Search Results for CMS

Showing 1 – 25  of 35

CMS Shifts Coding and Payment Policy for Biosimilars Under Medicare Part B By Zachary Brennan - Published 02 November 2017

The Centers for Medicare and Medicaid Services (CMS) late Thursday announced that it would finalize a policy to separately code and pay for biosimilar products under Medicare Part B, signaling a win for industry.

Categories: News, US, Biologics and biotechnology, Reimbursement

Tags: CMS, biosimilars

Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices By Mark Domyahn - Published 21 August 2017

This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy.

Categories: Features, US, FDA, Medical Devices, Reimbursement

Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage

2016 CMS Data on Industry Payments to US Physicians, Hospitals: Company Breakdowns By Zachary Brennan - Published 30 June 2017

The US Centers for Medicare and Medicaid Services (CMS) on Friday released 2016 data on more than $8 billion in payments (which is on par with 2015 data) made by 1,481 pharmaceutical, biotech and medical device companies to more than 600,000 physicians and 1,146 hospitals.

Categories: News, US, Biologics and biotechnology, Drugs

Tags: CMS open payments, drug industry payments to doctors

Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy By Zachary Brennan - Published 12 May 2017

Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services Secretary and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS), with concerns about the biosimilar reimbursement policy from a recently issued final rule.

Categories: News, US, FDA, Biologics and biotechnology, Reimbursement

Tags: biosimilar reimbursement, HCPCS, reimbursement code, CMS

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test By Zachary Brennan - Published 18 April 2017

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

Categories: News, US, Compliance, Crisis management, In vitro diagnostics, Medical Devices

Tags: Theranos, blood test, Arizona, CMS

New House E&C Chairman to Consider Value-Based Drug Price Negotiations By Zachary Brennan - Published 02 February 2017

The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices.

Categories: News, US, Drugs, Reimbursement

Tags: Walden, House E&C, Schrader, Merck, CMS drug negotiations

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

Senate Democrats to Trump: Work With us to Lower Drug Prices By Zachary Brennan - Published 20 December 2016

Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.”

Categories: News, US, Drugs, Reimbursement

Tags: Franken, Elizabeth Warren, Trump, CMS, drug prices

CMS Drops Medicare Part B Drug Payment Pilot By Zachary Brennan - Published 16 December 2016

The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending.

Categories: News, US, Drugs, Reimbursement

Tags: CMS Part B, Medicare drug costs, Medicare payment program, Medicare pilot

HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco By Zachary Brennan - Published 12 December 2016

In light of concerns over the misclassification of Mylan’s EpiPen and subsequent overcharging of the federal government for the life-saving allergy drug, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) late last week said it will review the Medicaid Drug Rebate Program.

Categories: News, US, FDA, Drugs, Government affairs, Reimbursement

Tags: CMS, EpiPen, Mylan, Andy Slavitt

CMS Updates Drug Pricing Dashboard, Calls for Affordable and Accessible Pharmaceuticals By Zachary Brennan - Published 14 November 2016

As the rising prices of pharmaceuticals continue to hurt Americans' pockets, the US Centers for Medicare & Medicaid Services (CMS) are using transparency to highlight some of the steepest price spikes that are costing Medicare and Medicaid the most.

Categories: News, US, Drugs, Postmarket surveillance, Reimbursement

Tags: CMS, drug spending dashboard, pharmaceutical prices

FDA and CMS Parallel Reviews of Devices to Continue By Michael Mezher - Published 21 October 2016

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday.

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel review, National coverage determination, Centers for Medicare & Medicaid Services, CMS

What Drugs Really Cost: GAO Wants CMS to Find Out By Zachary Brennan - Published 02 August 2016

In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). 

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs, Reimbursement

Tags: GAO, CMS drug prices, Part B, drug pricing, ASP

Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results By Michael Mezher - Published 06 July 2016

A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards.

Categories: News, US, FDA, Government affairs, In vitro diagnostics

Tags: Theranos, CMS, Test Results, Edison

FDA Draft Guidance to Assist CMS With IDE Coverage Decisions By Michael Mezher - Published 31 May 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS).

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement

Tags: CMS, Reimbursement, Investigational Device Exemption, IDE, Early feasibility studies, EFS, Category A, Category B, Medicare

Pew: Insurance Claims Must Include UDIs to Track Device Safety By Michael Mezher - Published 13 April 2016

The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care.

Categories: News, FDA, Medical Devices, Postmarket surveillance

Tags: Unique device identifier, UDI, claims forms, CMS, Pew Charitable Trusts, Josh Rising

Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms By Michael Mezher - Published 09 March 2016

Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: UDI, Unique Device Identifier, Sen. Elizabeth Warren (D-MA), Sen. Charles Grassley (R-IA), CMS, Centers for Medicare and Medicaid Services

FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests Published 20 April 2015

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: LDTs, Lab Developed Tests, CMS, CLIA, FDA/CMS Task Force on LDT Quality Requirements

FDA Announces First-Ever Approval Under CMS Parallel Review Program By Alexander Gaffney, RAC - Published 12 August 2014

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Reimbursement, Submission and registration

Tags: CMS, FDA CMS Pilot, Parallel Review, National Coverage Determination, NCD,

FDA-CMS Parallel Review Program Gets Expected Extension to Cover Medtronic, Other Devices By Alexander Gaffney, RF News Editor - Published 17 December 2013

Categories: US, FDA

Tags: CMS

Sunshine Act Reporting: Research Payments and Requests for Delayed Publication By Jane Wright-Mitchell, PharmD, JD - Published 18 June 2013

On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). This article focuses specifically on the issue of research and development-related payments.

Categories: US, FDA

Tags: Physician Payment Sunshine Act, Sunshine Act, Transparency, It's the Law, CMS, PPACA

Medtronic Renal Denervation Device Accepted for Joint FDA-CMS Review By Alexander Gaffney, RF News Editor - Published 07 March 2013

Categories: FDA

Tags: CMS

Long-Awaited Sunshine Act Regulation Released By Alexander Gaffney, RF News Editor - Published 04 February 2013

Tags: Physician Payment Sunshine Act, Sunshine Act, Transparency, Latest News, CMS, PPACA, regulation, industry

Senator Calls--Again--for White House to Release Sunshine Act Rules By Alexander Gaffney, RF News Editor - Published 23 January 2013

Categories: FDA

Tags: Lew, White House, Delay, Sunshine Act, Letter, Payment, Latest News, DHHS, CMS, Grassley, PPACA