Prescription Drugs Centers for Medicare & Medicaid Services

News & Analysis as of

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Health Law Insights Newsletter - Issue 8 - April 2016

McCarter & English, LLP’s Health Care Group presents Issue 8 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - New Payment Model for Part B Drugs Proposed -...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

CMS Delays Enforcement of Medicaid AMP Rules for 5i Drugs until July 1, 2016

CMS has announced that it is delaying until July 1, 2016 enforcement of new rules regarding the determination of the average manufacturer price (AMP) for inhalation, infusion, instilled, implanted or injectable drugs (“5i...more

CMS Issues Final 2017 Medicare Advantage Capitation Rates and Medicare Advantage/Part D Payment Policies

CMS has issued its final 2017 Medicare Advantage (MA) and Part D Rate Announcement and Call Letter, which includes a series of policy and payment changes related to these programs. CMS estimates that the final policies will...more

CMS Posts April 2016 Medicare Part B Drug Files

CMS has posted the payment amounts that will apply to Medicare Part B covered drugs for the second quarter of 2016. CMS notes that average prices for the top Part B drugs increased...more

CMS Finalizes 2017 Medicare Advantage Capitation Rates

On April 4, 2016, CMS released the final Medicare Advantage and Part D Prescription Drug Program payment and policy changes for 2017 (the “Final Notice”). In doing so, CMS announced a 0.85 percent increase in 2017 Medicare...more

Washington Healthcare Update

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices

Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements. A recently...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

Washington, D.C. Update – March 2016

With only a handful of items currently active on the House and Senate agendas, FY17 appropriations legislation is the major legislative game in town. The House and Senate Appropriations Committees are moving forward with...more

CMS Issues Proposed Rule to Establish a Medicare Part B Drug Pricing Demonstration

On March 11, 2016, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that establishes a demonstration to test alternative drug payment approaches under the Medicare Part B...more

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part...more

CMS Proposes Testing Medicare Part B Drug Payment Reforms to Promote Value

CMS has released a complex and controversial plan – the Part B Drug Payment Model — to test new Medicare payment methods for certain Part B drugs to determine whether alternative payment designs will reduce Medicare...more

CMS Delays Enforcement of Medicare Part D Prescriber Enrollment Requirement Until February 1, 2017

CMS is delaying until February 1, 2017 enforcement of previously-adopted regulations that require physicians and other eligible professionals who prescribe Part D drugs to be enrolled in Medicare (or have a valid opt-out...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Health Care E-Note - March 2016

On February 12, 2016, the Department of Health and Human Services’ Center for Medicare & Medicaid Services ("CMS") published its final rule. The final rule clarifies two key sections of the often described 60-Day Overpayment...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

CMS Issues Proposed Medicare Part B Drug Payment Model

On March 11, 2016, CMS published in the Federal Register its proposed new Medicare Part B Drug Payment Model. Comments are due by May 9, 2016. Below are some highlights of the proposed rule....more

CMS Unveils Proposed Part B Drug Payment Demo

On Tuesday, March 8, 2016, the Centers for Medicare & Medicaid Services (“CMS” or “the Agency”) published a proposed rule (“Proposed Rule”) to test new models ostensibly to improve how Medicare Part B pays for prescription...more

Manatt on Health Reform: Weekly Highlights - March 2016 #2

The IRS releases guidance on resolving Form 1095 conflicts; New Hampshire's Medicaid expansion renewal clears a hurdle in the State; and New York providers get $1.5 billion in long-awaited DSRIP capital and infrastructure...more

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

Proposed Rule - Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether...more

Big Payment Changes Revealed In New Medicare Part B Drug Payment Test

On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) unveiled a new Part B Drug Payment Model that, if implemented, would represent a radical change in Medicare reimbursement for outpatient drugs. The...more

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