Using 340B drug discounts to provide a financially sustainable medication discharge service.

The 340B Drug Pricing Program was intended to stretch federal resources by providing significant discounts to covered entities providing care to underserved populations. Program implementation and evidence of expanding services to higher income patients has brought more scrutiny and calls for elimination of the program. While additional review and reform may be warranted, profitability from 340B discounts enables covered entities to provide additional services that may not be feasible in absence of the program. This case report demonstrates one institution's use of 340B discounts to financially justify providing bedside medication delivery services for patients at the time of discharge from an inpatient admission. A simple financial model was developed using hospital data and inputs from available literature to estimate gross profit and earnings before interest, taxes, depreciation, and amortization (EBITDA) with and without 340B discounts. Without the 340B drug price discounts, the service would operate at a financial loss, and further investigation must be done to determine whether other clinical or economic benefits would warrant discharge medication delivery at the institution.

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Final rule; further delay of effective date.

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program.

The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program is intended as a safeguard to ensure access to affordable drugs to the indigeut. However, over the last two decades safety net health care providers have exploited financial incentives under the 340B Program at the expense of drug manufacturers and patients, including the most needy and vulnerable populations-they are committed to serve. Although the federal government has been applauded for increasing effortsto combat health care fraud and abuse including recovering $3.3 billion in 2014, federal officials and the general public have paid markedly less attention to pervasive abuse of the 340B Program. In 2014, drug purchases of 340B-designated drugs totaled $7 billion and are expected to increase to $12 billion: by 2016 as a result of the expansion of the program under the Affordable Care Act. The 340B Program has completely lost its way, and comprehensive legislation is necessary to realign the program with its intent.

The 340B discount program: outpatient prescription dispensing patterns through contract pharmacies in 2012.

Section 340B of the Public Health Service Act provides qualified organizations serving vulnerable populations with deep discounts for some outpatient medications. A 2010 regulatory change widely expanded the 340B program's reach, allowing these organizations to contract with retail pharmacies to dispense medications for eligible patients. Little is known about which medications are dispensed by contract pharmacies under the expanded program. We provide the first comparison of 340B prescriptions and all prescriptions dispensed in contract pharmacies. We used 2012 data from Walgreens, the national leader in 340B contract pharmacies. Medications used to treat chronic conditions such as diabetes, high cholesterol levels, asthma, and depression accounted for an overwhelming majority of all prescriptions dispensed at Walgreens as part of the 340B program. A higher percentage of antiretrovirals used to treat HIV/AIDS were dispensed through 340B prescriptions than through all prescriptions dispensed at Walgreens. The majority of 340B prescriptions dispensed at Walgreens originated at tuberculosis clinics, consolidated health centers, disproportionate-share hospitals, and Ryan White clinics. Our results suggest that 340B contract pharmacies dispense medications used to treat Americans' chronic disease burden and disproportionately dispense medications used by key vulnerable populations targeted by the program.

[Problems with countermeasures for health insurance treatment in neurology].

In order to tackle with the high price of new technology and new therapeutic drugs, Central Social Insurance Medical Council in Japan has begun to discuss the possibility to introduce technology assessment in the actual public health insurance system. It is indispensable to minimize the economic burden of patients to deliver technological advances in treatment. It is important for the physician to recognize the economic burden of patients and to reduce this burden as much as possible. Around 69% of the cancer patients had economic worries (n = 2037) in our survey "Economic burden of patient with cancer from the viewpoint of cancer economics". The mean out-of-pocket expense (752,000 yen) of the patients without economic worries was three-fourths that of the patients (987,000 yen) with economic worries. The out-of pocket expenses and the refunds/benefits were 1,217,000 yen and 652,000 yen for molecular targeted treatment (n = 494). The Intractable Diseases Control Act is to be enacted in 2016-17 to promote work on nanbyo control using all the resources of the nation, and this act should surely entail financial support.

Title VII and the development and promotion of national initiatives in training primary care clinicians in the United States.

