Heart failure coverage under Medicare | Ramesh Devi Thakur | PhD Candidate | Arizona State Universit

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Heart failure coverage under Medicare Ramesh Devi Thakur | PhD Candidate | Arizona State University College of Nursing and Health Innovation Information Education for Participation          I started with my blog on Medicare’s policy to include heart failure(HF) under cardiac rehabilitation (CR) program and progressed through the policy making process step by step starting from the historical background, premise, ethics, regulatory and legislative processes, health disparities, stakeholders, innovation and how to sustain the innovation. The focus of this blog is on the strategies to increase consumer participation in the policy process. It is imperative to involve the consumer in the planning, implementation and evaluation phase of the policy process to make it more successful, acceptable and sustainable. The consumers should not only be considered as users or choosers but as active participants in making and shaping the policy. They should be able to influence the governments and hold them accountable.        Patient participation remains poorly defined despite its substantial use in the literature. Multiple terms are used to denote participation such as patient collaboration, patient involvement, partnership, patient empowerment or patient centered care. It is associated with many aspects of healthcare such as decision making, self medication, self monitoring, patient education, and goal setting. Human beings have will and right to determination and they exercise their fundamental rights while participating in decision making. Like any consumer, the patient may demand quality services. Patient participation is a critical element for redesigning of healthcare system. According to world Health Organization’s Declaration of Alma Ata (1978), “the people have the right and duty to participate individually and collectively in the planning and implementation of their health care. It is evident in the literature that patient engagement can lead to better health outcomes.Patients’ participation at the policymaking level is fundamental for developing, implementing and evaluating national, state and local level programs. It indicates that health care system is geared around patients’ perspectives. Patient collaborates with community leaders and policy makers to solve community and social problems, and shape healthcare policy. One example of patient participation is the Health Information Technology Policy Committee, established by the American Recovery and reinvestment Act of 2009. The committee designed three of its twenty seats for consumer representatives to make recommendations on policies that promote the adoption and meaningful use of health information technology. Despite the benefits of participation, the barriers such as lack of knowledge regarding health care and policy options, lack of time and payment for involvement, lack of procedures how to select the consumers and lack of understanding of how consumers affect health care system might limit the involvement of consumers in health policy making. The medical terminology used, nature of language used in the present health care system is burdensome for the consumers. It was found that only 35% of American said that they know what the term “managed care” meant. The authoritative attitude of the providers is another barrier to accept the people in decision making roles because they cannot delineate the role of patient from that of citizen.Patient participation in coverage of heart failure under Medicare’s cardiac rehabilitation (CR) program, starting from the planning process, can contribute remarkably to improve underutilization of CR program. As patient is the core of healthcare policies so it is important to know the perspective of patient. Educating the patients about the CR program, its benefits and cost, can improve the participation. The referral and motivational counseling by the physician can increase the participation. The educational strategies should start when the patient is still in the hospital and the professionals who can play key role are physicians, nurses, physical therapists, physiologists, and dieticians. It is only through participation that needs of diverse and vulnerable populations might be addressed. Why they are not attending the complete sessions, what are the barriers? Only consumer can tell. Based on their feedback the policies can be modified and new models of delivery of CR program can be developed. There is need to develop more outcome measures.As patient is the direct beneficiary of cardiac rehabilitation so it is crucial to consider patient’s perspectives in planning, implementation and evaluation of policies related to the CR. They have knowledge of living with a disease condition, using health services and can provide vital information about diseases and impact of treatments and technologies used, such as benefits and unintended effects. Participation can equally serve the purpose of empowering as well as utilization of services. Nurse case managers assume responsibility for day to day care and can contribute significantly to reinforce the importance of outpatient cardiac rehabilitation referral to home health team. The physical therapist can be instrumental in guiding the patients in the inpatient settings and in improving the outpatient CR referral.By participation the consumers can develop their own voice and voice is democratic expression of preferences and expectations that can ensure accountability to the users or consumers of health care services. There is need of an evidential and policy context supporting consumer participation. Information sharing is critical to effective consumer participation. Consumers need clear accessible information at all levels of contact, from patient to boardroom. Participation improves service quality and safety, improves health outcomes and makes services more responsive to the needs of consumers. Motivational communication and trained lay volunteers may improve uptake of cardiac rehabilitation, information of cost on interventions, and increased provision of outpatient cardiac rehabilitation. Potential benefits of consumer involvement in health care include: policy, research, practice and patient information that includes consumers’ ideas or their concerns, improved implementation of research findings, better care and better health.There is need to redesign the healthcare system in such a way so that patients can play an active role in their care. It has been found in a study that patients who received help from their providers such as in sharing decision making process, had lower admission rates and healthcare cost. Consumers can be trained to participate in the policy making process. Internet based technologies can facilitate access to a vast range of policy information to the consumers. There should be improved reimbursement mechanisms for consumers involved in the activities related to policy. Above all consumer participation would only improve if healthcare professionals make adequate efforts to facilitate consumer input to create more effective health care system and accept the consumer as citizen not as patient. Thank you all for your valuable comments and time throughout this blog period.ReferencesLongtin, Y., Hugo, S., Leape, L. L., Sheridan, S. E., Donaldson, L., Pittet, D. (2010). Patient participation: current knowledge and applicability to patient safety. Mayo Clinic Proceeding, 85(1), 53-62.Piepoli, M. F. et al (2010). Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the cardiac rehabilitation section of European Association of cardiovascular prevention and rehabilitation. European Journal of Cardiovascular Prevention Rehabilitation, 17(1). Doi: 10. 1097/HJR.0b013e3283313592.Sleath, B. Rucker, T. D. (2001). Consumer participation in health policy decisions: empowerment or puffery? Journal of Health Care for the Poor and Underserved, 12(1), 35-49.Kraft, M. E., Furlong, S. R. (2013). Public policy: Politics, analysis and alternatives (4th ed). Thousands Oaks, CA: CQ Press.Longest, B. B. Jr. (2010). Health policymaking in the United States (5th ed.). Chicago, IL: Health Administration Press.      