Kristen Cilento Carter

Kristen Cilento Carter

Baker Donelson

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OIG Finalizes New and Amended Anti-Kickback and CMP Safe Harbors

On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...more

12/23/2016 - Ambulance Providers Anti-Kickback Statute Civil Monetary Penalty Cost-Sharing Free Health-Related Services HHS MCGDP Medicare Advantage OIG Pharmacies Remuneration Safe Harbors

OIG Still Rejects Lab's Free Labeling Services for Dialysis Facilities in Advisory Opinion No. 16-12

8 Years and New Reimbursement Methodology Later - On November 28, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued an unfavorable advisory opinion, No. 16-12, regarding a...more

12/20/2016 - Advisory Opinions Anti-Kickback Statute CMS Dialysis Providers Free Health-Related Services Labeling Laboratories OIG Provider Payments Remuneration Safe Harbors

CMS Finalizes Changes to the Future of Physician Reimbursement with the Quality Payment Program

CMS released the Final Rule with comment period delineating a portion of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) known as the Quality Payment Program (QPP) on October 14, 2016, with the official...more

10/28/2016 - ACOs Alternative Payment Models (APM) CMS Final Rules Medicare Access and CHIP Reauthorization (MACRA) MIPS Physician Fee Schedule Physician Payments Provider Payments Quality Payment Program (QPP)

Stark Updates Included in Final 2016 Physician Fee Schedule

With the final Medicare physician fee schedule (PFS) for 2016, the Centers for Medicare and Medicaid Services (CMS) has made a series of updates to the Stark physician self-referral regulations. The final rule is largely...more

12/2/2015 - CMS Physician Fee Schedule Physician Recruitment Agreement Physician-Owned Hospitals Stark Law Technical Standards

OIG Approves Health System's Complimentary Transportation Program

Recognizing that a narrowly tailored complimentary transportation program may pose minimal risk of fraud and abuse, the OIG posted favorable Advisory Opinion No. 15-13 on October 21, 2015. The Opinion approves an integrated...more

11/6/2015 - Advisory Opinions Anti-Kickback Statute Civil Monetary Penalty Fraud and Abuse Hospitals OIG

OIG Issues Favorable Advisory Opinion Regarding Employee Lease Arrangement Between Related Entities

Reviewing an arrangement involving the lease of employees and other operational and management services between a health system and its related psychiatric hospital, the OIG issued a favorable advisory opinion, Advisory...more

8/13/2015 - Advisory Opinions Anti-Kickback Statute CMS Healthcare Hospitals Leased Employees Medicare Non-Profit Hospitals OIG

Stark Regulations: Proposed Physician-owned Hospitals Provisions

In the proposed Physician Fee Schedule for 2016 [PDF], CMS recommends amending several requirements related to the physician-owned hospital and rural provider exceptions to the Stark law. As discussed more fully below, CMS...more

7/23/2015 - CMS Exceptions Hospitals Patient Referrals Physician Fee Schedule Physician-Owned Hospitals Rural Health Care Providers Stark Law

OIG Fraud Alert Serves as Stern Warning to Physicians Regarding Compensation Arrangements

Emphasizing its continued focus on physician compensation arrangements, the OIG issued a Fraud Alert on June 9, 2015, warning that physicians risk significant penalties if medical directorships and other compensation...more

6/22/2015 - Anti-Kickback Statute False Claims Act (FCA) Fraud Alerts Hospitals Medicaid Medicare OIG Patient Referrals Physician Compensation Arrangements Physicians Qui Tam

Two Laboratories Settle Claims Regarding Specimen Processing Fees

Continuing the scrutiny of laboratory arrangements with referring physician practices, the United States Department of Justice (DOJ) recently announced the settlement of False Claims Act allegations against two cardiovascular...more

5/11/2015 - Corporate Integrity Agreement DOJ False Claims Act (FCA) Laboratories OIG Patient Referrals Physician Payments Processing Fees Settlement

