October 16, 2017
AHRQ Reports Clearance Officer
AHRQ's OMB Desk Officer
Re: Proposed Information Collection Project: “Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality” (OMB control number 0935-0106); Generic Information Collection Request— “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” (OMB Control Number 0935-0179).
The Academy of Nutrition and Dietetics (the “Academy”) appreciates the opportunity to submit comments to the Agency for Healthcare Research and Quality (AHRQ) related to its open dockets regarding “Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality” and “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” published in the Federal Register on September 15, 2017. Representing over 100,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle. Every day we work with Americans in all walks of life — from birth through old age — conducting research and providing medical nutrition therapy (MNT)2 and other evidence-based nutrition counseling services that meet the health needs of all citizens.
A. Overview and Recent Improvements
As a user of AHRQ’s work products and services and a prospective recipient of a proposed survey identifying problem areas and seeking improvement, the Academy believes that the requests for information aligns with AHRQ’s mission “to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.” In response to the two referenced AHRQ information collections, the Academy offers qualitative feedback on strategies for achieving aspects of AHRQ’s mission below.
In addition to other duties, AHRQ is “authorized by Congress to provide scientific, technical, administrative, and dissemination support to the [United States Preventive Services Task Force (USPSTF or the “Task Force”),”3 which “is charged by the U.S. Congress to review the scientific evidence for clinical preventive services and to develop evidence-based recommendations for their delivery to the health care community.”4 We note that this description more closely reflects the actual congressional mandate5 than that published in the 2014 Guide to Clinical Preventive Services: “The U.S. Preventive Services Task Force (USPSTF) is mandated by Congress to conduct rigorous reviews of scientific evidence to create evidence-based recommendations for preventive services that may be provided in the primary care setting.”6 The Academy applauds AHRQ’s clarification that the congressional mandate does not limit the USPSTF’s recommended services only to the primary care setting, and offers the comments below in an effort to help AHRQ ensure this fact is better “understood and used” by HHS, CMS, and its other partners.
AHRQ recognizes that “[o]ur primary care system currently has significant—and perhaps unprecedented—opportunities to emphasize quality improvement (QI) and practice redesign in ways that could fundamentally improve health care in the United States.” Seizing one such opportunity, AHRQ and the Task Force are making tremendous progress in revising process and output to reflect new responsibilities and needs. We commend AHRQ for helping the USPSTF fulfill its “commit[ment] to improving the communication of [its] recommendations to a broader audience, including patients and policymakers”7 in recognition of its statutory role and the significance of its recommendations in the lives and health of millions of Americans.
Unfortunately, despite these recent efforts, confusion about the Task Force remains and its recommendations are all too often disregarded or severely attenuated when payers translate them into covered services. Quite simply, it makes no sense to provide coverage for preventive services only when provided in the primary care setting, particularly when there is no statutory basis for doing so and when it is provided more effectively and less expensively when provided by other clinicians upon referral in another setting. It also makes no sense to cover the costs of screening for diseases and then refuse to provide coverage for any USPSTF-recommended counseling services that will prevent, treat, or manage those diseases.
The Academy’s recommendations herein are intended to assist AHRQ with improving primary care practice by facilitating coordination of effective, evidence-based covered preventive services, such as MNT, between primary care clinicians and other clinicians to whom they refer. AHRQ’s mission can be significantly furthered by ensuring that the mandated covered services emanating from at least four Grade A or B USPSTF recommendations actually provide coverage for both screening and counseling outside the primary care setting—the only location for which the interventions have been shown to be effective. Specifically, the Academy notes that although the USPSTF recommends referring individuals to intensive behavioral interventions for obesity (adults),8 obesity diabetes,10 and cardiovascular disease prevention11 (collectively, the “Four Recommendations”), neither Medicare nor multiple other private insurers cover these services provided upon referral. Given the effectiveness of these interventions and the fact that virtually all prevalent chronic illnesses have a nutrition component, AHRQ can seize the opportunity to close huge gaps in the way our health care system addresses the important role of nutrition in preventing and treating such diseases —particularly in the Medicare program.