Communication network for innovative environments         In the previous blogs I have written about innovation and who are the innovators, what are their characteristics? Innovation has become the survival strategy of our time and for the survival of companies and organizations in this competitive era. It is well said in an article that innovation is a crucial element in all economic progress for nations, companies and careers of individuals. Many organizations and companies have creative ideas and creative people who are not effective at driving innovation in their organizations due to unfavorable environments. Government policies can support innovation by reforming and updating the regulatory and institutional framework within each innovative activity that takes place. There is need to plan development sustainably by taking all aspects into account and choices that maintain a maximum level of long term well being. Sustainable development provides a way of assessing current situation, setting goals and making the right choices.Current focus of innovation management techniques and organizational solutions is mainly on hard aspects of innovation such as growth strategy, technological investment while ignoring the softer aspects such as promoting creativity and discipline, stimulating entrepreneurship, accepting risk, encouraging teamwork, fostering learning and change, facilitating networking and communication. The scope of innovation is so wide that only few organizations appear to have thought about how to manage innovation in an integrated way today and tomorrow. The sustainable environment can be created by defining role, decision power, responsibilities of main players, how to measure innovation and decision on innovation budgets to all the team members.Information and communication technology system such as Collective Awareness Platforms are likely to support grassroots processes, create environmental awareness, and practices to share knowledge, to achieve change in life style, production and consumption patterns and to set up more participatory democratic processes. The main ingredients required for sustaining innovative environments include effective leadership, good interpersonal relationships, collaboration among the stakeholders and shared decision making. According to American Association of Critical Care Nurses, interdisciplinary collaboration and effective leadership are crucial elements for healthy work environments. Sustainable development needs stimulating, and revolutionary innovation through regulation of environment, health, economic and labor market to open up the participatory and political space and to enable new voices to contribute to thinking and solutions. According to Institute of Medicine, safety and quality issues exist in large part because dedicated health professionals work within systems that neither prepare nor support them to achieve optimal care outcomes.In the case of cardiac rehabilitation, how to sustain the environments for the innovation to continue there is need of skilled communication between team members, patients and stakeholders, effective decision making processes by involving the patients, having adequate staff, meaningful recognition of self and others and authentic leadership are the standards which will help to keep the environment healthy and to sustain the innovation as recommended by the AACN. The foundational elements of the sustainable development are people, environment and economic system which are interrelated and if not taken into consideration can lead to crisis. The underutilization of CR program has been the result of not paying attention to the economic status of people especially the minority populations including older adults, women, racial and ethnic groups. The approaches which can help to sustain the innovative environment in CR program are educating the patients, care providers, and policy makers about the program’s benefits, creating collaborative networks among the stakeholders and developing new models for the CR based on the needs of minority communities.The policies related to pre approved referral, making secondary prevention a priority for quality of care, good interpersonal relationships among the CR staff, authorities, and patient, incentive for patients for completing the sessions of CR, increasing capabilities or capacities of the CR program can help to sustain the change related to coverage of heart failure under CR program. Developing specialized workforce for CR can also help in improving referral, enrollment and quality of care. Conducting evaluation of the policy effects related to financial, organizational, human aspects, evidence of effectiveness and modifying the program based on the feedback is also important to sustain the innovative environment. Making the issue of reimbursement simple by involving third party payers can also sustain the innovative environment. It is found in the literature that despite its tremendous benefits the CR does not have people lobbying for it. There is need to create network of stakeholders and lobbyists. Use of technology can make wonders in improving communication and developing network which are crucial elements for sustainability. One more critical element is the inherent innovativeness and flexibility of the organization which can sustain the innovative environment.Government can play an important role in sustaining the innovative environments through setting of clear standards and policy goals. Community ownership of the planning and transition stages of the innovative learning environment is shown to be a catalyst for sustainable innovation. Emotions and a sense of self efficacy have significant interrelationship with motivation and ongoing effects on learning. However, organizations differ in their approach to innovation but the ability to conceive, create and bring to the market depends on the quality of talent and the environment in which the people work. Today, the emphasis is not on creating innovation rather it is on how to sustain it.ReferencesSinar, E.F., Wellins, R. S Pacione, C. (). Creating the conditions for sustainable innovation: the leadership imperative. Trend ResearchStrange, t., Bayley, A. (2008). Sustainable development: linking economy, society and environment. OECD Insights.Ashford, N. A. (2000). An Innovation-based strategy for a sustainable environment. In Innovation-oriented environmental regulation: theoretical approach and empirical analysis, J Hemmelskamp, K. Rennings, F. Leons (Eds) Heidelberg, New York pp 67-107.         In United States the portion of the health care system is market based that is paid by individuals and private employers. However in market based systems the government can provide health care to vulnerable populations. Healthcare is sponsored by US household, private businesses and federal, state and local governments responsible for financing the nation’s health care bill. Household accounted for largest share of spending (28%) in 2012. Health care spending has increased by 3.7% (2.8 trillion) or$ 8915 per person in 2012 but it is stable since 2009 because the income and employment growth was modest over this period. As a result of faster growth in gross domestic product as compared to spending, share of economy assigned to health care fell slightly from 17.3 to 17.2 percent between 2011 and 2012. National health spending can be attributed to five broad factors: economy wide inflation, medical specific inflation, population change, shifts in the age and sex mix of the population and other factors such as use and intensity of services.In this blog my main focus is on the financing and reimbursement system of Medicare, because policy related to coverage of heart failure under cardiac rehabilitation comes under Part B of Medicare. Medicare, a federal health insurance program caters for more than 50 million older adults, disabled Americans and pays for hospital and physician visits, prescription drugs and some acute and post acute services. The Medicare is funded by the “Medicare Trust funds” held by U.S. Treasury. The main sources of funds are general revenues (40%), payroll tax contributions (38%) and beneficiary premiums (13%). The first trust fund Hospital Insurance (HI) is financed primarily through mandatory payroll tax. All employees and self employed workers, who are covered under Part A, pay taxes to support the cost benefits for aged and disabled beneficiaries. Part B is financed through general revenues (72%), beneficiary premiums (25%) and interest and other sources (3%). Beneficiaries with annual incomes over $85,000/individual or 170,000/couple pay higher income related premium reflecting a larger share of total Part B spending, ranging from 35% to 80%. Despite medicare provides many benefits and financial protections, one in every four beneficiaries spend almost 30% from his/her pockets.The second trust fund is Supplementary Medical Insurance Trust Fund which is funded by the government, premiums from people enrolled in Medicare Part B and Medicare Prescription drug coverage and interest earned on the trust funds. It is accountable for Paying Part B benefits such as doctor services, outpatient services, preventive services (cardiac rehabilitation), durable medical equipment, and lab tests, cost for combating fraud and abuse as well as covers Part D. On the other hand, in 2012 the spending on Medicare was 16% of the federal budget and accounted for 21% of the total national health care spending, 28% on hospital care and 24% on physician services. The spending per beneficiary was highest among top10% of beneficiaries accounting for 57% of total Medicare spending in 2009, five times greater than the average across all beneficiaries in traditional Medicare. In case of cardiac rehabilitation the Centers for Medicare and Medicaid (CMS) has increased the payment for outpatient cardiac rehabilitation from $38 to $69 in 2011. As CMS covers 36 one hour sessions per patient it translates to $1100 additional revenue per patient to the hospital and $200 for the physician. But on the other hand, it will reduce hospitalization and readmission rates among heart failure patients, which would  help to lower the spending.Total expenditure incurred by Medicare was $536 billion in 2012. Out of total $536 billion expenditure of Medicare in 2102, Part A (Hospital in patient services and skilled nursing services) accounted for 31%, Part B (hospital outpatient services) 19%, Part A B (Home health) 17%, Part C (Medicare advantage) 23% and rest of the 10% on Part D (outpatient prescription drugs) (Figure 1). Total Medicare spending is projected to almost double from $592 billion to 1.1 trillion between 2013 to 2023 due to growth in population and increases in health care costs. The Medicare budget is projected to increase from15.6% to 18.2% and Medicare spending from 3.5% to 4.1% between 2012 and 2023. To address the issue of Medicare spending there is provision in the Affordable Care Act (ACA) of 2010 to reduce $716 billion Medicare spending in the next 10 years, by reducing annual payments updates to hospitals and other providers and Medicare Advantage Plans, increasing eligibility age and