Criteria for Determining Maternity Care Health Professional Target Areas, 53324-53329 [2021-20855]

Download as PDF 53324 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 changed by the CARES Act.7 We are aware that there have been scientific developments in the time since the proposed rule was issued including, among other things, the publication of two new studies on the absorption of sunscreen active ingredients,8 both of which reinforced the need for the sunscreen ingredient data requested in our proposed rule (and in the proposed order). The comment period on this proposed order affords an opportunity for the public to submit information that has become available since the closure of the comment period on the 2019 Proposed Rule. This includes information that has become available regarding the eight sunscreen active ingredients, identified above, that were the subject of timely requests for deferral in order to conduct studies to generate data first identified as lacking in the 2019 Proposed Rule. We note that if at any time the available evidence becomes sufficient to resolve the uncertainty as to the GRASE status of a sunscreen containing any of these ingredients, FDA intends to proceed to a revised final order reflecting our conclusion as to its status. However, if at the close of the comment period on this proposed order, the available data do not resolve the outstanding questions about each of these ingredients, but the Agency has received satisfactory indication of timely and diligent progress on the necessary studies for a specific ingredient, FDA would be prepared to initially defer issuance of a revised final order on the GRASE status of sunscreens containing that particular active ingredient. Such a deferral would be for a period of not more than 1 year, with a possibility of extension depending on further satisfactory progress with the studies. However, if, in FDA’s judgment, studies for any active ingredient do not appear to be proceeding in a timely manner or otherwise do not appear to be productive, the Agency expects that it will proceed to a revised final order on sunscreens containing such particular ingredient after this initial deferral. As noted above, the Agency also received a significant number of comments to the public docket during the previous public comment period on the proposals described in the 2019 Proposed Rule, which we continue to 7 See section 505G(k)(1) of the FD&C Act and 21 CFR 330.10(a)(4). 8 See ‘‘FDA in Brief: FDA Announces Results From Second Sunscreen Absorption Study,’’ available at https://www.fda.gov/news-events/fdabrief/fda-brief-fda-announces-results-secondsunscreen-absorption-study, describing Matta, et al. (2020) (Ref. 1), as well as a prior pilot study (Matta, et al. 2019) (Ref. 2). VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 review. FDA will consider all comments that were submitted to the public docket for the 2019 Proposed Rule within its comment period to be constructively submitted as comments on the proposed order being issued today. To enable the Agency to review and address these comments (and future comments that may be submitted on this proposed order) as expeditiously as possible, we request that commenters do not resubmit comments on this proposed order previously submitted on the proposed rule. FDA believes that this approach will allow us to efficiently consider public input as the Agency assesses the appropriate regulatory requirements for nonprescription sunscreens marketed without approved new drug applications. We emphasize in the proposed order, and here, that the proposed order does not represent a conclusion by FDA that the sunscreen active ingredients included in the 1999 Final Monograph, but proposed in the order as needing additional data, are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and exposure and evolving information about the potential risks associated with these products since originally evaluated. As in the 2019 Proposed Rule, this proposed order also advances proposals addressing the other conditions of use for sunscreen drug products marketed without an approved application, including broad spectrum protection, maximum SPF requirements, dosage forms, labeling, final formulation testing and recordkeeping, sunscreen-insect repellent combinations, and more. II. Paperwork Reduction Act of 1995 This proposed order is issued under section 505G(b) of the FD&C Act. Chapter 35 of title 44, United States Code does not apply to collections of information made under section 505G of the FD&C Act (see section 505G(o) of the FD&C Act). III. Electronic Access Persons may obtain the proposed order at the OTC Monographs@portal at https://www.accessdata.fda.gov/scripts/ cder/omuf/index.cfm or at https:// www.regulations.gov. IV. References The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 through Friday; these are not available electronically at https:// www.regulations.gov as these references are copyright protected. Some may be available at the website address, if listed. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Matta, M.K., J. Florian, R. Zusterzeel et al., ‘‘Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial,’’ Journal of the American Medical Association, vol. 323(3), pp. 256–267, 2020 (available at https:// jamanetwork.com/journals/jama/full article/2759002), accessed August 12, 2021. 2. Matta, M.K., R. Zusterzeel, R.P. Nageswara Matta et al., ‘‘Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial,’’ Journal of the American Medical Association, vol. 321(21), pp. 2082–2091, 2019 (available at https://jamanetwork.com/journals/ jama/fullarticle/2733085), accessed August 12, 2021. Dated: September 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–20780 Filed 9–24–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Criteria for Determining Maternity Care Health Professional Target Areas Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for public comment. AGENCY: In accordance with the requirements of the Public Health Service Act, HRSA, authorized by the Secretary of HHS, shall establish the criteria which will be used to determine maternity care health professional target areas (MCTAs) in existing primary care Health Professional Shortage Areas (HPSAs). This notice sets forth the proposed criteria which will be used to identify and score MCTAs. DATES: Submit written comments no later than November 26, 2021. ADDRESSES: Written comments should be submitted to SDMP@hrsa.gov. FOR FURTHER INFORMATION CONTACT: Dr. Janelle McCutchen, Chief, Shortage Designation Branch, Division of Policy SUMMARY: E:\FR\FM\27SEN1.SGM 27SEN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices and Shortage Designation, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857, (301) 443–9156. SUPPLEMENTARY INFORMATION: Section 332 of the Public Health Service Act, 42 U.S.C. 254e, provides that HRSA shall designate HPSAs based on criteria established by regulation. HPSAs are defined in section 332 to include (1) urban and rural geographic areas which HRSA determines have shortages of health professionals, (2) population groups with such shortages, and (3) public or private medical facilities or other public facilities with such shortages. The required regulations setting forth the criteria for designating HPSAs are codified at 42 CFR part 5. Section 332(k)(1) provides that HRSA shall identify shortages of maternity care services ‘‘within health professional shortage areas.’’ Section 332(k)(1) further requires HRSA to identify MCTAs and distribute maternity care health professionals within HPSAs using the MCTAs so identified. HRSA must also collect and publish data in the Federal Register comparing the availability and need of maternity care health services in HPSAs and must seek input from relevant provider organizations and other stakeholders. HRSA sought input regarding MCTA scoring from relevant stakeholders via a Request for Information issued in May 2020. HRSA received 24 comments from a variety of stakeholders, including State Primary Care Offices, Indian tribes, Federally Qualified Health Centers, and women’s health and public health advocacy groups. The comments addressed a wide range of maternity care concerns, including social determinants of health that impact maternal health outcomes, women’s access to prenatal care, prevalence of chronic disease, maternity care health professional provider types to be included in MCTAs, and the maternity care needs of women in rural areas and among tribes and Alaska natives. Several commenters also provided suggestions on data sources that HRSA could use to calculate MCTA scores. HRSA has carefully reviewed and considered all of the feedback provided. HRSA proposes the following MCTA scoring criteria, which will be used to distribute certain currently eligible National Health Service Corps (NHSC) clinicians who provide maternity care services. This includes obstetrician gynecologists (OB/GYNs) and certified nurse midwives (CNMs). The statute does not expand discipline eligibility for participation in the NHSC to health VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 professionals who are not already eligible for the NHSC. See section 332(k)(1). Approach for Determining Maternity Care Health Professional Target Areas of Greatest Shortage A MCTA score will be generated for each primary care HPSA using the HPSA’s service area. The following six scoring criteria will be included in a composite scale that will be used to identify MCTAs with the greatest shortage of maternity care health professionals: (1) Ratio of females ages 15–44-to-full time equivalent maternity care health professional ratio; (2) percentage of females 15–44 with income at or below 200 percent of the federal poverty level (FPL); (3) travel time and distance to the nearest provider location with access to comprehensive maternity care services; (4) fertility rate; (5) the Social Vulnerability Index; and (6) four maternal health indicators (prepregnancy obesity, pre-pregnancy diabetes, pre-pregnancy hypertension, and prenatal care initiation in the first trimester). Each of these six criteria will be assigned a relative weight based on the significance of that criteria relative to all the others. The weighted scores will be summed to develop a composite MCTA score ranging from zero to 25, with 25 indicating the greatest need for maternity care health professionals in the MCTA. Accordingly, the higher the composite score, the higher the degree of need for maternity care health services. Score for Population-to-Full-TimeEquivalent Maternity Care Health Professional Ratio HRSA is seeking public comment on the proposed approach to measuring the ratio of females ages 15–44-to-full time equivalent (FTE) maternity care health professional, as HRSA received overwhelmingly positive stakeholder feedback indicating that HRSA should consider the population-to-provider ratio as a component of the MCTA score. Accordingly, population-toprovider ratio will measure the number of women of childbearing age in the service area compared to the number of maternity care health professionals in the service area. The population-toprovider ratio continues to be a cornerstone in measuring the availability of primary care resources within a particular area. Based on the available literature and recommendations received, for purposes of MCTA scoring, women of childbearing age will be defined as PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 53325 women between the ages of 15–44 years old and maternity care professionals will be defined as Obstetrician/ Gynecologists and Certified Nurse Midwives (CNMs).1 A population-toprovider ratio of 1,500:1 will be used as a minimum requirement for a population to be considered reasonably served by Obstetrician/Gynecologists and CNMs.2 Based on comments received, research, and consultation with stakeholders, HRSA did not include General Surgeons, Anesthesiologists, Pediatricians, Doulas, and Lactation Specialists into the provider portion of the population-to-provider ratio for MCTA scoring, as these providers do not typically provide full-scope comprehensive maternity care. Additionally, HRSA considered including Family Medicine Physicians, Physician Assistants, Advance Practice Registered Nurses, and Registered Nurses who provide Women’s Health services or obstetric care into the provider portion of the population-toprovider ratio for MCTA scoring. With respect to Family Medicine Physicians, research shows that family medicine practitioners offering maternity care services has been in decline in recent years, and data demonstrating how much time these providers spend providing maternity care services is not readily available. Rayburn, Petterson, and Phillips conducted an observational study from 2003 to 2010 in which they examined the proportion of Family Physicians who perform deliveries.3 The proportion of Family Physicians performing deliveries declined by 40.6 percent, from 17.0 percent in 2003 to 10.1 percent in 2009, with deliveries being more common in nonmetropolitan areas. The researchers concluded that the proportion of Family Physicians performing deliveries continues to decline with most delivering Family Physicians performing 25 or fewer deliveries per year. In another study, Makaroff, et al., evaluated factors that are contributing to the decline of Family 1 Johantgen, M. et al. ‘‘Comparison of Labor and Delivery Care Provided by Certified NurseMidwives and Physicians: A Systematic Review, 1990 to 2008.’’ Women’s Health Issues, vol. 22, no. 1 (2012): e73–e81, doi: 10.1016/j.whi.2011.06.005. 2 Rayburn, W.F. et al. ‘‘Distribution of American Congress of Obstetricians and Gynecologists Fellows and Junior Fellows in Practice in the United States.’’ Obstet Gynecol, vol. 119, no. 5 (2012): 1017, doi: 10.1097/AOG.0b013e31824cfe50. 3 Rayburn, William F., Stephen M. Petterson, and Robert L. Phillips. ‘‘Trends in Family Physicians Performing Deliveries, 2003–2010.’’ Birth (Berkeley, Calif.) 41.1 (2014): 26–32. E:\FR\FM\27SEN1.SGM 27SEN1 53326 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices Physicians providing maternity care.4 Makaroff, et al. evaluated American Board of Family Medicine survey data collected from every family physician during application for the Maintenance of Certification Examination to determine the percentage of family physicians that provided maternity care from 2000 to 2010. This research team’s findings are in line with the results of the research conducted by Rayburn, Petterson, and Phillips in that they also found that maternity care provision by family physicians declined from 23.3 percent in 2000 to 9.7 percent in 2010 (p <0.0001). Furthermore, in 2018, a study from Goldstein, et al. shows that the percentage of family practitioners offering low and high volume maternity care services continues to decline in both the United States and Canada and is now at less than 5 and 1 percent, respectively. These findings are based on data from the American Board of Family Medicine Examination questionnaires. The data specifically showed that the number of family practitioners who offered high volume obstetric services has declined by 50 percent since 2009.5 Thus, while family physicians continue to play an important role in providing maternity care in many parts of the United States, there is a documented decline in the percentage of family physicians providing maternity care. HRSA recognizes the important contribution all of these professionals play in the delivery of obstetric care. However, as there is also not currently detailed nationwide data readily available outlining the number of hours individual providers provide these services, HRSA did not have an analytical basis for how to include them consistently. HRSA will continue to review the availability of these data points to determine if additional provider types (particularly Family Medicine Physicians, but also including General Surgeons, Anesthesiologists, Pediatricians, Doulas, Lactation Specialists, Physician Assistants, Advance Practice Registered Nurses, and Registered Nurses who provide Women’s Health services) may be incorporated into the MCTA scoring criteria in the future. HRSA is especially interested in recommendations for how to determine the amount of time Family Medicine Physicians spend providing maternity care services, as they may be the only providers of maternity services in areas with no OB/GYNs or CNMs. HRSA welcomes comments on how to incorporate these providers into future iterations of MCTA scoring, and any detailed nationwide data that may be available to do so. HRSA is seeking feedback on the assigned point values in the distribution, which are proposed to be as follows: Population-to-provider ratio Points Ratio ≥6,000:1, or No CNMs or OB–GYNs and Population (Pop) ≥500 ............................................................................................ 6,000:1 >Ratio ≥5,000:1, or No CNMs or OB–GYNs and Pop ≥400 ................................................................................................. 5,000:1 >Ratio ≥3,000:1, or No CNMs or OB–GYNs and Pop ≥300 ................................................................................................. 3,000:1 >Ratio ≥2,000:1, or No CNMs or OB–GYNs and Pop ≥200 ................................................................................................. 2,000:1 >Ratio ≥1,500:1, or No CNMs or OB–GYNs and Pop ≥100 ................................................................................................. Ratio <1,500:1, or No CNMs or OB–GYNs and Pop <100 ................................................................................................................ Score for Percentage of Population With Income at or Below 200 Percent of the Federal Poverty Level HRSA proposes to incorporate poverty data from the U.S. Census Bureau into the MCTA composite score, as the majority of commenters highlighted the disparities that women living in poverty face in accessing necessary maternity health services. The percentage of people living in the service area at or below 200 percent of the FPL will be used to score MCTAs, based on recommendations from commenters and poverty data from the U.S. Census Bureau. Maternal health literature demonstrates a high correlation between low income, low health status, and poor maternal health outcomes.6 HRSA is seeking feedback on the assigned point values in the distribution, which are proposed as follows: Population with income at or below 200% FPL ratio Percentage of population with income at or below 55% >Percentage of population with income at or 50% >Percentage of population with income at or 45% >Percentage of population with income at or 40% >Percentage of population with income at or 35% >Percentage of population with income at or Percentage of population with income at or below lotter on DSK11XQN23PROD with NOTICES1 Score for Travel Distance/Time to Nearest Source of Accessible Care Outside of the MCTA Several of the commenters highlighted the barriers in travel time and transportation that many women face in accessing maternity care 4 Makaroff, Laura A. et al. ‘‘Factors Influencing Family Physicians’ Contribution to the Child Health Care Workforce.’’ Annals of family medicine 12.5 (2014): 427–431. VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 200% below below below below below 200% FPL ≥55% 200% FPL 200% FPL 200% FPL 200% FPL 200% FPL FPL <30% 5 4 3 2 1 0 Points ................................................................................................ ≥50% ...................................................................................... ≥45% ...................................................................................... ≥40% ...................................................................................... ≥35% ...................................................................................... ≥30% ...................................................................................... ................................................................................................ 