Finally, before providing more specific comments below, we want to applaud the AHRQ and the USPSTF for adopting people-first language in the text of recent recommendations (e.g., “a person with obesity” rather than “an obese person”) and supporting evidence documents. People with conditions such as autism, diabetes, or asthma prefer to be considered as people first, and not be defined by their condition. Research shows that people-first language affects attitudes and behavioral intentions toward persons with disabilities.12 Because of this, people-first language has become the standard for most chronic diseases and disabilities and we are pleased that the Task Force has adopted this approach regarding individuals affected by obesity.
B. Encourage Clarity as to Studies’ Settings and Providers
AHRQ’s care coordination efforts are properly focused on a vision of person-centered care provided by an interdisciplinary team of qualified health care professionals specific to the person's needs and coordinated by a primary care provider. The Academy recognizes that the qualifications, skills, education, training, and credentials of the practitioner delivering the service is more important in assuring effectiveness than the service location. In addition, we affirm the critical role of the primary care provider (PCP) in coordinating care by screening and referring patients, while recognizing that the PCP delivers some but not all of the interventions. Better health care systems have PCPs who can rely upon a team that is not bound by physical walls, but rather is connected through coordination, communication, and technology.
The Four Recommendations show that after intensity, the specialized skills or type of practitioner conducting interventions is the second most significant factor in producing statistically significant improvements in dietary change or physiological results in most trials. Primary care providers are limited in their time, training, and skills and are thus disinclined to conduct the medium or high-intensity interventions recommended by the Task Force that are scientifically proved to be the most effective in producing the largest, most lasting results. The Academy encourages AHRQ to utilize its tools and its influence to guide researchers designing studies to plan to include specific details about both providers’ credentials and the setting in which each intervention will be provided. Relatedly, AHRQ or the USPSTF should conduct a secondary analysis to determine, for intensive behavioral therapy at a minimum, (1) the settings in which interventions occur (e.g., primary care provider’s office, obesity medicine clinic, ambulatory care facility, registered dietitian nutritionist’s office, etc.) and (2) if a particular setting leads to better outcomes for intensive behavioral therapy. It is critical that this evidence review provide this information to interested agencies such as the CMS as they are tasked with determining coverage and payment for successful evidence-based obesity interventions.
At present, insurance coverage of the preventive services emanating from the Four Recommendations generally does not include coverage for interventions provided by RDNs or other trained clinicians outside of the primary care setting even when referred by the primary care provider. This is particularly egregious given the fact that the USPSTF concluded, with regard to successful cardiovascular disease prevention for example, that “[i]interventions were delivered by specially trained individuals including dieticians [sic] or nutritionists, physiotherapists or exercise professionals, health educators, psychologists, and other trained professionals.”13 In the two well-researched interventions discussed in depth in the Draft Recommendation, providers (even when classified as “lifestyle coaches”) were specialized experts—either registered dietitian nutritionists or masters-level trained interventionists.14 In addition, the 2014 Evidence Review concluded that “dietary counseling practices of primary care clinicians fall short of recommendations, even for patients at high risk of CVD.”15 The same evidence review concluded that “[g]iven the intensity and expertise needed for these interventions, the counseling interventions evaluated are primarily referable from primary care, as opposed to delivered in primary care” and recognized that it is the “less intensive counseling that may be delivered in the primary care setting,” noting that additional research is needed to ascertain whether interventions conducted in the primary care setting are even effective. 16 The underlying evidence review for the 2003 Recommendation reached the same conclusion that “[a]lmost all of the effective medium- to high-intensity interventions were delivered by specially trained health educators or nurses, counselors or psychologists, dietitians or nutritionists, or exercise instructors or physiologists. Very few of these interventions involved the primary care physician at all.”17 It is critical that AHRQ use all tools at its disposal to ensure that the Task Force’s recommendations are being “understood and used” by enabling specially trained practitioners to deliver the results found in the reviewed studies are actually able to provide the interventions.
Given the statutory importance of and interpretive weight given to the USPSTF’s recommendation itself, the USPSTF should include explicit language for appropriate providers (i.e., use language similar to the 2003 Healthy Diet Recommendation for “referral to other specialists, such as nutritionists or dietitians.”)18 Explicitly denoting the providers demonstrated effective in the relied-upon studies will best facilitate the substance of the USPSTF’s recommendations. The Academy appreciates the USPSTF’s recognition of its statutory ability to drive consequential, effective preventive care in this country, and we urge the USPSTF as it finalizes its recommendations to ensure to the extent possible that its recommended preventive services would be covered in substance and not in name only.