accelerating the ACA’s delivery system reforms.In the future, the main concern for the policy makers is to find ways to reduce Medicare spending, setting fair payments to providers and plans and not affecting the care and increasing the burden on older adults and disabled beneficiaries. However the provision in the Affordable Care Act to constrain the spending by Medicare such as payments for physician’s services will be reduced by 25% and further in small amounts in subsequent years can make a difference. The other provision which is going to impact the Medicare spending is to impose permanent reduction in annual updates in Medicare’s payment rates, and ACA‘s Independent Advisory Board which will be submitting a proposal to reduce medicare spending if the 5 year average growth rate in Medicare per capita spending is projected to exceed per capita target growth rate, based on inflation or growth in the economy.ReferencesLongest, B. B. Jr. (2010). Health policymaking in the United States (5th ed.) Chicago, IL: Health Administration Press..American Heart Association and American Stroke Association. Cardiac rehabilitation putting more patients on the road to recovery. Retrieved from http://www.heart.org/HEARTORG/Advocate/IssuesandCampaigns/Advocacy-Fact-Sheets_UCM_450256_Article.jspKaiser Family foundation (2012). Medicare spending and financing fact sheet. Retrieved from http://kff.org/medicare/fact-sheet/medicare-spending-and-financing-fact-sheet/Martin, A. B. Benjamin, D. L. (2012). Growth in US health spending remained slow in 2010; health share of Gross Domestic product unchanged from 2009. Health Affairs, 31(1).Congressional Budget Office (September 18, 2013). An overview of the Medicare program. Retrieved from https://cbo.gov/publication/44587 Innovator: Persuasion and CollaborationInnovation leads to development of a novel policy, the adoption of policy in other area or significant impact of new policy. Policy innovations can thus be thought of as changes to existing policy practices, not necessarily entirely novel, but any combinations of the components which results in new outcomes. However adoption of policy innovation does not happen at a one go in a social system; rather it is a process where some people adopt the innovation faster than the others. It is also evident in the literature that people who adopt an innovation early have different characteristics than the people who adopt it later. In this blog I am focusing on the characteristics of innovators and change agents in general and in relation to cardiac rehabilitation policy.InnovatorsInnovators are the first 2.5% to adopt a new innovation; they tend to have extensive communication channels, extend across diverse knowledge areas and congregate with like innovators despite being geographically at distance. They are risk takers and interested in new ideas. They are often the first to develop new ideas. They spend great time energy and creativity on developing new ideas and gadgets. They take risks and plunge into a new activity; they like to talk about their gains. They are the independent test bed, for trying the innovation and reinventing in order to make it suitable for the majority population. They are also an easy audience; they do not need much persuasion. They are people to do many things first. Innovators are able to cope with higher levels of uncertainty about an innovation than are other adopter categories. The innovator’s role in diffusion is to import innovations from outside the usual professional boundaries. They must have the ability to understand and apply complex technical knowledge, accept an occasional set back and be financially stable to absorb risks.The innovators in the coverage of heart failure (HF) under cardiac rehabilitation (CR) are primary care providers, secondary care providers, and agencies such as AHA, AACVPR, ACC and HFSA who have acted as link between government agencies and consumers. Their main aim is to help the people suffering with heart failure, who are adversely affected by the outcomes and financial burden of the disease. They identified the problem and started their action based on the needs of the consumers such as burden of cost and caring. They have taken adequate steps to generate the evidence related to the benefits of cardiac rehabilitation, technological requirements for CR and the setting where it would be carried out. They have acted as link between the government agencies and the agencies directly catering for the consumers. Ultimately they have succeeded in getting the proposal approved which is in the final stages of publication.Change agentsNo one person can implement wide scale change, a coalition or network is important. For CR program also a multidisciplinary team is responsible for implementing change and sustaining the outcomes. As the CR policy of coverage of HF is in the last phase of approval and will be published soon, the role of change agents will be prominent for its implementation. They will work to influence the client’s decisions in the direction deemed desirable by the change agency. In case of inclusion of HF in the CR program, many change agents are going to play their role including healthcare providers such as clinicians, nurses, therapists, technicians, pharmacists, insurers and patients themselves. They will help to introduce the change among the consumers and will bring back feedback from the consumers to the agency. As per their agency protocol they would be educating, persuading and training the patients about cardiac rehabilitation program by adopting different models. The participation of the patient in decision making related to CR services is crucial for the success of the program.The change agents assess the client needs and accordingly involve them in the decision making and goal setting process. Change agent establishes an information-exchange relationship with his/her clients by developing rapport and enhances the relationship by creating credibility in competence, trustworthiness and empathy with the clients’ needs and problems. Change agents make their clients become aware of the need to alter their behavior. They suggest new alternatives to existing problems, emphasize importance of these problems and may convince clients that they can confront these problems.Change agents analyze problems in specific situations, in order to examine why existing alternatives do not meet their needs. The situation is viewed from the client’s perspective, not his or her own. Change must be client-centered instead of innovation centered. However there are certain factors like homophily (change agents have most contact with those clients who are most like themselves) and heterophily (change agents have less contact with the clients who have low socioeconomic status). It means they are going to have more contact with the educated and financially sound clients and less with the clients with low level of education and poor socioeconomic status, who in reality should get more attention of change agents. These issues should be addressed before starting journey of change.Thanks for following and comments.ReferencesXavier P. (2012). The importance of responsible-innovation and the necessity of ‘Innovation-care’ Research Center ESSEC working paper 1203.Schleien, S. J. Miller, K. D. (2010). Diffusion of innovation: a roadmap for inclusive community recreation services. Research Practice for Persons with Severe Disabilities, 35(3-4), 93-101.McManus, A. (2013). Health promotion in primary health care. Australasian Medical Journal, 6(1), 15-18Rogers, E. M. (1983). Diffusion of innovations (3rd ed). The Free Press: A Division of Macmillan Publishing Co. Inc. New York.Kingdon s Three Stream Policy Window ModelWorld is changing fast with the growing developments in the technological, social and cultural contexts, so the success of organizations depend upon their movement parallel to these developments. However to keep this movement in the right track there is need of policies and procedures but these also seek modifications or change, time to time as per demands. Further for navigating the policy making process or change in policies, the change theories act as roadmaps.In this blog I am going to focus on John Kingdon’s three stream policy window model, and how it relates to policy for coverage of heart failure under cardiac rehabilitation program. Kingdon’s policy window model of agenda setting tries to clarify why some issues are considered in the policy process and some are not. He identified three streams such as problem, policy and political, which must be coupled to make a policy change. Problem stream is a condition considered as a problem, policy stream is related to the alternatives that can be implemented and political stream is willingness and ability of politicians to make a policy change. This model seems to fit well with the issue of coverage of heart failure under cardiac rehabilitation program of Medicare.Problem StreamThe increased attention to an issue or some major events can release the problem stream. The identification of an issue or problem is the first step in the Kingdon’s model. The main problem on which the policy related to coverage of heart failure under cardiac rehabilitation is based, is the disproportionate increase in the incidence of heart failure and tremendous growth in the aging population, because majority of them are suffering with heart failure. It is evident in the literature that heart failure is chronic progressive and costly syndrome, responsible for higher rates of morbidity and mortality, readmissions and hospitalizations and cost of care.The other factor which made this problem more prominent is the maximum spending and poorer health outcomes by United States as