Health And Human Services Secretary Research Articles

Misleading Leadership: The Deliberate Deception of Recommendation 5.5.

On August 1, 2011, the Department of Health and Human Services accepted the Institute of Medicine's recommendation that all Food and Drug Administration-approved contraceptives and sterilization procedures be made available to women without incurring out-of-pocket costs. The Institute of Medicine and the Department of Health and Human Services have deliberately misled the American people by claiming that this mandate would not include abortifacient drugs, that conscientious objection would be honored, and that this provision is essential to preserving the health of women. The author rebuts each of these claims by appeal to the scientific, medical, legal, and political facts surrounding these claims. In doing so, he argues that the recommendations include at least three abortion-inducing contraceptive methods. Likewise, he illustrates that the current administration has shown no will to protect the inviolable right of conscience of both individuals and institutions. Finally, he draws the reader's attention to the known deleterious side effects of oral contraception, emphasizing that these recommendations ultimately encourage women to use drugs that put them at a greater risk of harm. The author concludes that the Institute of Medicine and the Department of Health and Human Services have neglected their responsibility to American women and have misled and deceived the American people. As the Patient Protection and Affordable Care Act was nearing passage, Senator Barbara Mikulski (D-Maryland) secured an amendment-the "Mikulski Women's Preventive Health Care Amendment"-that gave the Department of Health and Human Services (HHS) the authority to delineate preventive care uniquely necessary for women. The secretary of HHS, Kathleen Sebelius, tasked the Institute of Medicine (IOM) with undertaking a systematic review of those preventive services that should be covered, without payment, for all women. On July 19, 2011, the IOM submitted a 210-page report recommending eight preventive services. Seven of these recommendations involve important screening, counseling, and testing for common health risks facing women. Recommendation 5.5, unfortunately, was a recommendation of a different kind. It stated, "Women will have access to all Food and Drug Administration (FDA)-approved contraceptive methods, sterilization procedures, and patient education and counseling. These recommendations do not include abortifacient drugs." On August 1, 2011, in a quietly made announcement in the corner of the HHS website, the federal government accepted the IOM recommendations wholesale.

Medicare Steps Up Anti-Fraud Efforts

Medicare Steps Up Anti-Fraud Efforts

Endorsement of Health and Human Services Recommendation for Pulse Oximetry Screening for Critical Congenital Heart Disease

Incorporation of pulse oximetry to the assessment of the newborn infant can enhance detection of critical congenital heart disease (CCHD). Recently, the Secretary of Health and Human Services (HHS) recommended that screening for CCHD be added to the uniform screening panel. The American Academy of Pediatrics (AAP) has been a strong advocate of early detection of CCHD and fully supports the decision of the Secretary of HHS. The AAP has published strategies for the implementation of pulse oximetry screening, which addressed critical issues such as necessary equipment, personnel, and training, and also provided specific recommendations for assessment of saturation by using pulse oximetry as well as appropriate management of a positive screening result. The AAP is committed to the safe and effective implementation of pulse oximetry screening and is working with other advocacy groups and governmental agencies to promote pulse oximetry and to support widespread surveillance for CCHD. Going forward, AAP chapters will partner with state health departments to implement the new screening strategy for CCHD and will work to ensure that there is an adequate system for referral for echocardiographic/pediatric cardiac evaluation after a positive screening result. It is imperative that AAP members engage their respective policy makers in adopting and funding the recommendations made by the Secretary of HHS.

