August 23, 2016
Acting Administrator James Macrae, MA, MPP
Health Resources and Services Administration
U.S. Department of Health and Human Services
Rockville, MD 20857
Re: Ryan White HIV/AIDS Program Outcomes within the Context of the Affordable Care Act
Dear Mr. Macrae:
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 June 24, 2016 Federal Register. The Academy is the world’s largest organization of food and nutrition professionals, with more than 100,000 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 funded centers 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 continued efforts to provide increased support and coordination to providers and clients to ensure that there are no service gaps, particularly with regard to critical food and nutrition services (FNS), and to continue to support overall health outcomes.
A. Potential Changes for Patients with HIV Infection Resulting from ACA
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.3 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. The Academy supports HRSA’s efforts to identify impacts resulting from implementation of the Affordable Care Act and its efforts to ameliorate them.
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.
Although all citizens 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.
B. 2014 Special Study: Future of Ryan White Services
The Academy commented previously on HRSA’s proposed information collection, and appreciated the feedback from HRSA in response to our comments. Abt Associates worked with HRSA on a Special Study to look at the Future of Ryan White Services: A Snapshot of Outpatient Ambulatory Care.5 The study collected information on services provided, quality of care, and any barriers, gaps and challenges related to implementation of the ACA in 2014. The evaluation looked at 30 Ryan White provider sites, representing diverse regions of the country. Findings from both the providers and clients show that nutrition services were not available to individuals under the ACA, and were not accessible in the intensity needed to be effective.
In addition to the 2014 study, in April 2015 HRSA released a report on the Impact of Medicaid 1115 Waivers on the Ryan White HIV/AIDS Program.6 The study found that Medicaid coverage for people living with HIV/AIDS (PLWHA) does not replace or eliminate the need for the RWHAP. Nutrition therapy and food banks/home-delivered meals were both services that only the RWHAP covered.7
In the comments below, the Academy details specific food and nutrition services provided under Ryan White and the continued value of these services. We also demonstrate the role of food and nutrition services in meeting the goals of the National HIV/AIDS Strategy (NHAS).
C. Nutrition Services for People with HIV/AIDS (Parts A, B, D, F)
As the HIV epidemic in the United States increasingly impacts low-income individuals, the role of food and nutrition services for PLWHA cannot be overstated. Individuals who are food insecure routinely forego critical medical care – including making and keeping appointments for primary care and filling medication prescriptions - in order to pay for food.8 Food insecure PLWHA rely extensively on cheap, highly processed, low-nutrient foods.9
For PLWHA, proper nutrition is central to increasing absorption of medications, reducing side effects, and maintaining a healthy body weight. Research has identified the virus as an independent risk factor for cardiovascular, liver and kidney disease, cancer, osteoporosis and stroke. HIV medications can cause nausea and vomiting and may affect lab results testing lipids and kidney and liver function. These compounding health effects, caused by the virus, its medications, and co-morbidities reinforce the important role a nutrient-rich diet plays in a patient’s overall care. In addition, providing food and nutrition services facilitates access and engagement with medical care, especially among vulnerable populations.
Currently, the Ryan White HIV/AIDS Program funds the Food and Nutrition Services category as a core medical service. This includes medical nutrition therapy provided by a registered dietitian nutritionist, and food and nutrition services (FNS). MNT includes both the nutritional diagnostic, therapy and counseling services provided by RDNs outside of a primary care visit, and medically tailored home-delivered meals (MTMs), which are referred by a physician and developed by a RDN. MNT is a fundamental treatment for keeping PLWHA engaged in care, sticking to medication regimens, bringing viral loads to undetectable levels, and ultimately preventing the forward transmission of the virus.
Nutrition professionals who provide MNT to PLWHA are highly-trained and educated, grounded in nutrition science and follow evidence-based nutrition guidelines pertaining to HIV disease, body composition, co-morbidities, side effects, medications, food safety, and much more. These services are strongly recommended by the nationally and internationally reviewed HIV/AIDS Evidence-Based Nutrition Practice Guideline (“Practice Guidelines”),10 as well as the Los Angeles County Commission on HIV’s Medical Nutrition Therapy Standards of Care (“Standards of Care”).11 It is recommended that the RDN provide MNT to individuals with an HIV infection. Recommended treatment regimens are MNT sessions at least 1-2 times annually to asymptomatic patients, and 2-6 times annually to symptomatic patients.
