Health Care Reform Bill Research Articles

Requirements for Biosimilars and Interchangeable Biological Drugs in the United States—in Plain Language

After years of public debate, biosimilars and interchangeable biological products are closer to becoming reality for patients in the United States. President Obama's health care reform bill amends the PHS Act to strike a balance between “innovation and consumer interests.” This article provides the highlights of this legislation and includes, among other topics, the accepted and established scientific and regulatory principles supporting decision making for these products; marketing exclusivity for the innovator's reference product and the first approved interchangeable product; activities and timelines to foster communication to avoid lengthy discussion and court action in regard to patent infringement; and administrative issues, such as naming, guidance documents, and user fees.

US Biosimilar Pathway Unlikely to be Used†

In March 2010, the US passed the healthcare reform bill, including The Biologics Price Competition and Innovation Act of 2009, which established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars. The aBLA pathway may never be used. At the "Business of Biosimilars" meeting in Boston in September, developers of both innovator and generic biologics as well as representatives from the scientific, regulatory, and legal communities noted that, because of unclear requirements for clinical data and the need for public disclosure of proprietary data, manufacturers of generic biologics are unlikely to take advantage of the aBLA process, opting instead for a standard Biologic License Application (BLA). The implications of an unusable biosimilars pathway in the US dampen our already soft outlook for biosimilars. Companies will still develop follow-on biologics, but approved compounds will behave as new branded drugs. Biosimilars in the US are therefore not likely to lead to aggressive pricing, but will more likely mirror current situations where several similar biologics are available. For example, the interferon (IFN) β-1a products Avonex® and Rebif®, and Betaseron® (IFN β-1b) have all enjoyed >10% price increases for the last several years in spite of their clinical similarities. inThought reiterates its outlook for generic erosion of a typical biologic that projects a loss of revenue of 30% over 5 years compared to the 90% revenue loss for a typical branded small molecule.

Healthcare Reform: A Prescription for the 2010 Republican Landslide?

Less than two years ago, Barack Obama was sworn in as president amidst proclamations of a partisan realignment. But in this fall’s midterms, scores of his fellow Democrats lost their jobs. The best evidence suggests that Obama’s signature accomplishment—passage of a healthcare reform bill that had long eluded progressives—played a key role in the historic defeat. It also highlighted the delicacy of partisan regimes, particularly those prematurely designated as realignments by academic or popular observers.

Implementing Health Care Reform — An Interview with HHS Secretary Kathleen Sebelius

Kathleen Sebelius took charge of the Department of Health and Human Services (HHS) as Congress debated the health care reform bill that HHS must now administer. Sebelius shared her opinions in a recent interview with national correspondent John Iglehart.

