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
HHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination InformationIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting
Commercial Health Insurance
Connecticut Extends Expansion of Access to Telehealth ServicesConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicConnecticut Governor Expands Health Care Workforce, Access to Telehealth Services and Issues Other Important Health Care Updates in New Executive Orders
COVID-19
U.S. Supreme Court Upholds Health Care Worker Vaccine MandateNew COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
Department of Justice
DOJ 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 PaymentsOIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law
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
False Claims Act
DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations AboundHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsMassachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case
FDA
HHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination InformationIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting
Government Enforcement
U.S. Supreme Court Upholds Health Care Worker Vaccine MandateNew COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place
Healthcare Technology
Connecticut Extends Expansion of Access to Telehealth ServicesIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules
HIPAA
No Private Right of Action under HIPAA, but State Law Claims May Still be AssertedConnecticut Enacts Legislation to Incentivize Adoption of Cybersecurity Safeguards and Expand Breach Reporting ObligationsDiabetes, Endocrinology & Lipidology Center Becomes 19th Settlement with OCR for HIPAA Right-of-Access Violation
Legislation
New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesBiden COVID-19 Action Plan Expands Vaccine Mandates, Testing, and Treatment to Combat Spread of VirusNew Legislation Updates Laws Related to Hospital Admission and Discharge Practices
Managed Care
Massachusetts 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 InsurersPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules
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
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
Pharmacy Law
New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination InformationIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting
Physicians and Allied Health Professionals
CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in PlaceMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider WorkforceCMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
Private Equity
DOJ 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 DoctrinePrivate Equity Firm Named as Defendant in False Claims Act Case Targeting A Portfolio Company
Reimbursement
New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in PlaceConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information
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