C. Classifying Interventions As Either Formal Protocols or Individually Tailored
Policymakers would also be better able to ensure fidelity to the USPSTF recommendations if they were to classify or differentiate protocol-based interventions from interventions that are individually tailored based upon clinical guidelines and the professional judgment of the health care practitioner providing the service (either in the primary care setting or referred to by the primary care provider). For example, although both would be considered “intensive behavioral counseling,” the Diabetes Prevention Program is a formal protocol differentiated from the more complex, individualized Medical Nutrition Therapy that is a recognized necessary and effective component of care for individuals with multiple chronic conditions (including the conditions related to the Four Recommendations).19
In November 2013 the American Heart Association, American College of Cardiology, and The Obesity Society published two guidelines directly relevant to this question of formal protocols and individually tailored interventions for obesity and cardiovascular disease risk “based on the highest quality evidence available”20 from 1998-2009, although we note the timing of those guidelines likely precluded the USPSTF from considering them when preparing its Draft Recommendation.21 The AHA/ACC/TOS Guidelines frequently differentiate between “trained interventionists” and “nutrition professionals” in evaluating studies and classifying types of behavioral and dietary interventions. Trained interventionists (who are frequently RDNs but also include “psychologists, exercise specialists, health counselors, or professionals in training”)22 provide lifestyle/behavior modification by “adher[ing] to formal protocols” that are an appropriate and effective starting point for most patients with overweight or obesity.
However, the AHA/ACC/TOS Guidelines specify that highly skilled and differently trained “nutrition professionals” are required for more complex Medical Nutrition Therapy interventions: (1) when a specialized diet (for CVD risk reduction, diabetes, other medical condition) is prescribed; (2) when “a high-intensity comprehensive lifestyle intervention program is not available or feasible;” and (3) when the patient is unable to meet weight or targeted health goals through the lifestyle/behavior modification using formal protocols.23 In the studies that formed the evidence base for the AHA/ACC/TOS Guidelines, a “nutrition professional” was usually a registered dietitian nutritionist who “delivered the dietary guidance. . . .”24 When a patient has multiple co-morbidities or risk factors requiring diet and behavior modification, he or she needs the expertise of the RDN to individually tailor nutrition care, as formal protocols may actually conflict. The RDN’s expertise is invaluable in situations with increased complexity of decision-making, nutrition care planning, and coordination of care, and this differentiation in tiers of interventions is critical.
D. Specify Study Characteristics About Frequency and Spacing of Sessions
It would also be helpful if the USPSTF Recommendation Statement included language about the recommended frequency/spacing of the contact hours in the evidence report (i.e., does it matter if the contact hours are all within a month or spread out over a year), or if there is insufficient evidence to make a recommendation on this, to include similar language to other key questions (i.e., "We have found no studies meeting out inclusion criteria…"). Absent clear language regarding these parameters in the recommendation statement itself, many health insurance plans will continue to define what the plan believes to be sufficient level interventions that do not resemble the Task Force’s actual recommendation.
E. Clarification of “Primary Care Relevant”)
One passage in particular from Appendix D of the 2014 Guide to Clinical Preventive Service appears to conflict with other USPSTF statements and recommendations, specifically that the USPSTF’s “recommendations apply to people who have no signs or symptoms of the specific disease or condition to which a recommendation applies and are for services prescribed, ordered, or delivered in the primary care setting.”25 The Academy seeks specific clarification whether “services prescribed, ordered, or delivered in the primary care setting” includes behavioral counseling interventions “available for referral from primary care and delivered in other settings”26 by non-PCP clinicians, which the Draft Recommendation refers to as “primary care-relevant.”
F. Timeframe For Comment
The Academy has noticed and appreciates that “[i]n the last several years, the USPSTF has increased the transparency of its work, and these efforts have gained additional momentum in view of the enhanced importance of the recommendations under the new law, [and that p]ublic comments are welcomed at multiple points in the development of each recommendation to encourage additional input from experts, advocates and other stakeholders to help the Task Force craft relevant and clear recommendation statements.”27 However, we encourage AHRQ and USPSTF to allow longer comment periods of 60 days to facilitate broader engagement with professional associations’ membership and with each other as we seek to work with these agencies to collaboratively improve the process. The current abbreviated timelines are too compressed to ensure the most effective feedback on proposals issued by the agencies.
