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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

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

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling ShiftCourt Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot ProgramHHS Publishes 340B Guidance Proposing Rebate Pilot Program

Academic Medical Centers

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesTwo Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Accountable Care Organizations

DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine CliffMedicare Telehealth Flexibilities Extended through September 30, 2025DEA Extends Telehealth Lifeline for Patients

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

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised KickbacksOIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

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

Massachusetts Governor Healey Announces New Department of Insurance Regulations Intended to Streamline Prior Authorization PracticesCMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement EffortsTrump Administration Issues Executive Order Prioritizing Hospital Price Transparency Enforcement

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

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine Cliff

Department of Justice

DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine CliffSouth Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised KickbacksClean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case

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

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised KickbacksFalse 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 Claims

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

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesDEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine CliffAppeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation Requirement

Health Information Exchanges and Electronic Medical Records (EMRs)

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesAppeals 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

Health Information Technology

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesJoint Commission Releases Guidance for AI in Health CareCMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement Efforts

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

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesTwo Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

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

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesJoint 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 Requirement

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

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesTwo Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Laboratories

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised KickbacksOIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07Keeping Cool When ICE Arrives: Basic Raid Response Strategies for Laboratories

Legislation

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesTwo Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Licensure

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesJoint Commission Releases Guidance for AI in Health CareConnecticut Budget Bill Reinforces EMTALA and Emergency Medical Services Obligations for State Hospitals

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

Massachusetts Governor Healey Announces New Department of Insurance Regulations Intended to Streamline Prior Authorization PracticesCMS 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 Clinics

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

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026CMS Adds New Requirements to Hospital Price Transparency Reporting

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

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling ShiftCourt Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot ProgramAppellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed

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

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling ShiftDEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine CliffCourt Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot Program

Physicians and Allied Health Professionals

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesTwo Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

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

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026Massachusetts Governor Healey Announces New Department of Insurance Regulations Intended to Streamline Prior Authorization Practices

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

Two Weeks Notice for Covered Entities: February 16 Deadline Approaches to Update HIPAA Notice of Privacy PracticesU.S. Supreme Court Denies DSH Hospitals’ Attempts to Seek Higher Medicare Payments

Telehealth

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine Cliff

Telemedicine

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth FlexibilitiesSong Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine Cliff

The ColLABorative Brief

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is BackMedicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report RevealsSearch Bars, Chatbots, and Tracking Pixels: Practical Steps Labs Can Take to Reduce CIPA Risk in 2026

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

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