6 5 4 3 2 1 0 services, particularly in rural and underserved areas. In keeping with this feedback, HRSA will incorporate the travel time and distance to the Nearest Source of Care into the MCTA composite score. The Nearest Source of Care is defined as the closest provider location where the residents of the area or designated population have access to comprehensive maternity care services. Scientific literature presented by the American Academy of Pediatrics Committee on Fetus and Newborn and the American College of Obstetricians 5 Goldstein, Jessica, et al., ‘‘Supporting Family Physician Maternity Care Providers’’ Family Medicine 50:9 (2018). 6 Aftab., et al. ‘‘Effects of Poverty on Pregnant Women.’’ Department of Gynae and Obstetrics, Dow University of Health Sciences, Lyari General Hospital, Karachi, vol. 51, no.1 (2012). March of Dimes, ‘‘Nowhere to Go: Maternity Care Deserts Across the US,’’ (2018), available at https:// www.marchofdimes.org/materials/Nowhere_to_Go_ Final.pdf. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices and Gynecologists Committee on Obstetric Practice established that an individual’s proximity to care can affect health outcomes.7 Specifically for maternity care, the literature indicates that decision-to-incision time for emergency cesarean delivery is 30 minutes.8 53327 HRSA is seeking public comment on the assigned point values in the distribution, which are proposed as follows: Travel time and distance Points Time ≥105 min, or Distance ≥105 miles ............................................................................................................................................. 105 min >Time ≥90 min or 105 miles > Distance ≥90 miles .............................................................................................................. 90 min >Time ≥75 min, or 90 miles > Distance ≥75 miles ................................................................................................................. 75 min >Time ≥60 min, or 75 miles > Distance ≥60 miles ................................................................................................................. 60 min >Time ≥45 min, or 60 miles > Distance ≥45 miles ................................................................................................................. 45 min >Time ≥30 min, or 45 miles > Distance ≥30 miles ................................................................................................................. Time <30 min, and Distance <30 miles .............................................................................................................................................. Score for Fertility Rate HRSA proposes to include fertility rate as a criteria for the MCTA score to reflect the increased need for maternity care services among populations which experience a higher rate of births. Women of childbearing age will be derived from the American Community Survey and births will be derived from the National Vital Statistics System. 6 5 4 3 2 1 0 HRSA is seeking public comment on the assigned point values in the distribution, which are proposed as follows: Fertility rate Points Fertility Rate ≥90th Percentile ............................................................................................................................................................. 90th Percentile >Fertility Rate ≥50th Percentile .................................................................................................................................. Fertility Rate <50th Percentile ............................................................................................................................................................. Score for Social Vulnerability Index Several MCTA commenters highlighted associations between adverse maternal health outcomes and non-clinical factors such as poverty, unemployment, lack of adequate housing and transportation, minority status, and English language proficiency. The Agency for Toxic Substances and Disease Registry’s Geospatial Research, Analysis and Services Program within the Centers for Disease Control and Prevention (CDC) created databases to help emergency response planners and public health officials identify and map communities that will most likely need support before, during, and after a hazardous event. Per the CDC, Social Vulnerability refers to the resilience of communities when confronted by external hazards such as natural or human-caused disasters, or disease outbreaks. One such database is the Social Vulnerability Index (SVI), which uses U.S. Census data to determine the social vulnerability of every census tract based on the following four themes: Socioeconomic status, household composition and disability, minority status and language, and housing type and transportation. Each tract receives a separate percentile ranking which is represented by a number between zero and one for each of the four themes, as well as an overall ranking. These themes take into account various factors ranging from educational attainment and unemployment to multi-unit structures and single parent households. Public health literature supports the correlation between low English proficiency and late initiation of prenatal care as well as adverse perinatal outcomes due to lack of communication between the provider and patient.9 10 Currently, literature is not available that evaluates the use of the entire SVI to specifically quantify maternal health outcomes. However, 2 1 0 many of the individual factors within the SVI are known social determinants of health. Social determinants of health are the conditions in the environment in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. These social determinants of health as represented within the SVI, are critical in understanding external factors that affect the need for maternity care services. A score for overall social vulnerability will be incorporated into the MCTA composite score to reflect the increased need for maternity care services among populations which experience a higher rate of social vulnerability using the CDC’s SVI. HRSA is seeking public comment on the assigned point values in the distribution, which are proposed as follows: Social Vulnerability Index Points lotter on DSK11XQN23PROD with NOTICES1 Social Vulnerability ≥75th Percentile ................................................................................................................................................... 75th Percentile > Social Vulnerability ≥50th Percentile ...................................................................................................................... Social Vulnerability <50th Percentile ................................................................................................................................................... 