compared to other (OECD) countries. How to reduce the costs and maximize the benefits among patients with heart failure gave birth to the problem stream in the cardiac rehabilitation policy. However cardiac rehabilitation policy was already in place and required modification related to coverage, but main challenge was to generate adequate evidence because in the past heart failure was not included under the coverage due to inadequate evidence. The fundamental drivers in this policy were the interest groups who generated the adequate evidence.Political streamThe other stream which starts flowing alongside problem stream is the political stream. In this stream the problem is shared among policy communities that are composed of specialists in the area such as cardiovascular health in case of cardiac rehabilitation policy as well as different committee members in the congress, media and public. Further this community of specialists generates proposals, redrafts and debates them. The proposals are selected and considered seriously. The ideas from these experts flow like molecules and collide and ideas which are more powerful are carried forward in the movement by preparing an agenda. But during this movement the collaboration among participants is of paramount importance to reach the aimed target. However agenda related to coverage of heart failure under cardiac rehabilitation program has already crossed this stream.Policy streamPolicy stream produces short list of proposals but this is not consensus rather it is agreement that certain proposals are prominent. The major driving forces here are the interest groups who are committed to a particular policy change. In coverage of heart failure the main committed groups are American Heart Association, American College of Cardiology, and American Association of Cardiovascular and Pulmonary rehabilitation. The movement of policy stream continues by making variety of suggestions publicly and privately to resolve the problem. In cardiac rehabilitation the research has been conducted by focusing on different aspects such as infrastructure, process of carrying out the cardiac rehabilitation and technology requirements, to generate evidence and to reach the agreement.WindowsConvergence of problem, politics and policy stream results in public policy. These convergences according to Kingdon are called windows. There are driving forces like national mood, organizational interests, election repercussion, and orientation of elected politicians which open the window and lead to restructuring of the decision agenda but it requires joining of all three streams. So cardiac rehabilitation policy, according to Kingdon model has passed through the window after the convergence of problem, political and policy streams. As this policy is moving toward its approval so after that many formal and informal mechanisms and regulations are going to play a role in the implementation process. The impact of this policy change can be measured by using outcome based measures. Outcome driven mapping such as cataloguing desired outcomes, identifying potential policy and research paths, quantitative analysis of data and case studies can help diverse stakeholders in decision making and evaluating the effect of policy.According to Fieldlng and Briss (2008) accelerating the integration of scientific discoveries into routine public health practice and policy deserves priority attention and in the policy related to coverage of heart failure under cardiac rehabilitation program the evidence has been given prior attention. The policy makers have addressed the burden of disease, program and policy options, the distribution of benefits among the affected, situation specific solutions, political and technical feasibility and cost and cost effectiveness. The road map approach includes the input from both experts and public about what is health and which societal level outcomes are desired that can shape the healthcare system. In addition to this contextual awareness among the policy makers and stakeholder is crucial for the decision making (Garfinkel, Sarewitz, Porter, 2006).ReferencesKritsonis, A. (2005). Comparison of change theories. International journal of management, Business and Administration, 8(1),Garfinkel, M. S., Sarewitz, D., Porter, A. L., (2006). A societal outcomes map for health research and policy. American Journal of Public Health, 96(3), 441-446.Liebman, J B. (2013). Building on recent advances in evidence-based policy making. A paper jointly released by results for America and the Hamilton Project. Retrieved from http://www.brookings.edu/research/papers/2013/04/17-liebman-evidence-based-policyKingdon, J. W. (2010). Agendas, alternatives and public policies, updated Edition (2nd ed.). London: Longman Publishing Group.Fielding, J. E. Briss, P. A. (2008). Promoting evidence-based public health policy: can we have better evidence and more action? Health Affairs, 25(4), 969-978. Doi: 10. 1377/hlthaff.25.4.969.My intent in this blog is to discuss policies related to access and privacy of data and relate these to cardiac rehabilitation policy pertaining to heart failure. The health care is changing with the advancement of science and technology and research has become interdisciplinary, with the formation of collaborations around the world. As the data on health information has grown tremendously it has become challenge to the government as well as to the research community, to secure and maintain its privacy. So to manage this pool of health information new tools are being developed such as electronic health records, big data bases and cloud computing, but how  safe are these devices to secure and protect the health information is questionable? As many ethical issues are involved so how we can depend on the traditional ethical review committees?Health Insurance Portability and Accountability ActThe issue of privacy of health information was addressed by the government through Health Insurance Portability and Accountability Act (HIPPA) that encouraged development of electronic health records. The HIPPA went into effect in 2003 and protects most “individually identifiable health information” held or transmitted by a covered entity or its business associate, in any form or medium, whether electronic or paper or oral. This information is called protected health information which relates to mental health, provision of healthcare, payment for the provision of healthcare and common identifiers such as name, address, birth date, social security number. But the drawback of this system is that patients have no private right of action against the violators and once the data is de-identified it does not come under the preview of HIPPA.In case of cardiac rehabilitation policy regarding coverage of heart failure all the rules and regulations of HIPPA are applicable for sharing and privacy protection of data. Research to generate adequate evidence has been conducted after approval of ethical review committees. The data has been shared between different agencies nationally and internationally to collect the adequate evidence. In future also to evaluate the effects of policy related to heart failure coverage there is need of sharing data between different providers and patients.Further genomic research is also related to the heart failure because certain genes are risk modifiers and to generalize it there is need to have large samples which can be made possible by international collaboration, but yes the challenges of access of data and privacy of information would remain the same as in other areas. Genetic testing may motivate people to modify their behaviors to minimize the risks but the evidence is lacking and needs further investigation. In contrast to this genetic testing and information sometimes can lead to adverse effects; patient may think that this is out of his control to modify the genes.The Health Information Technology for Economic and Clinical Health Act (HITECH Act 2009) focuses on establishment of a national health infrastructure and on providing incentives for adoption of electronic health records and enhanced privacy protections. From electronic health records, patient can access their health information easily and be informed and more involved in their own care but again the questions  such as who is going to access this information and if it is compromised what to do? Still remain unanswered. The consistent efforts are on by the Federal government to have common laws in the states related to privacy of health information.  But as states have differences in their populations and health goals, so to have common laws is not the solution rather existing laws should be modified and strengthened.We know that genomic research can lead to health discoveries, but there is need to improve the governance system of ethics review to enable secure and seamless genomic and clinical data sharing. The National Institute of Health’s proposed data sharing policy and the European Medicines Agencies’ current development of a policy on the proactive publication of clinical data are the efforts in this direction.  Further the genetic information can be abused, misused or might lead to social stigma to the person and family members.In addition to this the complexity of issue further increases because in HIPPA policy the genomic data is not considered as identifying patient attribute. However many data generating projects provide free access to data online, the “Human Genome Project”, “The HapMap project” and “1000 Genomes Project” whereas some projects have their own policies to release data such as researchers must provide their credentials before they are allowed to access the information.Bermuda Principles in genomicsThe first policy related to data sharing in the field of genomics was the Bermuda Principles, agreed at the “First International Strategy Meeting on Human Genome Sequencing” in 1996, and was followed by the “Fort Lauderdale Agreement” in 2003. According to Bermuda Principle the pre-publication genome sequence should be freely available and in the public domain to encourage research and development and to maximize benefits to society.There are other systems which are helping to secure and protect the privacy of data but they are also having some lacunas.  