The Title VII, Section 747 (Title VII) legislation, which authorizes the Training in Primary Care Medicine and Dentistry grant program, provides statutory authority to the Health Resources and Services Administration (HRSA) to award contracts and cooperative agreements aimed at enhancing the quality of primary care training in the United States.More than 35 contracts and cooperative agreements have been issued by HRSA with Title VII federal funds, most often to national organizations promoting the training of physician assistants and medical students and representing the primary care disciplines of family medicine, general internal medicine, and general pediatrics. These activities have influenced generalist medicine through three mechanisms: (1) building collaboration among the primary care disciplines and between primary care and specialty medicine, (2) strengthening primary care generally through national initiatives designed to develop and implement new models of primary care training, and (3) enhancing the quality of primary care training in specific disease areas determined to be of national importance.The most significant outcomes of the Title VII contracts awarded to national primary care organizations are increased collaboration and enhanced innovation in ambulatory training for students, residents, and faculty. Overall, generalist competencies and education in new content areas have been the distinguishing features of these initiatives. This effort has enhanced not only generalist training but also the general medical education of all students, including future specialists, because so much of the generalist competency agenda is germane to the general medical education mission.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Learning from history: the legacy of Title VII in academic family medicine.

The current renaissance of interest in primary care could benefit from reviewing the history of federal investment in academic family medicine. The authors review 30 years of experience with the Title VII, Section 747 Training in Primary Care Medicine and Dentistry (Title VII) grant program, addressing three questions: (1) What Title VII grant programs were available to family medicine, and what were their goals? (2) How did Title VII change the discipline? and (3) What impact did Title VII family medicine programs have outside the discipline?Title VII grant programs evolved from broad support for the new discipline of family medicine to a sharper focus on specific national workforce objectives such as improving care for underserved and vulnerable populations and increasing diversity in the health professions. Grant programs were instrumental in establishing family medicine in nearly all medical schools and in supporting the educational underpinnings of the field. Title VII grants helped enhance the social capital of the discipline. Outside family medicine, Title VII fostered the development of innovative ambulatory education, institutional initiatives focusing on underserved and vulnerable populations, and primary care research capacity. Adverse effects include relative inattention to clinical and research missions in family medicine academic units and, institutionally, the development of medical education initiatives without core institutional support, which has put innovation and extension of education to communities at risk as grant funding has decreased. Reinvestment in academic family medicine can yield substantial benefits for family medicine and help reorient academic health centers. This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Two decades of Title VII support of a primary care residency: process and outcomes.

PURPOSE: To assess 23 years of Health Resources and Services Administration (HRSA) Title VII Training in Primary Care Medicine and Dentistry funding to the New York University School of Medicine/Bellevue Primary Care Internal Medicine Residency Program. The program, begun in 1983 within a traditional, inner-city, subspecialty-oriented internal medicine program, evolved into a crucible of systematic innovation, catalyzed and made feasible by initiatives funded by the HRSA. The curriculum stressed three pillars of generalism: psychosocial medicine, clinical epidemiology, and health policy. It developed tight, objectives-driven, effective, nonmedical specialty blocks and five weekly primary care activities that created a paradigm-driven, community-based, role-modeling matrix. Innovation was built in. Every block and activity was evaluated immediately and in an annual, program-wide retreat. Evaluation evolved from behavioral checklists of taped interviews to performance-based, systematic, annual objective structured clinical examinations. METHOD: The authors reviewed eight grant proposals, project reports, and curriculum and program evaluations. They also quantitatively and qualitatively surveyed the 122 reachable graduates from the first 20 graduating classes of the program. RESULTS: Analysis of program documents revealed recurring emphases on the use of proven educational models, strategic innovation, and assessment and evaluation to design and refine the program. There were 104 respondents (85%) to the survey. A total of 87% of the graduates practice as primary care physicians, 83% teach, and 90% work with the underserved; 54% do research, 36% actively advocate on health issues for their patients, programs, and other constituencies, and 30% publish. Graduates cited work in the community and faculty excitement and energy as essential elements of the program's impact; overall, graduates reported high personal and career satisfaction and low burnout. CONCLUSIONS: With HRSA support, a focused, innovative program evolved which has already met each of the six recommendations for future innovation of the Alliance for Academic Internal Medicine Education Redesign Task Force. This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Providing culturally competent care: residents in HRSA Title VII funded residency programs feel better prepared.

