The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more
With its March 31, 2014 denial of certiorari in U.S. ex rel. Nathan v. Takeda, the U.S. Supreme Court declined to wade into the ongoing debate over the degree of particularity with which a false claims relator must plead a...more
On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more
On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more
The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities,...more
The Federal Office of Medicare Hearings and Appeals (OMHA) was established in July 2005 to administer the Medicare appeals program. OMHA adjudicates appeals regarding Medicare entitlement and Medicare provider reimbursement....more
On January 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
In August, I wrote about the unusual decision by the U.S. Department of Justice (DOJ) to appeal a district court’s dismissal of a declined qui tam brought under the federal and state false claims acts (FCAs). In appealing...more
Outlining its high-level priorities and goals for the next five years, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Strategic Plan for 2014-2018. In the Strategic...more
For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers.
As we previously wrote, Senator Grassley has been among the most vocal of critics in...more
Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care...more
Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where – using the theory of implied certification - the alleged falsity is not apparent on the face of...more
The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more
Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting...more
The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation. ...more
Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more
This week the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, an...more
CMS wants to change the way that it rewards non-qui tam whistleblowers who report alleged fraudulent or unlawful conduct related to Medicare or Medicaid. Using an IRS program as a model, CMS recently proposed rule changes to...more
In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more
On April 1st, the Sixth Circuit reversed an $11.1 million dollar summary judgment finding entered against MedQuest Associates, a diagnostic testing company. In its opinion, the Sixth Circuit found that violation of two...more
In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees...more
Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more