According to advocates of de-identification the privacy of genomic data can be protected by removing explicit and quasi-identifying attributes.  Next de-nominalization is almost the same as de-identification, trusted third parties who are empowered with full data encryption and semi-trusted third parties who hold and distribute encrypted data, but there is risk of compromising privacy when data is re-identified. The current privacy protection methods do not guarantee the protection of the identities of data subjects.                Above all there can be abuse of data by the Federal government such as inappropriate use of data by law enforcement or national security agencies or use of data for objectionable purposes. The future thought of government getting involved in doing all things is scary. Maintaining participants and public trust around potentially contentious issues, including data access by for-profit entities, procedures for Federal accountability, and return of individual research finding to the participants and re-contacting the participants to seek permission for use of existing data are of paramount importance.What is next?                However total protection of privacy is increasingly unrealistic in an era in which Direct to Consumer Genetic testing (DTC) is offered on the internet and forensic technologies can potentially identify individuals. There is need to have regulatory approaches to ensure the quality, safety, security and utility of their services. Public genome databases should be interoperable and grant access to authenticated researchers internationally. Consumer protection agencies should monitor DTC site to ensure that these companies adhere to their own privacy policies.ReferencesCaulfield, T., McGuire, A. L. (2012). Direct-to-Consumer genetic testing: perceptions, problems and policy responses. Annual Review of Medicine, 63, 23-33.Knoppers, B. M. (2013). From tissues to genomes. G3, 3(8), 1203-1204Knoppers, B. M. (2010). Consent to ‘personal’ genomics and privacy. Direct-to- consumer genetic tests and population genome research challenge traditional notion and consent. Science Society, 11(6), 416-419.Trinidad, S. A., et al. (2010). Genomic research and wide data sharing: views of prospective participants. Genetics Medicine, 12(8), 486-495. Doi: 10.1097/GIM.0b013e3181e38f9e.Malin, B. A. (2005). An evaluation of the current state of genomic data privacy protection technology and a roadmap for the future. Journal of American Medical Informatics Association, 12, 28-34.Dove, E. S., Knoppers, B. M. Zawati, M. H. (2013). An ethics safe harbor for international genomics research? Genome Medicine. 5, 99Pritts, J. D. (2007). Federal efforts to impose uniformity on state health information privacy laws. Health Law PolicyMcGraw, D. (2013). Building public trust in uses of Health Insurance Portability and Accountability Act de-identified data. Journal of Medical Informatics Association, 20, 29-34. Doi: 10.1136/amiajnl-2012-000936United States Department of Health and Human Services. The privacy rule. Retrieved from http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/ Public-private sector collaboration for policy advancementInnovation is derived from the Latin verb innovate or in novus “into new” doing something different, or doing something better, or an act of creating an idea or a method. For example progression from gas lamps to incandescent bulbs to LEDs would be defined as series of innovations. Innovation is risky, costly and time consuming. Consider the example of apple invested to bring iPod to market and the business risks it likely took in diverting money away from market to research and development. Another example is the mobile device which is the fertile ground for innovative technology. New or improved product and processes are important drivers of competitiveness, growth and employment generation.Private sector is actively involved in the promotion of public health, reducing NCDs, strengthening health systems and promoting workplace wellness. The global initiatives by the private sector are healthy workforce and families, access to quality of care, healthy environments and strong education, training and research capacity. To optimize these individual efforts there is need of effective and strategic partnerships. For example in case of immunization enterprise’s success, Lewin (2012) mentioned his experience of sharing the public sector perspective with the companies and of companies with the public sector. The private investments in vaccine innovation are rewarded with policy recommendations based on public health evaluation which leads to higher use of vaccine and further encourages investments in research and innovation.Private sector is an integral part of development of a comprehensive set of quality measures and metrics for a national quality strategy. Private sector can provide expertise and firsthand experience in quality improvements efforts and its unique perspective on barriers and facilitators to certain measurement approaches. Private sector involvement may either bring a fresh approach to policy making, which can better respond to new challenges and it may aim either to push new ideas forward or to press the government to remove existing hurdles and launch a more modern policy. The government may invite representatives from high performing companies, prestigious business leaders and relevant associations to use their experiences and filter policy ideas and measures. Progressives in the state administration look to the private sector as a positive force driving towards increased modernization.In case of cardiac rehabilitation the guidelines were developed by 19 member private-sector panel whose co-chair was Dr. Nanette, K. Wenger. The guidelines were developed under the Agency for Healthcare Policy and Research (AHCPR) contract. Recently to bring the heart failure under the coverage of cardiac rehabilitation the efforts of private and public sector have led the CMS to propose decision to include the HF under the CR program. But there is vicious cycle the federal government provides funds to the agencies or entrepreneurs to conduct innovative research and the outcomes of this research advance the policies and it goes on. In case of heart disease the public-private initiative to prevent million heart attacks and strokes was launched in 2011, whose main aim is to empower Americans to have healthy choices and to improve care by targeting on ABCS (Aspirin, Blood pressure, Cholesterol management and Smoking cessation). Among the private sector stakeholders in this project are health advocacy groups, Walgreens, Health Insurers, and Pharmacists associations (U.S. Department of Health and Health Services).The remote patient management is a transformative technology that offers major opportunities to advance national goals of improved quality and efficiency. These new business models are emerging due to public-private policies designed to improve outcomes and reduce spending also in case of Congestive heart failure. One example where private sector is playing a key role is the Essentia Health, an integrated health system with 4 hospitals, 17 clinics and 750 physicians and almost 400,000 patients’ visits each year in Minnesota, North Dakota and Idaho. Success of this program has led to opening of more satellite programs and might impact the policies. Even I have seen the role of private sector at smaller scale as funding for the seminars and conferences where certain policy recommendations are made as well as advocating for their technologies.However innovation networks or partnerships are formed on the basis of competence of partners. Partners who are too similar have nothing to learn/share from each other so degree of competence differentiation is important. When the private sector and public sector come together on the same platform with different perspectives, they learn from each other and give birth to innovation by exchanging their viewpoints. One such example is “National Quality Strategy” that represents a collaborative effort across all sectors of healthcare community.  It is an important element of the Affordable Care Act and a roadmap to improve delivery of healthcare services, patient health outcomes and population health. Its main aim is to align the efforts of governmental and private sector stakeholders in improving the quality, reducing the cost of health care and advancing the health policy. The National Quality Forum’s National Priorities partnership (NPP) is a partnership of 52 major national organizations with a shared vision to achieve better health and a safe equitable and value driven health care system.The National Institute of Health is working continuously by providing funds to hospitals, small businesses, universities, independent research institutions and government labs to improve health and save lives.  