New HHS Data Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status

MANY RACIAL AND ETHNIC MINORITIES, PEOPLE with limited English-language proficiency, people with disabilities, and other commonly underserved populations face unique health challenges, have reduced access to health care and insurance, and often experience poorer health throughout their lives. In the past, identifying disparities and effectively monitoring efforts to reduce them have been limited by a lack of specificity, uniformity, and quality in data collection and reporting procedures. The importance in the documentation of disparities and the critical importance of rich data systems to understand and track interventions to reduce health disparities among population subgroups have been called for, dating back to the 1985 Report of the Secretary’s Task Force on Black and Minority Health and the recent Institute of Medicine report Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement. As noted in those reports, consistent methods for collecting and reporting health data will help better characterize the nature of health problems in underserved populations. The Department of Health and Human Services (HHS) has adopted new data standards for the collection of race, ethnicity, sex, primary language, and disability status for selfreported data collected from population-based health surveys. Data standards were developed in accordance with section 4302 of the Affordable Care Act. That section of the act focuses on the standardization as well as collection, analysis, and reporting of health disparities data. It requires the HHS secretary to establish data collection standards for race, ethnicity, sex, primary language, and disability status. The law requires that, once established, these data collection standards be used in national population health surveys. The law also gives the secretary the authority to require collection of additional demographic data on departmental population health surveys and to develop appropriate additional data collection standards. Even though data collection will not reduce disparities, having such data is fundamental to the department’s efforts to understand the causes of health disparities, design effective responses, and evaluate progress in reducing disparities. The new data standards for race, ethnicity, sex, primary language, and disability status represent a critical step in uniformly collecting data needed to track disparities and to ensure continued progress in efforts to reduce disparities.

Medicine and the Media: Balancing the Public's Right to Know With the Privacy of the Patient

The discussion surrounding the release of celebrity health information to the media is not a new issue for health care professionals to consider. The rapid dissemination of updates concerning the health of a “public person” is now available to a wide audience through Internet communication and social media systems. The “appetite” of the news organizations and the public at large to obtain “breaking news” on a medical topic of interest involving a recognized political figure, sports star, or entertainer needs to be carefully weighed against the current laws intended to protect the privacy of the individual. Minute-by-minute, no longer day-to-day, updates seem essential through a variety of media, including a mobile phone and other handheld electronic devices. Competition between news services has only increased the demand for the latest news. Regrettably, the more sensational and potentially unbelievable the health-related news story, the more likely it will be distributed faster and farther to a larger audience using contemporary electronic media. Two fairly recent events provide reason to pause and consider both the legal and the ethical standards involved in release of medical information by health care professionals. The tragic shooting of Congresswoman Gabrielle Giffords on January 8, 2011, captured the attention and concern of individuals throughout the world. She was one of 19 victims of this mass shooting, and there were 6 fatalities. Treating physicians were quick to reveal information regarding her condition to a shocked public. Regular updates on the nature of her injuries and the progress of her recovery were provided to an absorbed press trying to offer answers to a gripped national and international audience. According to separate reports, Ms Giffords’ husband, Astronaut Mark Kelly, gave the University Medical Center in Tucson, AZ, permission to disclose certain facts relevant to her progress and prognosis.1 A spokesperson for the hospital stated that any of the information released to the press would be discussed before-hand with her family.1 Despite Mr Kelly’s approval, some privacy experts remained surprised at the amount and type of health care data the press were privy to. Included were concerns of whether Ms Giffords herself would have approved of having so many medical and personal details being shared with a wide audience.1 Compared to Congresswoman Gabrielle Giffords’ extensive media exposure, the release of health information to the press surrounding the serious medical condition of Steve Jobs (CEO of Apple Inc) was far more reserved. Mr Jobs gave permission to release further information to the public several days after a Wall Street Journal article reported that he had received a liver transplant 2 months previously.2 During a June 2009 press release, the head of transplantation James D. Eason, MD, of the University of Tennessee Health Science Center, acknowledged that Mr Jobs had earlier undergone a liver transplant at that institution.3 The release detailed his progression through the United Network for Organ Sharing system as well as limited information about his present condition and prognosis.3 The report finished with a statement confirming that the “hospital respect[s] and protect[s] every patient’s private health information and cannot reveal any further information on the specifics of Mr Jobs’ case.”3 On August 24, 2011, Mr Jobs resigned his leadership position, indicating he “could no longer meet my duties and expectations as Apple’s CEO.”4 No further information was provided regarding this decision.4 The current article will explore the tort law and constitutional restrictions placed on the disclosure of information into the public forum. This will lay the framework for a discussion related to the exchange of health care information. Both ethical and legal standards are described with emphasis on the important role of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Major Rule Changes Proposed for Human-Subject Studies

