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January 29, 2018

Preserving 340B Is Essential to Our Most Vulnerable Patients

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ORGANIZATIONS PROVIDING CARE TO MEDICALLY UNDERSERVED rely on the 340B Drug Pricing Program, and ASHP is committed to fighting ongoing threats to the program that could have serious consequences for our patients. ASHP has a long history of support for the 340B program, and many of our members have seen firsthand the benefits of the program to the patients they serve. As Congress considered overhauling the nation’s healthcare system last year, ASHP developed Principles on Healthcare Reform that included our support for the 340B program. We continue to collaborate with numerous stakeholders, including our longstanding partners at the American Hospital Association (AHA) and 340B Health, to prevent cuts to program eligibility and scope.

Last August, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that cuts Medicare Part B reimbursement for drugs purchased through the 340B program from ASP plus 6 percent to ASP minus 22.5 percent. Along with the AHA and many other like-minded stakeholders, ASHP submitted comments to CMS opposing the cuts. In addition to the comments, ASHP lobbied on Capitol Hill to garner signatures to a Dear Colleague Letter from Congress to CMS urging the agency not to go through with the cuts. During ASHP’s annual Legislative Day in September, over 100 ASHP members met with their members of Congress to discuss, among other issues, the importance of the 340B program to their organizations and the critical role it plays in their ability to provide care to the medically underserved.

In November, CMS finalized the rule, and the reimbursement cuts were set to begin this year. AHA has filed a lawsuit challenging CMS’s authority to impose the cuts on the federal 340B program, and ASHP is supportive of AHA’s efforts. We are extremely disappointed that the rule putting the cuts in effect was finalized, and we remain committed to advocating for overturning this rule.

To that end, ASHP supports legislation (H.R. 4392) that would block the CMS-imposed cuts. Sponsored by Representatives David McKinley (R-W.V.) and Mike Thompson (D-Calif.), the bill currently has 181 co-sponsors in the House. In addition to our letter of support, ASHP has created a grassroots letter of support for our members to send using our electronic letter-writing platform.

We know that there will be additional threats to the 340B program in 2018. For example, recently introduced legislation (H.R. 4710) would impose a two-year moratorium on disproportionate share hospitals applying to become covered entities within the federal 340B program. This bill would also require additional reporting requirements, including reporting of the number of insured patients, total cost of charity care provided, reimbursement for all drugs, and a listing of all third-party vendors associated with the 340B program. ASHP has strong concerns over this legislation, and we expressed our opposition in writing to the bill’s sponsors. Similar legislation (S. 2312), was introduced in the Senate, and ASHP will oppose that bill as well.

We expect to see additional legislation later this year. The House Energy and Commerce Committee last week released a report on the 340B Drug Pricing Program. The committee has been examining the structure, operation, and oversight of the program over the past two years through stakeholder meetings, committee hearings, and document collection. Further, Committee Chairman Greg Walden (R-Ore.) has stated that there will be legislative efforts to change the 340B program this year to focus on definition, transparency, and oversight. ASHP developed an issue brief summarizing that report and the potential legislative options that may result.

ASHP remains committed to supporting the 340B Drug Pricing Program, and we will continue to do so through assertive advocacy on Capitol Hill, grassroots advocacy, comments to federal agencies, and meetings with agency officials. Further, ASHP will continue working with other program supporters such as AHA and 340B Health to protect the program from threats, both legislative and regulatory.

Thanks so much for continuing to advocate on behalf of your patients and the profession, and for being a member of ASHP.

Sincerely,

Paul

January 8, 2018

Drug Shortages Harm Patients

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ASHP AND OUR COLLEAGUES AT THE UNIVERSITY OF UTAH have been leaders in providing ASHP members, policymakers, and the entire healthcare community with timely information on drug shortages for nearly 15 years. We have also worked hand in hand with numerous stakeholders to find solutions to help minimize or prevent drug shortages. These efforts have included passing federal legislation and holding numerous multidisciplinary summits on drug shortages, with the most recent stakeholder summit taking place on November 6, 2017, at ASHP headquarters.

Today, although progress has been made, drug shortages are still significantly threatening the ability of ASHP members and their healthcare colleagues to provide care to patients. It is unacceptable in the United States that drug shortages can happen as frequently as they do — and certainly not acceptable for them to harm patients. Regardless, the problem persists and grows, with the most recent being the severe shortage of small-volume parenteral (SVP) solutions.

Soon after we became aware that an SVP shortage had emerged, ASHP and the University of Utah released a resource on the conservation and management of SVPs. This resource has proven useful to ASHP members and other providers, and its use has been encouraged by the FDA Commissioner.

We have also been working on a daily basis with the FDA, Congress, and numerous other concerned organizations to find solutions for all drug shortages and advocate for needed changes. Further, we are working to keep the entire shortage situation on the radar of the media. ASHP also immediately conducted a survey to better understand the magnitude of SVP and other shortages, and to use that survey data in our advocacy and media outreach on behalf of our members and their patients.

ASHP believes that it is time for Congress to get involved to stop this threat to safe and effective patient care. ASHP recently led the development of a congressional call to action with other key stakeholders. In that letter, ASHP and our partners asked Congress to examine the following questions to address the underlying causes of shortages:

  • Should manufacturers be required to disclose to the medical community their manufacturing sites and the products produced in those sites, in terms of volume and percentage of product line?
  • Should sole-source products be allowed to be produced in a single plant?
  • Should there be redundancy in production of critical products?
  • Should the FDA identify a list of “critical medications” that would require manufacturers to develop a reasonable contingency plan in the event of a production interruption or shutdown?
  • What incentives could be developed for other manufacturers to increase production when drug shortages occur?
  • What can be done to determine the best locations of pharmaceutical plants in addition to ensuring that backup systems can quickly accommodate needs in the event of a disaster, given there are several types of natural disasters that can occur?

We strongly believe that the current drug shortage situation is unacceptable and unsustainable. It threatens harm to patients, wastes valuable healthcare resources, causes great uncertainty, and disrupts the healthcare system. Congress should not wait to take action on drug shortages until the current crisis worsens even further. The time for leadership and action is now.

ASHP will continue to be the leader on this critical patient care and patient safety issue until we and our partners find solutions that ensure that no patient is ever affected as a result of a drug shortage. Please contact your member of Congress through ASHP’s call to action, and please continue to review ASHP’s website and other communications for updates. Also, please don’t hesitate to contact us if you have any questions or need assistance from our drug shortages staff team. ASHP is looking for both short-term relief to current shortages and long-term solutions. Therefore, fixing the drug shortage problem will remain a top priority for ASHP until meaningful and systemwide solutions are identified and implemented.

Thanks so much for being a member of ASHP, and for everything that you do for your patients.

Paul

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