7 Kilpatrick, Sarah J., et al. Guidelines for Perinatal Care. 8th ed., American Academy of Pediatrics, 2017. 8 Roa, Lina et al., ‘‘Travel Time to Access Obstetric and Neonatal Care in the United States.’’ Obstetrics and Gynecology (New York. 1953) vol. 136, no. 3 (2020): 610–612. VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 9 Pope, Charlene. ‘‘Addressing Limited English Proficiency and Disparities for Hispanic Postpartum Women.’’ Journal of Obstetric, Gynecologic & Neonatal Nursing, vol. 34, no. 4, 2005, pp. 512–20. Crossref, doi:10.1177/0884217505278295. 10 Vinson, Abigail, et al. ‘‘131: Maternal Language, Severe Maternal Morbidity and Access to Prenatal PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Care.’’ American Journal of Obstetrics and Gynecology, vol. 222, no. 1, 2020, pp. S99–100. Crossref, doi:10.1016/j.ajog.2019.11.147. E:\FR\FM\27SEN1.SGM 27SEN1 2 1 0 53328 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices Score for Maternal Health Indicators Many of the comments HRSA received raised concerns about social determinants of health that have an impact on women’s health outcomes, not only during and after pregnancy, but also before and in between pregnancies. In order to address these concerns, HRSA is seeking public comment on the use of maternal health indicators as scoring criteria for MCTAs. MCTA scores will consider health indicators that are associated with poor maternal health outcomes by looking at various data points related to pre-pregnancy health status and when prenatal care began. Scores will consider prepregnancy obesity, diabetes, and hypertension, as well as whether prenatal care began in the first trimester, as these are all conditions which may require additional workforce capacity to adequately address community needs. Only women of childbearing age will be considered for these indicators. HRSA will use the National Vital Statistics System as the data source to determine the sub-score for each of these four (4) maternal health indicators. Public health literature demonstrates that higher rates of obesity, diabetes, or hypertension, and later onset of prenatal care are all associated with poorer maternal health outcomes and will help identify the need for additional health professionals. A 2018 Centers for Disease Control and Prevention report on preconception health surveillance identified priority indicators for adverse maternal health outcomes.11 The study reviewed 50 preconception health indicators and prioritized those indicators that are most suitable for surveillance purposes. Weight, diabetes, and hypertension were all among the top 10 preconception health indicators recommended for surveillance.12 HRSA also considered incorporating maternal mortality data into the MCTA score. However, due to data suppression for privacy reasons, this data is not readily available publicly or to HRSA below the state level. As both HPSAs and MCTAs are designed to be able to provide meaningful differentiation of need between communities at a local level, HRSA decided not to incorporate maternal mortality data at this time. If this data eventually becomes available to HRSA at the county level or below, HRSA may include it in future MCTA score calculation. HRSA is seeking public comment on the proposed criteria and point scale distributions below. Service areas may receive one point each for meeting the criteria. • Pre-Pregnancy Obesity Pre-pregnancy obesity is defined as having a Body Mass Index of 30 or higher. One point will be awarded if the prevalence of pre-pregnancy obesity in the area is greater than or equal to the 75th percentile among all counties in the United States. If the prevalence of pre-pregnancy obesity in the area is less than the 75th percentile among all counties, zero points will be awarded. Pre-pregnancy obesity Points Prevalence of pre-pregnancy obesity ≥75th percentile ....................................................................................................................... Prevalence of pre-pregnancy obesity <75th percentile ....................................................................................................................... • Pre-Pregnancy Diabetes One point will be awarded if the prevalence of pre-pregnancy diabetes in the area is greater than or equal to the 75th percentile among all counties in the United States. If the prevalence of 1 0 pre-pregnancy diabetes in the area is less than the 75th percentile among all counties, zero points will be awarded. Pre-pregnancy diabetes Points Prevalence of pre-pregnancy diabetes ≥75th percentile ..................................................................................................................... Prevalence of pre-pregnancy diabetes <75th percentile .................................................................................................................... • Pre-Pregnancy Hypertension hypertension among women in the area is greater than or equal to the 75th percentile among all counties in the nation. If the prevalence of pre- One point will be awarded if the prevalence of pre-pregnancy 1 0 pregnancy hypertension among women in the area is less than the 75th percentile among all counties, zero points will be awarded. Pre-pregnancy hypertension Points Prevalence of pre-pregnancy hypertension ≥75th percentile .............................................................................................................. Prevalence of pre-pregnancy hypertension <75th percentile ............................................................................................................. • Prenatal Care Initiation in the 1st Trimester initiate prenatal care in the first trimester of their pregnancy is greater than or equal to the 75th percentile among all counties in the nation. Zero points will be awarded if the prevalence One point will be awarded if the prevalence of women who did not of women who did not initiate prenatal care in the first trimester of their pregnancy is less than the 75th percentile among all counties. lotter on DSK11XQN23PROD with NOTICES1 Prenatal care in first trimester Points Prevalence of No Prenatal Care in First Trimester ≥75th percentile .................................................................................................. Prevalence of No Prenatal Care in First Trimester <75th percentile .................................................................................................. 11 Robbins, Cheryl L., et al. ‘‘Preconception Health Indicators for Public Health Surveillance.’’ VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 Journal of Women’s Health, vol. 27, no. 4 (2018): 430–43. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 1 0 12 Ibid. E:\FR\FM\27SEN1.SGM 27SEN1 1 0 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices Diana Espinosa, Acting Administrator. SUPPLEMENTARY INFORMATION: Invitation to comment: HRSA invites comments regarding this notice. To ensure that your comments are clearly stated, please identify the section of this notice that your comments address. [FR Doc. 2021–20855 Filed 9–24–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES described in [statute] related to the purposes of the program.’’ 5 Home visiting programs could not achieve the standards described in the program’s authorizing statute without the support of home visiting models. HRSA, in collaboration with ACF, has developed a proposed transparent and standardized process for assessing home visiting service delivery model(s) against statutory requirements to determine model eligibility for implementation through the MIECHV Program. Through this notice, HRSA seeks to provide public notice of the proposed process and gather public comment, including from stakeholders. Since the establishment of this process may affect critical decision-making, and to better understand the implications of these changes for various stakeholders, HRSA seeks public comment on the proposed process for assessing home visiting models against the MIECHV statutory requirements. HRSA will consider these comments in finalizing this process. HRSA, in partnership with the Administration for Children and Families (ACF) within HHS, oversees the MIECHV Program, which supports voluntary, evidence-based home visiting services during pregnancy and to families with young children up to kindergarten entry. HRSA proposes to standardize a process for also assessing Home Visiting Evidence of Effectiveness (HomVEE)-approved home visiting models against the MIECHV statutory requirements for a model to determine which of the HomVEE-approved models can be used to implement the MIECHV Program. DATES: Comments on this request for public comment should be received no later than November 26, 2021. ADDRESSES: Submit your comments to homevisiting@hrsa.gov with ‘‘MIECHV Model Eligibility’’ in the subject line. 1.0 Background The MIECHV Program provides voluntary, evidence-based home visiting services to pregnant people and families with young children up to kindergarten entry living in at-risk communities.1 States, jurisdictions, certain non-profit organizations, and Tribal entities are eligible to receive funding from the MIECHV Program to implement service delivery model(s) that meet statutory requirements, including HHS criteria for evidence of effectiveness.2 3 The MIECHV authorizing statute specifies that a model selected by an eligible entity must include certain key components, including that it ‘‘conform to a clear consistent home visitation model that has been in existence for at least 3 years and is research-based, grounded in relevant empirically-based knowledge, linked to program determined outcomes, associated with a national organization or institution of higher education that has comprehensive home visitation program standards that ensure high-quality service delivery and continuous program quality improvement.’’ 4 In addition, the MIECHV-funded program must adhere to statutory standards applicable to model use, including adherence ‘‘to a clear, consistent model that satisfies the requirements of being grounded in empirically-based knowledge related to home visiting and linked to the benchmark areas specified in [statute] and the participant outcomes Requirement Standard used REQUIREMENT (1): Model is appropriate for voluntary service provision. REQUIREMENT (2): The model conforms to a clear consistent home visitation model. REQUIREMENT (3): The model . . . has been in existence for at least 3 years. There is evidence of model effectiveness in a voluntary setting. The model conforms to HomVEE’s definition of an early childhood home visiting model. The model is currently active and was first developed at least 3 years ago;. OR The model is inactive and was first developed at least 3 years before a model developer stopped providing implementation support; OR The model was implemented as a demonstration project that lasted at least 3 years. Social Security Act, Title V, § 511(e)(7)(A). target families with pregnant people and children from birth to kindergarten. Information about the HomVEE review is at https://homvee.acf.hhs.gov/. 3 By law, state and jurisdictional awardees must spend the majority of their MIECHV Program grants to implement evidence-based home visiting models, with up to 25 percent of funding available to implement a model that conforms to a promising and new approach to achieving the benchmark areas specified in Social Security Act, Title V, § 511 (d)(1)(A) and the participant outcomes described in Social Security Act, Title V, § 511 (d)(2)(B), has been developed or identified by a national organization or institution of higher education, and will be evaluated through well-designed and rigorous process. 4 Social Security Act, Title V, § 511(d)(3)(A)(i) 5 Social Security Act, Title V, § 511(d)(3)(B) Health Resources and Services Administration Statutory Requirements and Process Standardization: Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Model Eligibility Review Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for public comment. AGENCY: SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 53329 1 The MIECHV Program is authorized by Social Security Act, Title V, § 511; Section 50601 of the Bipartisan Budget Act of 2018 (Pub. L. 115–123) (BBA) extended appropriated funding for the MIECHV Program through FY 2022. 2 In current practice, HHS uses the HomVEE review to conduct a thorough and transparent review of the home visiting research literature and provide an assessment of the evidence of effectiveness for home visiting program models that VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 2.0 Process for Assessing Eligibility Against Statutory Requirements for a Home Visiting Model This notice presents statutory requirements for a MIECHV service delivery model and the proposed process to assess home visiting models against each MIECHV statutory requirement. Then, the notice will present the proposed process, with timeline, for collecting information to assess whether the model(s) meet these requirements and therefore can be used to implement the MIECHV Program. 2.1 Model Eligibility Requirements Statutory citation of requirement Social Security Act, Title V, § 511(d)(3)(A)(i)(I). Social Security Act, Title V, § 511(d)(3)(A)(i)(I). E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53324-53329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Criteria for Determining Maternity Care Health Professional 
Target Areas