Interest in Conflicts

Orthopaedics in general, and highly-compensated orthopaedists in particular, have come into the spotlight related to potential conflicts of interest. Studies have indicated that there has been inconsistent reporting of many potential conflicts, both by speakers at annual society meetings and by authors in orthopaedic journals. An article in the Archives of Internal Medicine in September 2010 reported a 46% nondisclosure rate of potential conflicts of interest among thirty-two orthopaedic surgeons whose work had been published in twenty-six orthopaedic-related journals and who were known to have been paid over $1 million in the year prior to the article’s publication1. A 2009 report that noted a 29% rate of nondisclosure among presenters and board and committee members at the 2008 Annual Meeting of the AAOS2 led to a mandatory disclosure policy for presenters and board and committee members before AAOS participation is allowed3. One part of the recent health-care reform bill requires industry, beginning in 2013, to publicly report all payments to physicians over $10 or over $100 in a year. Receiving disclosure information from authors has been hampered by the multitude of forms currently used to collect this information. Commonly, an author is required to fill out a different form for each journal, each presentation, and each society’s program participation. In 2009, the International Committee of Medical Journal Editors (ICMJE) prepared and piloted a Form for Disclosure of Potential Conflicts of Interest in an attempt to inject some uniformity into these disclosures. After an initial review, feedback from the medical journal community was used to modify this form to become the final ICMJE form for disclosure (www.icmje.org). This form covers three primary areas: (1) potential conflicts of interest with the research work and manuscript under consideration for publication, (2) relevant financial activities outside the submitted research and manuscript for the prior thirty-six months, and (3) other relationships that may have had an influence on the manuscript. Filled out and updated online, the ICMJE form is designed to be a standardized form that precludes the need to fill out a separate form for each journal. Recently, issues related to the adequacy of the current disclosure of potential conflict of interest policy at JBJS were addressed by our Board of Trustees and editorial team. The Board, the Deputy Editors, and I support the adoption of the ICMJE disclosure form for use by the authors of manuscripts submitted to JBJS. As of January 1, 2011, all authors must include a completed ICMJE form at the time of initial manuscript submission. As of July 1, 2011, all manuscripts published in JBJS will require an up-to-date completed ICMJE form prior to actual article publication. We plan to publish disclosure forms online for each author. The JBJS editorial office will manage these completed ICMJE disclosure forms. As is currently the case, disclosure of potential conflicts of interest will not affect the decision to accept or reject a submitted manuscript. Any request for additional levels of financial disclosure, other than that currently required, will not be implemented at this time. There is no doubt that orthopaedics and our patients have benefited greatly from the interaction that we have had with industry in developing new technology for improving patient care and outcomes. With the publication of research studies, whether sponsored by industry funding or other sources, our readers are entitled to know what relationships our authors have. As orthopaedic surgeons rely on orthopaedic journals more than any other source of orthopaedic information, our journals must insist on full disclosure of potential conflicts of interest. Improving our ability to obtain relevant disclosure of potential conflicts of interest will ensure that our readers understand the potential conflicts involved with every manuscript that we publish as JBJS continues our tradition of providing trusted orthopaedic information.

Health care access and utilization among children of single working and nonworking mothers in the United States.

To examine indicators of health care access and utilization among children of working and nonworking single mothers in the United States, the authors used data on unmarried women participating in the 1997-2008 National Health Interview Survey who financially supported children under 18 years of age (n = 21,842). Stratified by maternal employment, the analyses assessed health care access and utilization for all children. Outcome variables included delayed care, unmet care, lack of prescription medication, no usual place of care, no well-child visit, and no doctor's visit. The analyses reveal that maternal employment status was not associated with health care access and utilization. The strongest predictors of low access/utilization included no health insurance and intermittent health insurance in the previous 12 months, relative to those with continuous private health insurance coverage (odds ratio ranges 3.2-13.5 and 1.3-10.3, respectively). Children with continuous public health insurance compared favorably with those having continuous private health insurance on three of six access/utilization indicators (odds ratio range 0.63-0.85). As these results show, health care access and utilization for the children of single mothers are not optimal. Passage of the U.S. Healthcare Reform Bill (HR 3590) will probably increase the number of children with health insurance and improve these indicators.

Thinking Through Health Care Reform

Emotionality truly shapes critical thinking in the development of American health policy. President Obama has misgauged the emotions and thoughts of the Nation and Congress about the health care reform bill. Most Americans don’t approve of the design or impetus of health care legislation under the Obama administration. The enacted legislation provides health care insurance for all Americans. However, health care insurance for the lower class shows intense “red lights” for repeal of the legislation to members of the middle and upper classes. It violates their critical thinking processes and comes down to a kind of “class warfare” of poverty level and low income persons against the gut emotional feelings of the middle and upper classes to repeal the program. Sarah Palin and her Tea Party compatriots envision such “class warfare” with the implementation of the program, even “death panels” to mete out health care for those seriously or gravely ill.

Oral Health Provisions in U.S. Health Care Reform

During 2009, both chambers of the U.S. Congress passed health care reform bills that contained a variety of provisions specific to oral health and dental care. In March 2010, the Senate version-the Patient Protection and Affordable Care Act (referred to as the Affordable Care Act [ACA])-was signed into law. The authors establish the context for ACA dental provisions by reviewing prior federal legislation pertaining to dental coverage. They analyze the final U.S. House and Senate health care reform bills for their oral health content and draw observations regarding congressional interest in oral health. The authors identify and describe more than 30 provisions of direct relevance to dentistry within the domains of insurance coverage, dental workforce, safety net, prevention and surveillance. Although the two bills differed in many details, both address oral health infrastructure and delivery of care, with particular attention to underserved child and adolescent populations. The oral health provisions in the health care reform bills evidenced strong congressional interest in oral health and dental care, with an emphasis on equitable care for children. Practice Implications. The effect of each congressional action on the future of dental practice will depend on how the provisions are regulated and implemented. The dental profession needs to recognize the strong and ongoing interest of lawmakers in oral health care and must maintain active engagement in the policymaking process.

