Medicare Part D

News & Analysis as of

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

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...more

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

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

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Health Care Reform Implementation Update

In the past week, CMS has released several advisories including updates to the rating system for nursing homes, premium and deductible information for Medicare Part B and Part D for 2015, Pioneer ACO results, payment dispute...more

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

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”), which would amend the Anti-Kickback Statute...more

HHS Office of Inspector General Proposes Expansions of Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions

On October 3, 2014, the Office of the Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would amend regulations implementing the federal anti-kickback...more

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more

OIG Releases Proposed Rule Adding New Safe Harbors to the Anti-Kickback Statute

Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more

OIG Proposes Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...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

OIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use

On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more

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

OIG Reports Medicare Part B Supplying and Dispensing Fees Significantly Higher Than Those Under Part D and Medicaid

According to a recently released report from the HHS OIG, pharmacies are reimbursed significantly more for dispensing drugs under Medicare Part B than they would be for dispensing the same drugs under Medicare Part D and...more

OIG Issues Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons

On September 19, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons (the “Advisory Bulletin”) warning pharmaceutical...more

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

CMS Continues to Struggle with How to Provide High Quality Care to Dual Eligibles

Last week CMS announced that it would not execute its option to terminate its 2015 contracts with Medicare Advantage Plans and Part D plans that had scored three stars or less for three consecutive years. ...more

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more

CMS Retracts Hospice Preauthorization Requirements for Part D Drugs

On July 18, CMS released new guidance retracting a major portion of its controversial preauthorization requirement for hospice beneficiaries. The new guidance supersedes portions of the March 10, 2014 guidance [PDF] that...more

Health Headlines: Also in the News - July 2014 #3

CMS Revises Medicare Advantage and Part D Prescription Drug Plan Prior Authorization Requirement for Hospices – On July 18, 2014, CMS released a revised a memorandum outlining responsibility for drug payments for hospice...more

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