In current practice, RDNs connect and communicate with each client, and treat them as an individual with unique circumstances and nutrition-related problems. RDNs are able to establish relationships built on trust and truthfulness, and to get to the etiology of the client’s nutrition deficiencies. Clients who receive MNT are actively engaged to identify, strategize and determine solutions to manage their nutrition needs, as well as a range of nutrition-related problems that interfere with personal well-being, such as: lack of food resources, food safety, meal planning for daily use and to treat disease-related conditions, weight and body composition goals, and requirements for nutrition and medication. When a client manages their basic nutrition needs with an RDN, they will increase the chances of viral suppression and improving overall quality of life.
D. Under-Utilization of Medical Nutrition Therapy in Current Practice
However, there is still a great need to improve MNT and FNS services for PLWHA. The provision of any, let alone adequate, MNT services in HIV ambulatory outpatient medical care clinics is the exception rather than the rule. Even though MNT is a low-cost and clinically effective life-sustaining treatment, it is largely neglected. In HIV clinics, RDNs report that clients’ unaddressed or ongoing problems include: RDNs report clients’ unaddressed or ongoing problems:
- Correctable malabsorption, diarrhea, and nausea;
- Significant, prolonged, unhealthy weight;
- Unsafe food and water practices;
- Incorrectly taking medication or adjusting foods or meals; and
- Diabetes, hypertension, heart disease or other conditions without a referral to the RDN.
The 2011 Los Angeles County HIV Needs Assessment12 polled 450 HIV-Infected persons and found that:
- 68 percent were aware of Medical Nutrition Therapy as an available service; and
- 54 percent ranked the need for Medical Nutrition Therapy 7th of 47 individual service categories.
Based on the above information, MNT should occur when and where PLWHA receive medical care in order to optimize access, coordination, and communication with the medical team. This includes HIV-infected individuals covered by private insurance, the VA, Medicare, Medi-Cal or Medicaid, Ryan White, and the Affordable Care Act. Coverage of MNT is limited, complicated, chaotic and full of disparities. Hurdles include inadequate coverage, reimbursement, co-pays, documentation, authorization, timing of the visit, billing & coding, requirements, and so on. In 1991 HIV/AIDS resources were limited, but stakeholders were promised there would be more funding and HIV nutrition care would be included. However, costs of drugs, tests, and care have greatly expanded, and still, the inclusion of medical nutrition therapy, a low cost and effective life sustaining treatment has largely been neglected.
E. Evidence-Based Medications
The Academy is concerned that the prescription drug benefit in the EHBs applied to Medicaid pursuant to the proposed rule may not provide appropriate protections for people with chronic conditions like diabetes, HIV/AIDS, and obesity. We also are concerned that under Medicaid expansion waivers, PLWHA are subject to co-payments and deductibles for medications, which previously were permissible payments under the Ryan White ADAP program.13 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 again 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.14
F. Food and Nutrition Services are Essential to Meeting the Goals of the National HIV/AIDS Strategy
As the Ryan White program and HRSA continue to support the implementation of the NHAS, it is important to note that food and nutrition services are critical to the success of the strategy. In brief, the provision of FNS support the following goals of NHAS:
- NHAS Goal: Reducing new HIV infections
- PLWHA who are food insecure are less likely to have undetectable viral loads in a statistically significant way. Undetectable viral loads prevent transmission 96 percent of the time,15 thus, FNS is key to prevention.16
- NHAS Goal: Increasing access to care and improving health outcomes for people living with HIV
- PLWHA who receive effective FNS are more likely to keep scheduled primary care visits, score higher on health functioning, are at lower risk for inpatient hospital stays and are more likely to take their medicines.17
- NHAS Goal: Reducing HIV-related disparities and health inequities
- By providing FNS to PLWHA who are in need largely because of poverty, we improve health outcomes, thereby reducing health disparities.18
The Academy believes that the ACA and Ryan White both emphasize the importance and value of coordinated care and patient-centered care and thus have the potential to complement one another in serving the needs of eligible individuals. 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
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics
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, http://www.eatright.org/scope/, 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 Fields-Gardner C, Campa A. Position of the American Dietetic Association: Nutrition Intervention and Human Immunodeficiency Virus Infection. J Am Diet Assoc. 2010;110(7):1105-19.