BACKGROUND: The Health Resources and Services Administration (HRSA) funds primary care residency programs through its Title VII training grants, with a goal of ensuring a well-prepared, culturally competent physician workforce. The authors sought to determine whether primary care residents in Title VII-funded training programs feel better prepared than those in nonfunded programs to provide care to culturally diverse patients. METHOD: The authors analyzed data from a national mailed survey of senior resident physicians conducted in 2003-2004. Of 1,467 randomly selected family medicine, internal medicine, and pediatrics residents, 866 responded--403 in Title VII-funded programs and 463 in nonfunded programs (response rate = 59%). The survey included 28 Likert-response questions about residents' preparedness and perceived skills to provide cross-cultural care, sociodemographics, and residency characteristics. RESULTS: Residents in Title VII-funded programs were more likely than others to report being prepared to provide cross-cultural care across all 8 measures (odds ratio [OR] = 1.54-2.61, P < .01) and feeling more skilled in cross-cultural care for 6 of 10 measures (OR = 1.30-1.95, P < .05). Regression analyses showed that characteristics of the Title VII-funded residency training experience related to cross-cultural care (e.g., role models, cross-cultural training, and attitudes of attending physicians) accounted for many of the differences in self-reported preparedness and skills. CONCLUSIONS: Senior residents in HRSA Title VII-funded primary care residency training programs feel better prepared than others to provide culturally competent care. This may be partially explained by better cross-cultural training experiences in HRSA Title VII-funded programs.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Impact of Title VII training programs on community health center staffing and national health service corps participation.

PURPOSE: Community health centers (CHCs) are a critical component of the health care safety net. President Bush's recent effort to expand CHC capacity coincides with difficulty recruiting primary care physicians and substantial cuts in federal grant programs designed to prepare and motivate physicians to practice in underserved settings. This article examines the association between physicians' attendance in training programs funded by Health Resources and Services Administration (HRSA) Title VII Section 747 Primary Care Training Grants and 2 outcome variables: work in a CHC and participation in the National Health Service Corps Loan Repayment Program (NHSC LRP). METHODS: We linked the 2004 American Medical Association Physician Master-file to HRSA Title VII grants files, Medicare claims data, and data from the NHSC. We then conducted retrospective analyses to compare the proportions of physicians working in CHCs among physicians who either had or had not attended Title VII-funded medical schools or residency programs and to determine the association between having attended Title VII-funded residency programs and subsequent NHSC LRP participation. RESULTS: Three percent (5,934) of physicians who had attended Title VII-funded medical schools worked in CHCs in 2001-2003, compared with 1.9% of physicians who attended medical schools without Title VII funding (P<.001). We found a similar association between Title VII funding during residency and subsequent work in CHCs. These associations remained significant (P<.001) in logistic regression models controlling for NHSC participation, public vs private medical school, residency completion date, and physician sex. A strong association was also found between attending Title VII-funded residency programs and participation in the NHSC LRP, controlling for year completed training, physician sex, and private vs public medical school. CONCLUSIONS: Continued federal support of Title VII training grant programs is consistent with federal efforts to increase participation in the NHSC and improve access to quality health care for underserved populations through expanded CHC capacity.

Ryan White Title I Survey: services for HIV-positive substance users.

People living with HIV/AIDS who are also substance users need primary health care, substance abuse treatment, and support services. They also require care delivery strategies that are comprehensive and innovative. Forty-three of 51 Ryan White Care Act Title I grantees funding 197 substance abuse treatment agencies in the United States participated in this study. Grantees were surveyed to determine (1) use of Title I funding to provide services for HIV-positive substance users, (2) the types of substance abuse services provided, (3) strengths and weaknesses of different metropolitan substance abuse service delivery systems, (4) sources of information used to assess the needs of substance users, (5) gaps in knowledge about substance users and their service needs, and (6) examples of successful strategies within the eligible metropolitan areas. The results of the study demonstrate that most grantees use Title I funds to support some form of substance abuse treatment for people with HIV; however, many do not use the funds to address the barriers to care that they identified. Lack of provider knowledge, expertise, and awareness, were cited as important barriers to care by a majority of the grantees. The availability of harm reduction approaches to care is an area in which there is wide variation. Several Title I programs have supported innovative programs for HIV positive substance users that may be used elsewhere as program models. It is important to find ways to incorporate these issues into the needs assessment and service prioritization process.