August 2017The 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be unavailable from August 15, 2017 through mid-September, 2017.
As part of the transition to the new 340B Office of Pharmacy Affairs Information System (340B OPAIS), the current 340B database will be offline and unavailable as of August 15, 2017. HRSA will begin to archive the information in the current 340B database in preparation for the release of the registration component of the new 340B OPAIS in mid-September 2017. Specific dates will be forthcoming. During this time, covered entities will not be able to submit change requests or terminations. However, external users can continue to verify covered entity participation, manufacturer participation, and contract pharmacy locations in the 340B Program with the following available resources:
January 2017The Department of Health and Human and Human Services has withdrawn the final 340B program mega-guidance from White House review. The Office of Budget and Management announced the action on its Reginfo.gov website.
January 2017Office of Pharmacy Affairs Update January 2017 A Final rule titled "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation" was published in the Federal Register on Thursday, January 5, 2017. On June 17, 2015, HRSA issued a Notice of Proposed Rulemaking (NPRM) to implement Civil Monetary Penalties (CMPs) for manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug; to provide clarity on the requirement that manufacturers calculate the 340B ceiling price on a quarterly basis; and to establish the requirement that a manufacturer charge a $.01 (penny pricing policy) for drugs that calculation equals zero (80 FR 34583 (June 17, 2015)). The public comment period closed during August 2015, and HRSA received approximately 35 comments. After review of the initial comments, HHS reopened the comment period (81 FR 22960 (April 19, 2016)) to invite additional comment on specific areas of the NPRM: 340B ceiling price calculations that result in a ceiling price that equals zero (penny pricing); the methodology that manufacturers utilize when estimating the ceiling price for a new covered outpatient drug; and the definition of the “knowing and intentional” standard to be applied when assessing a CMP on manufacturers who overcharge a covered entity.
The comment period closed May 19, 2016, and HHS received approximately 70 additional comments. The rule was finalized and published on January 5, 2017. The provisions of the final rule include: • the requirement that a manufacturer calculate the 340B ceiling price on a quarterly basis; • the requirement that a manufacturer charge $0.01 per unit of measure if the 340B ceiling price calculation results in a ceiling price that equals zero (penny pricing); • the methodology manufacturers must use when estimating the ceiling price for a new covered outpatient drug; • an explanation of how a civil monetary penalty (CMP) would be imposed on a manufacturer that knowingly and intentionally overcharges a covered entity; and • an explanation of what would constitute an instance of overcharging to trigger a CMP. The final rule replaces all former guidance on Penny Pricing and New Drug Pricing, including the Penny Pricing Policy Release No. 2011-2 (November 21, 2011) and the Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 New Drug Pricing. The final rule will be effective March 6, 2017. However, HRSA recognizes that the effective date falls in the middle of a quarter. As such, HRSA plans to begin enforcing the requirements of this final rule at the start of the next quarter, which begins April 1, 2017. HRSA plans to post FAQs and host a webinar to provide an overview.
January 2016HRSA plans to publish its final 340B Program “mega-guidance” in September 2016. HRSA released the long-awaited “mega-guidance” in August 2015 and received over 800 comment submissions, many of which raised significant legal and operational concerns related to HRSA’s proposal. In addition to these comments, HRSA must also consider the impact of a recent federal court decision, which vacated HRSA’s orphan drug rule, calling into question HRSA’s rulemaking authority.
August 2015The Health Resources and Services Administration (HRSA) published the long-awaited 340B Drug Pricing Program Omnibus Guidance, more commonly referred to as the “Mega Guidance.” It includes recommended changes and clarifications to a number of 340B program items. Covered entities and other parties are encouraged to comment on the Mega Guidance; those comments must be submitted by October 27, 2015.
May 23, 2014From HRSA:
On May 23, 2014, the U.S. District Court for the District of Columbia issued a ruling in Pharmaceutical Research and Manufacturers of America v. US Department of Health and Human Services (HHS) (Civil Action No. 13-1501) that vacated the orphan drug regulation on the grounds that HHS lacks the statutory authority to engage in such rulemaking. However, the Court did not invalidate HRSA’s interpretation of the statute. HHS/HRSA continues to stand by the interpretation described in its published final rule, which allows the 340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation. HRSA is continuing to post updated Orphan Drug Designation Lists, found below, as well as the Orphan Selection File, found on the 340B database, in order to assist all 340B stakeholders in complying with HRSA's policy.
