Topics

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

2025 Connecticut Legislative Update

Connecticut Budget Bill Includes Notable Changes to CON LawsConnecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and LawsConnecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement Scope

340B

Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to ProceedHRSA Publishes 340B Rebate Pilot Program FAQs

340B Drug Pricing Program

HHS Publishes 340B Guidance Proposing Rebate Pilot ProgramStatus of 340B Payment Remediation and Manufacturer LitigationHRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

Academic Medical Centers

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation Requirement

Accountable Care Organizations

Medicare Telehealth Flexibilities Extended through September 30, 2025DEA Extends Telehealth Lifeline for PatientsHHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care 

Accreditation

Joint Commission Releases Guidance for AI in Health CareConnecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and LawsNew York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process

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 Budget Bill Reinforces EMTALA and Emergency Medical Services Obligations for State HospitalsConnecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement ScopeConnecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting Agencies

Ambulatory Surgical Centers (ASC)

Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement ScopeCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsConnecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting Agencies

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

Anti-Kickback Statute

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud CaseFirst Circuit Makes Historic Decision: “But-For” Causation is the Majority Standard in AKS-Based FCA Claims

Antitrust

Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to ProceedCMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement EffortsConnecticut Establishes Emergency Certificate of Need Process for Hospitals in Bankruptcy

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

Certificate of Need

Connecticut Establishes Emergency Certificate of Need Process for Hospitals in BankruptcyConnecticut Governor’s Health Care Bill Makes Important Changes to the Certificate of Need Process

Clinical

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Keeping Cool When ICE Arrives: Basic Raid Response Strategies for LaboratoriesNew COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

Clinical Research

FDA Sued Over Laboratory Developed Tests Final RuleAdvisory 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 Tests

Commercial Health Insurance

CMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement EffortsTrump Administration Issues Executive Order Prioritizing Hospital Price Transparency EnforcementOIG Audit Scrutinizes Hospital Compliance with Price Transparency Rule

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

Contract Law

Breaches Within Breaches: Contractual Obligations After a Security IncidentA Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete BanConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete Agreements

COVID-19

Update on Processing of Telehealth Claims Impacted During the Government ShutdownClean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud CaseTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  

Department of Justice

Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud CaseCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsDEA Extends Telehealth Lifeline for Patients

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

Education

Kentucky Governor Signs Bill Aimed at Mitigating Healthcare Workforce Shortages: Beginning of a Trend?OIG Issues Favorable Advisory Opinion Regarding Home Health Agency’s Proposal to Pay Tuition Costs for New Employees

Employment Law

A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete BanConnecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete Agreements

Employment/Labor

A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete BanConnecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and OvertimeConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete Agreements

EMTALA

Connecticut Budget Bill Reinforces EMTALA and Emergency Medical Services Obligations for State HospitalsConnecticut 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) Emergency

ERISA

Ninth Circuit Denies Health Care Providers’ ERISA Claims

False Claims Act

False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens CasesFirst Circuit Makes Historic Decision: “But-For” Causation is the Majority Standard in AKS-Based FCA ClaimsMassachusetts Enhances Regulatory Oversight of Health Care Transactions on For-Profit and Private Equity Investments

FDA

FDA Sued Over Laboratory Developed Tests Final RuleCOVID-19 Vaccine Update – February 2022HHS Again Requires FDA Premarket Review for COVID-19 Tests

Federal Trade Commission

A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete Ban

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

Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud CaseOIG Shines Spotlight on Billing for Remote Patient MonitoringOIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

Government Enforcement

Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation RequirementConnecticut Budget Bill Reinforces EMTALA and Emergency Medical Services Obligations for State HospitalsConnecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and Laws

Health Information Exchanges and Electronic Medical Records (EMRs)

Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation RequirementConnecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and LawsMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law

Health Information Technology

Joint Commission Releases Guidance for AI in Health CareCMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement EffortsMedicare Telehealth Flexibilities Extended through September 30, 2025

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

Health Policy

CMS Adds New Requirements to Hospital Price Transparency ReportingUpdate on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  

Healthcare Technology

Northeast Radiology Settles with OCRCMS Updates Guidance to Allow Texting of Patient OrdersONC’s HTI-1 Final Rule Updates Information Blocking Regulations

