Academic Medical Centers
Connecticut Governor Signs Bill Requiring Hospitals to Submit Reports on Policy Proposals Related to Emergency Department CrowdingConnecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting AgenciesKey Second Circuit Decision Defines AKS Willfulness Standard
Accountable Care Organizations
HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024Pending Illinois Legislation Could Heighten Merger Requirements for Health Care Facilities
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
COVID-19
DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7VDEA Extends Pandemic Telehealth Prescribing Flexibilities For Up To 18 Months
Department of Justice
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalSouth Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-DisclosureDOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes
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
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalSouth Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-DisclosureDOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
Fraud and Abuse
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalDOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse SchemesDOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
Government Enforcement
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalSouth Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-DisclosureDOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes
Health Plans
Two Pathways for Medicaid Self-Disclosures Announced by OMIGNew COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesDepartments of Labor, Health and Human Services, and the Treasury Issue FAQ guidance on the FFCRA, the CARES Act, and other health coverage issues related to COVID-19
Home Health Agencies
Connecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting AgenciesConnecticut Supreme Court Addresses Contested Case Issue in Ruling on Certificate of Need AppealsEighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information
Hospice
Connecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting AgenciesKey Second Circuit Decision Defines AKS Willfulness StandardEighteen States’ Attorneys General Send Letter to CMS in Support of Proposed Rule Requiring Disclosure of Certain Nursing Home and SNF Ownership Information
Hospitals and Health Systems
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalCalifornia Governor Vetoes Bill Imposing New Requirements for Private Equity in Healthcare TransactionsSouth Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-Disclosure
Laboratories
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalDOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse SchemesDOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
Long Term Care and Nursing Homes
Connecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting AgenciesDOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care FacilitiesNew York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process
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
Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeCOVID-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 Case
Physicians and Allied Health Professionals
South Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-DisclosureDOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical PracticesConnecticut Governor Signs Bill Requiring Hospitals to Submit Reports on Policy Proposals Related to Emergency Department Crowding
Stark Law
South Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-DisclosureOIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net ProfitsStark Settlement Targeting Hospital and Physicians a Reminder for Health Care Organizations