340B hospitals subject to the orphan drug exclusion (critical access hospitals, free-standing cancer hospitals, sole community hospitals and rural referral centers) are responsible for ensuring that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drugs are designated under section 526 of the Federal Food, Drug, and Cosmetic Act.
July 22, 2013Safety Net Hospitals for Pharmaceutical Access
Statement on 340B Orphan Drug Exclusion Final Regulation
Safety Net Hospitals for Pharmaceutical Access (SNHPA) is pleased to see that the Health Resources and Services Administration (HRSA) has finalized the reasonable interpretation of the 340B orphan drug exclusion that the agency previously published in its May 2011 proposed rule. HRSA’s final regulation is consistent with common sense and only excludes orphan drugs from the 340B drug discount program when a critical access hospital, sole community hospital, rural referral center or free-standing cancer hospital uses an orphan drug to treat the rare disease or condition for which the drug received its orphan designation from the Food and Drug Administration (FDA). The orphan drug exclusion has prevented these hospitals from accessing the full benefit of 340B, and this final regulation will help them advance their mission of serving the nation’s most vulnerable patients. These hospitals are ready and willing to implement the systems necessary to ensure compliance with the final regulation and uphold the integrity of the 340B program. Nevertheless, we continue to believe the underlying provision in the law is fundamentally flawed. It discourages the affected rural and free-standing cancer hospitals from enrolling in or fully benefitting from 340B while doing little to advance the objectives of the orphan drug program.
July 15-17 201317th Annual 340B Coalition Conference on Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws will be held at the Omni Shoreham Hotel in Washington, DC
May 7, 2013AHF: Fed Court Throws Out California Pharmacy Cuts Federal Court Permanently Enjoins the State of California’s Department of Health Care Services (DHCS)— the Agency that Administers the State’s Medicaid Program—From Enforcing a California Law that Slashed Reimbursements for Safety Net Providers that Participate in the Federal 340B Drug Pricing Program
In a sharp rebuke to California Medicaid officials, a federal court has invalidated a California state law that hurt safety net medical providers that participate in a federal program known as the 340B Drug Pricing Program, which allows qualified health care organizations that care for underserved people to purchase outpatient drugs at discounted prices. On Friday, the United States District Court, Central District of California, ruled that defendant Toby Douglas, Director of the California Department of Health Care Services (DHCS) and “…his agents, servants, employees, attorneys, successors, and all those working in concert with him, are permanently enjoined from enforcing Section 14105.46.” (of California’s Welfare and Institutions Code) The ruling came in the case ‘AIDS Healthcare Foundation vs. Toby Douglas, Director of the California Department of Health Services et al’ (case number CV 09-8199-R). The legal action, filed by AIDS Healthcare Foundation (AHF), challenged the State’s attempt to solve its fiscal woes by slashing drug reimbursements to 340B safety net providers and forcing them to accept an amount that undisputedly could not cover their actual dispensing costs. The court granted AHF’s motion for summary judgment because: “(a) the State of California and Defendant failed to obtain federal approval of a state plan amendment before implementing Section 14015.46, and (b) neither the Legislature nor the Defendant considered the relevant Title 42 U.S.C. § 1396(a)(30)(A) factors before implementing Section 14105.46.” In other words, the State slashed 340B providers’ drug reimbursement – but not those of their commercial pharmacy counterparts – without considering whether doing so would be consistent with Medicaid program efficiency, economy, and quality of beneficiary care, nor did the State consider whether Section 14105.46 would have an adverse impact on Medi-Cal beneficiaries’ access to health care services to the same extent as the general public. “The federal court has slapped down yet another California state effort to fix its budget problems on the backs of the poor and the powerless,” said Laura Boudreau, Chief Counsel for Operations for AHF. “This is an important victory for safety net providers throughout California and nationwide.
November 2012340B Flexibilities During Disasters
The Secretary of the U.S. Department of Health and Human Services has determined that a public health emergency exists and has existed in the State of New York (since October 27, 2012) and the State of New Jersey (since October 26, 2012). Accordingly, the Office of Pharmacy Affairs has begun rolling admission to the 340B program for covered entities in New York and New Jersey as well as for new contract pharmacy arrangements between covered entities in the two states and their partners.
Affected covered entities in New York and New Jersey may register at any point throughout the duration of the emergency; entities may begin participating on the start date reflected in the 340B Program database. Entities in the two states that were previously approved for 1/1/2013 start dates may begin utilizing the program as soon as their records have been updated in the program database. In addition, change requests from New York and New Jersey entities will be prioritized to ensure continued access to 340B pricing.