Accreditation
Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records ArrangementsRecent Joint Commission Guidance Recommends Steps for Health Care Organizations to Reduce Workplace ViolenceProviding Patient Written Plan of Care Eliminated from The Joint Commission’s Standards for Deemed Home Health Agencies
Advisory Opinions
OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to Receive Data from a Digestible Medication SensorOIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory OpinionOIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities
Americans With Disabilities
CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility WorkersOCR Reaches Early Case Resolutions with the State of Connecticut and a Private Hospital Regarding Rights of Persons with Disabilities to Have Reasonable Access to Support Persons in Hospital Settings During COVID-19Connecticut Legislature Permits Facilities to Administer Emergency Medication to Defendants Without Consent in Limited Circumstances
Clinical Research
Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical TrialHHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information
Department of Justice
Suspect Characteristics Identified under a Telehealth Special Fraud AlertDOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations AboundHHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments
Employment Law
New Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesConnecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency ContractsNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities
EMTALA
Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicHHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) EmergencyNew Connecticut Legislation Updates Laws Concerning Urgent Care Centers, Hospital-Based Facility Fees and Freestanding Hospital Emergency Departments
Hospitals and Health Systems
Second Circuit Affirms HHS Rejection of Direct Copayment Assistance under Anti-kickback StatuteAdvisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning ProgramOIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic
Long Term Care and Nursing Homes
New Jersey Governor Signs Act Concerning Changes in Control of Health Care EntitiesNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
Managed Care
FTC Takes Action to Block Hospital Transactions in Utah and New JerseyMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider WorkforceConnecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers
Medical Devices
NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvaMed Updates its Code of EthicsAdvisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial
Medical Staff and Peer Review
COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActMassachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower CaseConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic
Medicare and Medicaid
Advisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning ProgramOIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the PandemicNew Final Rule Under the No Surprises Act Released
Office of Inspector General
A COVID-19 Laboratory Testing Conviction under EKRAAdvisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning ProgramOIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic
Pharmacies
Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy ProfessionalsConnecticut Enacts Law to Increase Access to Epinephrine Auto InjectorsCBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components
Physicians and Allied Health Professionals
Advisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning ProgramOIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the PandemicREMINDER: October 6 Deadline for Information Blocking Rules Approaches
Private Equity
New York State Legislature Passes Act Enacting Moratorium on For-Profit HospicesDOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve FCA AllegationsNew York Court of Appeals Holds that PCs that Cede Excessive Control to MSOs Violate the Corporate Practice of Medicine Doctrine
Stark Law
CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice StructureCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law RegulationsPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules
Telehealth
Suspect Characteristics Identified under a Telehealth Special Fraud AlertNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services
Telemedicine
OIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the PandemicSuspect Characteristics Identified under a Telehealth Special Fraud AlertNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities