Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Oct. 28 — A group of 23 Republican lawmakers Oct. 28 asked the Office of Management and Budget to revise a pending CMS rule that would subject innovations for abuse-deterrent versions of opioids to additional Medicaid rebate obligations.
The proposed rule, issued by the Centers for Medicare & Medicaid Services in 2012 (77 Fed. Reg. 5,318, Feb. 2, 2012) (CMS-2345-F), would penalize innovation in a field that is important to the fight against prescription drug abuse, the lawmakers said in a letter. The White House OMB started its review of the final rule on Medicaid outpatient drug reimbursement in August.
“We are concerned that unless there are substantial modifications to the proposed rule, under the final rule, manufacturers of medications with abuse-deterrent formulations (ADF) would be subject to additional rebate obligations under the Medicaid program,” the letter said. “This policy outcome would be a misunderstanding of Congressional intent. Additional mandatory rebate obligations would also serve as a strong disincentive for industry leaders developing ADF products that can help reduce prescription opioid overdose deaths in our country.”
The letter, spearheaded by Senate Finance Committee Chairman Orrin G. Hatch (R-Utah) and House Energy & Commerce Committee Chairman Fred Upton (R-Mich.), garnered the support of nearly two dozen Republican lawmakers in both the Senate and House.
In comments on the proposal submitted in 2012, stakeholders said they have concerns, including administrative burdens associated with it, rebate provisions and various definitions related to pricing.
The Centers for Disease Control and Prevention (CDC) estimates that opioid abuse costs the U.S. economy tens of billions of dollars each year in lost productivity and health-care costs, according to a press release from the lawmakers. Currently, more than 4 million Americans misuse or abuse prescription painkillers, and more than 16,000 individuals die from prescription painkiller overdoses each year.
Drug overdose related deaths account for the majority of injury-related deaths in the country, the press release said.
The Oct. 28 letter is addressed to Howard Shelanksi, administrator of the Office of Information and Regulatory Affairs at the OMB. According to information on the OMB's reginfo.gov website, the final CMS rule “revises requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act.” The rule “also revises other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program,” the OMB said.
To contact the reporter on this story: Bronwyn Mixter in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
The letter is at http://src.bna.com/NR.
The proposed rule is at http://www.gpo.gov/fdsys/pkg/FR-2012-02-02/html/2012-2014.htm.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)