Back to table of contents Previous article Next article Government NewsFull AccessMajor Rule Changes Proposed for Human-Subject StudiesMark MoranMark MoranSearch for more papers by this authorPublished Online:2 Sep 2011https://doi.org/10.1176/pn.46.17.psychnews_46_17_4_1AbstractThe federal government is hoping to streamline and standardize informed consent and reporting requirements for research involving humans and to tailor administrative requirements for reporting to the level of risk involved in different studies. The Department of Health and Human Services (HHS) has issued an "advance notice of proposed rule making" that would make sweeping changes to the regulations for research involving human subjects that were formulated in the 1970s and 1980s and implemented in the early 1990s. These regulations, which govern risk assessment and informed consent in human research, became accepted by multiple federal agencies that oversee research and were codified as the "Common Rule." The advance notice was posted in the Federal Register on July 25 and appears under the title "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators." The advance notice permits HHS to get public and professional feedback before formally putting forward its proposal. APA leaders and experts on research law said that the proposed rule changes are largely welcome and will help to bring administrative and reporting requirements in line with major changes that have happened in the research landscape (see Research Regulation Changes Could Make Process More User Friendly). For instance, in the time since the Common Rule was established, multisite trials have become more common. But under the Common Rule, every institution participating in the trial must establish a separate Institutional Review Board (IRB) to approve the research—a cumbersome requirement that has greatly increased the cost and administrative burden associated with multisite trials. But under the new rules proposed by HHS, a multisite trial would require only one IRB of record.Darrel Regier, M.D., M.P.H., head of APA's Division of Research, told Psychiatric News that the proposed changes are welcome. "Our DSM-5 field trials have 11 different participating sites," he said. "We would have liked to have something like this change in place when we got started." Robert Charrow, an attorney who serves on the IRB for the American Psychiatric Institute for Research and Education (APIRE), agreed. "These proposed changes will make it easier for clinical trials," he said. "Currently, multisite trials are extraordinarily difficult with multiple IRBs that almost invariably do not use the same informed-consent forms. This change would obviate that problem and reduce the cost of doing multisite trials." Another major proposal is to tailor administrative requirements to the level of risk involved to humans. Charrow said there is much research today that poses little or no risk to humans, but which is subject to the same level of scrutiny as research that poses a very high risk to vulnerable human subjects. Under the Common Rule, there is a list of research protocols, approved by the secretary of HHS, that involve "minimal risk" and that are eligible for "expedited review" with one reviewer instead of a convened IRB. But the new rule would allow that list to be updated regularly. Moreover, continuing review would not be required of studies that are eligible for expedited review unless the reviewer determines at the time of initial review that continuing review is required and documents why. The proposed rule also aims to provide greater specificity about how consent forms should be written and what information they should contain so they can be shorter and more user friendly. A single Web site would be established where adverse events can be reported electronically, thus meeting all federal reporting requirements, with the resulting data being stored in a single database. And reporting requirements would be harmonized across agencies that approve federally funded research. The proposed regulations are posted at <www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm>. ISSUES NewArchived