Health-care reform in the USA: what does it mean for neurologists?

Health-care reform in the USA: what does it mean for neurologists?

A Matter of Life & Death: Advocates in New York Respond to Medical Repatriation

This article is about the response of one group of advocates to the practice of medical repatriation, also referred to as medical deportation, in which hospitals choose to send non-citizen patients, usually those in need of long-term care, back to their home countries for treatment without engaging the federal immigration process. In an effort to better grapple with the problem, the Health Justice Program at New York Lawyers for the Public Interest (“NYLPI”) along with the New York Immigration Coalition (“NYIC”) and the New York Academy of Medicine (“NYAM”) decided to convene a statewide workgroup on medical repatriation and long-term care for undocumented immigrants. In this Article, we share our workgroup’s approach to understanding and addressing medical repatriation in the hope that some of what we have learned in New York will inform the advocacy of practitioners elsewhere. Part I shares the findings of a series of structured interviews we conducted with health care providers, community advocates and hospital social workers, which provide very preliminary data on the scope of the medical repatriation problem in New York and the reasons for its persistence. Part II discusses strategies that emerge out of the factual research we have conducted thus far. Part III concludes with a discussion of the recently enacted health care reform bill and the implications, if any, it may have for medical repatriation as well as with a discussion of the communications challenges that remain on the workgroup’s agenda if we are to make meaningful progress in providing care to some of the country’s must vulnerable patients.

Abstract A86: Sociodemographic correlates of cancer survivors in the United States

Abstract Introduction: Approximately 40% of the more than 1 million Americans diagnosed with cancer each year are working-age adults, likewise more than 11 million people in the U.S. are cancer survivors. Given almost 50% of cancer survivors are under 65 years of age, a large proportion of them return to work after treatment or even maintain regular work schedules during their cancer treatment. We described the socio-demographic characteristics and risky health behaviors of U.S. adults diagnosed with cancer by the five most commonly diagnosed cancer types. Methods: Data pooled from the 1997-2009 National Health Interview Survey (NHIS) on adults 18 years of age and older with self-reported physician diagnosed cancer (n=27,906) were analyzed. Estimates on self-reported socio-demographic characteristics (age, gender, race, ethnicity, education, employment status, and job type) general health status, and negative health behaviors (risky alcohol drinking [men who consume ≥ 2 drinks and women who consume ≥1 drink per day] and cigarette use [current, former, never]) were stratified by specific-cancer type (non-melanoma skin cancer, lung cancer, colorectal, prostate, and breast) and employment status. Results: Thirty-three percent of adults diagnosed with cancer work post-diagnosis. Among employed cancer survivors, 69.3% were employed in white collar jobs while 14.7% were in service jobs. This distribution differed among employed persons without a cancer diagnosis, with 58.5% employed in white collar jobs and 23.4% in service jobs. Among employed persons with cancer, 65.9% were 35-54 years old, while 15.6% were greater than 55 years. Breast and non-melanoma skin cancer rates were highest among those who returned to work. The percentage of cancer workers reporting fair-poor health was greater than workers without cancer. Lastly, workers with cancer reported lower risky drinking (7.8%) and cigarette use (4.7%) compared to workers without cancer (14.5% and 11.4%, respectively). Conclusion: A large occupational health disparity exists among persons returning to work following a cancer diagnosis. Among all worker types, we found service workers were less likely (as compared to white collar workers) to be currently employed suggesting the need for integrating vocational rehabilitation programs and treatments services tailored to their workplace organization. In addition, the changing gender distribution in the U.S. workforce reflects our study findings that twice as many females as males continued to work following cancer diagnosis. The new U.S. healthcare reform bill that supports workplace health promotion programs may assist employers in developing the aforementioned reintegration programs and thwart the burgeoning occupational health disparities among working cancer survivors. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A86.