4 Ryan White and Affordable Care Act Outreach, Enrollment and Benefits Counseling, HRSA Website at http://hab.hrsa.gov/affordablecareact/outreachenrollment.html accessed February 20, 2014.
5 Abt Associates. The Future of Ryan White Services: A Snapshot of Outpatient Ambulatory Medical Care. November 4, 2015. Accessed August 8, 2016 at: http://abtassociates.com/AbtAssociates/files/36/3647b637-9110-4b6f-9853-6eb269c8fcec.pdf.
6 Health Resources and Services Administration Resources & Publications. Impact of Medicaid 1115 Waivers on the Ryan White HIV/AIDS Program-Case Studies. April 2015. Accessed on August 1, 2016 at: http://hab.hrsa.gov/newspublications/medicaidwaivers.pdf.
8 Aidala A, Yomogida M, Vardy Y & the Food & Nutrition Study Team. Food and Nutrition Services, HIV Medical Care, and Health Outcomes. New York State Department of Health: Resources for Ending the Epidemic, 2014. Available at https://www.health.ny.gov/diseases/aids/ending_the_epidemic/docs/key_resources/housing_and_supportive_services/chain_factsheet3.pdf.
9 Adaila A, Caban M, Castro C, Cespedes H, Sharma N, Yomogida M. Who Needs Food & Nutrition Services and Where Do They Go for Help? Available at http://www.nyhiv.org/pdfs/chain/CHAIN%202013-2%20Brief%20Report_Food%20Insecurity%20Fact%20Sheet_2.pdf.
10 Academy of Nutrition and Dietetics. 2010 HIV/AIDS Evidence-Based Nutrition Practice Guideline. Available at http://www.andeal.org/topic.cfm?menu=5312. Accessed August 18, 2016.
11 Los Angeles County Commission on HIV. Medical Nutrition Therapy Standards of Care, 2006. Available http://hivcommission-la.info/cms1_034030.pdf. Accessed August 18, 2016.
12 Division of HIV and STD Programs, Los Angeles County Department of Public Health and the Los Angeles County Commission on HIV, Los Angeles Coordinated HIV Needs Assessment‐Care (LACHNA‐Care): 2011 Final Report, December 2011:1‐153 http://hivcommission-la.info/cms1_173837.pdf
13 Health Resources and Services Administration Resources & Publications. Impact of Medicaid 1115 Waivers on the Ryan White HIV/AIDS Program-Case Studies. April 2015. Accessed on August 1, 2016 at: http://hab.hrsa.gov/newspublications/medicaidwaivers.pdf.
14 Centers for Medicare and Medicaid Services. Medicare Prescription Drug Benefit Manual. Accessed on August 1, 2016 at t: http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Chapter6.pdf. Accessed December 14, 2012.
15 Palar K, Laraia B, Tsai A, Weiser SD (2013). Food insecurity is associated with sexually transmitted infections and HIV serostatus among low income adults in the National Health and Nutrition Examination Survey (NHANES) (1999-2010). Presented at the American Public Health Association 141st Annual Meeting, Boston, MA, November 5, 2013.
16 Weiser SD, Frongillo EA, Ragland K, Hogg RS, Riley ED, Bangsberg DR. Food insecurity is associated with incomplete HIV RNA suppression among homeless and marginally housed HIV-infected individuals in San Francisco. J Gen Internal Med 2009; 24(1):14-20.
17 Aidala A, Yomogida M, Vardy Y & the Food & Nutrition Study Team. Food and Nutrition Services, HIV Medical Care, and Health Outcomes. New York State Department of Health: Resources for Ending the Epidemic, 2014. Available at https://www.health.ny.gov/diseases/aids/ending_the_epidemic/docs/key_resources/housing_and_supportive_services/chain_factsheet3.pdf.
18 Weiser SD, Frongillo EA, Ragland K, Hogg RS, Riley ED, Bangsberg DR. Food insecurity is associated with incomplete HIV RNA suppression among homeless and marginally housed HIV-infected individuals in San Francisco. J Gen Intern Med. 2009 Jan;24(1):14-20. doi: 10.1007/s11606-008-0824-5. Epub 2008 Oct 25.