The D&amp;T Report

The D&amp;T Report

Curing Cell Lines

Curing Cell Lines

States Receive Guidance on Health-Reform Waivers

Back to table of contents Previous article Next article Government NewsFull AccessStates Receive Guidance on Health-Reform WaiversRichard FaustRichard FaustSearch for more papers by this authorPublished Online:15 Apr 2011https://doi.org/10.1176/pn.46.8.psychnews_46_08_10_1AbstractIn March the departments of Health and Human Services (HHS) and Education issued a proposed rule for states applying for waivers from provisions of the Affordable Care Act (ACA). In addition, President Obama has announced his support for bipartisan legislation that would move the timeline for availability of state waivers from 2017 to 2014. In January's State of the Union Address, the president stressed that he was open to new ideas for improving the health care reform law. Echoing this commitment, HHS Secretary Kathleen Sebelius stated in a press release announcing the new rule that "Innovation Waivers empower states to take the lead on implementing the Affordable Care Act." The waivers are designed to give states the latitude to implement their own health care policies, which may differ from those in the ACA as long as they meet specified criteria. The press release lays out the criteria contained in the proposed rule, requiring states to provide coverage that meet these requirements: It must be at least as comprehensive as that offered through health insurance exchanges—new competitive, private health insurance marketplaces. It must be at least as affordable as the cost-sharing protect ions through the exchanges.It must provide coverage to at least as many residents as otherwise would have been covered under the Affordable Care Act.It must not increase the federal deficit.An HHS fact sheet on the proposed rule notes that states receiving waivers would also be required to submit quarterly and annual reports tracking measures in the four areas listed above and that the regulations suggest areas for continued monitoring of the waivers, such as choice of health plans and coverage of individuals with preexisting conditions. The president has thrown his support behind a bipartisan bill to move the start date for implementation of state waivers from 2017 to 2014. The start date is important because many of the provisions of the ACA do not go into effect until 2014. If states can receive wavers at that time, they can continue with any innovations they already have in the works without stopping to switch to implementing the federal requirements. Sens. Ron Wyden (D-Ore.) and Scott Brown (R-Mass.) first introduced the Empowering States to Innovate Act last November. In a press release Wyden stated that "some of the most innovative approaches to health policy have originated at the local level, where lawmakers have a unique insight into their constituents' lives, and the state waiver simply gives states the bandwidth to pursue those kinds of approaches." Brown said that "states shouldn't be forced by the federal government to adopt a one-size-fits-all health care plan." Julie Clements, deputy director for regulatory affairs in APA's Department of Government Relations, stated that "we support the secretary's requirement that any innovative state programs substituting for Affordable Care Act provisions must still satisfy the ACA's goals of coverage, cost-sharing, and comprehensive benefits. These requirements preclude the waiver program from being a means to circumvent the goals of ACA regarding coverage, cost-sharing, and comprehensiveness." APA will likely submit brief comments to the Centers for Medicare and Medicaid Services reiterating support for the goals of ACA and the hope that states that "do innovate will go above and beyond the more positive aspects of the ACA and how it treats mental health." The comment period on the proposed rule is open until May 13.The proposed rule is listed in theFederal Register at <http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2011_register&docid=fr14mr11-23.pdf>. The Empowering States to Innovate Act is posted at <http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.844:>. ISSUES NewArchived

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.

Weighing in on the future of gene patenting

Weighing in on the future of gene patenting

Preventive Medicine: A Ready Solution for a Health Care System in Crisis

Preventive Medicine: A Ready Solution for a Health Care System in Crisis

Invited Commentary: Population-based Human Subjects Research in the Era of Enhanced Privacy Regulation

Privacy seems to be of increasing public concern, as evidenced by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, a regulatory framework that appears to hinder access to data and thus to limit population-based research. A 2009 Institute of Medicine (IOM) report urged Congress, via the US Department of Health and Human Services (HHS), to develop a new approach to protecting privacy that would not employ the HIPAA Privacy Rule. In an accompanying article in the Journal, Nattinger et al. (Am J Epidemiol. 2010;172(6):637-644) employ one of the constructs recommended in the IOM report: use of a centralized honest broker. Unfortunately, Nattinger et al.'s approach would not be acceptable to all institutional review boards. The IOM report also urged the HHS to reduce variability in interpretations of the HIPAA Privacy Rule by privacy boards through revised and expanded guidance and harmonization. HHS Secretary Kathleen Sebalius has not acted upon any of the IOM report recommendations. The need to remove major barriers to human health research cannot be forgotten. At risk is America's progress in finding solutions to our most pressing health concerns.

