William Mathias

William Mathias

Ober|Kaler

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CMS Announces Plans to Streamline the Stark Self-Referral Disclosure Protocol

On May 6, 2016, CMS published a notice (Notice), required under the Paperwork Reduction Act (PRA), seeking public comment on its plans to revise the information collected under the Medicare Self-referral Disclosure Protocol...more

5/26/2016 - CMS Look-Back Measurement Period Medicare Overpayment Physicians Public Comment Reporting Requirements Self-Referral Disclosure Protocol Stark Law

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

5/25/2016 - Burden of Proof False Claims Act (FCA) Federal Health Care Programs (FHCP) Fraud and Abuse Guidance Update Health Care Providers OIG Permissive Exclusion Authority Rebuttable Presumptions Self-Disclosure Requirements Yates Memorandum

OIG Approves Free Transportation and Lodging for Certain, Low-Income Pregnant Women - Advisory Opinion 16-02

On March 1, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-02 [PDF], approving an academic medical center's (AMC's) provision of free transportation and lodging...more

3/10/2016 - Advisory Opinions Anti-Kickback Statute Civil Monetary Penalty Free Health-Related Services Health Care Providers HHS Hospitals OIG Pregnancy

OIG Approves Charitable Program Providing Financial Assistance for MRIs in Advisory Opinion 15-14

On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more

2/17/2016 - Advisory Opinions Anti-Kickback Statute Charitable Organizations Civil Monetary Penalty Inducements Medicaid Medicare MRI OIG Patient Assistance Programs

OIG Approves Another Patient Assistance Program in Advisory Opinion 15-16

On December 28, 2015, the Office of Inspector General (OIG) approved another patient assistance program in Advisory Opinion 15-16. The OIG analyzed contributions to a private charitable organization under the anti-kickback...more

2/15/2016 - Advisory Opinions Anti-Kickback Statute Charitable Organizations Civil Monetary Penalty Inducements OIG Patient Assistance Programs Prescription Drugs

Charity's Patient Assistance Program Passes OIG Muster in Advisory Opinion 15-17

On December 28, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued OIG Advisory Opinion 15-17, approving a charity’s proposal to unveil a new patient assistance program dedicated to...more

2/12/2016 - Advisory Opinions Anti-Kickback Statute Charitable Organizations Civil Monetary Penalty Inducements OIG Patient Assistance Programs Prescription Drugs

OIG Issues (Another) Favorable Advisory Opinion Regarding Medigap/Preferred Hospital Network Arrangement in Advisory Opinion 16-01

On January 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-01, approving yet another insurer’s proposed contract with a preferred hospital network. The...more

2/11/2016 - Advisory Opinions Anti-Kickback Statute Discounts Inducements Medicare Medigap OIG Preferred Hospital Networks Arrangement

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 Home Health Provider's Free Introductory Visit Policy

On August 6, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a for-profit home health provider’s policy to offer free introductory visits to...more

9/28/2015 - Advisory Opinions Anti-Kickback Statute Civil Monetary Penalty Free Health-Related Services Health Care Providers Home Health Care OIG Sanctions

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

8/27/2015 - Anti-Kickback Statute Cancer Cost-Sharing Free Health-Related Services Free-Drug Programs Health Insurance HHS Medicare Part D OIG Patients Pharmaceutical Industry Pharmacies

Open Payments Update: End of CME Exception for Sunshine Reporting

On July 17, 2015, CMS announced updates to the Law and Policy page on the Open Payments website to provide additional guidance regarding the termination of the continuing medical education (CME) exception for reporting under...more

8/17/2015 - CME CMS Medicare Open Payments Reporting Requirements Sunshine Act

Stark Regulations: Technical Revisions

The proposed Physician Fee Schedule for CY 2016 includes multiple technical revisions to the regulations implementing the Stark law. These revisions appear to be designed to provide greater clarity and flexibility with...more

7/22/2015 - Anti-Kickback Statute CMS Commercial Leases Exceptions Physician Compensation Arrangements Physician Fee Schedule Remuneration Self-Referral Disclosure Protocol Signatures Stark Law Timeshare

Again, the OIG Approves a Medigap Policy Contract with Preferred Hospital Networks

On June 12, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-08. This opinion continues the well-established pattern of favorable advisory opinions which...more

7/3/2015 - Anti-Kickback Statute Civil Monetary Penalty Fraud and Abuse Health Insurance HHS Hospitals Medigap OIG Preferred Hospital Networks Arrangement