Due to these efforts deaths related to heart disease have decreased by 50% in the last four decades. The research evidence which led the CMS to propose decision to include heart failure under cardiac rehabilitation program was also funded by NIH and included 2331 participants. Further the partnership between NIH, university research scientists and private sector companies is helping to produce life saving products, fueling economic growth, creating new jobs and advancing policies. On one side the public sector research is focused on upstream basic research to identify the mechanism and pathways of disease and the levels of intervention where as on the other side the private sector research is focused on applied research to discover drugs that can be used to treat the disease and to bring these drugs to the market. In some instances the research carried out by public sector acts as foundation for the private sector research.The other example where private sector is involved in the innovation is U.S Department of Home Security’s program known as the Science and Technology Directorate that is funding private sector research efforts to drive development of technologies that would help in the safety and security of internet and other crucial networks. Obama Administration’s startup America Initiative is an ongoing initiative to improve the environment of high growth entrepreneurship. To maximize the private sector innovation the government should strengthen efforts to foster entrepreneurship and to ensure that conditions exist in which private sector can thrive.  So the role of private sector in research and development is incredible that leads to policy advancement but it cannot be innovative in isolation, collaboration with public sector is fundamental.HHS News, New public-private sector initiative aims to prevent I million heart attacks and strokes in five years. Retrieved from http://millionhearts.hhs.gov/docs/Million_Hearts_Press_Release.pdfAgency of Healthcare Research and Quality. Innovation exchange. Heart failure disease management improves outcomes and reduces costs. Retrieved from http://www.innovations.ahrq.gov/content.aspx?id=275U.S. Department of Health and Human Services (2012). National Strategy for quality improvement in healthcare. Annual Progress Report to congress. Retrieved from http://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdfLewin, C. (2012). Building bridges between the public and private sectors. Human Vaccines Immunotherapeutics, 8(2), 155-158.United for Medical Research. (July, 2013) Profiles of prosperity: how NIH supported research is fueling private sector growth and innovation.Inzelt, A. (2008). Private sector involvement in science and innovation policy making in Hungary. Science and Public Policy, 35(2), 81-94.Medicare Implementation of policy includes actions by a variety of actors, designed to put programs into effect, ostensibly in such a way as to achieve goals. The success of operational stage of any policy depends upon its design and construction and congruency between characteristics of implementing organization and policy objectives.  In addition it also depends on the competence of managers of the concerned organizations (Longest, 2010). Statutory and regulatory vagueness is one reason for problems in implementation.The fight over implementation of Medicare was contentious the same way as the Affordable Care Act (ACA). The American Medical Association strongly opposed the law by running the advertisements across the country, denouncing the program as the beginning of socialized medicine. President Johnson signed Medicare into law on July 30, 1965.  Next the federal government launched “Project Medicare Alert” a program that hired 5000 workers to enroll seniors in Medicare. However efforts worked and 93% of the eligible seniors were enrolled by summer of 1966. By July 21, 1966, less than 0.5 percent of hospitals were not certified for Medicare eligibility.To further increase its impact legislators began to look the ways to expand Medicare program. A bill was proposed to cover the drugs under Medicare.  But surprisingly it became law after 4 decades, when congress created the Medicare part D.  For Medicare Part D the Bush administration faced a tough political battle to get the bill passed in 2003. Enrollment was set to begin in late 2005 but a Kaiser Family foundation poll found that only 27% of the respondents understood the law and only 21% favored it so it was delayed.  On the other side In case of Affordable Care Act according to Kaiser Poll in April, 2013, 35% favored the Act and less than half felt they were well informed of the details.The other issue related to the Medicare site which was meant to help seniors to pick up benefit plans, was supposed to work in October 13, 2005 but did not until late in November.  In case of ACA the same happened related to the website. In Medicare as well as in ACA there were problems at the time of enrollment, to get accurate information. There are many similarities in Medicare and ACA implementation however it is larger and daunting task in ACA. Medicare’s national coverage decision was provided for covering patients with stable angina, CABGs and acute myocardial infarction in 1982 and was modified in December, 1985 related to the payment of occupational therapist services. Next modification related to the physician supervision came in 1989. In 2001 CMS generated a formal national request to cover additional conditions such as heart valve replacement, coronary angioplasty, and heart transplant including heart failure and requested the other agencies to do the assessment of resources in relation to physician supervision and technology required. The Agency for Healthcare Research and Quality (AHRQ) gave its final report about technology assessment and proposed decision memorandum was posted for public comments in December 2005.This reconsideration was closed and national coverage determination process was reopened in order to review clinical indications and current evidence related to various cardiac conditions.  In 2008 Medicare Improvements for Patients and Providers Act established coverage provisions for CR and finally it became effective from January 2010, but according to inadequate clinical evidence the heart failure was not covered. However agencies such as American Heart Association and American College of Cardiology have been successful in providing adequate evidence to include heart failure in the CR program and CMS has proposed the decision memo to cover it.Medicaid The program known as Medicaid became law in 1965 and was jointly funded by the federal and state governments. It is the largest source for funding medical and health related service to the poorest people of America.  In the beginning of this program more than 50% of the states implemented a Medicaid program within the first year of federal funding became available and nearly all states were participating in Medicaid within four years.  Overtime the states have met new federal requirements to expand Medicaid coverage. In 1970s Medicaid began to cover care for people in intermediate care facilities and program for assistance for elderly and disabled was also established. The early and periodic screening, diagnostic and treatment plan was developed for children under 21. In 1981, waivers were created for freedom of choice, home and community based care. In addition to this each individual state was then required to pay hospitals that provided healthcare services to low income patients. It took 18 years for the Medicaid to become available in every state and Arizona was the last. In 1989 the dental services were added but were not approved by each state.In 1991 the Medicaid Drug Rebate Program was put into place, initially created by Omnibus Reconciliation Act of 1990. In 2000 the breast and cervical cancer treatment and prevention act was taken by Medicaid. Medicaid is an ever evolving service that strives to provide care for low income families. The regulatory guidance for Medicaid and Children’s health Insurance Program (CHIP) is given by the Center for Medicare and Medicaid Services (CMS) in the form of letters to State Medicaid Directors, letters to state health officials, and information bulletins.Affordable Care ActAfter the congress passed the ACA in 2010, it became the responsibility of the U.S. Department of Health and Human Services and other federal agencies to implement the law.  Important regulations related  to this law  such as essential health benefits, Health Insurance Market Rules, Nondiscriminatory Wellness Programs, Stage 3 Definition of Meaningful use of Electronic Health Records and Medicaid payments have been released since November, 2012 elections. Additional rules were released in February, 2013, March, 2013 and April, 2013.The implementation of ACA has been the most controversial among all the social welfare policy in American history. There has been conflict between republican and democrats since the inception of this law and the republicans have tried their best to thwart the implementation with the support of opposition stakeholders. It even led to the shutdown of government which impacted the U.S. economy adversely. The significant challenge for implementation was the U.S. Supreme Court’s decision, which upheld the constitutionality of the entire law and requiring that Medicaid expansion be optional for states. The U.S. House of Representatives which is controlled by republican’s majority has played substantial role in undermining the law but it was passed by democratic controlled senate.The partnerships between the federal and state governments were also a challenge especially in the states with Republican governors. As a result Medicaid expansion is adopted by 50% of the states and less than 20 have chosen to operate their own marketplaces. One self inflicted injury by the Obama Administration was the faulty launch of marketplaces website in October, 2013, which caused problems for enrollment for millions of potential customers. The essential implementation date was January 1st, 2014 when Medicaid expansion, private insurance subsidies, individual mandate and health insurance regulatory reforms were implemented.The previous major health laws that established Medicare and Medicaid in 1965 have undergone continuous debate, review and amendment of nearly 50 years. And it is the beginning in case of ACA. In case of cardiac rehabilitation coverage of heart failure the statutory and regulatory processes have followed the same pathway as other policies and being a part of Medicare, for implementation also it is likely to follow the same journey but the halts might be less as compared to other policies.ReferencesMcCracken, A.L. (2010). Medicare, healthcare reform, and older adults. Journal of Gerontological Nursing, 36(12), 16-19.Switzer, J. V. (2001). Local government implementation of the Americans with Disabilities Act: Factors affecting statutory compliance. Policy Studies Journal, 29(4), 654-662.Longest, B. B. Jr. (2010). Health policymaking in the United States (5th ed.) Chicago, IL: Health Administration Press.McDonough, J. E. (2014). Health system reform in the United States. International Journal of Policy Management, 2(x), 1-4.TheWashington Post.  (May, 17, 2013). When Medicare Launched, nobody had any clue whether it would work.Kingdon, J. W. (2010). Agendas, alternatives and public policies, updated Edition (2nd ed.). London: Longman Publishing Group.U.S. Department of Health Human Services. Key features of the Affordable Care Act by year. Retrieved from http://www.hhs.gov/healthcare/facts/timeline/timeline-text.htmlThe Kaiser Commission on Medicaid and the Uninsured (2013). Medicaid a primer. Key information on nation’s health coverage program for low income people. Retrieved from http://kaiserfamilyfoundation.files.wordpress.com/2010/06/7334-05.pdfThe governments in last four decades have utilized variety of techniques to justify a wide range of public policy decisions. There is growing reliance of regulatory agencies on scientific and technical advisers and advisory bodies. The focus of government currently is to eliminate situations in which different policies undermine each other, to make better use of resources, to create synergies by bringing together multiple stakeholders in a particular policy area and to offer citizens comprehensive rather than fragmented services. The emphasis is on public-private partnerships and that is evident in the U.S. emerging trend in collaborative public management. In order to address health disparities and disabilities in the U.S. population the government is taking many collaborative initiatives.Health disparitiesFirst of all it is imperative to have some overview of health disparities and disabilities prevalent among the U. S. population. The distribution of health opportunities is not the same for everyone in the United States. The minority populations experience poorer health outcomes in comparison to non-minorities populations. They are likely to die as infants, have higher rates of diseases and disabilities and have shorter life expectancies. According to “Federal Office of Minority Health” health disparities are “the persistent gaps between the health status of minorities and non-minorities in the U. S.”Health disparities originate from biologic and social factors that affect individuals across their lifespan. The conditions in which the individuals are born, grow, work, live and age can make a difference in their lives.  The characteristics such as race, religion, socioeconomic status, gender, age, mental health, disability, sexual orientation, geographic location or the factors linked to discrimination are known to influence health status. The gross differences in socioeconomic status and lack of access to care exist among racial and ethnic groups.According to Institute of Medicine (IOM) report in 2002, lack of health insurance was identified as a significant contributor to health care disparities. The racial and ethnic populations constitute one third of the U.S. population and more than half of the 50 million uninsured populations. In case of under insured in 2007 there were almost 25 million Americans, mostly sicker and older because they can’t afford comprehensive coverage. According to the “National Health Disparities Reports” (NHDR) racial and ethnic minorities often receive poor quality of care and are not able to get preventive care, acute treatment or chronic disease management the same way as non-Hispanic white people. The rate of hospitalization is double for racial and ethnic minorities than the Non-Hispanic Whites.Cardiovascular diseases account for largest proportion of inequality in life expectancy between African American and Non-Hispanic Whites.  Instead of declines in cardiovascular mortality over last 3 decades disparities among different population groups are widening. Heart failure is the leading cause of medical admissions in the Medicare population and incidence and frequency of admissions is significantly higher in African Americans than Whites. The mortality rates and functional limitation are higher among the African Americans with advanced ventricular dysfunction. According to the National Healthcare Disparities Report 2007 the proportion of Medicare patients with heart failure, who received the recommended hospital care, was lower for Indians/Alaska Natives and Hispanics, compared to whites. In one of the survey 35% cardiologists agreed that disparities in overall care exist in U.S. and 5% believed disparities exist in the care of their own patients.Public Sector initiatives related to health disparities The “American Heart Association” (AHA) advocates meaningful, affordable, high quality health care coverage for all U.S residents. The initiatives to attain this goal are through “The Minority health Improvement and Health Disparity Elimination Act of 2007” and “Health Equity and Accountability Act” by increasing the workforce diversity and competence, promote healthcare access and awareness, research and planning. In addition to this there is “Indian Health Care Improvement Act of 2007” which is meant for addressing the health disparities among Native Americans and Alaska Natives. AHA also supports promotion of health information technology use, which can help in reducing health disparities.The next initiative, Community Health Center Program of “Health Resources and Services Administration” (HRSA) is also focusing on the issue of provision of quality health care to racial and ethnic populations. The community Health Center Program provides access to comprehensive, culturally relevant, and qualitative health care services. On the other hand to address disparities the Center for Disease Control’s “Racial and Ethnic Approaches to Community Health” (REACH) program has empowered the people to seek better health, change healthcare practices and to implement evidence based public health programs to reduce disparities.To minimize the disparities in scientific knowledge and innovation, “the Office of Management and Budget”(OMB) is setting the standards to collect adequate data related to race, ethnicity, and language spoken by patients and other users of healthcare system that would allow better understanding and would help in planning the programs. The other steps taken in the direction of minimizing the health disparities is through the “Affordable Care Act” by insurance coverage, access to care, prevention, data collection, and quality improvement. It will also help by giving people more control over their own care. Other initiatives are through “National Strategy for Quality Improvement in Healthcare” and “National Prevention and Health Strategy”.In addition to this the “Department of Health and Human Services” has other initiatives such as “Healthy People 2020” to achieve health equality, eliminate disparities and improve health of all groups. The National HIV/AIDS Strategy to provide high quality care to people with HIV regardless of all the disparities. The two main  federal programs designed to help individuals to maintain a minimum level of income after the retirement are “Social Security Act” and  “Personal Responsibility and Work Opportunity Reconciliation Act of 1996”, reauthorized in 2006. These two programs are the chief components of social welfare in America. Social security was to address the poverty among elderly and has been successful in attaining that goal.Public sector initiatives related to disabilitiesAccording to WHO (2006) estimates 10% of the world’s population has some form of a disability. Disability increases with the increasing age and is more common among the oldest old but little attention has been paid to this group of population. According to U.S. Census Bureau’s American Community survey 37% of individuals age 65 years and older have disabilities. The people living with disabilities experience health disparities. So there has been a growth nationwide in policy strategy that promotes self–management and empowerment among vulnerable groups.The “Americans with Disabilities Amendments Act” (ADA) of 2008, is the amended version of ADA 1990, which  guarantees that people with disabilities have the same opportunities as everyone else to participate in the mainstream of American life and provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities. The scope of coverage of disabilities has been expanded. Next the “Administration for Community Living” by Obama administration will work for increasing access to community support and community participation for individuals with disabilities. The other federal agency is “National Council on Disability” which makes recommendations to president and congress to improve the quality of life of Americans with disabilities.In addition to this “Supplemental Security Disability Insurance” is another Federal government program for the workers who become disabled and cannot work after paying Social Security taxes. The 1999 Olmstead decision directs that people with disabilities must have access to community based options for support and service. In 2009, the Civil Rights division launched an aggressive effort to enforce Olmstead to eliminate unnecessary segregation of individuals and ensure that they receive services in most integrated settings appropriate to their needs. In “Affordable Care Act” also the community participation has been described as a goal for persons with disabilities based on a history of marginalization.ConclusionThe efforts of public sector in aiding the uninsured, underinsured, disabled are incredible but the main focus of research by funding agencies is on disability and disease instead of on improving access and quality of care. There is lack of evidence base and trained professionals in disparities and disabilities related areas.  