OIG Nixes Arrangements Involving Free Tests

Labs Attempt to Counter Exclusive Lab Arrangements - With increasing frequency, clinical laboratories have found themselves unable to receive any payments for tests performed for individuals whose third-party insurer...more

4/14/2015 - Alternative Fee Arrangements Anti-Kickback Statute Clinical Laboratories Free Health-Related Services Laboratories Medicaid Medicare OIG Physicians

OIG Approves Nonprofit Foundation's Proposed Copayment Assistance Program

On January 5, 2015, the OIG posted a favorable advisory opinion, OIG Advisory Opinion 14-11, regarding a 501(c)(3) charitable foundation’s (Foundation) proposal to establish a patient assistance program that would provide...more

1/19/2015 - 501(c)(3) Advisory Opinions Charitable Organizations Co-payments Health Care Providers Healthcare Hospitals OIG

Specialty Pharmacy Per-fill Fee Rejected by OIG

On August 15, 2014, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a “negative” opinion regarding a specialty pharmacy’s proposal to pay a per-fill fee to local pharmacies for support...more

9/4/2014 - Anti-Kickback Statute Fraud and Abuse HHS OIG Patient Referrals Pharmacies Prescription Drugs

Part II: Exploration of Common Exceptions to the Stark Law

In this Presentation: Kristin Cilento Carter presented “Exploration of Common Exceptions to the Stark Law” as part of the program “Stark Physician Self-Referral Law,” an installment in the Fraud and Abuse Basics...more

3/13/2014 - Fraud Fraud and Abuse Healthcare Healthcare Fraud Stark Law

CMS Releases CY 2014 Hospital OPPS and ASC Final Rule

CMS has published its Calendar Year (CY) 2014 Final Rule for Medicare policy and payment rates for hospital outpatient prospective payment systems (OPPS) and Ambulatory Surgical Center (ASC) services. This final rule with...more

12/13/2013 - Affordable Care Act Ambulatory Surgery Centers CMS Healthcare Hospitals Medicare Medicare Part B Outpatient Quality Reporting Patient Prospective Payment System Pharmaceutical Industry Value-Based Purchasing

OIG Report Concludes that Physician-owned Distributors Increase Utilization

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

11/8/2013 - Anti-Kickback Statute Healthcare HHS Hospitals Medical Devices Medicare OIG Physician-Owned Distributors

CMS Issues FAQs Regarding Self-Referral Disclosure Protocol

CMS has released its responses to eight frequently asked questions [PDF] regarding its Self-Referral Disclosure Protocol (SRDP). The questions fall into three categories, listed below, and respond to issues that are often...more

10/11/2013 - CMS DOJ Medical Liability OIG Patient Self-Referral Required Documentation Self-Disclosure Requirements Stark Law Voluntary Disclosure

CY 2014 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rules Released by CMS

CMS released its Calendar Year (CY) 2014 Proposed Rule for outpatient services furnished in hospitals and ambulatory surgical centers (ASCs). CMS anticipates that payments under the outpatient perspective payment system...more

7/15/2013 - Ambulatory Surgery Centers CMS Healthcare Hospitals Medicaid Medicare Prescription Drugs

Court Rules That Supervision and Enrollment Issues Don't Give Rise to False Claims Act Liability

Following the ever-growing progeny of cases holding that Medicare conditions of participation do not give rise to False Claims Act (FCA) liability, the United States Court of Appeals for the Sixth Circuit overturned an $11...more

4/19/2013 - CIGNA False Claims Act (FCA) Medicare MedQuest Supervision

American Taxpayer Relief Act of 2012: Physician Cuts Averted, Hospitals to Carry Portion of Price Tag

Avoiding sending American taxpayers over the so-called “fiscal cliff,” Congress enacted the American Taxpayer Relief Act of 2012 (the “Act”) [PDF] that was signed into law on January 2, 2013. Of biggest note, the Act included...more

1/17/2013 - Ambulance Providers American Taxpayer Relief Act Diagnostic Imaging Services Dialysis Providers Disproportionate Share Adjustments Fiscal Cliff Hospitals Medicare Physician Medicare Reimbursements

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