FDA Announced Final Guidance on “Nonproprietary Naming of Biological Products”
The FDA announced the release of the final guidance on the “Nonproprietary Naming of Biological Products.” The agency has decided on a naming convention that supports a distinguishable randomized, four-letter suffix, devoid of any meaning for biosimilars. However, the FDA is still continuing to consider the appropriate suffix format for interchangeable biological products. Please select the button below for the full guidance.
The Federal Register alert mentions the open comment period; exact dates are not set yet, but would likely be February 13.
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CMS Medicare Part B Proposal Draws Criticism
More than 300 groups, are urging House and Senate leadership to press CMS to permanently withdraw the Innovation Center experiment to overhaul payments for Part B drugs. Work is also ongoing with federal lawmakers, to garner additional pressure on the administration regarding the proposal.
FDA Guidance and Biologics 2020
Some medical products regulated by FDA as drugs will be considered biologic medicines come March 23, 2020 per the biologics law created under the Affordable Care Act. With that change FDA says that any unexpired period of exclusivity for a transitional product – those approved as drugs that will convert to biologics in 2020.
Congress Passes Affordable Care Act Repeal.
On January 6, 2016, Congress successfully passed a bill to repeal the Affordable Care Act (ACA). This action is largely symbolic as President Obama vetoed the bill on January 8, 2016. While Senate Republicans will not be able to produce enough votes to override the veto, they cite the passage HR 3762 as evidence that they kept their promise to repeal Obamacare.
Biosimilar Coding and Payment.
Per their final rule issued October 30, 2015, CMS will begin to assign all Biosimilars the same HCPCS code as the biologic reference product. Payment will be based the average sales price of all national drug codes included within the same billing and payment code. The rule became effective January 1.
July 20, 2009
Dear WRA Member,
Thanks to Nilsa Cruz our local advocacy “hawk” we have some issues that will pay big dividends for a small investment of your time.
Prompt pay discount legislation advocacy site for physicians supporting infusible drugs: PLEASE CLICK HERE TO LEARN MORE. IT ONLY TAKES ONE MINUTE TO FILL OUT THE CONTACT INFORMATION!!!
CONSULTATION codes are being deleted by Medicare for year 2010. This goes against current AMA CPT coding guidelines, however CMS already indicated that AMA's CPT guidelines are not followed by Medicare. The ACR (Tiffany Schmidt) wants to hear from you as well--addressing this issue is on their agenda--. Specifically, you can send comments to Tiffany at email@example.com. Please indicate how these changes impact you, your practice, and the patients you serve.
It is expected that the "New" patient allowable increase for 2010 will not even come close to your loss of revenue by the inability to utilize consultation codes.
The above applies to inpatient consults as well.
Below you will also find a GREAT explanation by another rheumatologist, identifying what else is going to happen with YOUR infusions and infusion admin codes$$$...as proposed by CMS. Moreover, "Academic rheumatology practices are highly consultative and the impact on Rheumatology Divisions of cutting 40% of the new patient consultations would be enormous and would further reduce teaching in rheumatology to fellows, residents and students as clinical academic rheumatologists would have to see even more patients in less time.”
CLICK HERE TO READ THE FULL PRESS RELEASE.
April 23, 2009
We are notifying our members about the proposed House of Representatives Bill 1392. This bill is requesting that the prompt pay discount which manufacturers pass on to wholesalers is removed from the ASP calculation for reimbursement of drugs to the providers for Medicare. This discount is given to the wholesaler if they pay promptly within 30 days. By this 1-2% discount being included, it decreases the reimbursement to the provider for the drugs which they administer in their practices. If this Bill passes, the prompt pay discount will be removed and the reimbursement for drugs will be at a higher rate.
We are asking that our members contact their Congressmen requesting that they support HR Bill 1392. Please go to http://www.geocities.com/CollegePark/Den/7179/WI.htm to find your respective Congressman and send them an e-mail.
Bill 1392 and also a sample letter written to a Congressman from an oncology society are available below for your review.
April 7, 2009
Last week, Senators Blanche Lincoln (D-Ark.) and Olympia Snowe (R-Maine) and Representatives Shelley Berkley (D-Nev.) and Michael Burgess, MD (R-Texas) introduced the “Medicare Fracture Prevention & Osteoporosis Testing Act” (S.769/H.R.1894).
If passed, this legislation would improve access to, and increase utilization of, bone mass measurement by restoring payments of duel-energy X-ray absorptiometry (commonly called DXA) to 2006 levels. Restoring payments to these levels is critical to ensure access to this essential procedure.
Please take a few moments to contact both of your senators and your U.S. representative and urge them to support this important legislation.
When you contact your legislators, you will want to ask:
- Both of your senators to co-sponsor S. 769
- Your U.S. representative to co-sponsor H.R. 1894
You can do this by:
For more information, e-mail Aiken Hackett or contact her by phone at (404) 633-3777.
State Representative Robin Vos
State Capitol – Room 321 East
Post Office Box 8953
Madison, Wisconsin 53708
Phone: (608) 266-9171
Toll Free: (888) 534-0063
Fax (608) 282-3663