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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

340B Drug Pricing Program

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

Academic Medical Centers

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Enacts Legislation Making Various Changes to Public Health LawsMassachusetts Updates State Telemedicine Guidance for Physicians

Accountable Care Organizations

CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility WorkersConnecticut Extends Expansion of Access to Telehealth ServicesHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

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 Enacts Legislation Making Various Changes to Public Health LawsConnecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 PandemicMassachusetts Issues COVID-19 Orders and Guidance for Providers

Ambulatory Surgical Centers (ASC)

Connecticut Repeals Tax on Ambulatory Surgical CentersCMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

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

Antitrust

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyONC Information Blocking Data Show Majority of Claims Against Health Care ProvidersConnecticut Budget Bill Includes Important Changes to Network Participation Contracts Between Health Care Providers and Insurers

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

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

Commercial Health Insurance

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Expands OHS AuthorityConnecticut Extends Expansion of Access to Telehealth Services

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

Connecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

COVID-19

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOSHA Taking Comments on Proposed Permanent Healthcare COVID-19 Standard

Department of Justice

DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations AboundHHS 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 Law

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

Connecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency ContractsNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesCMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

Employment/Labor

Connecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency Contracts

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

DOJ Announces $3.8 Million Settlement to Resolve Allegations of False Claims Act and Anti-Kickback Statute ViolationsDOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations AboundHHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

FDA

COVID-19 Vaccine Update – February 2022HHS Again Requires FDA Premarket Review for COVID-19 TestsConnecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information

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

Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOIG Creates New Telehealth Resources WebpageMarketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

Government Enforcement

FTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Enacts Legislation Making Various Changes to Public Health LawsNOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD Facilities

Health Information Exchanges and Electronic Medical Records (EMRs)

ONC Information Blocking Data Show Majority of Claims Against Health Care ProvidersConnecticut Enacts Legislation to Incentivize Adoption of Cybersecurity Safeguards and Expand Breach Reporting ObligationsHHS Warns Hospitals to Fix Security Vulnerability in PACs

Health Information Technology

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesOIG Creates New Telehealth Resources WebpageONC Information Blocking Data Show Majority of Claims Against Health Care Providers

Health Plans

New 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

Healthcare Technology

OIG Creates New Telehealth Resources WebpageOIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19Connecticut Extends Expansion of Access to Telehealth Services

Healthcare Transactions

Connecticut Enacts Legislation Making Various Changes to Public Health Laws

HIPAA

Connecticut’s Privacy Law Signed by GovernorONC Information Blocking Data Show Majority of Claims Against Health Care ProvidersNo Private Right of Action under HIPAA, but State Law Claims May Still be Asserted

Home Health Agencies

Connecticut Prohibits No-Hire Provisions in Homemaker and Home Health Agency ContractsNew York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure AmendmentsThe Joint Commission Announces COVID-19 Vaccine Surveys Have Begun

Hospice

New York State Legislature Passes Act Enacting Moratorium on For-Profit HospicesThe Joint Commission Announces COVID-19 Vaccine Surveys Have BegunCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place

Hospitals and Health Systems

Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement MethodologyFTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Expands OHS Authority

Laboratories

Connecticut Enacts Legislation Making Various Changes to Public Health LawsCOVID-19 Vaccine Update – February 2022New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

Legislation

New York State Legislature Passes Act Enacting Moratorium on For-Profit HospicesConnecticut Expands OHS AuthorityConnecticut Enacts Legislation Making Various Changes to Public Health Laws

Life Sciences

AdvaMed Updates its Code of EthicsCOVID-19 Vaccine Update – February 2022HHS Again Requires FDA Premarket Review for COVID-19 Tests

Long Term Care and Nursing Homes

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesCMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in PlaceCMS Finalizes Guidance on Hospital Co-Location

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

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

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

Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement MethodologyAdvisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOIG Creates New Telehealth Resources Webpage

Nursing Facilities

OSHA Announces COVID-19 Enforcement Initiative for Hospitals and Nursing Care FacilitiesCMS Finalizes Guidance on Hospital Co-LocationMassachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce

Office of Inspector General

Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOIG Creates New Telehealth Resources WebpageOIG: Telehealth “Critical” to Maintaining Access to Care Amidst COVID-19

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

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 MillionCOVID-19 Vaccine Update – February 2022HHS Again Requires FDA Premarket Review for COVID-19 Tests

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

Connecticut Makes Significant Changes to its Collaborative Drug Therapy LawsCOVID-19 Vaccine Update – February 2022New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

Physicians and Allied Health Professionals

Connecticut Expands OHS AuthorityConnecticut Makes Significant Changes to its Collaborative Drug Therapy LawsConnecticut Expands Advanced Practice Providers’ Scope of Practice to Include Certain Forms of Abortion

Privacy and Security

Connecticut’s Privacy Law Signed by GovernorONC Information Blocking Data Show Majority of Claims Against Health Care ProvidersNo Private Right of Action under HIPAA, but State Law Claims May Still be Asserted

Private Equity

New 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 AllegationsNew York Court of Appeals Holds that PCs that Cede Excessive Control to MSOs Violate the Corporate Practice of Medicine Doctrine

Reimbursement

Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement MethodologyFTC Takes Action to Block Hospital Transactions in Utah and New JerseyConnecticut Expands OHS Authority

Stark Law

CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice StructureCMS 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

Survey and Certification

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

Telehealth

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOIG Creates New Telehealth Resources Webpage

Telemedicine

NOTICE TO PROVIDERS: CMS Phasing Out Certain COVID-19 Regulatory Waivers in Long-Term Care Facilities, Hospices, and ESRD FacilitiesAdvisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth ServicesOIG Creates New Telehealth Resources Webpage

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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