340B Drug Pricing Program
340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court WinSupreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement MethodologyDelaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA
Accreditation
California Governor Signs Bill Further Increasing Oversight of Hospice AgenciesDepartment 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 Violence
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
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
Fraud and Abuse
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActOIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsDOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests
Government Enforcement
California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideCalifornia Governor Signs Bill Further Increasing Oversight of Hospice AgenciesNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act
Hospice
New York Governor Vetoes Act Prohibiting Establishment and Expansion of For-Profit HospicesNo More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActNew York State Legislature Passes Act Enacting Moratorium on For-Profit Hospices
Hospitals and Health Systems
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActCMS Issues Final Rules Concerning the 2023 Outpatient Prospective Payment System Rates and Physician Fee ScheduleDOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests
Long Term Care and Nursing Homes
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActNew 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 Facilities
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
Office of Inspector General
No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims ActOIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory TestsTiming is Everything: The Antitrust Division and OIG Sign Cross-Agency Agreement as Government Investigations Are Expected to Surge
Pharmaceuticals and Biologics
Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant SanctionsSecond Circuit Affirms HHS Rejection of Direct Copayment Assistance under Anti-kickback StatuteMarketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million
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
Private Equity
California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities StatewideNew 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 Allegations