News & Analysis as of

Medicare Anti-Kickback Statute

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

by Polsinelli on

Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Second Circuit Accepts Appeal of False Claims Act First-To-File Issues

by Farrell Fritz, P.C. on

The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more

Hospitals and Others Respond to “Red Tape Relief Project” Requests

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first...more

Value-based health care: the role of payors

by Ropes & Gray LLP on

Bill Knowlton, Ropes & Gray health care partner, examines the critically important role of payors in value-based health care programs. ____________ Payors are critically important to value-based health care because they're...more

House Bipartisan Act Would Amend Stark Law and Medicare Part B

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Concierge Medicine – Is it for you?

by Farrell Fritz, P.C. on

According to the 2016 Kaiser/HERT Employer Health Benefits Survey, the average annual premium for employer-sponsored family health insurance coverage in 2016 was $18,142 – representing a 20% increase since 2011 and a 58%...more

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more

Court Puts the Brakes on Whistleblower's FCA Parking Claims

by Baker Ober Health Law on

The Department of Justice (DOJ) reports that, in fiscal year 2016 ending September 30, it obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims. More than half of this...more

FCA Deeper Dive: Pleading the Alleged Fraud Scheme

by Bass, Berry & Sims PLC on

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we are...more

FCA Issues to Watch: FCA Claims Concerning Physician Compensation

by Bass, Berry & Sims PLC on

Physician employment arrangements with hospitals have remained a significant area of regulatory scrutiny in recent months with the announcement of several high profile settlements and decisions in key FCA cases involving...more

Ambulatory Surgery Center (ASC) Case Demonstrates Differential Value Theory of Remuneration

by Ruder Ware on

A relatively recent case involving buy-in terms in an ambulatory surgery center demonstrates how different valuations for referral sources and non-referral sources can be evidence of remuneration under the Medicare...more

Leasing to Health Care Tenants: What You Need to Know

by Pepper Hamilton LLP on

Commercial office building landlords frequently find themselves leasing to health care provider tenants. A landlord may not consider doctor’s offices or diagnostic labs as specialty uses, but there are several lease...more

Provider Beware: MACRA Implementation Fraught with Fraud and Abuse Implications

by Carlton Fields on

Although the fate of the Center for Medicare and Medicaid Innovation (CMMI) and the mandatory alternative payment models thereunder face threat of repeal under Republican leadership, the Medicare Access and Chip...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

by Mintz Levin on

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

What’s in Your Local Transportation Policy?

by Nossaman LLP on

Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on...more

Analysis of HHS OIG Final Rule to Amend the Anti-Kickback Safe Harbors and CMP Rules on Beneficiary Inducements

by Reed Smith on

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP)...more

New Year, New Resolutions, New Safe Harbors

by Akerman LLP on

As we welcome the new year and its endless possibilities, we also welcome some new Anti-Kickback Statute safe harbors and concomitant business possibilities. In December, the U.S. Department of Health and Human Services...more

OIG Interprets and Incorporates Statutory Exceptions to CMP Law

by Dorsey & Whitney LLP on

As of January 6, 2017, final rules published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) implementing certain exceptions to the Civil Monetary Penalty law (“CMP”)...more

New Year, New Possibilities: OIG Final Rule Amends Beneficiary Inducement Rules

by Davis Wright Tremaine LLP on

The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more

HHS OIG Revises Various Safe Harbors Related to Beneficiary Inducements

by McGuireWoods LLP on

On Dec. 7, 2016, the U.S. Department of Health and Human Services’ (HHS’) Office of Inspector General (OIG) published a final rule revising federal Anti-Kickback Statute (AKS) safe harbors and the beneficiary inducement...more

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

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