Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
7/12/2019
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Safe Harbors ,
Secretary of HHS ,
Trump Administration
On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more
7/24/2018
/ Anti-Kickback Statute ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more
5/14/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
REMS ,
Section 340B ,
Trump Administration
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more
5/23/2017
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HCPCS ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Obama Administration ,
Pharmaceutical Industry ,
Reimbursements ,
Rollbacks ,
Trump Administration
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more
4/26/2017
/ Business & Professions Code ,
Disclosure Requirements ,
Fiduciary Duty ,
Incentives ,
Licensing Rules ,
Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Rebates ,
State and Local Government ,
Transparency
In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified...more
4/17/2017
/ Attorney General ,
Business Associates ,
Enforcement Actions ,
False Claims Act (FCA) ,
HIPAA Privacy Rule ,
Kickbacks ,
Patient Privacy Rights ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Settlement
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more
3/16/2017
/ ACOs ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medicare Shared Savings Program ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Safe Harbors ,
Stark Law ,
Value-Based Care
There has been much controversy over the Medicare Part B payment demonstration proposed by the Center for Medicare and Medicaid Innovation (CMMI) in March 2016. As we await the release of the final rule, the fate of this...more
Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to...more
Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would...more
In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
12/9/2015
/ AstraZeneca ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
FDA Approval ,
HRSA ,
Kickbacks ,
Kmart ,
Novartis ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Value-Based Purchasing
Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more
As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more
Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more
On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more
As part of our continuing series on CMS’s 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks. In the Call Letter, CMS raises concerns about preferred...more
On December 19, 2014, the Internal Revenue Service (“IRS”) issued a private letter ruling (the “Ruling”) allowing corporations that manage physician practices through a so-called “friendly physician” arrangement to treat the...more
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more
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
10/21/2014
/ Affordable Care Act ,
Ambulance Providers ,
Anti-Kickback Statute ,
CMP Law ,
Gainsharing ,
Hospitals ,
OIG ,
Pharmacies ,
Physicians ,
Proposed Regulation ,
Safe Harbors
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
The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more