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

340B Drug Pricing Program

Status of 340B Payment Remediation and Manufacturer LitigationHRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based ClinicsConnecticut Places Checks on PBM Contracts in Support of 340B Covered Entities

Academic Medical Centers

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law

Accountable Care Organizations

DEA 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 DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

Accreditation

New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need ProcessConnecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing AvenuesConnecticut Governor Signs Bill Introducing Programs to Improve Maternal Health

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 Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting AgenciesKey Second Circuit Decision Defines AKS Willfulness StandardConnecticut Enacts Legislation Making Various Changes to Public Health Laws

Ambulatory Surgical Centers (ASC)

CMS 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 AgenciesKey Second Circuit Decision Defines AKS Willfulness Standard

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

DOJ 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

Antitrust

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleA Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete BanOpposing Decisions – Does the FTC Have the Authority to Ban Non-Compete Clauses?

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 Governor’s Health Care Bill Makes Important Changes to the Certificate of Need Process

Clinical

New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing PracticesDOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound

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

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleConnecticut Governor Signs Health Care Bill Revising Connecticut’s Facility Fee LawConnecticut Health Care Bill Revises Provider-Payor Contracting Requirements to Address Competitive Concerns

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

A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete BanConnecticut Legislature Passes Law Limiting Physician, PA and APRN Non-Compete AgreementsAdvisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic

COVID-19

DEA Extends Telehealth Lifeline for PatientsDEA 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. 7V

Department of Justice

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsDEA Extends Telehealth Lifeline for PatientsMiddle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional

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 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

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMiddle 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-Disclosure

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

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMiddle 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 Schemes

Government Enforcement

FDA Sued Over Laboratory Developed Tests Final RuleOCR Active with Settlements and Enforcement Actions in November and Early DecemberOIG Audit Scrutinizes Hospital Compliance with Price Transparency Rule

Health Information Exchanges and Electronic Medical Records (EMRs)

Massachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap LawHHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care ONC’s HTI-1 Final Rule Updates Information Blocking Regulations

Health Information Technology

What to Know About the HHS HIPAA Security Standards ProposalMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap LawMicrosoft Report Highlights Attacks Against Healthcare Organizations

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

What to Know About the HHS HIPAA Security Standards ProposalFDA Sued Over Laboratory Developed Tests Final RuleOIG Audit Scrutinizes Hospital Compliance with Price Transparency Rule

Healthcare Technology

CMS Updates Guidance to Allow Texting of Patient OrdersONC’s HTI-1 Final Rule Updates Information Blocking RegulationsHHS Proposes Disincentives for Providers that Commit Information Blocking

Healthcare Transactions

California Governor Vetoes Bill Imposing New Requirements for Private Equity in Healthcare TransactionsHealth Care Transactions and Civil Investigative Demands: What Third Parties Need to KnowTwo Pathways for Medicaid Self-Disclosures Announced by OMIG

HIPAA

What to Know About the HHS HIPAA Security Standards ProposalOCR Active with Settlements and Enforcement Actions in November and Early DecemberMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law

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

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsKey Second Circuit Decision Defines AKS Willfulness StandardCMS Announces 0.8 Percent Aggregate Home Health Payment Increase in 2024

Hospice

CMS 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 AgenciesKey Second Circuit Decision Defines AKS Willfulness Standard

Hospitals and Health Systems

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law

Laboratories

FDA Sued Over Laboratory Developed Tests Final RuleCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMiddle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional

Legislation

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap LawDEA Extends Telehealth Lifeline for Patients

Licensure

CMS Updates Guidance to Allow Texting of Patient OrdersNew York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need ProcessConnecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing Avenues

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

CMS 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 AgenciesDOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities

Long Term Care Facilities

CMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider WorkforceCMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

Managed Care

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based ClinicsConnecticut Places Checks on PBM Contracts in Support of 340B Covered EntitiesFTC Takes Action to Block Hospital Transactions in Utah and New Jersey

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

Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision UnconstitutionalDOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical PracticesKey Second Circuit Decision Defines AKS Willfulness Standard

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 Audit Scrutinizes Hospital Compliance with Price Transparency RuleMiddle 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-Disclosure

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

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMA and CT Pave the Way for Emergency Contraception Vending MachinesHRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

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

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsDEA Extends Telehealth Lifeline for PatientsDEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

Physicians and Allied Health Professionals

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap Law

Privacy and Security

OCR Active with Settlements and Enforcement Actions in November and Early DecemberMassachusetts Supreme Court Rules Online Tracking Technologies Do Not Violate State Wiretap LawMicrosoft Report Highlights Attacks Against Healthcare Organizations

Private Equity

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsCalifornia Governor Vetoes Bill Imposing New Requirements for Private Equity in Healthcare TransactionsAdditional States Implement Notice Requirements for Healthcare Transactions

Reimbursement

OIG Audit Scrutinizes Hospital Compliance with Price Transparency RuleCMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsMiddle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional

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

Telehealth

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsRemote Patient Monitoring Enforcement InitiativesDEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

Telemedicine

CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related OverpaymentsDEA Extends Telehealth Lifeline for PatientsDOJ Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes

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