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Request for public comment.

-----------------------------------------------------------------------

SUMMARY: In accordance with the requirements of the Public Health 
Service Act, HRSA, authorized by the Secretary of HHS, shall establish 
the criteria which will be used to determine maternity care health 
professional target areas (MCTAs) in existing primary care Health 
Professional Shortage Areas (HPSAs). This notice sets forth the 
proposed criteria which will be used to identify and score MCTAs.

DATES: Submit written comments no later than November 26, 2021.

ADDRESSES: Written comments should be submitted to [email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Janelle McCutchen, Chief, Shortage 
Designation Branch, Division of Policy

[[Page 53325]]

and Shortage Designation, Bureau of Health Workforce, HRSA, 5600 
Fishers Lane, Rockville, Maryland 20857, (301) 443-9156.

SUPPLEMENTARY INFORMATION: Section 332 of the Public Health Service 
Act, 42 U.S.C. 254e, provides that HRSA shall designate HPSAs based on 
criteria established by regulation. HPSAs are defined in section 332 to 
include (1) urban and rural geographic areas which HRSA determines have 
shortages of health professionals, (2) population groups with such 
shortages, and (3) public or private medical facilities or other public 
facilities with such shortages. The required regulations setting forth 
the criteria for designating HPSAs are codified at 42 CFR part 5.
    Section 332(k)(1) provides that HRSA shall identify shortages of 
maternity care services ``within health professional shortage areas.'' 
Section 332(k)(1) further requires HRSA to identify MCTAs and 
distribute maternity care health professionals within HPSAs using the 
MCTAs so identified. HRSA must also collect and publish data in the 
Federal Register comparing the availability and need of maternity care 
health services in HPSAs and must seek input from relevant provider 
organizations and other stakeholders.
    HRSA sought input regarding MCTA scoring from relevant stakeholders 
via a Request for Information issued in May 2020. HRSA received 24 
comments from a variety of stakeholders, including State Primary Care 
Offices, Indian tribes, Federally Qualified Health Centers, and women's 
health and public health advocacy groups. The comments addressed a wide 
range of maternity care concerns, including social determinants of 
health that impact maternal health outcomes, women's access to prenatal 
care, prevalence of chronic disease, maternity care health professional 
provider types to be included in MCTAs, and the maternity care needs of 
women in rural areas and among tribes and Alaska natives. Several 
commenters also provided suggestions on data sources that HRSA could 
use to calculate MCTA scores.
    HRSA has carefully reviewed and considered all of the feedback 
provided. HRSA proposes the following MCTA scoring criteria, which will 
be used to distribute certain currently eligible National Health 
Service Corps (NHSC) clinicians who provide maternity care services. 
This includes obstetrician gynecologists (OB/GYNs) and certified nurse 
midwives (CNMs). The statute does not expand discipline eligibility for 
participation in the NHSC to health professionals who are not already 
eligible for the NHSC. See section 332(k)(1).

Approach for Determining Maternity Care Health Professional Target 
Areas of Greatest Shortage

    A MCTA score will be generated for each primary care HPSA using the 
HPSA's service area. The following six scoring criteria will be 
included in a composite scale that will be used to identify MCTAs with 
the greatest shortage of maternity care health professionals: (1) Ratio 
of females ages 15-44-to-full time equivalent maternity care health 
professional ratio; (2) percentage of females 15-44 with income at or 
below 200 percent of the federal poverty level (FPL); (3) travel time 
and distance to the nearest provider location with access to 
comprehensive maternity care services; (4) fertility rate; (5) the 
Social Vulnerability Index; and (6) four maternal health indicators 
(pre-pregnancy obesity, pre-pregnancy diabetes, pre-pregnancy 
hypertension, and prenatal care initiation in the first trimester). 
Each of these six criteria will be assigned a relative weight based on 
the significance of that criteria relative to all the others.
    The weighted scores will be summed to develop a composite MCTA 
score ranging from zero to 25, with 25 indicating the greatest need for 
maternity care health professionals in the MCTA. Accordingly, the 
higher the composite score, the higher the degree of need for maternity 
care health services.

Score for Population-to-Full-Time-Equivalent Maternity Care Health 
Professional Ratio

    HRSA is seeking public comment on the proposed approach to 
measuring the ratio of females ages 15-44-to-full time equivalent (FTE) 
maternity care health professional, as HRSA received overwhelmingly 
positive stakeholder feedback indicating that HRSA should consider the 
population-to-provider ratio as a component of the MCTA score. 
Accordingly, population-to-provider ratio will measure the number of 
women of childbearing age in the service area compared to the number of 
maternity care health professionals in the service area. The 
population-to-provider ratio continues to be a cornerstone in measuring 
the availability of primary care resources within a particular area. 
Based on the available literature and recommendations received, for 
purposes of MCTA scoring, women of childbearing age will be defined as 
women between the ages of 15-44 years old and maternity care 
professionals will be defined as Obstetrician/Gynecologists and 
Certified Nurse Midwives (CNMs).\1\ A population-to-provider ratio of 
1,500:1 will be used as a minimum requirement for a population to be 
considered reasonably served by Obstetrician/Gynecologists and CNMs.\2\
---------------------------------------------------------------------------

