Nathaniel Arden

Nathaniel Arden

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.

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Connecticut Office of Health Strategy Prepares to Resume Certificate of Need Application Review with Virtual Hearings

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.”…

Joint Commission to Resume Surveys in June

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

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 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: …

Governor Lamont’s Announces COVID-19 Medical Surge Plan that Includes Opening of Vacant Nursing Homes

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. …

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 …

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

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 Issues Order Temporarily Recognizing Reciprocal Health Care Practitioner Licenses

In alignment with both New York and Massachusetts, earlier today Connecticut’s Commissioner of the Department of Public Health issued an order (Order) permitting physicians, nurses, respiratory care practitioners, emergency medical services personnel and other health care practitioners who are licensed in another state to provide temporary assistance in Connecticut for a period of 60 days. The Order is subject to the following conditions:

  • No practitioner may provide services beyond the scope of practice permitted under Connecticut law relating to the applicable profession;
  • Each practitioner must maintain malpractice and other insurance

DEA Allows Providers to Prescribe Controlled Substances Without an In-Person Medical Examination During COVID-19 Public Health Emergency

The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public health emergency. …

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 …

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.…

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.…

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

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 …

HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil monetary penalties law because no claims for reimbursement from federal programs would be sought by …

HHS Issues Favorable Advisory Opinion for Online Health Care Directory Charging Per-Click Fees

On September 5, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion 19-04 (Advisory Opinion). The Requestor asked OIG if providing an online health care provider directory (Directory) to federal health care program beneficiaries (beneficiaries) would violate the Anti-Kickback Statute (AKS) or constitute a prohibited Beneficiary Inducement. The online directory would allow beneficiaries to search and book medical appointments, and the Requestor would charge health care professionals a per-click or per-booking fee to be listed in the directory. The directory …

White House Issues Executive Order to Increase Transparency in American Healthcare

On June 24, 2019, President Donald Trump issued an “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First” (the Order). The Order requires multiple federal agencies to issue regulations and take other actions as part of an ongoing focus of the Trump Administration to “enhance the ability of patients to choose the healthcare that is best for them” through transparency and competition. The Order addresses the following five initiatives.…

CMS Announces New Direct Contracting Care Models

On April 22, 2019, the Centers for Medicare and Medicaid Services (CMS) announced two new voluntary risk-sharing payment models—Professional Population-Based Payment (PBP) and Global PBP. Under the Professional PBP model, CMS will pay participating organizations (referred to as Direct Contracting Entities or DCEs) a monthly, risk-adjusted primary care capitation payment, as well as 50 percent of shared savings/losses for enhanced primary care services. The Global PBP model, which is aimed at larger organizations, offers a higher level of risk and reward. DCEs participating in the Global PBP will receive/be responsible …

Connecticut Superior Court Ruling Addresses 2016 Physician Non-Compete Law

Connecticut’s Superior Court Stamford recently ruled to modify four physician non-compete agreements into compliance with Connecticut’s physician non-compete statute (Conn. Gen. Stat. § 20-14p), which limits certain covenants not to complete involving physicians to one year after employment and in a 15-mile geographic radius from the physician’s primary practice site, among other restrictions. Importantly, the Connecticut non-compete statute applies to non-competes that are “entered into, amended, extended or renewed on or after July 1, 2016.”…

OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion

On November 16, 2018, the Office of the Inspector General of the Department of Health and Human Services (OIG) posted an unfavorable Advisory Opinion No. 18-14 regarding an arrangement where a vendor (Requestor) of a commonly used drug would supply free doses of the drug to hospitals for treatment of inpatients with a rare and serious form of epilepsy (Proposed Arrangement). The drug is not separately reimbursable in the inpatient setting. As a result, and according to the Requestor, many hospitals do not stock sufficient quantities of the drug and …

2019 Physician Fee Schedule Rule Review: Use of Telehealth Expanded

Telehealth for Treatment of Substance Use Disorders

As part of the CY 2019 Medicare Physician Fee Schedule (PFS), the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period to expand the use of telehealth for the treatment of substance use disorders and co-occurring mental health disorders. Existing law provides for reimbursement of telehealth services only if the originating site is located in a rural health professional shortage area, is not in a metropolitan statistical area or is an entity that participates in a federal …

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