Impact of the New US Health-Care-Reform Legislation on the Pharmaceutical Industry: Who Are the Real Winners?

Over the past two years, the US pharmaceutical and biotechnology industries were preparing themselves for passage of some type of health-reform legislation with a clear appreciation-and concern-about the enormous impact any law would be likely to have on the structure and viability of the research-based industry. Now, with final passage in March 2010 of the Patient Protection and Affordable Care Act and its companion "quick-fix" and budget bill, the Health Care and Education Reconciliation Act, it is a good time to take a look at how the industry fared and assess how the various provisions of the health-care reform bill might affect the industry's long-term prosperity and growth.

Technology's role in healthcare reform

Technology's role in healthcare reform

Next on the Menu: Labeling Law Could Mean New Career Opportunities for RDs

The registered dietitians (RDs) of the American Dietetic Association (ADA) are always alert to new ways to improve the health of Americans and enhance the profile of the dietetics profession. So when President Obama signed the Health Care Reform bill into law, RDs—particularly those with an entrepreneurial spirit—saw an opportunity.

Health Reform, Primary Care, and Graduate Medical Education

The 2010 health care reform bill requires that every eligible American purchase health insurance, but the clinician workforce may not be adequate to provide access for the newly insured. The author reviews regulations included in the bill and current policy debates relevant to expanding the primary care workforce and improving graduate medical education.

Patient Protection and Affordable Care Act of 2010: Summary, Analysis, and Opportunities for Advocacy for the Academic Emergency Physician

The Patient Protection and Affordable Care Bill, commonly referred to as the "Health Care Bill" or the "Health Care Reform Bill," was enacted in March 2010. This article is a review and analysis of the sections of this Act that are relevant to researchers and teachers of emergency care. The purpose of this document is to serve as a citable reference for interested parties and a reference to quickly locate the sections of the Bill relevant to academic emergency physicians. When appropriate, text was copied verbatim from the Bill. The source of the downloaded Act, and the page numbers of the text sections, are provided to help the reader to find the sections described. This review is presented in two parts. Part I presents 11 sections extirpated from the Act, with short interpretations of the significance of each section. Part II presents an analysis of the sections that the authors believe represent opportunities for emergency care researchers and teachers to make the most impact, through active involvement with the various departments and agencies of the federal government that will be charged with interpreting and implementing this Act. The Act contains sections that could lead to new funding opportunities for research in emergency care, especially for comparative clinical trials and clinical studies that focus on integration and efficiency of health care delivery. The Act will establish several new institutes, centers, and committees that will create policies highly relevant to emergency care. The authors conclude that this Act can be expected to have a profound influence on research and training in emergency care.

It's all happening—at the hospital

As of this writing, the health care reform bill has passed the House, but the health care legislative controversy continues. Will we see real health care reform in my lifetime? Who knows? However, I am pleased looking at this issue to see that our profession continues to be focused on improving patient care, both in the hospital and out of it. The editorial by Michele Klein-Fedyshin, AHIP, sets the tone, with a convincing case for why now more than ever, physicians need ready access to the kind of quality, filtered information that librarians are trained to provide. She points to a puzzling conundrum: pressures are growing to reduce medical errors and increase the use of evidence-based treatment at the same time that requirements to fund professional librarians are declining. Klein-Fedyshin points to some positive developments and envisions a future in which hospitals will be scored on their “information readiness.” Also in this issue we are fortunate to publish the papers from an Association of Academic Health Sciences Libraries (AAHSL) symposium on electronic health records held in November in Boston. Two of the papers sound a cautionary note. Kenneth Mandl's keynote address describes structural flaws in the current generation of electronic health records (EHRs) that may prove significant obstacles to their widespread adoption. William Garrity speaks to the need to remember the setting in which EHRs are used: a busy clinician may not have time to consult the evidence even if access to it is easy. However, other papers recount positive experiences with EHRs that may encourage us to move forward in spite of these obstacles. The papers from health sciences librarians at such disparate institutions as the University of Pittsburgh, the University of Washington, the University of Arkansas, and Vanderbilt University recount how these libraries have successfully used their institutions' introduction of the EHR as a means to further their goals. Finally, Marianne Burke, AHIP, and her colleagues at the University of Vermont describe their attempt to introduce an information prescription protocol into a family medicine practice. In this case study, we learn that it can be done, but that the process is far from easy. Organizations do not change their behavior patterns overnight, and it seems, a clinic is no exception to this common observation. While not on the subject of patient care, one paper appealed to me particularly. As editor of the Journal of the Medical Library Association (JMLA), I was very interested in the results of the survey recounted by Sally Harvey, AHIP, and Janene Wandersee on the rate of publication of abstracts and papers presented at MLA annual meetings. It seems that we have a lower rate of publication than other biomedical associations. I hope their paper will encourage JMLA readers to take the time to write up their papers and posters and contribute them to the “evidence-base.” Enjoy the issue.

