The determination of the essential health benefits (EHB) package (including whether more categories of care will be added to the 10 listed in Section 1302 of the Patient Protection and Affordable Care Act (ACA) or whether specific services will be classified within the existing categories), the role of state mandates in shaping the EHB package, approaches to medical necessity determinations and appeals, cost-sharing practices, and the “required elements for consideration” included in Section 1302(b)(4), are of interest to numerous stakeholders. On January 14, 2011, the committee heard five-minute presentations from 15 stakeholders, including providers, consumers, and researchers. The themes across these presentations were that in order to ultimately improve patient outcomes, the EHB package should be comprehensive, evidence-based, affordable, accommodate individual needs, and take a long-term view of the value of interventions.
Dr. Morrison, the Director of NPCRC, advocated for the inclusion of palliative care1 in the EHB package, stating that patients with serious illness have high clinical needs and therefore significantly contribute to health care costs (Morrison and Meier, 2004; Morrison et al., 2011). Under the current health insurance model, he said, the only reimbursement for palliative care is for hospice,2 which some insurers do not cover. For those that do, to qualify for hospice reimbursement, the individual has to have a prognosis of six months or less to live, which
1 In Dr. Morrison’s words, palliative care is the medical specialty focused on preventing, treating, and relieving the pain and other debilitating effects of serious and chronic illness, including cancer, cardiac disease, respiratory disease, kidney failure, Alzheimer’s, AIDS, ALS, and MS. Palliative care is interdisciplinary and patient/family centered. It is provided from the time of diagnosis and involves the relief of pain and other symptoms that cause discomfort, such as shortness of breath and unrelenting nausea. Palliative care involves extensive patient and family communication, decision making, and coordination of care. Unlike hospice care, it is not dependent on a terminal prognosis and may actually help an individual recover from illness by relieving symptoms such as pain, anxiety, or loss of appetite while undergoing sometimes difficult medical treatments or procedures, such as surgery and chemotherapy.
2 In Dr. Morrison’s words, hospice is considered the model for quality compassionate care for people facing a life-limiting illness. Hospice provides expert medical care, pain management, and emotional and spiritual support expressly tailored to the patient’s needs and wishes. In most cases, care is provided in the patient’s home but may also be provided in freestanding hospice centers, hospitals, nursing homes, and other long-term care facilities. In 2009, approximately 1.56 million patients (approximately 40 percent of all U.S. deaths) received services from hospice (Sutton, 2011).
Dr. Morrison called “extremely limiting.” He advocated for insurers to cover palliative care “sooner than hospice” (i.e., at the time of diagnosis).
A recent study indicates that when palliative care is provided in concert with curative care at the time of diagnosis, palliative care results in better patient outcomes and survival. Lung cancer patients receiving early palliative care lived 23.3 percent longer than those who delayed palliative treatment, and median survival for “early” palliative care patients was 2.7 months longer than for those receiving standard care (Temel et al., 2010). Additionally, a 2007 study found hospice patients had a 29-day longer mean survival than patients not receiving hospice (Connor et al., 2007).
Furthermore, Dr. Morrison noted, hospice and palliative care services can lower health care costs. A study conducted at Duke University demonstrated that hospice services reduce Medicare expenses by an average of $2,309 per hospice patient while improving the quality of care provided to patients with life-limiting illness (Taylor et al., 2007). Moreover, the study found that Medicare costs would be further reduced for seven out of 10 hospice recipients if hospice was used for a longer period of time. For cancer patients, up to 233 days of hospice care decreased Medicare costs, while for non-cancer patients, up to 154 days of hospice care decreased Medicare costs. Palliative care programs in hospitals also provide “substantial savings.” In a recent study comparing Medicaid beneficiaries in four New York State hospitals, provision of palliative care reduced hospital costs by $4,098 per admission for patients discharged alive and $7,563 for patients who died in the hospital. Consistent with the goals of a majority of patients and their families, palliative care recipients spent less time in intensive care, were less likely to die in intensive care units, and were more likely to receive hospice referrals than usual care patients (Morrison et al., 2011).
Ms. Dhillon, a staff attorney with NHeLP, outlined several principles for the EHB package, including flexibility to allow for the best treatment options. She advised the committee to rely on Medicaid for guidance on developing the EHB package. The standards of care for children and adolescents in Medicaid, for example, provide an array of important services, including early and periodic screening, diagnostic, and treatment services (EPSDT). NHeLP believes Medicaid EPSDT “can be an instructive model for these packages to ensure a comprehensive and robust set of services for very low-income and/or special needs children.”
Ms. Dhillon suggested that the standards of care recognized by the professional academies be used to determine the scope of coverage in EHB packages. This criterion, she said, should apply both to the U.S. Department of Health and Human Services’ (HHS’) initial determination of the EHB package as well as to the coverage policies of insurers offering EHB packages. Relying on approved standards of care, she said, would address regional variation in implementation and prohibit plans from “providing piecemeal coverage to insured individuals where a more comprehensive scope of covered services would be more appropriate, both in saving costs and improving health.” NHeLP believes that health care providers should provide information about all treatment options in accordance with the proper standards of care, based on the individual’s needs, and with the overall goal of maximizing wellness. Furthermore, insurers should not be allowed to base the scope of coverage on non-clinical reasons, such as moral or religious grounds. Insurers should not be permitted to limit coverage of reproductive health services, for example.
NHeLP recognizes that in some cases, an individual may require services outside the scope of covered benefits. Therefore, NHeLP recommends that all EHB packages have a clinical exceptions process that is timely, not overly burdensome, and easily navigable by patients and providers. Medicaid can be instructive in this context; while Medicaid allows for higher cost sharing for non-preferred drugs, it also provides an exception whereby if the prescribing provider determines the preferred drug would not be as effective or if the patient would have an adverse outcome, the Medicaid enrollee can then gain access to the non-preferred drug. In some cases, Ms. Dhillon said, step therapy may be an effective strategy for providing safe, cost-effective care. However, because step therapy policies may encourage insurers rather than providers to “have the final word in treatment options,” there must be “special oversight” when this policy is used. The potential negative effects of step therapy can be mitigated,
Ms. Dhillon said, by implementing a clinical exceptions process that allows “first fail” to be avoided if there is an important clinical reason for pursuing a different medical option as established by the treating provider.
Ms. Dhillon recommended that insurers directly address health disparities impacting their enrollees by offering preventive and treatment services that correspond to the health needs of specific populations. For example, if a significant number of women of childbearing age in a coverage area have diabetes, the insurer should promote reproductive health, primary care, and podiatry care, among other appropriate services. This recommendation, she said, would require insurers to conduct needs assessments of current and potential enrollees. Finally, NHeLP recommends that the process for reviewing and updating the EHB package be transparent and public, allowing time for public review and comment.
Mr. Spielman, Senior Policy Advisor and Counsel for Autism Speaks, urged the committee to be mindful in making recommendations to the Secretary of congressional intent to improve the health of people with autism spectrum disorders (ASDs). The clause “including behavioral health treatment” in Section 1302(b)(1)(E) of the ACA was added by committee amendment. In the House, the amendment was offered by Representative Mike Doyle (D-PA), co-chair of the 157-member Congressional Autism Caucus, and in the Senate, the amendment was offered by Senator Robert Menendez (D-NJ). Senator Menendez’s amendment, Mr. Spielman noted, was given a budget score of zero, indicating that it did not add to the cost to the health care package (U.S. Senate Committee on Finance, 2009). Additionally, Mr. Spielman referenced a letter written to the Institute of Medicine (IOM) committee by Senators Menendez, Dick Durbin (D-IL), and Robert Casey (D-PA) on the needs of individuals with autism and the importance of behavioral health care for individuals with ASDs. In a separate letter, Representative Doyle “went even further to say that it was Congress’ intention” to cover applied behavioral analysis (ABA) in the EHB package. Mr. Spielman concluded that section 1302(b)(1)(E) should be understood as requiring behavioral health treatments for ASDs in the EHB benefit package.
Mr. Spielman argued that the committee should view state mandates “as informed judgments of what is needed by populations.” In evaluating state mandates, Autism Speaks believes the Secretary should consider justice, cost-effectiveness, and continuity of care. Mr. Spielman noted that because underinsurance adversely affects the health of people with ASDs, Autism Speaks encourages state legislatures to enact laws mandating coverage of ASD-related benefits. Autism Speaks retained a consultant to evaluate the cost of state mandates related to autism and found that the mandates add approximately 0.42 percent to premiums (Lambright, 2011). This premium increase, Mr. Spielman argued, is offset by savings associated with increased capabilities and decreased dependence of people with ASDs. Mr. Spielman concluded that state autism laws strike a sound balance between short-term costs and long-term savings, and noted that these laws have been, and continue to be, relied upon by people with ASDs and their families.
When IOM committee member Dr. Nelson asked Mr. Spielman to describe how eligibility for an autism benefit should be determined, Mr. Spielman responded that determinations should be “person-centered.” There is not a “one-size-fits-all package.” An individual’s needs vary depending on the severity of their symptoms; some individuals need significant amounts of care, while others need much less. In 2006, the Centers for Disease Control and Prevention (CDC) found “an average prevalence of ASDs in the United States approaching 1 percent” (CDC, 2006). Thus, Mr. Spielman said, in defining the EHB, the health needs of individuals with ASDs must be adequately addressed.
As Deputy Director of CDHP, Ms. Booth advocated in favor of the inclusion of pediatric dental care in the EHB package and promoted a comprehensive, robust, affordable, and evidence-based package. She began by noting that the ACA failed to include oral health as an essential benefit necessary for individuals of all ages, but that it
did include oral health services as part of the pediatric essential benefit.3 She added that the historic separation of medical and dental services, as well as limited efforts to address dental disease alongside other pediatric chronic conditions, challenges the implementation of a pediatric dental benefit that is inclusive of oral health care. Currently, over 90 percent of people with dental insurance receive coverage through a plan that functions separately from their medical coverage (Delta Dental, 2011). Ms. Booth noted that commercial dental coverage is typically structured as a “dental benefit plan” rather than as “dental insurance.”
Prepayment vs. Risk-Sharing
To ensure affordability for employers while covering a wide range of dental services, dental benefit plans function as limited prepayment programs as opposed to risk-sharing insurance programs. These benefit plans typically provide lifetime and annually capped benefits (usually up to $2,000 annually) with potentially high out-of-pocket expenses resulting from co-payments, exclusions, frequency and age limitations, and for care delivered after an individual has reached the annual and lifetime caps. Unlike Medicaid and some Children’s Health Insurance Program (CHIP) plans, these commercial benefit plans, she said, do not use a medical necessity definition as the standard for benefit determinations. This structure leaves little incentive to prevent or manage dental disease as a chronic condition.
The advantage of the existing dental benefit model, Ms. Booth pointed out, is that it allows an employer to assume a fixed and predictable premium for providing the elected level of dental coverage. The cost of the benefit is controlled by the limits placed on the scope of the benefit, which requires the enrollee to pay for care that falls outside the scope or exceeds the stated limits. The prepayment plan approach, however, fails to promote adoption of potential scientific and technologic advancements in determining covered benefits. In managing financial risk and bypassing dental necessity as the standard by which benefits are determined, commercial dental benefit plans have little incentive to modify benefit designs to respond to advances in dental science. Consequently, this model perpetuates a standard of care that should be discarded in favor of new, more effective standards that are based on individual risk and the best scientific evidence.
Fostering Prevention in the Definition of Care
Ms. Booth noted that better oral health outcomes are achieved at a lower cost if dentally necessary care is initiated in early childhood (Jokela and Pienihakken, 2003; Ramos-Gomez and Shepard, 1999; Zavras et al., 2000). Oral health risk assessments and disease management are the standards of care for determining the appropriateness and necessity of particular procedures. The American Dental Association (ADA) and the American Academy of Pediatric Dentistry (AAPD) have promoted early intervention, risk-based individualized care, and behavioral and pharmacological management of dental disease. Nonetheless, adoption of these standards by dentists “remains modest.” Ms. Booth argued that the current coverage and financing of dental care continues to reward surgical treatment over pharmaco-behavioral disease management.
Models of oral health coverage provided under the EPSDT program and CHIP provide a “foundation that can be drawn upon to realign payment with a focus on prevention and disease management.” These programs, she said, provide some insight for how dental necessity could be implemented in the commercial market. Commercial insurers that participate in Medicaid and CHIP typically have specialized subsidiaries that provide dental benefits. Consequently, these private insurers have experience with the administration of dental benefit design.
The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA)4 defined a dental benefit that was specific to the needs of children and could be used by state programs:
coverage of dental services necessary to prevent disease and promote oral health, restore oral structures to health and function, and treat emergency conditions.
3 Patient Protection and Affordable Care Act of 2010 as amended. Public Law 111-148 § 1302(b)(1)(J), 111th Cong., 2d sess.
4 The Children’s Health Insurance Program Reauthorization Act of 2009. Public Law 111-3, 111th Cong., 1st sess. (February 4, 2009).
CDHP recommends that the CHIPRA definition serve as a minimum standard for the essential pediatric dental benefits and suggested that the committee institute a dental necessity definition for the essential pediatric benefits that parallels a medical necessity definition and provides the opportunity to maintain parity in benefits.
CDHP aims to ensure access to affordable, comprehensive pediatric services that include a dental benefit. In designing dental benefits, Ms. Booth said, it is difficult and likely irrelevant to dictate whether a dental benefit is provided as part of a medical benefit or if it is provided through a separate limited scope dental plan. The marketplace, Ms. Booth said, “will serve as the judge in that arena.” What remains critically important, however, is that regardless of the coverage structure, the system should make use of the best available research to address the unique needs of children and incentivize prevention and wellness.
Dr. Racine, Director of General Pediatrics at the Children’s Hospital at Montefiore, spoke on behalf of the American Academy of Pediatrics (AAP). He emphasized that the health care needs of infants, children, and adolescents are sufficiently distinct from those of adults and that a health care system designed for adults “will not meet the needs of America’s children and should not be imposed upon them.” He urged the committee to recommend comprehensive benefits modeled on the EPSDT and the recommendations contained in Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents (Hagan et al., 2008). These latter recommendations are stipulated in Section 2713 of the ACA.5 As infants and children are in constant stages of development, their capabilities, physiology, size, cognitive abilities, judgment, and response to interventions must be continuously monitored to ensure that these changes are proceeding within an acceptable trajectory.
Medical Necessity and Evidence Development
Dr. Racine proceeded to emphasize several points from the AAP’s “Policy Statement on Contractual Language for Medical Necessity for Children”:
- Medically necessary services include age-appropriate prevention, diagnosis, treatment, amelioration or palliation of physical, mental, behavioral, genetic or congenital conditions, injuries, or disabilities.
- Interventions should be evidence-based but because large-scale randomized controlled trials (RCTs) are “significantly less plentiful” for children than for adults, observational studies, professional standards of care, and the consensus of pediatric experts must serve as acceptable substitutes.
Dr. Racine advised the committee that when considering coverage for experimental or investigational treatments for which no RCTs have been conducted, “individuals with the requisite knowledge of pediatric medical necessity” should be consulted to review the protocols or interventions. The “inescapable actuarial reality,” he said, is that the “benefits of certain interventions in children become manifest only with a significant time lag.” This time lag incentivizes plans with limited time horizons to minimize the importance of these interventions. Such incentives, he said, place children at a distinct disadvantage when coverage decisions are being made.
When committee member Dr. Selby asked for additional details about the evidence-base in pediatrics and whether the application of observational data has interfered with coverage for individual children, Dr. Racine responded that observational studies are often—and indeed have to be—used because few RCTs exist. However, Dr. Racine noted that that while there is a lot of off-label use of medications for children, most health plans will not cover these uses because the use is not supported by a RCT Furthermore, he said, health plans have denied habilitative services on the grounds that occupational therapy for children with cerebral palsy is not supported by evidence.
5 Section 1001 of the Affordable Care Act, amending the Public Health Service Act by inserting Section 2713 outlines specific preventive services each health plan must provide without any cost sharing, including specific services for children, like screenings and immunizations supported by CDC and HRSA.
Full Range of Care
Children are uniquely dependent on caregivers to detect medical problems, provide access to health care, translate the nature of their symptoms to clinicians, receive recommendations for care, and arrange for and monitor ongoing treatments. As most children are healthy, the epidemiology of disease is different than in the adult population. Nevertheless, Dr. Racine said, an “important segment of children” suffer from chronic conditions that affect their development and require specific attention to generating, maintaining, and restoring age appropriate functioning. He also noted that children differ from adults in that the economic, ethnic, and racial demographics of the U.S. pediatric population put children at risk of adverse outcomes due to existing health care disparities.
To account for these differences between children and adults, Dr. Racine argued that EHB for infants, children, and adolescents must include not only preventive care, but “the full range of diagnostic, therapeutic, and ongoing counseling and monitoring” for both healthy children and children with developmental disorders, chronic conditions, and behavioral, emotional, and learning disabilities. Dr. Racine concluded by advising the committee that the mechanisms created to update the EHB package should include input from physicians. Furthermore, he said, the EHB package should be periodically reviewed to ensure that it appropriately reflects ongoing changes in clinical science.
Dr. Harmon began by emphasizing that AMA policy is that the EHB should maximize patient choice of health plans and benefit packages and that the AMA supports the use of health savings accounts (HSAs). The AMA, he noted, believes that the interpretation of “essential” in the context of an EHB package should align with existing federal guidelines regarding types of health insurance coverage. Existing regulations, such as those governing the operation of the Federal Employees Health Benefit Program (FEHBP), for instance, reflect the reality that patients define “essential” based on individual health care needs and budgetary restrictions. The AMA believes that health insurance should provide coverage for hospital care, surgical and medical care, and catastrophic medical expenses, as defined in the tax code.6 Section 9832 of the tax code refers to “medical care” as care for the
diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body and for transportation essential to medical care.
Secondly, AMA supports using the existing FEHBP as a reference “when considering if a given plan” would provide meaningful coverage. Dr. Harmon noted that all FEHBP plans cover basic hospital, physician, surgical and emergency care, even though the program does not require a standard benefit package. FEHBP follows existing evidence-based guidelines for preventive care for children and adults, and plans are required to cover additional benefits including child immunizations, prescription drugs, mental health services (with parity to medical care coverage), and a catastrophic limit for out-of-pocket (OOP) costs. It is important to note, he said, that even with these requirements, FEHBP “is able to offer high-deductible health plans coupled with HSAs, as well as consumer-driven health plans.”
Third, the AMA “firmly believes” that the development of an EHB package should not “undercut the vital role in the health insurance marketplace of high-deductible health insurance plans issued to individuals and families in conjunction with HSAs.” Offering a range of health plan choices, including high-deductible health plans (HDHPs) coupled with HSAs, will enable patients to select health plans that meet their health care needs and budgetary realities.
In response to the committee’s inquiry about how insurers apply medical necessity, Dr. Harmon provided the AMA definition of medical necessity:
6 U.S. Code, Title 26 § 213.
Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the patient, treating physician, or other health care provider.
He noted that the “prudent physician” standard of medical necessity ensures that physicians are able to use their expertise and to exercise discretion, consistent with good medical care, in determining the medical necessity of care provided to individual patients.
Furthermore, Dr. Harmon argued that the “prudent physician” standard will only be strengthened by results of comparative effectiveness research (CER). Such research, he said, has the potential to have a “profoundly positive impact on the quality of the information available to physicians and patients” by fostering the delivery of patient-centered care and enhancing physician clinical decision making. Dr. Harmon argued that strong physician-patient relationships allow physicians and patients to jointly participate in making value-based health care decisions. At the point of decision making, physicians should have access to the best available evidence. Clinical information about health conditions, treatment options, and potential outcomes can then be discussed with patients.
The AMA has historically opposed definitions of medical necessity that emphasize cost and resource utilization above quality and clinical effectiveness. Such definitions of medical necessity, Dr. Harmon argued, interfere with the patient-physician relationship and prevent patients from getting needed medical care. To determine medical necessity, health plans should develop formal protocols that distinguish between when in-house medical expertise is sufficient and when outside consultation is necessary. Medical necessity determination processes should include an opportunity for the treating physician to provide additional evidence before a final coverage decision is made. Additionally, when health plans deny coverage for reasons of medical necessity, the plan needs to facilitate the expeditious handling of requests for reconsideration and appeal.
Required Elements for Consideration
Rather than striving for an “appropriate balance” among the 10 categories of care included in the ACA, Dr. Harmon urged the committee “that the goal instead should be to ensure parity in terms of access and coverage among the ten categories listed.” In ensuring parity among these categories, factors such as OOP costs and benefit limits must be considered. A “prudent physician” standard could be applied, he said, as physicians have the “unique ability” to help ensure that patients “get the right care, at the right time, in the right place.”
In deciding what is medically necessary, age and disability have to be taken into consideration by the “prudent physician,” Dr. Harmon stated. EHB, like any other health insurance benefit, need to be age-appropriate. Individuals within each age group should have a wide variety of coverage options from which to choose, including coverage options more comprehensive than the EHB package. The EPSDT program can be used as a model to account for the health care needs of diverse segments of the population. Under EPSDT, if a medical treatment or service will help a child, the treatment can be authorized by the Medicaid medical director even when the state Medicaid program does not specifically cover the treatment.
When committee member Dr. Michael Chernew asked Dr. Harmon how to deal with situations in which a service is covered, but not necessarily for every patient, Dr. Harmon reiterated the importance of the “prudent physician” standard. It is difficult, he said, “to micromanage each individual patient that has his or her own requirements,” but standards (including those based on CER) should be established. Dr. Harmon noted that individuals with congenital or acquired disabilities should have access to appropriate and affordable medical care throughout their lives. Furthermore, benefits deemed to be essential for individuals with disabilities may need to be more comprehensive than those for individuals without disabilities. High-risk pools, Dr. Harmon suggested, could be used to provide affordable care for individuals with additional health care needs. Additionally, he said, the AMA supports the coverage of care, services, treatments, and interventions uniquely for women. Furthermore, the AMA believes an appeals process should be established in every state (through the state department of insurance or other state agency) to ensure fair and non-discriminatory practices in the application of the EHB package.
Updating the EHB Package
To assess whether and how enrollees are facing difficulty accessing needed services for reasons of cost or coverage, Dr. Harmon suggested that HHS establish surveys, a hotline, and a website to receive information from patients, physicians, hospitals, and other stakeholders. Dr. Harmon also advocated for the inclusion of patient groups (e.g., AARP and Families USA) and physician organizations when assessing the experiences of enrollees with the EHB package. To update the EHB package, Dr. Harmon said HHS should convene an advisory committee that includes practicing physicians and patient representatives.
Dr. Murphy, Vice President of Health Policy and Advocacy for ASPS, insisted that Section 1302 needs further clarification regarding medical and surgical care. For instance, ambulatory patient services, he said, should include surgical care (e.g., anesthesia, minimally invasive and noninvasive procedures). He proceeded to argue that the EHB package should cover reconstructive surgery when the surgery meets the AMA definition of reconstructive surgery:
surgery performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. It is generally performed to improve function, but may also be done to approximate a normal appearance. (ASPS, 2005)
This definition was included in the Children’s Access to Reconstructive Evaluation and Surgery (CARES) Act of 2009,7 which distinguished between cosmetic and reconstructive surgery (using the AMA definition) and specifically excluded cosmetic surgery (defined as surgery performed to reshape normal structures of the body to improve appearance or self-esteem).
Denials of Care on an Insurer-Deemed Cosmetic Basis
According to the March of Dimes, 3 percent of babies born annually (120,000) suffer from birth defects8 and approximately 40,000 require reconstructive surgery (ASPS, 2009). Although surgeons are able to correct many of these problems, Dr. Murphy noted that an increasing number of insurers deny coverage by labeling the procedures “cosmetic” or “non-functional” in nature. An ASPS survey found that 54 percent of respondents had pediatric patients who had been denied coverage or who experienced “significant and deleterious obstacles in obtaining approval for coverage” of surgical procedures (ASPS, 2009). Furthermore, although insurers may provide coverage for the initial procedure, Dr. Murphy said, they “regularly resist coverage of the later stage procedures,” claiming the procedures are cosmetic and not medically necessary. He argued that “too many American families are experiencing delays or denials to health care that would prevent long-term physical and psychological injuries.” He reiterated that the procedures used to treat these children are, by definition, reconstructive, and should be covered by insurance. When committee member Dr. Santa asked which services should be covered, Dr. Murphy indicated the need for consumer involvement in these decisions and that the ASPS believes decisions should be based on the strength of evidence supporting a procedure.
7 Children’s Access to Reconstructive Evaluation and Surgery (CARES) Act of 2009, HR 1339, 1st sess. (March 5, 2009).
8 Defined as an abnormality of structure, function, or body metabolism present at birth that results in physical or mental disabilities or is fatal (e.g., cleft lip, cleft palate, skin lesions, vascular anomalies, malformations of the ear, hand, or foot, and other more profound craniofacial deformities).
Ms. Fishman, Vice President of Public Policy Analysis and Development for the AHA, proposed that the EHB package cover a broad range of services including medical, psychiatric, rehabilitative, dental, vision, preventive and hospice services, as well as pharmaceuticals. The package, she said, should be patient-centered, accessible, and adhere to accepted professional guidelines. She suggested a three-pronged framework for assessing which benefits to include:
- Are the benefits responsive to individual needs?
- Do the benefits take affordability into account?
- Are the benefits easily understood and transparent?
Furthermore, she argued that any limits placed on the EHB package be “grounded in clinical best practices.” Such limits, she said, could focus on services that are marginally effective and could change as underlying scientific evidence or CER informs clinical best practices. However, “particular types of services should not be eliminated wholesale.” Rather, limits could include the number or frequency of diagnostic tests or procedures. Ms. Fishman concluded by arguing that the lack of a consistent and recognized standard for essential benefits “allows insurers to control not only coverage decisions but also treatment decisions, sometimes overriding clinical standards and the patient’s needs.” The rules and decision processes that govern EHB and medical necessity should, she said, be transparent so that enrollees understand in advance the limitations of their coverage.
Mr. Falardeau, Vice President of Government Relations for the American Chiropractic Association, outlined principles for the committee’s consideration. Care that increases health and reduces health care costs must be considered in designing the EHB package, he said. To achieve cost reductions, HHS should focus on covering “more conservative, low-risk, outpatient services that emphasize partnering with patients.” More invasive, high-risk, inpatient procedures “should be used sparingly” and only if they have “a very strong evidence base of comparative clinical effectiveness and relative safety.” Ensuring transparency and creating greater patient involvement are two overarching goals of the ACA, he noted. Those same principles should be applied to the EHB package. Mr. Falardeau advised the committee to include all benefits that are mandated by at least 25 states in the EHB.
Mr. Falardeau argued that “the [committee’s] top priority should be to ensure a complete” EHB package, as opposed to having “an equal number of services in each of the 10 categories.” He also cautioned the committee to “guard against the possibility” of the EHB being denied against the wishes of patients based on age, expected length of life, and other considerations. To “protect” these benefits, he said, determinations cannot solely be left to individual or collective health plans. If an EHB is denied, patients should have the right to an independent, third-party review of the claim. This process, he said, could be similar to the regulations that require all new group plans to have a straightforward and independent appeals process.9
Certification of Coverage
Mr. Falardeau advised HHS to develop a template certificate of coverage or summary plan description for health insurers. This could be similar, he said, to Blue Cross Blue Shield’s FEHBP brochure and could list the 10 categories of services outlined in the ACA with the EHB mandated by HHS outlined beneath each category. By requiring plans to use a template certificate of coverage, HHS and health insurance exchanges could more easily determine if the benefits offered by the plan meet the requirements of the law. Additionally, the template would be helpful to consumers as they compare coverage and would ensure plans are clearly communicating to patients that the services listed under “essential benefits” must be made available to them (provided the patient is receiving
9 Patient Protection and Affordable Care Act of 2010 as amended. Public Law 111-148 § 10101(g) and (h), amending the Public Health Service Act by inserting §2719, 111th Cong., 2d sess.
the service from a licensed health care provider acting within their scope of practice), without discriminatory restrictions or limitations.
Dr. Cohen, Chairman of the Department of Obstetrics and Gynecology at Albert Einstein Medical Center, spoke on behalf of ACOG. He began by asking the committee to look to ACOG’s clinical and practice guidelines when determining the EHB related to women’s health. He also remarked that defining the EHB as specifically as possible “is the surest way to protect our patients against potential conflict or debate regarding medical necessity.” Every pregnant woman should have the ability to determine for herself whether first-trimester ultrasounds or screening for Down syndrome, for instance, are appropriate. Plans should not decide whether a specific screening is “right or wrong, or medically necessary.” Furthermore, as the ACA guarantees direct access to obstetricians/gynecologists (OB/GYNs), pregnant women should not have to rely on referrals for pregnancy-related services such as maternal/fetal medicine consultations or ultrasounds. Dr. Cohen also argued that plans should not limit contraceptive choices. Currently, he said, some plans cover only one type of contraceptive pill or intrauterine device (IUD), despite that there are many alternatives available.
The definition of medical necessity, he said, should ensure quality of care while safeguarding insurers from unexpected circumstances. He asked the committee to adopt the definition of medical necessity developed by the AMA, but advised that some terms in the definition need further clarification. For instance, a physician practice should be deemed “in accordance with generally accepted standards” if s/he adheres to the guidelines developed and adopted by the practice’s medical specialty. For example, an OB/GYN would be considered a prudent physician if s/he followed ACOG guidelines, such as when non-medically indicated elective inductions of labor before 39 weeks of gestation are and are not appropriate.
The definition of medical necessity, Dr. Cohen argued, must allow for medically appropriate off-label use of FDA-approved drugs and devices, a common practice in OB/GYN. For example, he noted that although the FDA does not approve the use of terbutaline to delay delivery for the purposes of enhancing fetal maturation, its use for this purpose is accepted medical practice. Similarly, misoprostol, which is FDA approved for use in peptic ulcer disease, is not approved to treat incomplete or missed abortions. The drug, though, is commonly used by OB/GYNs for this purpose.
Furthermore, the definition of medical necessity should allow for coverage of preventive interventions and counseling services that are often not covered (e.g., nutrition counseling, weight-loss management, smoking cessation, and counseling for postpartum depression). While these services are supported by varying levels of scientific evidence, ACOG has reviewed this evidence to develop guidelines that can serve as the standard for coverage, he said. Dr. Cohen closed by stating that ACOG believes medical necessity decisions should be made through peer-review processes that include expert specialists and sub-specialists.
Mr. Sellers, President and CEO of the NCCS, presented his organization’s recommendations for the EHB related to cancer care. The committee, he urged, should recognize the multidisciplinary nature and complexity of cancer care, rapid changes in evidence-based care as a result of clinical investigation, the evolution of cancer as a chronic disease, and the importance of facilitating patient decision making. Well-planned and well-coordinated cancer care, he said, is in the best interest of patients and is “best for the health care system because it ensures the appropriate utilization of the health care resources.” NCCS recommends coverage of cancer care planning
and coordination, coverage of off-label uses for cancer therapies, and coverage of routine patient care costs for patients enrolled in clinical trials.
For the purposes of defining EHB, cancer should be considered a chronic disease so that cancer patients can access care planning and coordination services. Specific elements of planning and coordination services and the frequency of these services should be included. Additionally, Mr. Sellers noted that “the frequency of access to cancer care planning services should be defined to ensure that the service is available across the continuum of care.” Specifically, access to the service should be available for treatment planning, treatment plan modifications, creation and communication of a summary of treatment, and follow-up survivorship care. Greater specificity, Mr. Sellers said, is necessary to ensure that cancer care plans adequately define all the elements of active treatment, symptom management, and survivorship care, and encourage care coordination among all providers across all sites of care. Including such services as a part of the EHB package is, Mr. Sellers said, “an important investment in quality care, and it goes a long way towards implementing the recommendations of the Institute of Medicine’s 2006 report, From Cancer Patient to Cancer Survivor: Lost in Transition” (IOM, 2006a).
Off-Label Drug Use
Mr. Sellers reiterated that “it is critically important” that the definition of EHB include access to off-label uses of cancer drugs. Between 50 and 75 percent of all uses of cancer drugs are off-label use, according to the National Comprehensive Cancer Network (ASCO, 2005). Although cancer research attempts to rapidly define supplemental uses of drugs approved by the FDA, this research does not necessarily or rapidly lead to changes in product labeling. To ensure patient access to evidence-based therapies, plans should not be permitted to prohibit payment for off-label uses of cancer drugs.
Medicare statutes, Mr. Sellers said, balance the need to ensure access to off-label use with reliance on evidence. According to Medicare statutes, off-label use of a cancer drug must be covered if the use is listed in a CMS-approved medical compendium. Furthermore, off-label use may be covered if the use is supported by peer reviewed medical literature.10 These standards, Mr. Sellers said, have “worked well and have generally been followed by private third-party payers.” To protect access to quality cancer care and all appropriate treatment options, NCCS recommends the definition of off-label use coverage standards in the EHB package.
The ACA includes a provision requiring the coverage of routine patient care costs for patients enrolled in clinical trials for cancer or other life-threatening diseases or conditions.11 NCCS, Mr. Sellers said, recommends that the EHB package clearly reflect this standard and that HHS consider expanding coverage to routine patient care costs for individuals enrolled in all clinical trials (i.e., not just clinical trials related to cancer or other life-threatening diseases). Mr. Sellers concluded by noting that cancer advocates “worked for many years to establish a standard for coverage of cancer trials through the Medicare program” and that when CMS established a policy of coverage of routine patient care costs in clinical trials, the agency made the policy applicable to trials in all diseases (CMS, 2007). This Medicare policy, he said, has “yielded significant benefits for individual patients and for the health care system” because patients are permitted to enroll in trials without fear that their routine costs will be denied.
Mr. Zimmerman, Vice President for Government Relations at the NKF, noted that medical coverage is typically determined by what is reasonable and necessary, a “vague definition” that can inhibit innovation and patient choice. For example, Medicare’s dialysis reimbursement policy, which reimburses three treatments weekly, has
10 Social Security Act, 42 U.S.C. 1395w-102§ 1860D-2(e).
11 Patient Protection and Affordable Care Act of 2010 as amended. Public Law 111-148 § 1201, amending the Public Health Service Act by inserting § 2709 as added by § 10103(c), 111th Cong., 2d sess.
remained virtually unchanged over 40 years. Such a rigid policy, he said, inhibits utilization of new modalities. For example, despite the convenience of home daily dialysis, its use has remained low over the past few decades. Ninety percent of dialysis patients receive traditional in-center dialysis.
The NKF, Mr. Zimmerman said, believes dialysis therapy should “best fit the needs of the individual patient.” Home therapies may be more convenient for patients in the workforce, and they eliminate transportation challenges. Furthermore, a recent study demonstrated that frequent dialysis consisting of six weekly hemodialysis treatments improved left ventricular mass and self-reported health (The FHN Trial Group, 2010). As a result of this finding and others, Mr. Zimmerman urged HHS to include all dialysis modalities in the EHB package.
Similarly, coverage limitations may be a barrier to kidney transplantation, which is often the most cost-effective alternative for candidates with kidney failure. Private insurance will often only cover a prospective living organ donor’s medical tests if that individual becomes a donor. In many instances, however, a patient with kidney failure must go through several prospective living organ donors before one is identified as appropriate. As the gap between the number of individuals on the kidney waiting list and the number of available organs continues to widen, living donation is an increasingly important mode of transplantation.
Mr. Zimmerman noted that the NKF argues against limits on specific benefits such as limits on the modality or number of dialysis sessions for a patient, or limits on access to repeated transplants for failed grafts. Additionally, to ensure the best outcomes for individual transplant recipients, the EHB package, he said, should cover the necessary immunosuppressive drugs, laboratory tests, and post-transplant examinations.
Prevention in High-Risk Populations
An individual with advanced chronic kidney disease is likely to die of complications prior to needing renal replacement therapy. Stage 4 kidney patients, for example, are more likely to die of congestive heart failure than to progress to dialysis (Foley et al., 2005; Keith et al., 2004). The 2010 U.S. Renal Data System (USRDS) Annual Report notes that because a patient with chronic kidney disease is more likely to have a cardiovascular event and die than to reach end-stage renal disease, it is imperative to identify chronic kidney disease among individuals who have been diagnosed with diabetes and/or hypertension, the two leading causes of chronic kidney disease and end-stage renal failure. This identification would allow patients and their providers to monitor risk factors for cardiovascular events and address the progression of kidney disease (USRDS, 2010). Mr. Zimmerman noted that group health plan enrollees are less likely to see a nephrologist prior to end-stage kidney failure than their Medicare counterparts (USRDS, 2010).12
In conclusion, Mr. Zimmerman stated that virtually all end-stage renal disease patients, regardless of age, are covered by Medicare 30 months after the start of their kidney-replacement therapy or, in the case of those who do not have group health insurance, three months after the start of kidney-replacement therapy. Therefore, he said, insurers may be reluctant to cover preventive and early detection for chronic kidney disease, expending resources on interventions only to see those policyholders move to another insurer.
Mr. Smith, Senior Vice President for Policy and Research at PhRMA, noted that his organization represents the nation’s biotechnology and pharmaceutical research companies and believes the definition of EHB plays “an important role in assuring” support for needed treatments across the benefit categories, regardless of the treatment setting or mode. Furthermore, the design of the EHB package, he said, plays a role in providing adequate financial protection for all patients, “whether they live with a chronic condition or have acute health care needs.”
12 The data reported here have been supplied by the U.S. Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.
The committee, Mr. Smith argued, should consider four principles:
- Coverage should provide access to needed medical treatment across benefit categories, regardless of the setting or mode of treatment.
- Risks should be spread broadly rather than concentrated on patients with high costs.
- The needs of patients with chronic as well as acute conditions should be recognized.
- Providers and patients should have choices among therapeutic options, and new treatments should be incorporated into coverage.
Provider and patient choice is essential to ensuring that the EHB meet patients’ diverse health care needs. Insurers should have flexibility to manage costs but must provide patients and providers with a “meaningful choice of treatment options,” including brand medicines and generic drugs. Employer-sponsored insurance typically features a tiered cost-sharing formula that includes broad coverage for preferred-brand drugs on the second tier and uses various management tools. These tools, he noted, must allow for meaningful access to needed care and focus on the full range of benefits rather than simply on costs.
Extensive evidence shows that high cost sharing discourages patients from taking needed medications (DiMatteo, 2004) and plays a role in what Mr. Smith called “the non-adherence problem.” This problem is estimated to generate $100 to $300 billion in higher health care costs and lost productivity annually (Shorter, 1993). Because the impact of high cost sharing is most pronounced for low-income patients, cost sharing has been cited as a contributing factor to increasing health disparities (Chernew et al., 2008). In recognition of the problems created by high cost sharing, Mr. Smith said, employers have begun to introduce innovative programs that reduce or eliminate cost sharing for medicines. These programs improve adherence, enhance productivity, and reduce overall costs (Freudenheim, 2007; Fuhrmans, 2007).
Mr. Smith urged the committee “to focus on the statutory standard,” and ensure benefits are not “unduly weighted toward any one category, given the rapid changes in the patterns of care and the important role that oral, injected, and infused medicines and vaccines play in effective prevention and management of conditions.” The protection against high OOP costs is one of the principal functions of insurance—to broadly pool high- and low-risk individuals in order to provide financial protection against catastrophic costs. “Simply put,” he said, “severely and/or chronically ill patients should not bear a disproportionately high share of the cost of care.” Additionally, he said, increasing cost sharing transfers a financial burden from the health plan to the patient and does little to reduce overall health care spending (Goldman et al., 2006). Some tiered cost-sharing designs shift costs to sick patients rather than creating meaningful incentives for high-quality care. Some Medicare Part D plans, for example, have created a specialty tier that typically features high cost sharing for medicines to treat cancer, HIV/AIDS, multiple sclerosis, and rheumatoid arthritis. PhRMA urges the IOM and HHS to carefully consider how to set guidelines consistent with the goals of ACA. These goals, he said, include ensuring that policies do not unfairly shift burdens to the sickest patients and create barriers to needed care.
Historically, most insurance was intended to provide protection for acute needs. Today, however, many treatments allow for effective control of chronic conditions that have previously had few management options. The needs of patients with chronic conditions, Mr. Smith said, “require focused attention.” Quality health insurance should reflect these needs and provide adequate protection to all patients, including those whose costs are spread out over time rather than concentrated in a single episode of care.
Mr. Smith closed by noting that access to new treatments is important to improving quality of life, reducing costs, and preventing, treating, and potentially curing serious and chronic conditions. Therefore, standards for formulary design and medical management should recognize the development of new treatments and therapies.
For example, some of the rules for implementing Medicare Part D recognized new therapies by building on best practice formulary designs and medical management tools used in the private sector.
Mr. Gallagher, Senior Vice President for Government Affairs at the American Pharmacist Association (APhA), stated that his organization represents over 62,000 pharmacists in a variety of settings. He began by defining medication therapy management (MTM) as a distinct service or group of services that optimizes therapeutic outcomes for individual patients (Bluml, 2005). The focus of MTM, he said, is providing team-based, individualized care to the patient. A foundational MTM service delivery model has specific “core elements” (i.e., medication therapy review, personalized medication record, medication-related action plan, intervention and referral, documentation, and follow-up) (APhA and NACDS, 2008).13 The goals of MTM are to improve collaboration among pharmacists, physicians, and other health professionals; enhance communication between patients and the health care team; and empower patients to optimize medication use for improved health care outcomes.
Mr. Gallagher noted that because services included in the definition of MTM are also included in the calculation of the medical loss ratio, these services should be included as an essential health benefit. Because MTM can optimize the use of medications and decrease overall health care costs by preventing adverse events, reducing hospital admissions, readmissions, and medical errors, Congress, he said, referenced MTM in Section 3503 of the ACA,14 and is a required benefit for targeted beneficiaries through Medicare Part D.15 Furthermore, Mr. Gallagher emphasized that “inappropriate use of medications costs an estimated $177 billion” (Ernst and Grizzle, 2001) and results in over 1.5 million preventable medication-related adverse events annually (IOM, 2006b). The Public Health Service has successfully used MTM and pharmacist intervention since the 1960s and numerous studies have documented the cost benefits of MTM to patients and health care systems (Chisholm-Burnes et al., 2010; Moore and Abramek, 1992; Perez et al., 2008; Schumock et al., 2003).
APhA developed the definition and core elements service model for MTM by convening diverse stakeholder groups (including physicians and other health care providers, policy makers, health plans, and quality organizations) and continues the dialogue about MTM services with these stakeholders. While all patients using prescription, nonprescription, herbal and other dietary supplements could potentially benefit from MTM, patients in transitions of care, patients who have changed medication regimens, and patients who have multiple medications, multiple chronic conditions, or a history of non-adherence are most likely to benefit. Patients who are empowered to take an active role in medication self-management have improved health as a result of a better functioning health care team. Mr. Gallagher noted that medication use can be optimized by removing barriers such as co-pays and deductibles (Bunting and Cranor, 2006). While medication spending may actually increase under MTM, overall medical costs for hospitalizations can be reduced (Bunting and Cranor, 2006; Fera et al., 2009).
Mr. Gallagher concluded by reiterating that medications are central to managing many disease states. “If the system is going to spend huge percentages of money for medications, we should be making sure that those medications are used optimally.” He encouraged the committee to recommend that the EHB package include a mechanism to optimize medication use through MTM services.
Dr. Wolfe, President of the American Society for Metabolic and Bariatric Surgery (ASMBS), spoke on behalf of the OCC. This coalition is comprised of the Obesity Action Coalition, American Dietetic Association, Obesity Society, and ASMBS, and represents the interests of individuals affected by overweight and obesity and the health care professionals and researchers who care and develop treatments for this growing population. The Congressional
13 A visual representation of MTM is presented in Appendix E of Medication therapy management in pharmacy practice: Core elements of an MTM service model, available at: http://www.accp.com/docs/positions/misc/CoreElements.pdf (accessed August 18, 2011).
14 Patient Protection and Affordable Care Act of 2010 as amended. Public Law 111-148 § 3503, amending Title IX of the Public Health Service Act by inserting § 935, 111th Cong., 2d sess.
15 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 1860D-4 (c)(2).
Budget Office estimated that over the past 20 years, the impact of obesity on health care expenditures has doubled and that obese individuals have at least 20 percent higher costs than lean subjects (CBO, 2010).
Obesity is a disease with multiple co-morbidities. Behavior modification and surgery, Dr. Wolfe said, are effective treatments for obesity and the prevention of obesity-related events, including death due to cardiovascular disease, cancer, and diabetes (Adams et al., 2007; Knowler et al., 2002; Sjostrom et al., 2007). Epidemiologic studies, he noted, demonstrate that mortality sharply increases when an individual’s body mass index (BMI) is above 30, the threshold for diagnosing obesity (Calle et al., 1999; Prospective Studies Collaboration, 2009). As 5 percent of the U.S. population has a BMI exceeding 40, the need to prevent and treat obesity is “pressing” (Sturm, 2007). Co-morbidity data from the NIH Consortium on Bariatric Surgery (LABS) show that 35 percent of obese individuals have diabetes and more than 50 percent have sleep apnea and hypertension (LABS Consortium, 2008). Despite this high cardiovascular risk, bariatric surgery, Dr. Wolfe said, presents a “window of opportunity” (LABS Consortium, 2008). However, access to obesity prevention and treatment is severely limited.
Obesity treatment is clearly recognized as an important component of comprehensive health care services. The U.S. Preventive Services Task Force recommends that clinicians screen adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults. Similarly, the Oregon Medicaid prioritized list of health services defines obesity treatment as “intensive nutritional/physical activity counseling and behavioral interventions” and lists it as the eighth highest priority (out of 679 conditions). Dr. Wolfe noted that bariatric surgery is one treatment for certain obese individuals with Type II diabetes, which ranks as thirty-third priority (OHSC, 2010). Intense behavior modification can result in a modest but definite sustained weight loss of 5 percent after four years (Look AHEAD Research Group, 2010). This weight loss was associated with a reduction in the need for diabetes and hypertension medication and improved control of these chronic conditions.
Weight loss following bariatric surgery is substantially greater than the weight loss associated with usual care (Sjostrom et al., 2007). Dr. Wolfe argued that bariatric surgery is safe, citing a mortality rate of 0.3 percent and a complication rate of 4.3 percent among all patients undergoing laparoscopic gastric bypass, open surgery, and laparoscopic adjustable gastric banding (LABS, 2009). Using data from a multi-year study conducted in Sweden, Dr. Wolfe showed that after 13 years the survival gap between patients who had bariatric surgery and those who received “the customary treatment for obesity at their centers of registration” widened (Sjostrom et al., 2007). This gap occurred, Dr. Wolfe said, as the result of remission of diabetes, hypertension, hyperlipidemia, sleep apnea, and a reduction in the incidence of cancer (Buchwald et al., 2004; Sjostrom et al., 2007).
Despite these demonstrated benefits of weight loss, intensive weight loss counseling is infrequently reimbursed by insurers (Tsai et al., 2006), and less than 2 percent of eligible patients undergo bariatric surgery annually (Kofman and Miller, 2010; Livingston, 2010). Dr. Wolfe argued that this lack of uptake results from a lack of knowledge of the benefits of bariatric surgery and a lack of financial coverage (Lee et al., 2010). Insurers often do not cover obesity treatment, he said, because (1) of the delay on return of investment of 2 years or more, resulting from the upfront cost of bariatric surgery and subsequent reduced health care costs associated with improved outcomes (Crémieux et al., 2008), (2) employers reject obesity treatment riders (Blackstone, 2010), and (3) there is a “bias against obesity” due to the perception that obesity results from self-induced inappropriate lifestyle, which can and should be corrected by individual lifestyle changes (Puhl and Heuer, 2009).
When committee member Mr. Schaeffer asked about the costs of laparoscopic gastric bypass, open surgery, and laparoscopic adjustable gastric banding, Dr. Wolfe noted that while the costs and complications vary, laparoscopic bypass costs approximately $17,000 and open gastric bypass costs approximately $26,000, excluding complica-tions (Crémieux et al., 2008). Open surgery, he said, is only done on patients who have complex problems from previous surgery or hernias (approximately 10 percent of the population). Laparoscopic gastric banding, on the
other hand, is generally done on a same-day outpatient basis and costs between $10,000 and $15,000. Dr. Wolfe concluded that reimbursement for the treatment of obesity requires special consideration due to the remarkable health benefits achieved.
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