Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health...more
On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more
The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last...more
Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule), this post focuses on a few...more
GAO recently released a report analyzing the use of pharmacy benefit managers (“PBMs”) and efforts to manage drug spending and use in the Medicare Part D program. Importantly, the report found that use of PBMs reduced Part D...more
Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs?
...The Medicare Advantage...more
Earlier this month, CMS proposed changes to the Medicare Physician Fee Schedule and Quality Payment Program with the goal of “modernizing Medicare and restoring the doctor-patient relationship.” The proposed changes achieve...more
7/23/2018
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Medicaid ,
Medicare ,
Medicare Part B ,
MIPS ,
Physician Fee Schedule ,
Physicians ,
Proposed Regulation
HHS’s Office of Medicare Hearings and Appeals (OMHA) has long faced a backlog in Medicare appeals to Administrative Law Judges (ALJs). In an effort to address this backlog, OMHA established a Settlement Conference...more
5/31/2018
/ Administrative Backlogs ,
Administrative Law Judge (ALJ) ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Healthcare ,
Medicare ,
OMHA ,
Settlement Agreements ,
Settlement Conferences
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more
3/5/2018
/ Advance Notice ,
Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Healthcare ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs
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
Featured Unsealed Cases
United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) -
Complaint Filed: May 6, 2013 -
Complaint Unsealed: October 24, 2016...more
3/17/2017
/ Anti-Retaliation Provisions ,
Civil Penalty Fund ,
Co-Conspirators ,
Corporate Integrity Agreement ,
Criminal Penalties ,
Dismissals ,
False Billing ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Former Employee ,
Guilty Pleas ,
Home Health Care ,
Intervenors ,
Kickbacks ,
Medicaid ,
Medicare ,
Qui Tam ,
Relators ,
Stark Law ,
State False Claims Acts ,
Whistleblowers
CMS issued a final rule, published in the Federal Register on Friday, June 10, 2016, updating how the performance of ACOs participating in the Medicare Shared Savings Program (MSSP) is measured and compensated. This rule is...more
Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712...more
Last week I attended the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland. Taking a comprehensive approach to reimbursement issues, the program offered a variety of...more
As a final addition to our series on the 2016 Draft Call Letter, we highlight some of the MA contracting issues raised by the Centers for Medicaid and Medicare Services (“CMS”). Specifically, CMS (1) recommends Medicare...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
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
10/24/2014
/ Co-payments ,
Coupons ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
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