Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more
On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining...more
4/24/2024
/ Agents ,
Beneficiaries ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Final Rules ,
Health Care Providers ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
Medicare Part C ,
Medicare Part D ,
Mental Health ,
Prescription Drugs ,
Social Security Act
In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more
6/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
GAO ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Oversight ,
Reporting Requirements ,
Transparency
Continuing our series discussing the CY 2023 Medicare Advantage and Part D Final Rule (Final Rule), this post focuses on the D-SNP related provisions under the Final Rule. As we discussed, the Centers for Medicare & Medicaid...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
Last month, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a report finding that Medicare Part D, and Medicare beneficiaries, could reduce spending with increased use of...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
Last week, CMS announced proposed rules seeking to increase consumer protections and reduce health care disparities in Medicare Advantage (MA) and Part D, with a strong emphasis on individuals who are dually eligible for...more
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more
Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more
10/29/2020
/ Biologics ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Investigational New Drug Application (IND) ,
Proposed Rules ,
Provider Relief Fund ,
Public Health Emergency ,
Vaccinations
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
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription...more
5/29/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Gag Clauses ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs
Last month, we highlighted a few of the changes CMS proposes in Parts I and II of the Advance Notice and Draft Call Letter. Here, we take a look at CMS’s next steps to combat opioid misuse. CMS says it best in its Fact...more
CMS recently proposed several important changes for the Medicare Advantage ("MA") program that relate to payment, benefit design, and new actions to combat the opioid crisis. These changes, among others, were proposed in...more
2/7/2019
/ Advance Notice ,
Bipartisan Budget Act ,
Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Healthcare ,
Medicare Advantage ,
Medicare Part D ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Adjustment Formula
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
As we highlighted earlier this month, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. These documents are not typically released at the same time,...more
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
Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule (Proposed Rules) by setting out a...more
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
As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more
Last week, the Centers for Medicare & Medicaid Services (CMS) released its 2017 Advance Rate Notice and draft Call Letter (“2017 Draft Call Letter”) for the Medicare Advantage (“MA”) and Part D programs. With the final 2017...more
For too long, health industry stakeholders have bandied about massive amounts of information that could not be used in a comparative sense. Both public and private payers had their own proprietary reporting metrics,...more
The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more