This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.
REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.
The Inflation Reduction Act’s Medicare DrugPrice Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.
Throughout 2022, Novartis was at the opposing ends of legal cases. Multiple lawsuits and petitions have been filed in an attempt to block the imminent release of generic versions of Novartis’ blockbuster drugs Gilenya (fingolimod) and Entresto (sacubitril/valsartan). These actions allegedly led to the extension of Novartis’ patents.
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. 20 National Health Council, National Health Council 2023 Public Policy Issue Areas Survey (internal survey, Policy & Government Affairs, 2022).
The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. had Part D expenditures on or before August 16, 2022).
The survey results also indicated that drugpricing and reimbursement constraints will be the second biggest concern, hampering the industry’s growth, as indicated by 30% of the surveyed respondents. To adapt is the only way to thrive. The pharmaceutical sector will need to find new ways to offset regulatory and inflationary pressures.
Biden’s SOTU: 500 Drugs To Be Subject to Medicare DrugPrice Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.
Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drugprice transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drugprice transparency reporting.
CMS Releases Guidance Memo on Medicare DrugPrice Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare DrugPrice Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.
The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drugprices under Medicaid as part of a new proposal. This new plan builds on President Biden’s Executive Order on Lowering Drug Costs for Americans signed in October 2022.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
52 
Let's personalize your content