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Health Law Diagnosis

Monitoring the Pulse of Health Care and Life Sciences

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2018 Connecticut Legislative Update

Connecticut Enacts Law Revising Various Department of Public Health StatutesConnecticut Enacts Legislation to Address Hospital-Insurer Network ConflictsConnecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

2019 Connecticut Legislative Update

New Connecticut Legislation Affecting Healthcare Providers and Entities Effective October 1, 2019Connecticut Expands Minors’ Confidential Access to Treatment for HIV and AIDS, Adds Reporting RequirementConnecticut Empowers DSS to Expand Medicaid Coverage of Telehealth Services

340B Drug Pricing Program

HHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)

Academic Medical Centers

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

Accountable Care Organizations

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law RegulationsCMS Issues New Interim Final Rule With Sweeping Regulatory Changes in Response to the COVID-19 Pandemic

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

Ambulance

Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicMassachusetts Issues COVID-19 Orders and Guidance for ProvidersMassachusetts COVID-19 Updates and Guidance Issued

Ambulatory Surgical Centers (ASC)

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicHHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

Americans With Disabilities

OCR 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 CircumstancesAppeals Court Reverses ADA Jury Verdict for Pharmacist with Fear of Needles

Antitrust

DOJ and FTC Issue Joint Statement on Antitrust Enforcement and the COVID-19 PandemicOHS Streamlines Application Process for CON Waivers to Respond to COVID-19FTC and Commonwealth of Pennsylvania Challenge Proposed Hospital Merger

Arbitration

CMS Issues Final Rule Restricting Arbitration Agreements with Long Term Care FacilitiesNinth Circuit Denies Arbitration in a False Claims Act CaseU.S. Supreme Court – the FAA Preempts State Court Ruling in Nursing Home Arbitration Case

CBD - Cannabis

CBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

Clinical Research

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingCMS Announces Merit-Based Incentive Payment for Clinicians Participating in COVID-19 Clinical TrialSpurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to Facilitate Provision of Coordinated Care

Commercial Health Insurance

Connecticut 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 OrdersDepartments 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

Connecticut Legislative Update 2017

Connecticut Enacts Legislation Intended to Curb Opioid Drug AbuseConnecticut Enacts Legislation Updating HIV Testing LawsConnecticut Legislature Expands Universe of Available Disciplinary Actions Against Licensed Practitioners

COVID-19

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActOCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling AppsIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

Department of Justice

HHS 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 LawDOJ and FTC Issue Joint Statement on Antitrust Enforcement and the COVID-19 Pandemic

Dialysis - ERSD

CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule

Dietary Supplements

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

Employment Law

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care ProvidersNew York Legislature Passes Bill Allowing Employees to Place a Lien on Employer’s Property for Wage ClaimsConnecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

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

ERISA

Ninth Circuit Denies Health Care Providers’ ERISA Claims

False Claims Act

HHS 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 CaseCMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

FDA

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingRhode Island Issues Emergency Regulations on Off-Label Prescribing for COVID-19, and Guidance on Telehealth and Reciprocal LicensureCBD Update: FDA Issues Statement, Calls Public Hearing, and Announces Warning Letters on Products Containing Cannabis and its Components

Food and Beverage

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

FQHC

DOJ Settles Allegations of Fraudulent Loan Program Between Hospital System and FQHC

Fraud and Abuse

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law RegulationsMassachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

Government Enforcement

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

Health Information Exchanges and Electronic Medical Records (EMRs)

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsCMS 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

Health Information Technology

OCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling AppsHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

Health Plans

Departments 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

Healthcare Technology

In 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 RulesCMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

HIPAA

Excellus Health Plan Pays $5.1M to OCR in Settlement Following Data BreachFifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against HospitalOCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling Apps

Home Health Agencies

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsHHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General DistributionHHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

Hospice

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsHHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General DistributionCMS Releases Additional Blanket Waivers in Response to COVID-19 Pandemic

Hospitals and Health Systems

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActOCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling AppsIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

Laboratories

CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health EmergencyCMS Interim Rule Makes Changes to COVID-19 Laboratory Test Ordering and Payment For Medicare and Medicaid Providers and Beneficiaries

Legislation

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law RegulationsREMINDER: November 6 Deadline for New CARES Act Funding Approaches

Life Sciences

Connecticut DPH Updates List of Reportable Laboratory Findings to Include Negative SARS-CoV-2 Test ResultsGovernment Continues to Closely Scrutinize Pharmaceutical Marketing PracticesAdvaMed Revises Code of Ethics on Interactions with Health Care Professionals

Long Term Care and Nursing Homes

HHS Announces Additional Distribution of $10 Billion to Safety Net Hospitals, and $15 Billion to Medicaid and CHIP Providers Left Out of General DistributionHHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund PaymentsCMS Releases Additional Blanket Waivers in Response to COVID-19 Pandemic

Long Term Care Facilities

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care ProvidersMassachusetts Board of Registration in Medicine Makes Significant Changes to Regulations Governing Licensure and Practice of MedicineNew York Legislature Passes Bill Allowing Employees to Place a Lien on Employer’s Property for Wage Claims

Managed Care

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final RulesConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicConnecticut Expands Scope of Practice for Advanced Practice Registered Nurses

Medical Devices

CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and SuppliesCARES Act Provides Vital Financial Support for Health Care Providers on COVID-19 Front LinesFederal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

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 Advantage

OIG Advisory Opinion Allows PHO Network Hospitals to Give 100% Discount on Medigap-Covered Inpatient Deductibles, with Savings Shared as a Premium Credit to Patients

Medicare and Medicaid

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsCMS 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

Nursing Facilities

Medicare Proposes Revised Telehealth Services and PaymentsCMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)CMS Announces First Advanced Alternative Payment Model Under MACRA: Bundled Payments for Care Improvement Advanced

Office of Inspector General

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

OSHA

Recent Joint Commission Guidance Recommends Steps for Health Care Organizations to Reduce Workplace Violence

Pharmaceuticals and Biologics

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsConnecticut DCP Issues Guidance for Remotely Refilling Prescriptions

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

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

Physicians and Allied Health Professionals

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP ActOCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling AppsIn Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

Privacy and Security

Excellus Health Plan Pays $5.1M to OCR in Settlement Following Data BreachFifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against HospitalOCR Announces it Will Not Impose HIPAA Penalties for Use of COVID-19 Vaccine Scheduling Apps

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

In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and ReportingCMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law RegulationsREMINDER: November 6 Deadline for New CARES Act Funding Approaches

Stark Law

CMS 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 RulesThe benefit of COVID-19 waivers to Stark Law, anti-kickback statute

Survey and Certification

CMS Announces Targeted Plan for Healthcare Facility Inspections in Light of COVID-19

Telehealth

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final RulesCOVID-19 Pandemic Brings Telehealth into U.S. HomesCMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

Telemedicine

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP RegulationsPhysician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final RulesCMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance

Uncategorized

CMS issues Request for Information on the burdens the Stark Law may Impose on Care CoordinationHorizon BCBS of New Jersey Pays State $1.1 million for HIPAA violations

Health Law Diagnosis

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