The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more
As part of its 2025 Medicare Advantage and Part D Final Rule (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) made a number of enrollment changes impacting dual eligible special needs plans (DSNPs). The...more
On February 15, 2024, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Prescription Payment Plan Draft Part Two Guidance (Part Two Guidance) as part of the Inflation Reduction Act’s (IRA) efforts to...more
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more
Most of the recent focus around the implementation of the Inflation Reduction Act (IRA) by the press and the industry has been on the Medicare Drug Price Negotiation Program and its potential impact on manufacturers. But the...more
Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more
Private equity (PE) ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. For...more
Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the...more
Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA)...more
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
At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best...more
As we noted, Centers for Medicare & Medicaid Services (CMS) recently proposed its Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed...more
At the end of September, the Departments of Health and Human Services (HHS), Labor, and Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), released Part II of its regulations...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
7/20/2021
/ Antitrust Provisions ,
Biden Administration ,
Biosimilars ,
Competition ,
CREATE Act ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Pharmaceutical Industry ,
USPTO
Late last week, the Departments of Health and Human Services (HHS), Labor, and Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), released the “Requirements Related to Surprise...more
With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more
In November 2019, the U.S. Department of Health and Human Services, along with the U.S. Department of Treasury and the U.S. Department of Labor, (collectively, the Departments) released a proposed rule requiring group health...more
1/30/2020
/ Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Employer Group Health Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare Costs ,
Proposed Rules ,
Public Comment ,
Transparency ,
U.S. Treasury
Recently, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG...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
As of January 30, 2019, CMS lifted its temporary provider enrollment moratoria (“Enrollment Moratorium”) for home health agencies (“HHAs”) in Florida, Illinois, Michigan and Texas. The Enrollment Moratorium had prevented new...more
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more
10/17/2018
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Disclosure Requirements ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Television Commercials
Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”),...more
States may be starting to take aim at prescription automatic refill programs. Automatic refill programs have been proven to increase patient adherence, especially among patients with chronic conditions. However, these...more