SCID suggested for uniform newborn screening panel

SCID suggested for uniform newborn screening panel

Federal Rule Limits Use Of Genetic Test Results

Back to table of contents Previous article Next article Government NewsFull AccessFederal Rule Limits Use Of Genetic Test ResultsRich DalyRich DalySearch for more papers by this authorPublished Online:6 Nov 2009https://doi.org/10.1176/pn.44.21.psychnews_44_21_007AbstractFederal regulators recently issued an interim final rule to implement a 2008 law barring insurers and employers from using Americans' genetic information to deny them insurance coverage, change their rates, or discriminate against them in the workplace. But more protections may be needed.The departments of Health and Human Services (HHS), Treasury, and Labor issued the rule on October 1 to implement provisions of the Genetic Information and Nondiscrimination Act of 2008 (GINA, PL 110-233), which states that health insurers cannot cancel, deny, refuse to renew, or change the terms or premiums of coverage based solely on an individual's genetic risk of a specific disease. It also forbids employers from using a person's genetic information when making hiring, firing, promotion, and other employment-related decisions.A 90-day public-comment period has been set for the interim final rule, closing on January 5, 2010.“Echoing the late Sen. Ted Kennedy, our efforts to protect Americans undergoing genetic testing from having the results of that testing used against them by their insurance companies is one of the first major new civil rights of the new century,” said HHS Secretary Kathleen Sebelius in a written statement about the rule.Under the rule, insurers cannot request, require, or buy genetic information, and they are generally prohibited from asking individuals or family members to undergo a genetic test. The rule, however, allows three potential exceptions to the overall ban on requests for someone to undergo genetic testing—when a “health care professional” requests one, for payment-determination questions, and for research purposes. The rule also defines genetic information, genetic services, genetic testing, and related terms and phrases.Aim Is to Encourage TestingThe law and the interim final rule aim to encourage more Americans to undergo potentially lifesaving genetic testing without fear that the information will be used against them. Genetic testing can help in the early diagnosis and treatment of several disorders, help assess risk, and provide scientists with valuable data as they try to develop new medicines, treatments, and therapies, said Sebelius.APA is reviewing the regulations and working on preparing a response. APA has long supported such a genetic-privacy measure as part of its advocacy for greater patient confidentiality protections. APA's concerns about privacy in this area stem, in part, from the increasing number of links researchers have identified between genetics and some mental illnesses. The misuse of such information could have a devastating impact on people with mental illness, supporters of the legislation had warned when Congress was considering it.Loopholes Could Undermine IntentSome privacy rights advocates have warned, however, that loopholes in the GINA law will allow future discrimination by employers and insurers.Psychiatrist Deborah Peel, M.D., founder of Patient Privacy Rights, an advocacy group, said that GINA and the new rule do nothing to keep employers and insurers from accessing patients' genetic information.“How on earth are you going to know if [insurers and employers] use the information against you if they already have access to it?” Peel told Psychiatric News. “Genetics are not destiny, but [insurers and employers] don't care.”The Coalition for Patient Privacy, which Peel founded and includes the American Civil Liberties Union and the Bazelon Center for Mental Health Law, plans to push for legislation requiring that informed consent be obtained from individuals before their genetic information can be released.Further information on GINA and the new rule is posted at <www.hhs.gov/ocr/privacy/hipaa/understanding/special/genetic/index.html>. ISSUES NewArchived

Federal Declaration of a Public Health Emergency

During certain emergencies (naturally caused or deliberate) that can have a significant impact on the public's health, the Secretary of the U.S. Department of Health and Human Services (HHS) has broad discretion to declare a Public Health Emergency (PHE). While many public health emergencies will not require a formal declaration, this type of declaration can be an important and necessary step to authorize the secretary to take a variety of actions that enable the department to respond optimally to an emergency. This article outlines the HHS Secretary's PHE authority, discusses possible discretionary actions that the secretary may take after declaring a PHE, and provides examples of PHE declarations that have been issued.

