July 26, 2013

AACP Policy Framework
AACP Issue Briefs
Advocacy Sign On Letters
Budget and Appropriations Tables
Letters to Congress and the Administration
Academic Pharmacy Now - Capitol Hill News
AACP Advocacy Updates and Alerts

July 26, 2013 

United States Congress

Senate committees move funding bills: The Senate Appropriations Committee has passed two FY14 funding bills that include provisions of importance to academic pharmacy. The Labor, Health and Human Services and Education bill (S1284 and the accompanying report S113-71) recommends FY14 funding levels that do not recognize the reductions to FY13 funding levels due to sequestration. This makes comparison of FY14 levels to FY13 levels a bit difficult. A few, such as the NIH, get a small increase and others are flat funded or are decreased.

The House Appropriations Subcommittee on Labor, Health and Human Services and Education cancelled the markup it had scheduled for Thursday July 25, 2013. It was rumored that the House LaborH bill might include language prohibiting the NIH from supporting studies related to health economics. AACP will continue to monitor the inclusion of this language in any LaborH legislation that might be forthcoming.

Funding for the National Science Foundation (NSF) is included in the Commerce, Justice and Science appropriations bill (S1329 and accompanying report S113-78). The Senate proposes a FY14 funding level for NSF of $7.4 billion. The House Appropriations Committee proposes a NSF FY14 funding level of just $7.0 billion.

On Tuesday the House Appropriations Subcommittee on the Interior marked up what became a very publicly contentious FY14 funding bill. This bill includes funding for the Indian Health Service (IHS). Programs of interest to academic pharmacy within the Interior appropriations bill include the health professions loan repayment program and the pharmacy residency training program. The pharmacy residency training program is included in the IHS base budget. The total funding for the IHS in the House subcommittee bill is $4.1 billion which is $227 million less than the FY13 enacted level, but equal to the current funding level due to the sequester. Loan repayment would be funded at $36 million.

Tables of FY14 funding levels proposed by Senate Appropriators are available and regularly updated on the AACP advocacy web page. Report language of interest is included in these tables.

Appropriations legislation includes a report that states how the respective chamber expects the agencies to operate and expend their funds. Frequently this report language reflects the interests of organizations impacted by or dependent on a particular agency. Senate report language of interest:

The Senate is concerned that the One NSF framework is taking the focus off of NSF core programs. The One NSF framework supports interdisciplinary research.

The Senate opposes the administration’s effort to increase PHS evaluation tap from current 2.5% to 3.0% stating "because of the effect on PHS Act agencies that are used as a source of evaluation transfers, most notably NIH." This increase essentially reduces the overall funding of a "tapped" agency.

Stopping government intrusion: The House Committee on Education and the Workforce passed the "Supporting Academic Freedom Through Regulatory Relief Act," (HR 2637) on Tuesday. The legislation would repeal the state authorization, gainful employment and credit hour regulations that have been established by the US Department of Education. These three issues were published as final rules in the October 29, 2010 Federal Register. The legislation would prohibit the Department from revisiting these issues until the Higher Education Act is reauthorized.

In July of 2011 a US District Court vacated parts of the state authorization rule 600.9(c) and the Department delayed implementation until July 1, 2014 of the rules 600.9(a) and (b) in a Federal Register notice dated May, 21, 2013. Graduate and professional degree programs have been determined NOT to be subject to the gainful employment rules and this is stated in a guidance document published by the Department posted to their website on June 24, 2011.

Student loan interest rates: On Wednesday, the Senate passed legislation that would roll back the interest rate of unsubsidized undergraduate student loans initiated on or after July 1, 2013. The Senate amended the House passed "Smarter Solutions for Students Act" (HR 1911) by replacing that bills language with the "Bipartisan Student Loan Certainty Act" (S 1334). After passage of HR 1911 as amended by the Senate the legislation was sent to the House for consideration.

