News & Analysis as of

Health Law Alert: OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule that revises safe harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules regarding...more

Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing...

On October 3, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil...more

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

OIG Proposes New Safe Harbors to the Anti-Kickback Statute and New Exceptions to the Two Civil Monetary Penalty Provisions

On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more

Proposed Updates to the Civil Monetary Penalties Law for Health Care Providers

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”) that would amend certain rules under the Civil...more

Providers Challenge CMS's Non-Hospital Rotation Rules for GME and IME

Prior to the enactment of the Affordable Care Act (ACA), CMS required hospitals to comply with a number of exacting payment and documentation rules in order to include as part of their graduate medical education (GME) and...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Sunshine Act Update: First Data Set Published

On September 30, the Center for Medicare & Medicaid Services (CMS) published the first set of data reported by pharmaceutical, medical device, biotechnology and medical supply companies, and group purchasing organizations...more

Compliance with Internal Revenue Code §501(r) – the IRS (and Others) are Watching

Two public interest groups recently filed a complaint (Complaint) with the IRS claiming that Jackson Health System (JHS) failed to comply with the requirements of Internal Revenue Code (IRC) § 501(r) as enacted as part of the...more

OIG Offers Greater Protections for Health Care Providers in New Proposed Rule

On October 3, 2014, the U.S. Department of Health and Human Services of the Office of Inspector General (OIG) issued a Proposed Rule amending both the safe harbors to the anti-kickback statute and the civil monetary penalty...more

Sometimes the Government is Here to Help: OIG Proposes More Flexibility in Rules Governing Local Transportation, Beneficiary...

The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more

It Is Finally Here-the Sun Shines on a New Era

The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more

OIG Proposes Rules on Free Transportation, Hospital Gainsharing, and Other Access to Care Arrangements

The proposed rule to give providers more protections to promote beneficiary access to care solicits significant industry input. On October 2, the Department of Health and Human Services (HHS) Office of Inspector...more

The Evolution of Efficiencies and Treatment of Quality of Care Defenses in Light of Changing Health Care Industry Dynamics

The consolidation of health care markets and the impact of this consolidation on prices, costs, and quality, has been a hotly debated topic in the health care industry. Hospitals across the country are merging and acquiring...more

Hospital Mergers Pave The Way For Antitrust Training

Milton Friedman, an American economist and writer once said, “I was a great supporter of antitrust laws, I thought enforcing them was one of the few desirable things that the government could do to promote more...more

Health Reform + Related Health Policy News - September 2014, Issue 1

In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more

FTC Continues Aggressive Scrutiny of Hospital Mergers

A recent New York Times article highlighted new developments regarding the Federal Trade Commission’s (FTC) continued focus on hospital mergers. Although the FTC’s enforcement has been well-documented over the past few...more

Critical Issues in Hospital and Health System M&A

In This Issue: - Executive Summary - Preparing a Hospital or Health System for Sale or Partnership Transactions - Developing a Hospital Transaction Strategy and Process - The Role of the Nonprofit Hospital...more

Immigration Alert: September 2014

Sixth Circuit Expands the Liability of Health Care Employers for Sponsorship Costs - On August 20, 2014, the U.S. Court of Appeals for the Sixth Circuit issued its decision in Kutty v. U.S. Department of Labor, No....more

North Carolina’s Medicaid RAC Program - Don't Let Your Guard Down

With Section 6411(a) of the Patient Protection and Affordable Care Act (ACA) and the Final Rules found at 42 CFR Part 455, the Recovery Audit Contractor (RAC) program has been expanded to the North Carolina Medicaid program,...more

Independent Hospitals Innovating, Finding New Partnerships in Response to Market Pressures

Standard & Poor’s (S&P) Rating Services recently warned the health care sector was at “a tipping point where negative forces have started to outweigh many providers’ ability to implement sufficient countermeasures.” S&P noted...more

Advocacy Organizations’ Complaint Puts a Spotlight on Potential Noncompliance by Nonprofit Hospitals

On August 25, two advocacy organizations filed a complaint with the Internal Revenue Service (IRS) alleging noncompliance by a hospital system with respect to certain community benefit requirements imposed by the Patient...more

Antitrust Considerations Surrounding Health Care Consolidation Among Hospitals and Physicians

The Affordable Care Act (“ACA”) has resuscitated the demand for hospital and health care provider mergers. The law explicitly encourages collaborative care—through, for example, financial incentives surrounding the creation...more

The Reformed Health Care Industry: Creative Structures and Alliances Can Yield Great Benefits, but Also Great Risks

Since the Affordable Care Act (the “ACA”) was enacted in 2010, the health care industry has been on the edge of its proverbial seat waiting to see which care delivery models are best suited to sustain all the changes: to...more

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