A quick round up of news And inform Ation from our community

A quick round up of news And inform Ation from our community

End‐Stage Renal Disease Reform Moves into the Regulatory Process

Now that the Medicare legislation has become law, the center of activity has moved from Congress to the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS). The broad language of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) gives the HHS secretary discretion over many of its provisions, including the design and implementation of the bundled payment system of reimbursement for the treatment of end-stage renal disease (ESRD). MIPPA, which became law on July 15, 2008, creates a bundled payment that covers items and services included in the composite rate as of December 31, 2010; erythropoiesis-stimulating agents and their oral equivalents; and laboratory tests. Under the law, the secretary of the HHS has the discretion to include in the “bundle” other drugs, biologics, and their oral equivalents as well as other items and services furnished to individuals for the specific treatment of ESRD. The case-mix adjusters specified in the law are patient weight, body mass index, comorbidities, length of time on dialysis, age, race and ethnicity. However, the law gives the HHS secretary discretion to include additional adjustments, such as those relating to geographic factors and for pediatric and rural facilities. There is also an adjustment for high-cost outliers to be decided by the secretary. MIPPA requires that low-volume, high-cost facilities receive a minimum add-on adjustment of 10 percent during the 4-year phase-in of the bundle. The secretary has discretion in determining the facilities that qualify for the add-on and the amount, if any, over 10 percent. The unit of payment under the bundle is also left to the discretion of the secretary, who may set it on a per-treatment, weekly or monthly basis. Developing the ESRD regulations will be a multiyear process; even though CMS may be starting the process now, the ultimate decisions will be made under a new administration. MIPPA requires CMS to initiate a pay-for-performance program. According to the law, the bundled payment rate will be reduced by up to 2 percent for facilities that do not achieve or make progress toward specified quality measures starting January 1, 2012. Anemia management, patient satisfaction, iron management, bone mineral metabolism, and vascular access are specified in the law as quality measures. The secretary will establish the specific benchmarks used in measuring quality, the design of the overall system, the implementation process, and the details of the public notice requirements. The secretary will also develop the criteria for participation and selection in the five-year chronic kidney disease demonstration project required by MIPPA and the content of the chronic kidney disease education sessions and material that will now be reimbursed by Medicare. MIPPA includes specific language that precludes judicial or administrative review of any of the secretary's decisions. In essence, the secretary and the administration have broad unilateral authority in developing the specific policies for implementing the statutory ESRD requirements. Although the law gives the secretary broad authority in the design of the reimbursement, quality and demonstration programs, CMS will play a crucial role in their development. The implementation decisions will be made through the regulatory process, which begins with CMS. The path for the development of regulations is that the initial decisions are made by CMS, reviewed by the secretary of the HHS, forwarded to the Office of Management and Budget (OMB) for analysis and concurrence, and published as proposed regulations with a public comment period. The comments are reviewed, and changes can be made in the proposed regulations, which must then be reviewed again by the secretary of the HHS and the OMB before being published as final regulations. Once the final regulations are published, there is normally a 60- to 90-day period before implementation. Developing the ESRD regulations will be a multiyear process. Even though CMS may be starting the process now, the ultimate decisions will be made under a new administration. This means that a new secretary of the HHS, administrator of CMS, and director of the OMB, along with other top officials, will have a direct impact on the regulations. The regulatory process is where the action will be focused for the next year.

CPT®: An Open System That Describes All That You Do

The American Medical Association, with the cooperation of multiple major medical specialty societies, including the ACR, responded in 1966 to the need for a complete coding system for describing medical procedures and services with the first publication of Current Procedural Terminology (CPT). This system, now CPT IV, forms the basis of reporting of virtually all inpatient and outpatient services performed by physicians and nonphysician health care providers as well as facilities. This coding system and its maintenance process have evolved in complexity and sophistication, particularly in the past decade, such that it is now integral to all facets of health care, including tracking new and investigational procedures and reporting and monitoring performance measures (read "pay for performance"), in addition to its long-standing use for reporting for reimbursement. To paraphrase a recent automobile commercial, "This is not your father's CPT." The author describes the development of CPT as it exists today, examining the forces that molded its current form, the input opportunities available to medical specialty societies and others, the ever increasing transparency of the CPT maintenance process, and the availability of resources allowing all to stay current. Understanding this system, critical to the practice of all of medicine, including radiology, will aid all health care providers in maintaining the quality, efficiency, and accuracy of their practices' business operations as well as assist them in a world of increasingly complex reporting requirements.

31: Update on the C.W. Bill Young Cell Transplantation Program & National Cord Blood Inventory

31: Update on the C.W. Bill Young Cell Transplantation Program & National Cord Blood Inventory