HR 1911

S 1334

Interest Rate

Direct Stafford subsidized 10-year Treasury Bill + 2.05%

Direct Stafford subsidized undergrad 10-year Treasury Bill + 2.05%

 

Direct Stafford unsubsidized 10-year Treasury Bill + 2.05%

Direct Stafford unsubsidized undergrad 10-year Treasury Bill + 2.05%

 

 

Direct Stafford unsubsidized grad/professional 10-year Treasury Bill + 4.6%

 

PLUS loans 10-year Treasury Bill + 4.5%

PLUS loans 10-year Treasury Bill + 4.6%

Cap

Direct Stafford subsidized and unsubsidized = 8.5%

PLUS loans = 10.5%

Direct Stafford subsidized undergrad = 8.25%

Direct Stafford unsubsidized undergrad = 8.25%

Direct Stafford unsubsidized grad/professional = 9.5%

PLUS loans = 10.5%

Compounding legislation: During the annual meeting I was asked about the status of congressional legislation regarding compounding. Currently there are two bills that attempt to define the separation of compounding and manufacturing.

The "Pharmaceutical Compounding Quality and Accountability Act," (S 959) has passed the Senate Committee on Health, Education, Labor and Pensions (HELP). S 959 defines compounding as: the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a marketed drug;

  • (ii) compounding a drug from a bulk drug substance; and
  • (iii) repackaging; and
  • (B) exclude mixing, reconstituting, or other such acts with respect to a marketed drug that are limited to and performed in accordance with specific directions for such acts contained in approved labeling provided by a drug's manufacturer, when performed based upon a prescription order for an identified individual patient.

In the House of Representatives a similar piece of legislation the "VALID Compounding Act," (HR 2186) has been introduced and was referred to the Committee on Energy and Commerce. This legislation is a bit more complex than S 959, the controlling language defining compounding is that "the drug product is compounded for an identified individual patient based on the receipt of a prescription order."

Each bill has additional language that describes exceptions to their respective definition of compounding. The compounder using bulk substances must comply with USP or National Formulary standards.

Administration

HHS seeks entrepreneurs: The U.S. Department of Health and Human Services (HHS) is seeking candidates for the second cohort of HHSEntrepreneurs. The application deadline is August 16, 2013. The application webpage includes the eligibility criteria and additional information regarding this exciting opportunity to influence healthcare policy and innovation.

Summer reading list

Institute of Medicine

AACP member institutions now participate in 25 Clinical and Translational Science Awards programs supported through the National Institutes of Health (NIH). These programs are making significant contributions to improving the translation of ever-increasing clinical knowledge to providers. While the original intent of the program is being met there are additional actions that if instituted would improve the efficiency of the CTSAs to improve clinical translation and improve care quality. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research presents these additional actions.

While the three identified areas of concern- complexity, cost and outcomes- are nothing new to health educators and policy makers the implications for organizations such as AACP to strengthen their leadership within collaborative and partner organizations makes Best Care at Lower Cost: The Path to Continuously Learning Health Care in America a must read.

"Physicians, nurses, and pharmacists and other health professionals represent the frontlines of health care delivery and the primary interface for patients and consumers. Expanding the supply of clinical information, promoting the use of evidence, and better involving patients in their care are all contingent upon the engagement and teaming of health professionals.

By convening their constituent professionals and providing a forum for action, professional societies have important roles in achieving the vision of a learning health care system. Through guidelines, performance measures, quality improvement initiatives, and data infrastructure for assessing performance with respect to specific procedures or conditions, these societies can take a leadership role in improving quality, safety and efficiency."

IOM Quality reports: IOM Roundtables provide a forum for the presentation and discussion of some of the most vexing issues impacting health care delivery. Roundtable summaries find their way into more complete reports published through the IOM. Find links to these summaries and reports and a graphic showing the impact they have on public policy on the Roundtable on Value and Science-Driven Health Care web page.

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Founded in 1900, the American Association of Colleges of Pharmacy (AACP) is a national organization representing the interests of pharmacy education and educators. Comprising all accredited colleges and schools of pharmacy including more than 6,400 faculty, 57,000 students enrolled in professional programs and 5,700 individuals pursuing graduate study, AACP is committed to excellence in pharmacy education.

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