, 2020.

Past Special Fraud Alerts have portended heightened enforcement activity.

On November 16, 2020, the Office of Inspector General of the Department of Health & Human Services (OIG) issued a Special Fraud Alert (Alert) highlighting the fraud and abuse risks posed by speaker

On June 30, 2020, the Connecticut Office of Health Strategy (OHS) announced in a newsletter that the agency will prepare to resume the Certificate of Need (CON) application review process. This includes transitioning to virtual hearings, as Connecticut’s COVID-19 restrictions still prevent any in-person hearings. While OHS has yet to announce a specific date for resumption of CON hearings, “OHS officials expect the first of these virtual CON public hearings to be held sometime this summer.”
Continue Reading Connecticut Office of Health Strategy Prepares to Resume Certificate of Need Application Review with Virtual Hearings

The Joint Commission (JC) announced yesterday that it will resume its regular surveying and reviews beginning in June. The JC will identify and prioritize low-risk organizations, and organizations due for a survey can expect to be contacted by the JC for an assessment of the impact that COVID-19 has had on the organization. Although surveying will resume, the JC announced there will be changes to the process to maintain social distancing and protect all parties involved. Those changes include:

  • Limited number of individuals in meetings and increased use of audio and/or video conferencing.
  • Use of masks by all surveyors. The JC expects the organization being surveyed to provide appropriate protective equipment for the JC surveyors.
  • Use of technology to avoid extended periods of contact with an organization’s employees or to avoid entering high-risk areas. Examples include using screen-sharing to review electronic medical records and interviewing patients and staff by phone.


Continue Reading Joint Commission to Resume Surveys in June

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 CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

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 CMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical Trial

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: 4/9/20” and “New: 4/10/20” and provide useful insight for billing various types of services, including telehealth, outpatient hospital services, physician services and ACO payment issues. A selection of the FAQs is outlined below; however, these are non-inclusive and providers would be well advised to review the updated CMS FAQ document in full.
Continue Reading CMS Updates and Revises COVID-19 FAQs on Medicare FFS Billing

On April 1, 2020, Connecticut Governor Ned Lamont announced a medical surge plan to address the state’s needs for responding to the COVID-19 public health emergency. The plan, under which the state will collaborate with long-term care facilities, involves the creation of dedicated spaces for COVID-19 positive patients and moving non-infected patients to separate facilities.
Continue Reading Governor Lamont’s Announces COVID-19 Medical Surge Plan that Includes Opening of Vacant Nursing Homes

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 such health care items and services while addressing the COVID-19 crisis. The Blanket Waivers apply to remuneration that is between an entity (as defined under the Stark Law) and (1) a physician, (2) the physician organization in whose shoes the physician stands (under 42 C.F.R. 411.354(c)) or (3) the physician’s immediate family member.
Continue Reading CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts