March 4, 2014
Administrator Mary Wakefield, Ph.D, R.N.
Health Resources and Services Administration
U.S. Department of Health and Human Services
Rockville, MD 208570
Re: Ryan White HIV/AIDS Program Solicitation of Comments
Dear Dr. Wakefield:
The Academy of Nutrition and Dietetics (the "Academy) appreciates the opportunity to submit comments to the Health Resources and Services Administration (HRSA) in response to the information collection published in the January 3, 2014 Federal Register. The Academy is the world's largest organization of food and nutrition professionals, with more than 75,000 members comprised of registered dietitian nutritionists (RDNs),1 dietetic technicians, registered (DTRs), and advanced-degree nutritionists. We are committed to improving the nation's health through food and nutrition and providing medical nutrition therapy (MNT)2 and other nutrition counseling services to meet the health needs of all citizens, including those with HIV infection. RDNs are integral components of the coordinated health care team at Ryan White HIV/AIDS Program fundedcenters across the nation at which low-income, uninsured, and under-insured individuals with HIV infection can get proper medical care.
The Academy strongly supports the proposed information collection and urges HRSA to include whether access and coverage to nutrition care are impacted by the Affordable Care Act (ACA). The Ryan White HIV/AIDS Program ("Ryan White") provides HIV-related care and support services in the United States for individuals who do not have sufficient health care coverage or financial resources for coping with HIV disease. As the ACA expands health coverage to a subset of individuals presently served by Ryan White, the Academy supports HRSA's efforts to provide increased support and coordination to ensure clients do not experience gaps in coverage or gaps in care, particularly with regard to critical food and nutrition services (FNS).
Potential Changes for Patients with HIV Infection Resulting from Affordable Care Act
It is the position of the Academy of Nutrition and Dietetics that efforts to optimize nutritional status through individualized medical nutrition therapy, assurance of food and nutrition security, and nutrition education are essential to the total system of health care available to people living with HIV infection throughout the continuum of care. With greater understanding of the mechanisms of HIV disease and its impact on body function, development of new treatments, and wider ranges of populations affected, the management of chronic HIV infection continues to become more complex and demanding. Achievement of food and nutrition security and management of nutrition-related complications of HIV infection remain significant challenges for people living with HIV infection and health care professionals.
Payment for medical care for people living with HIV infection can come from several sources, depending on insurance coverage, enrollment in state and federal support programs, and other resources. Ryan White funds may be available to help pay premiums of health insurance plans and medication co-pays, but may no longer pay for medical visit or laboratory co-payments. HRSA should identify and publish where AIDS Drug Assistance Programs and Medicaid programs may provide for medically necessary nutrient supplementation. In addition, Medicare and other funding sources may be available for nutrition-related care for diabetes, renal disease, and cardiovascular disease.
As the ACA is implemented and primary care is provided to people with HIV infection through an expanded Medicaid program or insurance procured through state marketplaces, the future of Ryan White—and therefore the ability of beneficiaries to receive comprehensive HIV/AIDS care—becomes uncertain. The Academy affirms that coverage under the ACA is not a substitute for Ryan White; Medicaid and private insurance in most states does not cover the unique food and nutrition services provided by Ryan White and many states have declined to expand Medicaid eligibility for their most needy citizens. As the Kaiser Family Foundation notes, Ryan White "will also likely continue to be important for many who gain new coverage, given that two-thirds of current Ryan White HIV/AIDS Program clients already have insurance.3
Although all citizens will now have access to primary care and essential health benefits through health insurance marketplaces, this does not include certain core medical and social services now covered by the Ryan White HIV/AIDS Treatment Modernization Act, such as nutrition services and MNT, access to nutrition experts, or oral health services. In addition, Ryan White ensures individuals with HIV infection receive medically necessary FNS and valuable medical case management services "to ensure timely and coordinated access to medically appropriate levels of health and support services and continuity of care"4 that are traditionally not available under state Medicaid programs or private, subsidized insurance available on state marketplaces. HRSA should consider the ways in which nutrition services and medical nutrition therapy are coded and billed under a new coverage scheme to ensure these core medical services are provided when needed.
In the comments below, the Academy details specific food and nutrition services provided under Ryan White and their value; we encourage HRSA to determine the extent to which gaps in the critical Food and Nutrition category are created or widened with implementation of the Affordable Care Act.
Nutrition Services for People with HIV/AIDS (Parts A, B, D, F)
The Food and Nutrition category includes both MNT FNS, such as home-delivered meals, congregate meals, grocery bags, food pantries, and vouchers that complement MNT as essential parts of HIV treatment. As part of FNS, patients receive nutrition education that empowers them to make healthy food choices and facilitate behavior change. Part A of Ryan White properly emphasizes the value of identifying and providing services, including MNT and FNS, to people who know their HIV status but are not in care. Poor nutritional status, including both undernutrition and overnutrition, can affect immune function independent of HIV infection.5 6 Death rates are higher among HIV-infected clients with malnutrition, including those receiving antiretroviral therapies (ARTs).7 8 9 A well-nourished person with HIV who has a controlled viral load is more likely to be able to withstand the effects of HIV infection, supporting immune status and possibly delaying the progression of HIV disease to AIDS.10 11 The negative effects of malnutrition are often preventable and are usually not easily reversed. Nutrition-related alterations can occur early in HIV infection; thus, nutrition intervention should begin soon after diagnosis. FNS connects people to care and maintains them in care, improving medical outcomes.
A combination of approaches are often necessary to address nutrition-related problems faced by people living with HIV infection. For instance, weight status and body composition may require a combination of nutritional counseling, nutritional supplements, and medication therapies to accomplish appetite stimulation, energy balance, hormone modulation, and symptom management.
Nutrition interventions should support a client's medication treatment goals while reducing any negative nutrition-related health effects of the disease and medication regimens, including prediabetes, lipodystrophy, and co-infections such as hepatitis C. The efficacy of ART and other medications is important to maintenance of nutritional status.12 Conversely, nutrients and nutritional status affects absorption, utilization, elimination, and tolerance to medications.13 Adherence to medications is affected by nutrition-related impacts of medication side effects and the potential for the development or exacerbation of body fat changes, as seen in lipodystrophy. Some clients have stopped treatment because of body image issues. At this time, life-long pharmacotherapy are required for continuous disease management and presents challenges to nutritional status maintenance of potential interactions with food, metabolism, and side effects.
Assuring Access to RDN-Provided Nutrition Care Services (Parts A, B, D, F)
Since 2006, RDN-provided MNT has been included as a clinically effective core medical service in Ryan White funded HIVclinics. The Academy supports the integration of MNT and nutrition counseling for people living with HIV infection as evidenced in its evaluation of existing evidence; seven studies were evaluated regarding MNT and/or nutrition counseling in people with HIV infection. 14 One study completed prior to highly active ARTs stressed that early intervention may prevent progressive weight loss.15 Four studies regarding MNT reported improved outcomes related to energy intake and/or symptoms (with or without oral nutritional supplementation) and cardiovascular risk indices, especially with increased frequency of visits.16 Two studies regarding nutritional counseling (non-MNT) also reported improved outcomes related to weight gain, CD4 count, and quality of life.1
RDNs are also familiar with both nutrient-based and non-nutrient treatments to improve nutritional status and nutrient metabolism, ranging from exercise prescription and complementary/alternative medicine therapies to pharmacologic modulation.18 RDNs provide varied nutrition care and support services under Ryan White in addition to MNT, including nutrition education, evaluating nutrition and health-related psychosocial factors, and medical case management. The Academy finds that RDNs who participate in obtaining annual grants or in the grantee's planning council meetings are generally able to ensure provision of sufficient nutrition and food programs to meet patients' needs. HRSA should endeavor in the reauthorization of Ryan White to ensure that everyone with HIV infection is guaranteed sufficient access19 to the benefits of coordinated nutrition care services and nutrition education provided by an RDN through the Ryan White HIV/AIDS Program.
Minority AIDS Initiative (Parts A, B)
The Academy also supports the work and focus of the Minority AIDS Initiative (MAI), given the disproportionate impact of HIV/AIDS on minorities and comparatively low rate of insurance coverage in many of these same communities. Prevalence rates are six times higher for black men compared to white men and 18 times higher for black women compared to white women. Latinos had three times the prevalence rate of whites. In addition, the MAI is appropriate to remedy the fact that the most affected minority groups were usually diagnosed at a later stage of HIV infection, when related or concurrent diseases were already present. Delayed care may be more common in these groups due to lack of economic, insurance, food security, and other resources or competing subsistence needs, and Ryan White provides care at an earlier stage.20 21 Educational disparities also contribute to treatment adherence and care acquisition as individual healthcare literacy is insufficient to comprehend importance and severity of disease pathology. The MAI integrates educational initiatives on self-care and self-monitoring techniques to improve healthcare outcomes.22 Because of these disparities, providing MNT and FNS to these communities is essential.
Interventions for Women, Infants, Children, Youth, and Their Families (Part D)
Low-income women with infants and children are eligible for and receive Medicaid, yet Ryan White still plays a vital role in providing necessary, additional coordinated services to those with HIV infection. In addition, coverage for MNT provided by RDNs in state Medicaid programs varies widely. The Program helps to level the playing field and avoid disparities of care.
Maintenance of energy balance is an important feature of MNT efforts, particularly among children, where energy balance deficits frequently result in growth failure in children with HIV infection. Inability to achieve a normal weight for height, growth stunting, failure to thrive, malnutrition, impaired cognitive development, and wasting are potential adverse nutrition-related outcomes in pediatric HIV.23 HIV-positive children are at high nutritional risk, and should be referred for ongoing nutrition assessment and counseling with an RDN.
The goals of Part D intervention unique to children with HIV infection include the critical dimension of growth and development. Guidelines for breastfeeding are importantly different in the context of HIV infection. Other goals include the maintenance of nutritional status and management of disease and its treatments. Mothers with HIV should be made aware of the risks and benefits of different infant feeding options, including the risk of transmission of HIV through breastfeeding. The Academy notes that Ryan White funded services can benefit from working collaboratively with other non-duplicative nutrition assistance programs, such as state Women, Infants, and Children (WIC) agencies and SNAP-Ed providers. By coordinating efforts, mothers with HIV infection will obtain vital education, nutrients, and calories for extremely vulnerable infants with needs not able to be met solely by existing WIC programs and personnel.
Special Projects of National Significance (SPNS) (Part F)
New HIV infections are disproportionately affecting people with lower incomes and less access to health care, creating challenges to supporting treatment access and goals. In addition to HIV disease and its complications, many clients face economic insecurity, social isolation, stigmatization, incarceration or institutionalization, substance use, and additional comorbidities. Many people with HIV and AIDS face hunger and multiple barriers to food and nutrition security. The Academy supports Part F of Ryan White, Special Projects of National Significance (SPNS), which seeks to address issues of economic insecurity and other complications affecting underserved populations diagnosed with HIV infection.
Part F properly targets providers who serve minority populations, the homeless, rural communities, incarcerated persons, and Ryan White HIV/AIDS Program–funded sites. RDNs play integral roles in education and training centers, and require continued support at they train other RDNs, health care providers, and educators. The Academy believes Part F training on nutrition-related issues of evaluation and treatment in HIV infection should be an ongoing process for RDNs and other care providers. The team approach of collaboration with and referral to other specialties may help to overcome pressing challenges with mental health, drug addiction, and economic constraints.
The Academy is concerned that the prescription drug benefit in the EHBs applied to Medicaid pursuant to the proposed rule does not provide appropriate protections for people with chronic conditions like diabetes, HIV/AIDS, and obesity. While the evident proposed requirement to cover the greater of 1 or the number of drugs in a benchmark plan's category is an improvement over the requirements outlined in the pre-rule bulletin, the new regulation could still result in insufficient access to medications for people with diabetes, HIV/AIDS, obesity, and other chronic conditions. Specifically, we are concerned that focusing on a number of drugs covered, as opposed to ensuring a breadth of drugs are covered, could result in a selection of drugs that meets the minimum requirement yet still discriminates against potential enrollees. Furthermore, the requirements in the proposed rule only refer to coverage, not tiering or utilization management controls, which can have a significant impact on access to critical medications. The Academy requests that, consistent with §1927 of the Social Security Act and the ACA, HHS require states to implement beneficiary protections consistent with Part D, where CMS considers the specific drugs, tiering and utilization management strategies employed in each formulary and identifies outliers from common benefit management practices for further evaluation.24
The Academy believes that the ACA and Ryan White both emphasize the importance and value of coordinated care and prevention and thus have the potential to complement one another if Ryan White is conscientiously reauthorized. Any changes impacting patients should be clearly communicated in advance; education about wellness benefits and primary care practice are critical. It is imperative to ensure that implementation of the ACA does not diminish the funding or effectiveness of Ryan White or the vital services provided to patients.
The Academy appreciates the opportunity to offer comments regarding the Ryan White HIV/AIDS Program. We are pleased to offer our assistance and expertise, including information from our Evidence Analysis Library (for which HRSA generously provided funding) in Ryan White's assessment and reauthorization. We are willing to work with HRSA in developing quantitative and qualitative data, working with providers and patients to ensure the Program continues to be able to effectively fulfill its mission throughout the implementation and duration of the ACA. Please contact either Jeanne Blankenship at 202-775-8277 ext. 6004 or by email at email@example.com or Pepin Tuma at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS RDN
Vice President, Policy Initiatives and Advocacy
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process focused on prevention, delay or management of diseases and conditions, and involves an in-depth assessment, periodic re-assessment and intervention. [Academy of Nutrition and Dietetics' Definition of Terms list, Scope of Practice, accessed 31 June 2012.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.
3 "Assessing the Impact of the Affordable Care Act on Health Insurance Coverage of People with HIV" Kaiser Family Foundation website, accessed February 20, 2014.
4 Ryan White and Affordable Care Act Outreach, Enrollment and Benefits Counseling, HRSA Website, accessed February 20, 2014.
5 Hughes S, Kelly P. Interactions of malnutrition and immune impairment, with specific reference to immunity against parasites. Parasite Immunol. 2006;18:577-588.
6 Rasouli N, Kern PA. Adipocytokines and the metabolic complications of obesity. J Clin Endocrinol Metab. 2008;93:64-73.
7 Mangili A, Murman DH, Zampini AM, Wanke CA. Nutrition and HIV infection: Review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort. Clin Infect Dis. 2006;42:836-842.
8 Paton NI, Sangeetha S, Earnest A, Bellamy R. The impact of malnutrition on survival and the CD4 count response in HIV-infected patients starting antiretroviral therapy. HIV Med. 2006;7:323-330.
9 Marazzi MC, Liotta G, Germano P, Guidotti G, Altan AD, Ceffa S, Lio MM, Nielsen-Saines K, Palombi L. Excessive early mortality in the first year of treatment in HIV type 1-infected patients initiating antiretroviral therapy in resource-limited settings. AIDS Res Hum Retroviruses. 2008;24:555-560.
10 Fergusson P, Chinkhumba J, Grijalva-Eternod C, Banda T, Mkangama C, Tomkins A. Nutritional recovery in HIV-infectedand HIV-uninfected children with severe acute malnutrition. Arch Dis Child. 2009;94:512-516.
11 Thomas AM, Mkandawire SC. The impact of nutrition on physiologic changes in persons who have HIV. Nurs Clin North Am. 2006;41:455-468, viii.
12 Ferrando SJ, Rabkin JG, Lin SH, McElhiney M. Increase in body cell mass and decrease in wasting are associated with increasing potency of antiretroviral therapy for HIV infection. AIDS Patient Care STDS. 2005;19:216-223.
13 See, e.g., López JC, Moreno S, Jiménez-Oñate F, Clotet B, Rubio R, Hernández-Quero J. A cohort study of the food effect on virological failure and treatment discontinuation in patients on HAART containing didanosine enteric-coated capsules (FOODDIe Study). HIV Clin Trials. 2006;7:155-162.
14 Academy of Nutrition and Dietetics (formerly American Dietetic Association). HIV/AIDS Nutrition Evidence Analysis Project, Accessed 29 July 2012.
15 Chlebowski RT, Grosvenor M, Lillington L, Sayre J, Beall G. Dietary intake and counseling, weight maintenance, and the course of HIV infection. J Am Diet Assoc 1995; 95(4): 428-435.
16 Fitch KV, Anderson EJ, Hubbard JL, Carpenter SJ, Waddell WR, Caliendo AM, Grinspoon SK. Effects of a lifestyle modification program in HIV-infected individuals with the metabolic syndrome. AIDS. 2006; 20: 1843-1850. Kaiser JD, Donegan E. Complementary therapies in HIV disease. Alternative Therapies in Health and Medicine. 1996; 2(4): 42-46. Tabi M, Vogel RL. Nutritional counselling: An intervention for HIV-positive patients. Journal of Advanced Nursing. 2006; 54(6): 676-682. Topping CM, Humm DC, Fischer RB, Brayer KM. A community-based, interagency approach by dietitians to provide meals, medical nutrition therapy, and education to clients with HIV/AIDS. J Am Diet Assoc. 1995; 95: 683-686.
17 Rabeneck L, Palmer A, Knowles JB, Seidehamel RJ, Harris CL, Merkel KL, Risser JMH, Akrabawi SS. A randomized controlled trial evaluating nutrition counseling with or without oral supplementation in malnourished HIV-infected patients. J Am Diet Assoc. 1998; 98: 434-438. Schwenk A, Steuck H, Kremer G. Oral supplements as adjunctive treatment to nutritional counseling in malnourished HIV-infected patients: randomized controlled trial. Clinical Nutrition. 1999; 18(6): 371-374.
18 See, e.g., Academy of Nutrition and Dietetics (formerly American Dietetic Association). HIV/AIDS Nutrition Evidence Analysis Project at http://www.adaevidencelibrary.com/conclusion.cfm?conclusion_statement_id=250967. Accessed 29 July 2012.; Liu JP, Manheimer E, Yang M. Herbal medicines for treating HIV infection and AIDS. Cochrane Database Syst Rev. 2005; 20:CD003937.
19 The Academy's Evidence-Based Practice Guidelines for HIV/AIDS contains recommendations rated "Imperative" related to screening for nutrition-related problems and frequency of MNT care:
- The Registered Dietitian Nutritionist (RDN) should provide at least one to two Medical Nutrition Therapy (MNT) encounters per year for people with HIV infection (asymptomatic) and at least two to six (or more) MNT encounters per year for people with HIV infection (symptomatic but stable, acute or palliative), based on the following: Appropriate disease classifications; Nutritional status; Comorbidities; Opportunistic; Infections; Physical changes; Weight or growth concerns; Oral or gastrointestinal symptoms; Metabolic complications; Barriers to nutrition; Living environment; Functional status; Behavioral concerns; or unusual eating behaviors. Evidence Analysis Library. Accessed February 27, 2014.
- The registered dietitian (RD) should collaborate with other health care professionals, administrators and public policy decision-makers to ensure that all people with HIV infection are screened for nutrition-related problems, based on referral criteria regardless of setting, at every visit. People with HIV infection are at nutritional risk at any time-point during the course of their illness. Evidence Analysis Library. Accessed February 27, 2014.
21 Kates J, Levi J. Insurance coverage and access to HIV testing and treatment: Considerations for individuals at risk for infection and for those with undiagnosed infection. Clin Infect Dis. 2007;45(suppl 4): 255-260.
22 Kalichman SC, Pope H, White D, Cherry C, Amaral CM, Swetzes C, Flanagan J, Kalichman MO. Association between health literacy and HIV treatment adherence: Further evidence from objectively measured medication adherence. J Int Assoc Physicians AIDS Care. 2008;7: 317-323.
23 Majaliwa ES, Mohn A, Chiarelli F. Growth and puberty in children with HIV infection. J Endocrinol Invest. 2009;32:85-90.
24 Centers for Medicare and Medicaid Services. Medicare Prescription Drug Benefit Manual.