G. Difference Between Recommendation and Recommendation Statement
Lastly, the Academy seeks clarification whether the terms “Recommendation” and “Recommendation Statement” are wholly interchangeable, or whether one term is a subset of the other term. We appreciate your willingness to assist in this regard.
The Academy appreciates the opportunity to comment on the proposed information collections regarding improving AHRQ’s processes and services. Please contact either Jeanne Blankenship at 312/899-1730 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277 or by email at email@example.com with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1The Academy 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.
2Medical nutrition therapy (MNT) is an evidence‐based application of the Nutrition Care Process. According the Academy's definition, the provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/ re‐assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions. [Academy of Nutrition and Dietetics Definition of Terms List. Accessed March 1, 2016.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans. Further, the Academy's definition of MNT is broader than the definition of MNT in the Social Security Act (42 U.S.C. 1395(vv)(1)).
3U.S. Preventive Services Task Force. Content last reviewed June 2014. Agency for Healthcare Research and Quality, Rockville, MD.
4Current Processes: Refining Evidence-based Recommendation Development. U.S. Preventive Services Task Force. January 2014.
5See, 42 U.S.C. 299-299c-7 as amended by Public Law 106-129 (1999) (“Such a task force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous clinical preventive recommendations.”).
6Guide to Clinical Preventive Services, 2014. Preface. Content last reviewed June 2014. Agency for Healthcare Research and Quality, Rockville, MD.
8USPSTF A and B Recommendations. U.S. Preventive Services Task Force. September 2017.
(“The USPSTF recommends screening all adults for obesity. Clinicians should offer or refer patients with a body mass index of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions.”). (Emphasis added.)
9Id. (“The USPSTF recommends that clinicians screen for obesity in children and adolescents 6 years and older and offer or refer them to comprehensive, intensive behavioral interventions to promote improvements in weight status.”). (Emphasis added.)
10Id. “The USPSTF recommends screening for abnormal blood glucose as part of cardiovascular risk assessment in adults aged 40 to 70 years who are overweight or obese. Clinicians should offer or refer patients with abnormal blood glucose to intensive behavioral counseling interventions to promote a healthful diet and physical activity.” (Emphasis added.)
11Id.(“The USPSTF recommends offering or referring adults who are overweight or obese and have additional cardiovascular disease (CVD) risk factors to intensive behavioral counseling interventions to promote a healthful diet and physical activity for CVD prevention.”). (Emphasis added.)
12Kyle TK, Puhl RM. Putting people first in obesity. Obesity (Silver Spring). 2014;22(5):1211.
13U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Accessed May 29, 2014.
15 USPSTF website. “Behavioral Counseling to Promote a Healthy Lifestyle for Cardiovascular Disease Prevention in Persons With Cardiovascular Risk Factors: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Accessed June 4, 2014 at 4.
17 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force2003, accessed 18 May 2014.
18 “Behavioral Counseling in Primary Care to Promote a Healthy Diet: Recommendations and Rationale,” U.S. Preventive Services Task Force 2003, accessed 18 May 2014.
19 Grade 1 data. Academy Evidence Analysis Library. [Grade Definitions: Strength of the Evidence for a Conclusion/Recommendation Grade I, “Good evidence is defined as: “The evidence consists of results from studies of strong design for answering the questions addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of serious doubts about generalizability, bias and flaws in research design. Studies with negative results have sufficiently large sample sizes to have adequate statistical power.”
20 Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 at 4.
21 28 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013; Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 (“The goals of the American College of Cardiology (ACC) and the American Heart Association (AHA) are to prevent cardiovascular (CV) diseases, improve the management of people who have these diseases through professional education and research, and develop guidelines, standards and policies that promote optimal patient care and CV health.”)
22 The AHA/ACC/TOS Guidelines note that “[i]n a few cases, lay persons were used as trained interventionists; they received instruction in weight management protocols (designed by health professionals) in programs that have been validated in high quality trials published in peer-reviewed journals.” Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013.
23 Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013 at 20, 22.
26U.S. Preventive Services Task Force website. Draft Recommendation Statement: Behavioral Counseling to Promote a Healthy Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Known Risk Factors. Accessed May 29, 2014.
27Guide to Clinical Preventive Services, 2014. Preface. Content last reviewed June 2014. Agency for Healthcare Research and Quality, Rockville, MD.