Karen Lovitch

Karen Lovitch

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OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more

8/24/2023  /  Advisory Opinions , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Medicaid , Medicare , OIG , Self-Referral

CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and...

Private equity (PE) ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. For...more

2/22/2023  /  Business Ownership , Centers for Medicare & Medicaid Services (CMS) , Disclosure Requirements , Medicaid , Medicare , Private Equity Firms , Proposed Rules , REIT , Skilled Nursing Facility

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more

8/1/2022  /  Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , CLFS , Clinical Laboratories , Department of Health and Human Services (HHS) , Medicaid , Medicare , Medicare Part B , Medicare Part C , PAMA , Proposed Amendments , Reimbursements

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

5/6/2022  /  Anti-Kickback Statute , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , False Claims Act (FCA) , Fraud , Health Insurance , Laboratories , Medicare , OIG , Payment Systems

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

2/11/2022  /  Clinical Trials , Coronavirus/COVID-19 , Cybersecurity , Department of Justice (DOJ) , Enforcement Actions , False Claims Act (FCA) , Fraud and Abuse , Health Care Providers , Healthcare Fraud , Kickbacks , Medical Devices , Medicare , Medicare Advantage , Nursing Homes , Pharmaceutical Industry , Pharmacies , Qui Tam , Telehealth

DOJ Announces Criminal Charges against Lab Executive Accused of Fraudulently Promoting COVID-19 Tests

The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded...more

6/12/2020  /  Bribery , Coronavirus/COVID-19 , Criminal Conspiracy , Criminal Prosecution , Department of Justice (DOJ) , Enforcement Actions , Guilty Pleas , Health Care Providers , Healthcare Fraud , Kickbacks , Medicare , Public Health Emergency , Securities Fraud

CMS Relaxes Medicare and Medicaid Ordering Requirements for COVID-19 Testing and Finalizes Coverage of Antibody Testing

In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare...more

5/5/2020  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Coronavirus/COVID-19 , Medicaid , Medicare , Physicians

CMS Offers Unprecedented Flexibility in Medicare Enrollment Requirements in Light of the COVID-19 Pandemic

As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician...more

3/27/2020  /  Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Enrollment , Medicare , Medicare Administrative Contractors (MAC)

Key Takeaways from CMS’s Final Rule Requiring the Disclosure of Affiliates during Provider Enrollment

The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in...more

9/13/2019  /  Affiliates , Bad Actors , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Comment Period , Disclosure Requirements , Enrollment , Final Rules , Health Care Providers , Health Insurance , Medicaid , Medicare

OIG Issues Fraud Alert Regarding Fraudulent Genetic Testing Schemes

Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the...more

6/6/2019  /  Enforcement Actions , Fraud Alerts , Genetic Testing , Identity Theft , Medicare , Medicare Beneficiaries , OIG , Telehealth

Independent Laboratory Settles Medical Necessity Allegations

The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more

2/22/2019  /  Department of Justice (DOJ) , Failure to Comply , False Claims Act (FCA) , Health Care Providers , Local Coverage Determination (LCD) , Medical Necessity , Medicare , Physician Medicare Reimbursements , Physicians , Qui Tam , Relators

A Tale of Two False Claims Act Settlements Involving EHR Vendors

Last week the Department of Justice (DOJ) announced a $57 million settlement with electronic health record (EHR) software vendor Greenway Health LLC (Greenway). According to DOJ, Greenway violated the False Claims Act (FCA)...more

2/14/2019  /  Department of Health and Human Services (HHS) , Department of Justice (DOJ) , EHR , Electronic Health Record Incentives , False Claims Act (FCA) , Health Care Providers , Meaningful Use , Medicaid , Medicare , OIG , Settlement Agreements , Software , Third-Party Service Provider

OIG Advisory Opinion Allows Routine Waiver of Federal Cost-Sharing Obligations

In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more

1/21/2019  /  Advisory Opinions , Anti-Kickback Statute , Cost-Sharing , False Claims Act (FCA) , Fraud and Abuse , Health Clinics , Healthcare Facilities , Low-Income Issues , Medicare , OIG , Pediatrics , Waivers

CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the...more

8/11/2017  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Diagnostic Tests , Hospitals , Laboratory Developed Tests , Medicare , Outpatient Prospective Payment System (OPPS) , Outpatient Services , Provider Payments

Lessons Learned from FCA Settlement Involving Waiver of Medicare Coinsurance Amounts

The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry. Despite the near absence of clear legal...more

10/25/2016  /  Aetna , CIGNA , Co-Insurance Payments , Deductibles , Department of Health and Human Services (HHS) , False Claims Act (FCA) , Medicare , OIG , Out of Network Provider , Waivers

At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more

6/20/2016  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Final Rules , Laboratory Developed Tests , MCLFS , Medicare , PAMA , Provider Payments

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

9/29/2015  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Comment Period , Cost-Sharing , Data Collection , Diagnostic Tests , Medicaid , Medicare , Medicare Part B , MPFS , PAMA , Proposed Regulation , Reimbursements , Reporting Requirements

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more

8/18/2014  /  False Claims Act (FCA) , Healthcare , Medicare , Medicare Part A , Medicare Part B

Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more

4/3/2014  /  Clinical Laboratories , Healthcare , Medicare , Pharmaceutical Industry

CMS Issues Medicare Physician Fee Schedule Without Finalizing Proposal Most Harmful to Independent Laboratories

On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the...more

12/4/2013  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Healthcare , Medicare , MPFS , Physician Fee Schedule , Physicians

CMS Continues To Issue Guidance On Sunshine Act Reporting

Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more

8/23/2013  /  Centers for Medicare & Medicaid Services (CMS) , Data Collection , GPOs , Medicaid , Medicare , Physician Payments , Sunshine Act

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more

8/8/2013  /  Ancillary Agreements , Civil Monetary Penalty , Department of Health and Human Services (HHS) , GAO , Medicare , OIG , Stark Law

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more

7/22/2013  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Medical Research , Medicare , Payment Plans

CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the...more

2/5/2013  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Medicaid , Medicare , Proficiency Testing
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