On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a particular item or service is “reasonable and...more
As we begin the new year, we wanted to highlight two final developments from December 2020:
First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more
1/8/2021
/ Civil Monetary Penalty ,
Consolidated Appropriations Act (CAA) ,
Drug Pricing ,
Financial Stimulus ,
MACPAC ,
MDRP ,
MedPAC ,
New Legislation ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more
On December 14, 2020, the U.S. Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) process for the 340B Drug...more
On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored Nation” demonstration model (MFN Model) to test...more
11/24/2020
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Healthcare Reform ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Reimbursements
On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations. Comments are due no later than 5:00 p.m....more
The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized generic drugs in the Average Manufacturer...more
Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (RO Model), which would make fundamental (but temporary) changes to the...more
On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more
4/29/2019
/ Add-ons ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
Life Sciences ,
Long Term Care Facilities ,
Medical Devices ,
Payment Systems ,
Regulatory Agenda ,
Request For Information ,
Rulemaking Process
On 18 April 2019 the Centers for Medicare & Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters final rule for 2020 (2020 Payment Notice) applicable to qualified health plans (QHPs) offered on health...more
Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule (Final Rule) that accelerates the effective and implementation date of the 340B Ceiling Price and Civil Monetary Penalties final rule...more
This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
10/30/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices.
...more
5/15/2018
/ Biosimilars ,
Comment Period ,
Competition ,
Drug Pricing ,
Life Sciences ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B ,
Trump Administration
On March 23, 2018, the Centers for Medicare and Medicaid Services (CMS) published Final Notice that implements a substantially revised Medicaid National Drug Rebate Agreement (NDRA). All agreements currently in place will...more
On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more
2/16/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
MDRP ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Medicare Part B ,
Medicare Part D ,
Section 340B ,
Trump Administration
Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the...more
On June 22, 2017, Republican Senators released a “discussion draft” of the Better Care Reconciliation Act (BCRA). The draft is the first public glimpse at the Senate version of the American Health Care Act bill, which...more
6/23/2017
/ Abortion ,
Affordable Care Act ,
Employer Mandates ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Reform ,
Individual Mandate ,
Medicaid ,
Proposed Legislation ,
Repeal ,
Tax Credits ,
Trump Administration
Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate...more
5/12/2017
/ Billing ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Veterans Affairs ,
Federal Supply Schedule (FSS) ,
Healthcare Facilities ,
Indian Health Service (IHS) ,
Medicaid ,
Medicaid Reimbursements ,
Native American Issues ,
Prescription Drugs ,
Regulatory Standards
On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule)...more
On 15 February 2017, the Centers for Medicare & Medicaid Services (CMS) took a step toward addressing concerns about the stability of the individual and small group health insurance markets by proposing a modicum of...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
1/9/2017
/ Affordable Care Act ,
Civil Monetary Penalty ,
Covered Entities ,
Drug Pricing ,
Final Rules ,
Healthcare ,
HRSA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Trump Administration