by admin | December 16, 2014 3:31 pm
December 16, 2014—For the 340B community, 2014 will go down as the year that a federal court invalidated the 340B orphan drug exclusion regulation, derailing the long-awaited 340B “mega-reg” plus other program regulations in the works. [ms-protect-content id=”2799″]
This year’s 10 most-popular Drug Discount Monitor stories (based on unique page views) show that regulations were our readers’ main concern in 2014. Eight of the 10 articles dealt with either the mega-reg, the orphan drug rule, or planned rules on state AIDS drug assistance 340B rebates, hemophilia treatment centers 340B-derived program income, dispute resolution, ceiling prices, and manufacturer civil monetary sanctions.
Here are DDM’s Top 10 for 2014:
10. PhRMA Lays Down Markers for 340B Mega-Reg[1]
Calls for program to be limited to “uninsured individuals”
May 29, 2014—The nation’s major drug companies gave White House officials a 16-page document detailing changes they wanted to see made to the 340B drug discount program in the comprehensive 340B regulation.
9. Congress Agrees to More than Double 340B Program Funding[2]
OPA would be expected to implement long-delayed requirements
January 14, 2014—House and Senate negotiators signed off on a federal spending bill that more than doubled the Health Resources and Services Administration Office of Pharmacy Affairs’ budget, including $6 million for new 340B program integrity efforts.
8. Recent Court Decision May Affect Hospitals’ 340B Eligibility[3]
Ruling involves how HHS calculates DSH adjustment percentages going back to 2004
April 22, 2014—A federal appellate court left open the possibility that the Secretary of Health and Human Services would calculate Medicare disproportionate share adjustment percentages going back 10 years in a way that disqualifies some hospitals for 340B drug discounts.
7. OMB Is Reviewing 340B Mega-Reg[4]
Signs point to publication in early July
April 9, 2014—HRSA sent its proposed 340B “mega-reg” to the White House Office of Management and Budget for review prior to publication in the Federal Register, according to a notation on the OMB website.
6. HRSA Plans to Issue Two More 340B Regulations[5]
Rules will apply to AIDS drug assistance programs and hemophilia treatment centers
June 3, 2014—HRSA planned to issue two more proposed 340B program regulations on top of its comprehensive program rule.
5. HRSA Setting 60-Day Comment Period for 340B Mega-Reg[6]
Agency would consider letting drugmakers audit providers at random, Pedley says
April 2, 2014—Stakeholders were to have received 60 days to comment on the proposed 340B “mega-reg” that was on track to be published in June, OPA Director Cmdr. Krista Pedley said at a drug industry conference.
4. HRSA to Issue Three More 340B Regulations[7]
Rules will create dispute resolution system and establish sanctions for manufacturers and providers
March 6, 2014—While attention focused on the 340B “mega-reg,” HRSA was moving ahead with three other regulations that would have created a mandatory administrative dispute resolution process for 340B; imposed fines on drugmakers for knowing and intentional overcharges; and imposed fines on safety-net providers for violating the 340B statute knowingly and intentionally and removed them from 340B for systematic and egregious misconduct.
3. HRSA Withdraws 340B Mega-Reg, Will Issue Guidance Instead[8]
Publication expected early next year
November 13, 2014—HRSA said it was withdrawing its planned comprehensive 340B program regulation and instead would issue guidance in early 2015 revising policies for key program elements.
2. Will 2014 Be the Year of the 340B Mega-Reg?[9]
A rundown of what’s in store for 340B in the coming year
January 10, 2014—With just one exception, the federal government always managed the 340B program without formal regulations, setting 340B’s rules of the road instead through guidelines, policy releases, FAQs, and the like. All of that might have shifted in 2014 if HRSA had achieved its oft-stated goal of publishing a far-reaching proposed regulation for 340B.
1. Federal Judge Invalidates 340B Orphan Drug Regulation[10]
Rules that Congress did not grant HHS the requisite rulemaking authority
May 23, 2014—A federal district judge ruled that HHS has no authority under the 340B statute to promulgate regulations implementing the Affordable Care Act’s 340B orphan drug exclusion, which applies to hospitals registered in 340B as critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals.
Coming in early January – Our comprehensive preview of what’s in store for 340B in 2015. [/ms-protect-content]
Source URL: https://340bemployed.org/the-top-ten-340b-stories-of-2014/
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