Health Care Reform Bill Contains Opportunities for Integrative Medicine

Homeopathic care has not been well documented in terms of its impact on patients' utilization of drugs or other complementary and alternative medicines (CAM). The objective of this study was to describe and compare patients who visit physicians in general practice (GPs) who prescribe only conventional medicines (GP-CM), regularly prescribe homeopathy within a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho).The EPI3-LASER study was a nationwide observational survey of a representative sample of GPs and their patients from across France. Physicians recorded their diagnoses and prescriptions on participating patients who completed a self-questionnaire on socio-demographics, lifestyle, quality of life Short Form 12 (SF-12) and the complementary and alternative medicine beliefs inventory (CAMBI).A total of 6379 patients (participation rate 73.1%) recruited from 804 GP practices participated in this survey. Patients attending a GP-Ho were slightly more often female with higher education than in the GP-CM group and had markedly healthier lifestyle. They did not differ greatly in their comorbidities or quality of life but exhibited large differences in their beliefs in holistic medicine and natural treatments, and in their attitude toward participating to their own care. Similar but less striking observations were made in patients of the GP-Mx group.Patients seeking care with a homeopathic GP did not differ greatly in their socio-demographic characteristics but more so by their healthier lifestyle and positive attitude toward CAM. Further research is needed to explore the directionality of those associations and to assess the potential economic benefits of homeopathic management in primary care.

Rebirth of a Profession: Hybrid Positions on the Rise in Clinical, Manufacturing Settings

n the not-so-distant future, the professionals who keep medical devices humming might not have the job title or responsibilities of today’s “clinical engineer” (CE) or “ biomedical equipment technician (BMET).” That’s because working with medical devices increasingly requires a skill set that goes beyond those of many medical technology professionals in the field today. Hospitals and manufacturers are responding by creating new, hybrid jobs that require a broader range of skills. Moreover, more institutions are realigning their organizational, operational, and reporting structures to reflect the changing nature of job roles and responsibilities. In this environment, the days of carving a career out of “fixing boxes,” in the words of several medical technology professionals, is giving way to an era of new opportunities for careers focused on integrating, managing, and servicing highly sophisticated and interconnected systems.

Two countries divided by a common language: health systems in the UK and USA

Despite the historic significance of the healthcare reform bill that was passed into law by President Obama in March 2010, the debate still rages. The UK National Health Service (NHS) has featured prominently in the current American debate on healthcare reform, with critics calling attention to its perceived shortcomings. Some of these, such as the existence of 'death panels', can easily be dismissed, but others, such as the cancer survival deficit, cannot. This paper reviews the evidence on outcomes from cancer and other chronic non-communicable diseases, the two leading causes of death in both countries. The headline figures showing better cancer survival in the USA are exaggerated by methodological issues, but a gap remains, due in large part to better outcomes among older people. Outcomes among younger people with chronic disease are, however, much worse in the USA. Paradoxically, given the nature of the debate in the USA so far, those parts of the US health system that get the best results, such as the Veterans' Administration, or the elderly on Medicare, are those that most closely resemble the British NHS - but which are funded somewhat more generously.