William Mathias

William Mathias

Ober|Kaler

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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-Drug Programs Health Insurance HHS Medicare Part D OIG Patients Pharmaceutical Manufacturers 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 Device Manufacturers 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 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 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 Manufacturers 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 Drug Manufacturers HHS OIG Pharmaceutical Manufacturers 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

OIG Proposes Updates to Exclusion and CMP Authority

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a pair of proposed regulations to update its exclusion and civil monetary penalty (CMP) authority. The proposed regulations...more

6/3/2014 - Affordable Care Act Civil Monetary Penalty CMS Compliance Exclusions Healthcare Healthcare Reform HHS Medicaid Medicare OIG

OIG Supplemental Special Advisory Bulletin Raises New Concerns About Independent Charity Patient Assistance Programs

In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more

5/30/2014 - Anti-Kickback Statute Healthcare Medicare Medicare Part D OIG Patient Assistance Programs Pharmaceutical

Chance to Comment on Future of DMEPOS Payments

CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more

3/26/2014 - Affordable Care Act CMS Competitive Bidding Durable Medical Equipment Healthcare Medical Devices Medicare

Program Integrity Priorities Revealed in FY 2015 HHS Budget

On March 14, 2014, President Obama unveiled his Administration’s proposed fiscal year 2015 budget for the Department of Health and Human Services (HHS). In total, the Administration is seeking $77.1 billion to fund HHS in FY...more

3/14/2014 - Affordable Care Act CMS Federal Budget Healthcare Fraud Healthcare Reform HHS Medicare Physician Medicare Reimbursements Stark Law

Dodging the AKS: Marketplace Plans Are Not "Federal Health Care Programs"

In an October 30th letter addressed to Congressman Jim McDermott, the Department of Health and Human Services (HHS) Secretary, Kathleen Sebelius, left little to interpretation: Qualified health plans (QHPs) purchased through...more

11/8/2013 - Affordable Care Act Anti-Kickback Statute CMS False Claims Act Health Insurance Exchanges Healthcare Healthcare Reform HHS OIG Premiums Qualified Health Plans

OIG Advisory Opinions Provide Some Helpful Guidance

In spite of a slow start, the OIG has issued a number of interesting advisory opinions to date in 2013. Here are a few of the highlights. The OIG reiterated its long-standing concern about arrangements which “carve out”...more

7/19/2013 - Advisory Opinions Health Insurance Healthcare Hospitals Medicare Medigap OIG

2013 Healthcare Fraud and Abuse Bootcamp Webinar Series, Part V: Compliance

Bill Mathias of Ober|Kaler's Health Law Group presented on compliance as a part of the 2013 Healthcare Fraud and Abuse Bootcamp Webinar Series sponsored by the American Health Lawyers Association. This webinar...more

6/17/2013 - Anti-Kickback Statute Audits CMS Compliance Documentation False Claims Act Healthcare Fraud Internal Investigations Medicaid Medicare OIG Penalties Self-Disclosure Requirements Stark Law

OIG Calls PODs "Inherently Suspect"

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

3/29/2013 - Ambulatory Surgery Centers Anti-Kickback Statute Client Referrals Fraud Healthcare Hospitals Joint Venture Manufacturers Medical Devices OIG Physician-Owned Distributors Physicians

Physician Payment Sunshine Rule is Finalized

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

2/15/2013 - Applicable Manufacturers Biologics CMS Common Ownership Continuing Medical Education Covered Products Covered Recipients Dispute Resolution Drug Manufacturers GPOs Medical Devices Medical Research Medical Supplies Payment Records Physician Payments Physicians Sunshine Act Teaching Hospitals Transfers of Value

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