340B Reform Legislation: Is Anything in the Offing?

By Alyce Katayama on March 31, 2015 Posted in Legislation

As readers of this blog already know, manufacturers and some legislators believe the 340B program has grown too large, suffers from mission creep and needs reform. They argue that the program’s purpose is simply to reduce drug costs for the uninsured and the indigent, nothing more. All three of the federal agencies with program oversight (HRSA, GAO, and the HHS OIG) see its purpose as helping safety-net providers stretch scarce resources.

Spoonful_Pills_101337746 These three agency viewpoints were presented on March 24, 2015 at a hearing held by the House Energy & Commerce Health Subcommittee. The subcommittee’s original news release announcing the hearing stated that its members would review the functionality of the program “to ensure it is meeting its goal of improving access to prescription drugs for needy patients at facilities serving these populations.” A later announcement took a blander tone: “Subcommittee members will review the functionality of the program to ensure it is meeting its intended goals.” This may be indicative of some disagreements behind the scene, as views on the intent of the program continue to evolve. It is not inconceivable that there could be an effort over the next couple of years to clarify the intent in new legislation. One subcommittee member even invited HRSA to be more forthcoming in requesting more legislative authority if needed.

The questioning at the hearing revealed the political fault lines on this topic. Republicans seemed more concerned about the lack of any legal requirement for covered entities to account for their uses of 340B savings, while Democrats seemed more supportive of allowing the program to generally improve access to care for the underserved. However, both parties seem to agree that improved program oversight is needed.

340B Program Covered Entities: Some Items for Your Worry List

By Alyce Katayama on March 22, 2015 Posted in Contract Pharmacies, Covered Entities, Manufacturers, Orphan Drugs

When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them.

Orphan Drugs

There is a possibility that the orphan drug issue will be resolved unfavorably to covered entities. That issue arises out of a 2014 court decision, Pharmaceutical Research and Manufacturers of American v. Department of Health and Human Services (May 23, 2014). In that case, the Pharmaceutical Research and Manufacturers of American (PhRMA) challenged HRSA’s authority to promulgate a legislative rule requiring manufacturers to provide 340B discounts on orphan drugs when used for non-orphan indications. The district court found that HRSA did not have authority to engage in legislative rule-making on that subject. HRSA has since issued a virtually identical interpretive rule requiring manufacturers to provide 340B discounts to covered entities on orphan drugs used for non-orphan indications. To reinforce its position, HRSA has recently posted on its website a list of the manufacturers who are not following this rule, stating that this will assist states in pursuing appropriate rebates, since there is no risk of duplicate discounts.

Meanwhile, back in the courts, PhRMA has again sued HRSA, this time to challenge its interpretive rule. In a motion seeking summary judgment, PhRMA accuses HRSA of “dressing a vacated regulation in the new clothing of an interpretive rule and attempting to circumvent the law.” Covered entity access to orphan drugs for non-orphan indications at 340B discounts continues to hang in the balance. Continue Reading

The Message Is Clear from OPA Director Pedley

By Alyce Katayama on February 16, 2015 Posted in Audits, Compliance, Contract Pharmacies, Covered Entities, Duplicate Discounts, Manufacturers, Orphan Drugs

Covered entities should be constantly preparing for audit. That was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast at the recent Winter Conference of the 340B Coalition in San Francisco. That preparation, she said, should include making use of the compliance tools available through Apexus (the contractor for HRSA’s Prime Vendor Program), doing self audits, and attending 340B University (the educational programs periodically offered by Apexus).

The Prime Vendor Program provides OPA with information on purchases and sales and acts as an early warning system for possible non-compliance in that area. OPA is working on having a secure website ready in 2015 where ceiling price information can be accessed.

HRSA has conducted 277 on-site audits since 2012, which included examining 3290 outpatient facilities and 8500 contract pharmacy locations. All audits done in FY12 have been finalized, but only 18 of the 99 audits done in FY14 have been finalized. This means that a lot of covered entities remain in the dark about how best to achieve compliance.

Summer 2015, perhaps June, is the target date for issuance of the “mega guidance”, which will address, among other topics, covered entity recertification, audits, and prevention of duplicate discounts, including in the context of Title XIX managed care.

All stakeholders will have an opportunity to comment on this guidance. Several notices of proposed rulemaking can also be expected this year. These will deal with civil money penalties, the calculation of ceiling prices and administrative dispute resolution. Continue Reading

340B Covered Entities: What to Expect When OPA Comes Knocking

By Alyce Katayama on February 2, 2015 Posted in Compliance, Covered Entities

Door_Knocker

Now that OPA has ramped up its audit activities, covered entities should not be surprised to find themselves on the receiving end of a 340B program review conducted by HRSA/OPA. The likelihood of this may be increased if the entity uses contract pharmacies. It is important therefore to be aware of what information is likely to be requested. This could include documentation showing the entity’s basis for eligibility in the 340B program. (This underscores the need to keep all information in the OPA database accurate and current, including information for all covered entity sites and contract pharmacies.)