Further there is need to know the outcomes of these initiatives, develop innovative and comprehensive interventions, strategic partnerships with communities, community-based organizations, state and local governments, and public and private partners from both health and other sectors to address the disparities and disabilities among minority populations.ReferencesHHS Action Plan to Reduce Racial and Ethnic Health disparities. A nation free of disparities in health and healthcare.  Retrieved from http://minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete.pdfAdministration on Aging (2012). A profile of older Americans: 2012. Retrieved from http://www.aoa.gov/Aging_Statistics/Profile/2012/docs/2012profile.pdfNational Council on Aging. Fact sheet. Economic security for seniors retrieved from http://www.ncoa.org/assets/files/pdf/FactSheet_EconomicSecurity.pdfNIH Fact sheets. Disability in older adults. Research Portfolio Online Reporting Tools (RePORT)Todd, S. R., Sommers, B. D. (September, 2012). Overview of the uninsured in the United States: a summary of the 2012 current population survey report. U.S. Department of Health Human services.Hahn, J. E., et al. (2013). Multidimensional health risk appraisal among adults aging with acquired disabilities. Disability and Health Journal, 6, 195-203.American Heart Association. Bridging the gap: CVD health disparities.Statutory mechanism in policy makingPolicy making is a multidimensional, as well as multidisciplinary process, which consists of policy formulation phase including agenda setting and development of legislation and policy implementation phase composed of rule making and operation. To follow this process a bill may take years to become a law or may die during its journey. It is evident in the literature that how statutory and regulatory processes in policy making have evolved over time? How various ACTS have undergone amendments? And how the new laws have been enacted to cope with the challenges of progressive era? On the other hand regulatory mechanisms are fundamental to enhance the accountability of organizations, providers and other participant agencies in the health issues. As the policy related to cardiac rehabilitation comes under the preview of Medicare so it will be pertinent to go through the statutory and regulatory processes related to Medicare policies.The first Federal Medicare statute which is responsible for setting forth number of federal Medicare laws is “Title XVIII of the Social Security Act”.  As statutes of Medicare are extremely specific, related to provider reimbursement benefits, cost sharing, managed care and provider conditions of participation, so its rule-making capacity is limited. The “Ways and Means Committee” in the House has primary jurisdiction over Medicare but often shares jurisdiction on some issues with the “Energy and Commerce committee”. In the Senate, the Finance Committee has primary jurisdiction of Medicare. Further the “Medicare Payment Advisory Commission” advises the congress on Medicare issues and this committee proposes major changes in policy. Medicare legislative changes are mainly achieved through “Budget Reconciliation Bills” rather than having separate legislation.The federal Medicare rules are promulgated by “Centers for Medicare and Medicaid Services”. Medicare rules are developed by the relevant operating center with the CMS such as “Center for Medicare Management” for fee for service Part A and Part B issues,  so the proposed decision related to coverage of heart failure under the cardiac rehabilitation policy comes under Part B of Medicare and is being dealt by “Centers for Medicare and Medicaid”. However legal advice comes from Department of Health and Human Services Office of General Counsel (OGC). Before entering in the Federal Register, all proposed and final rules require approval of the Department of Health and Human Services secretary and the White House Office of Management and Budget (OMB) which has separate Medicare Branch to review the Medicare rules.Regulatory mechanisms of policy makingIn early America regulation was local and judicial because Americans distrusted centralized powers of government. How this regulation was enforced? Local governments effectively used the common law to regulate public safety, trade, space, and public health.  During the progressive era in America, political institutions underwent a revolutionary change where political power became centralized in state and federal governments. This was a response to the greater complexity of the modern economy that required specialized knowledge. Professional and specialists were required to understand the causes of diseases and the chemical compositions of food and drugs and as well as pricing practices.The responsibility to establish specific policies and procedures to implement the law rests with the Executive Branch.  Regulations specify a program’s operating procedures, determine how funds may and may not be spent, and determine required qualifications for participation in a program. Regulatory process provides an opportunity for the interested parties to comment on the proposed regulation. The regulatory process begins with publication of the proposed regulation and public has an opportunity to comment on it. It is also evident in the proposed decision regarding coverage of heart failure under cardiac rehabilitation program.The focus of regulatory mechanisms in policy making is to set market entry restrictions, rate or price controls on health services providers, and quality control on the provision of health services, market preserving controls and social regulation. Licensing of health related practitioners and organizations, control of reimbursement rates to hospitals by the federal government, adherence to acceptable level of quality in services by the providers are also part of the regulation. There are regulatory agencies such as Food and Drug Administration which is responsible to ensure that new pharmaceuticals meet standards of safety and efficacy and the “Medical Devices Amendments” places all the medical devices under regulation.  The federal and state laws pertaining to environmental protection, disposal of medical waste, childhood immunization are examples of social regulations.Further regulatory mechanisms limit the discretion of individuals and agencies or compel certain types of behaviors. The interpretation of these policies is important to know which behavior is good and which one is bad. CMS develops conditions for participation and conditions for coverage that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. These conditions are foundations for improving quality and protecting the health and safety of beneficiaries of various programs including cardiac rehabilitation. ReferencesMajone, G. (2007). The regulatory state and its legitimacy problems. West European Politics, 22(1), 1-24. Doi: 10.1080/01402389908425284. Center for Medicare Medicaid Services. Conditions for coverage conditions for participations.  Retrieved from http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index.htmlFrakes, M. A. Evans, T. (2006). An overview of Medicare reimbursement regulations for advanced practice nurses. Nursing Economics. 24(2), 59-65.Weinberg, J., Hilborne, L. H., Nguyen, Q. (1999). Regulation of health policy: patient safety and the states.  Advances in patient safety. 1 Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK20479/pdf/ch29.pdfAmerican Association of Critical-Care Nurses. (2014) Introduction to legislative and regulatory process.Piper, K. (2007). White House oversight of CMS and FDA: office of Management and Budget gets expanded role in Medicare, Medicaid and drug industry policy.Department of Health and Human Services (May 16, 2012). Medicare and Medicaid program: regulatory provisions to promote program efficiency, transparency, and burden reduction. Federal Register, 77(95)/ Rules and Regulations.Longest, B. B.Jr. (2010) Health policy making in United States (5th ed). Chicago, IL: Health Administration Press.Seidenfeld, M. (oct. 13, 2013). A process failure theory of statutory interpretation. Public Law research paper no. 651.Heniff Jr, B., streeter, S., Lynch, M. S., Tollestrup, J.  (Dec. 2, 2010). In troduction to federal budget process. Congressional Research Service. Privacy Cookies: This site uses cookies. By continuing to use this website, you agree to their use. To find out more, including how to control cookies, see here: Cookie Policy

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Ramesh Devi Thakur | PhD Candidate | Arizona State University College of Nursing and Health Innovation

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