Healthcare Transactions

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory OpinionConnecticut Establishes Emergency Certificate of Need Process for Hospitals in BankruptcyMassachusetts Enhances Regulatory Oversight of Health Care Transactions on For-Profit and Private Equity Investments

HIPAA

Joint Commission Releases Guidance for AI in Health CareAppeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation RequirementPIH Health Settles HIPAA Violations for $600,000

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 

Home Health/ Home Care

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement Scope

Hospice

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement Scope

Hospitals and Health Systems

CMS Adds New Requirements to Hospital Price Transparency ReportingUpdate on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  

Laboratories

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Keeping Cool When ICE Arrives: Basic Raid Response Strategies for LaboratoriesClean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

Legislation

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Telehealth Services on the Brink Again – Is a 7-Week Stopgap the Only Fix?

Licensure

Joint Commission Releases Guidance for AI in Health CareConnecticut Budget Bill Reinforces EMTALA and Emergency Medical Services Obligations for State HospitalsConnecticut Budget Bill Includes Notable Changes to CON Laws

Life Sciences

New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health CareSuspect Characteristics Identified under a Telehealth Special Fraud AlertAdvaMed Updates its Code of Ethics

Long Term Care and Nursing Homes

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement Scope

Long Term Care Facilities

Connecticut Governor Signs Bill Adding Requirements for Hospitals and Expanding DPH’s Enforcement ScopeCMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

Managed Care

CMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement EffortsHRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based ClinicsConnecticut Places Checks on PBM Contracts in Support of 340B Covered Entities

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

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

CMS Adds New Requirements to Hospital Price Transparency ReportingUpdate on Processing of Telehealth Claims Impacted During the Government ShutdownFrom Risk to Readiness: Navigating the Payor Audit Landscape

Nursing Facilities

New York OMIG Issues 2022 Annual ReportConnecticut Governor Signs Legislation Implementing New Requirements for Hospitals and Nursing Home FacilitiesOSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care Facilities

Office of Inspector General

OIG Shines Spotlight on Billing for Remote Patient MonitoringOIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory OpinionOIG Audit Scrutinizes Hospital Compliance with Price Transparency Rule

OSHA

OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 StandardOSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care FacilitiesU.S. Supreme Court Upholds Health Care Worker Vaccine Mandate

Pharmaceuticals and Biologics

Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to ProceedCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMA and CT Pave the Way for Emergency Contraception Vending Machines

Pharmacies

New York OMIG Issues 2022 Annual ReportMassachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy ProfessionalsConnecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

Pharmacy Law

Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation RequirementAppellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to ProceedHRSA Publishes 340B Rebate Pilot Program FAQs

Physicians and Allied Health Professionals

Telehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Telehealth Services on the Brink Again – Is a 7-Week Stopgap the Only Fix?Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation Requirement

Privacy and Security

Joint Commission Releases Guidance for AI in Health CareAppeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation RequirementConnecticut Enacts Wide-Ranging Health Care Law Modifying Various Existing Rules and Laws

Private Equity

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory OpinionMassachusetts Enhances Regulatory Oversight of Health Care Transactions on For-Profit and Private Equity InvestmentsMassachusetts Expands FCA Liability To Owners and Private Equity Investors

Reimbursement

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Telehealth Services on the Brink Again – Is a 7-Week Stopgap the Only Fix?

Stark Law

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsSouth 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 Profits

Survey and Certification

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

Tax Exemption/Charitable Organizations

U.S. Supreme Court Denies DSH Hospitals’ Attempts to Seek Higher Medicare Payments

Telehealth

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Telehealth Services on the Brink Again – Is a 7-Week Stopgap the Only Fix?

Telemedicine

Update on Processing of Telehealth Claims Impacted During the Government ShutdownTelehealth Survives Again: What the Most Recent Flexibility Extension Means for Providers  Telehealth Services on the Brink Again – Is a 7-Week Stopgap the Only Fix?

The ColLABorative Brief

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Keeping Cool When ICE Arrives: Basic Raid Response Strategies for LaboratoriesClean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

Uncategorized

OCR Settles Fourth Ransomware InvestigationHHS Proposes Rule to Align Part 2 Records and HIPAA340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win