The covered entity will also have to produce its organizational chart reflecting the individuals or positions responsible for administering and supporting the 340B drug program and non-340B drugs if applicable. The covered entity ought to be able to provide a brief narrative providing an overview of its 340B program and how that program is implemented and managed. Continue Reading

340B Program Participants: It’s Time to Ramp Up Compliance

By Alyce Katayama on January 15, 2015 Posted in Compliance, Covered Entities

Checklist

340B covered entities need to revisit and perhaps ramp up their compliance efforts. The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open in touting the fact that HRSA has invested in program integrity to make sure that manufacturers and covered entities remain compliant and that benefits for the intended beneficiaries of the 340B program are maximized.

To this end, OPA has created a third branch devoted to program performance and integrity. This branch will be focusing on audit activity and educating covered entities and manufacturers about compliance. Part of the education effort will include posting any agreed upon corrective action plans on the OPA website, as a public mea culpa from the audited entity for the edification of all other covered entities.

HRSA expects covered entities to self-report any identified breaches in their compliance obligations. HRSA is also adding some teeth to the compliance effort by adding questions about compliance to the process by which it reviews applications for grants from HRSA. Continue Reading

340B and the OIG Work Plan

By Jaya White on December 12, 2014 Posted in Covered Entities

Online Banking OIG’s recently issued FY 2015 Work Plan has made duplicate discounts a new focus for FY 2015. OIG “will assess the risk of duplicate discounts for 340B-purchased drugs paid through Medicaid managed care organizations (MCOs) and describe States’ efforts to prevent them.” Under the Affordable Care Act, states were required to collect rebates for drugs paid through Medicaid MCOs, and prohibit duplicate discounts under the 340B Program for the drugs. OIG’s concern, however, is that the current processes to prevent duplicate discounts for fee-for-service Medicaid may not be enough for drugs paid through MCOs.

The FY 2015 Work Plan also renewed an area of focus from the prior year’s Work Plan: exploring the opportunity to reduce Medicare Part B spending if Medicare were able to share in 340B cost savings. OIG plans to calculate the amount by which average sales price-based payments exceed 340B prices, and estimate potential savings. Medicare Part B reimburses for almost all covered outpatient drugs, including those drugs purchased by 340B entities on the basis of average sales price. If Medicare Part B could share in the 340B cost savings, providers could have additional cost savings between the average sales price based payment and the discounted 340B purchase price.

We will continue to monitor and update this blog with any activity by OIG involving the 340B program.

Controversy Continues to Swirl Around the 340B Program

By Alyce Katayama on December 10, 2014 Posted in Covered Entities

controversy_image Although the 340B program accounts for only two percent of over $300 billion in annual drug purchases in the US, there continues to be a lot of ink spilled over the question of whether the 340B program is serving its legislative intent of stretching federal resources to reduce drug costs and expand health services to appropriate patients. It is true that the program has grown and changed since 2004. The proponents argue that that growth does not reflect abuse or inappropriate use but is rather the intended result of the Medicare Modernization Act and other legislation which has expanded the program so that presently it covers six types of hospitals. Almost a third of US hospitals can now access the program for covered outpatient prescription drugs. Drug spending covered by the program is expected to grow.

As far back as 2011, the Government Accountability Office found program oversight to be inadequate.

The Mega Rule is Dead! Long Live the Interpretive Guidance Documents!

By Alyce Katayama on December 5, 2014 Posted in Covered Entities

Question_Mark_Sign

HRSA/OPA announced the withdrawal of the so-called mega rule last November. This major piece of legislative rulemaking had been over four years in the works. The rule had spent the past six months at the Office of Management and Budget, the last step prior to publication. The DC District Court ruling in Pharmaceutical Research and Manufacturers of American v. Department of Health and Human Services (May 23, 2014 https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2013cv1501-43), (relating to orphan drugs) raised serious concern about whether HRSA has any substantial rulemaking authority with respect to the 340B program. Fearing that its limited authority would not extend to any of the topics which the mega rule was expected to address, HRSA chose to withdraw it.

HRSA is now expected to take the same approach to general 340B program guidance that it is taking on the orphan drug issues.

Specifically, in the absence of authority to issue a legislative regulation, HRSA has instead issued an “interpretative rule” to the same effect. Continue Reading