OIG Approves Charitable Organization's Patient Assistance Program

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a charitable organization’s proposal to provide financial assistance to individuals with...more

6/24/2015 - Advisory Opinions Charitable Organizations Healthcare OIG Patient Assistance Programs

OIG Approves Subsidies to Medicare Beneficiaries Provided by a Clinical Research Study

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a medical device manufacturer’s proposed arrangement to provide subsidies to certain...more

6/23/2015 - Advisory Opinions Anti-Kickback Statute Civil Monetary Penalty Clinical Trials HHS Medical Devices Medicare OIG Subsidies

Medigap Insurer's Contract with Preferred Hospital Network Approved (Yet Again)

On April 22, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-05 [PDF], approving a Medigap insurer’s proposed contract with a preferred hospital network. The...more

5/9/2015 - CMP Law Health Insurance HHS Medicare Medigap OIG PPOs Preferred Hospital Networks Arrangement

New Compliance Guidance for Health Care Boards

New compliance guidance for Boards of health care organizations was issued April 20, 2015. The document – “Practical Guidance for Health Care Governing Boards on Compliance Oversight” – was a joint effort of the Office of...more

4/27/2015 - AHLA Board of Directors Compliance Corporate Governance DOJ Health Care Providers HHS New Guidance OIG

Excluded Individual Not Precluded from Payment for Pre-exclusion Services

In Advisory Opinion 15-02 [PDF], issued February 9, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) looked favorably on the Requestor’s inquiry as to whether receipt of Federal health...more

2/28/2015 - Advisory Opinions False Claims Act (FCA) HHS OIG

OIG Approves Free Diapers and Playpen in Connection with Medicaid Program Promoting Pre- and Post-Natal Care

On January 26, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving an entity’s practice of advertising and providing free diapers and free portable...more

2/16/2015 - Advertising Advisory Opinions Anti-Kickback Statute Children's Products Civil Monetary Penalty Free Health-Related Services HHS Medicaid OIG Pregnancy Preventive Health Care

Paperwork Burden Eased in CMS Voluntary Self-Referral Disclosure Protocol Filings

In late December 2014, CMS made a small change to its voluntary Self-Referral Disclosure Protocol (SRDP) to help reduce some of the paperwork burden associated with filing under the SRDP. Section 6409 of the Affordable...more

1/20/2015 - Affordable Care Act CMS Healthcare HHS Self-Referral Disclosure Protocol Stark Law

ACO Fraud and Abuse Waivers Extended Through November 2, 2015

On October 17, 2014 the Centers for Medicare and Medicaid (CMS) and Office of Inspector General (OIG) within the Department of Health and Human Services published a continuation notice in the Federal Register extending the...more

11/21/2014 - ACOs Anti-Kickback Statute CMP Law CMS Fraud and Abuse HHS OIG Shared Savings Program Stark Law Waivers

OIG Warns About Risk of Drug Coupons, But Offers No Solution

On September 18, 2014, the OIG simultaneously issued a Report [PDF] and Special Advisory Bulletin [PDF] warning about the potential fraud and abuse risks posed by coupons offered by pharmaceutical manufacturers when those...more

9/26/2014 - Co-payments Fraud and Abuse Medicare Part D OIG Pharmaceutical Industry Pharmacies Prescription Drugs

Discount Drug Program Passes OIG Scrutiny

On July 28th, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) released favorable advisory opinion 14-05, concluding that a pharmaceutical manufacturer’s direct-to-patient discounted, cash...more

8/14/2014 - Anti-Kickback Statute Civil Monetary Penalty HHS OIG Pharmaceutical Industry Prescription Drugs

OIG Special Fraud Alert Questions Laboratory Payments to Physicians

On June 25, 2014, the Office of the Inspector General (OIG) issued a Special Fraud Alert addressing the issue of remuneration offered and paid by laboratories to referring physicians. The Special Fraud Alert expands upon...more

7/7/2014 - Clinical Laboratories Fraud OIG Physician Payments Risk Alert

Medicare Proposes Prior Authorization Process for Certain DMEPOS Items

On May 28, 2014, CMS issued a proposed rule to establish a permanent prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are “frequently subject to...more

6/9/2014 - CMS DMEPOS Enforcement Healthcare Medicare Prior Authorization Proposed Regulation

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