    \1\ Johantgen, M. et al. ``Comparison of Labor and Delivery Care 
Provided by Certified Nurse-Midwives and Physicians: A Systematic 
Review, 1990 to 2008.'' Women's Health Issues, vol. 22, no. 1 
(2012): e73-e81, doi: 10.1016/j.whi.2011.06.005.
    \2\ Rayburn, W.F. et al. ``Distribution of American Congress of 
Obstetricians and Gynecologists Fellows and Junior Fellows in 
Practice in the United States.'' Obstet Gynecol, vol. 119, no. 5 
(2012): 1017, doi: 10.1097/AOG.0b013e31824cfe50.
---------------------------------------------------------------------------

    Based on comments received, research, and consultation with 
stakeholders, HRSA did not include General Surgeons, Anesthesiologists, 
Pediatricians, Doulas, and Lactation Specialists into the provider 
portion of the population-to-provider ratio for MCTA scoring, as these 
providers do not typically provide full-scope comprehensive maternity 
care. Additionally, HRSA considered including Family Medicine 
Physicians, Physician Assistants, Advance Practice Registered Nurses, 
and Registered Nurses who provide Women's Health services or obstetric 
care into the provider portion of the population-to-provider ratio for 
MCTA scoring. With respect to Family Medicine Physicians, research 
shows that family medicine practitioners offering maternity care 
services has been in decline in recent years, and data demonstrating 
how much time these providers spend providing maternity care services 
is not readily available.
    Rayburn, Petterson, and Phillips conducted an observational study 
from 2003 to 2010 in which they examined the proportion of Family 
Physicians who perform deliveries.\3\ The proportion of Family 
Physicians performing deliveries declined by 40.6 percent, from 17.0 
percent in 2003 to 10.1 percent in 2009, with deliveries being more 
common in nonmetropolitan areas. The researchers concluded that the 
proportion of Family Physicians performing deliveries continues to 
decline with most delivering Family Physicians performing 25 or fewer 
deliveries per year. In another study, Makaroff, et al., evaluated 
factors that are contributing to the decline of Family

[[Page 53326]]

Physicians providing maternity care.\4\ Makaroff, et al. evaluated 
American Board of Family Medicine survey data collected from every 
family physician during application for the Maintenance of 
Certification Examination to determine the percentage of family 
physicians that provided maternity care from 2000 to 2010. This 
research team's findings are in line with the results of the research 
conducted by Rayburn, Petterson, and Phillips in that they also found 
that maternity care provision by family physicians declined from 23.3 
percent in 2000 to 9.7 percent in 2010 (p <0.0001). Furthermore, in 
2018, a study from Goldstein, et al. shows that the percentage of 
family practitioners offering low and high volume maternity care 
services continues to decline in both the United States and Canada and 
is now at less than 5 and 1 percent, respectively. These findings are 
based on data from the American Board of Family Medicine Examination 
questionnaires. The data specifically showed that the number of family 
practitioners who offered high volume obstetric services has declined 
by 50 percent since 2009.\5\
---------------------------------------------------------------------------

    \3\ Rayburn, William F., Stephen M. Petterson, and Robert L. 
Phillips. ``Trends in Family Physicians Performing Deliveries, 2003-
2010.'' Birth (Berkeley, Calif.) 41.1 (2014): 26-32.
    \4\ Makaroff, Laura A. et al. ``Factors Influencing Family 
Physicians' Contribution to the Child Health Care Workforce.'' 
Annals of family medicine 12.5 (2014): 427-431.
    \5\ Goldstein, Jessica, et al., ``Supporting Family Physician 
Maternity Care Providers'' Family Medicine 50:9 (2018).
---------------------------------------------------------------------------

    Thus, while family physicians continue to play an important role in 
providing maternity care in many parts of the United States, there is a 
documented decline in the percentage of family physicians providing 
maternity care. HRSA recognizes the important contribution all of these 
professionals play in the delivery of obstetric care. However, as there 
is also not currently detailed nationwide data readily available 
outlining the number of hours individual providers provide these 
services, HRSA did not have an analytical basis for how to include them 
consistently. HRSA will continue to review the availability of these 
data points to determine if additional provider types (particularly 
Family Medicine Physicians, but also including General Surgeons, 
Anesthesiologists, Pediatricians, Doulas, Lactation Specialists, 
Physician Assistants, Advance Practice Registered Nurses, and 
Registered Nurses who provide Women's Health services) may be 
incorporated into the MCTA scoring criteria in the future. HRSA is 
especially interested in recommendations for how to determine the 
amount of time Family Medicine Physicians spend providing maternity 
care services, as they may be the only providers of maternity services 
in areas with no OB/GYNs or CNMs. HRSA welcomes comments on how to 
incorporate these providers into future iterations of MCTA scoring, and 
any detailed nationwide data that may be available to do so.
    HRSA is seeking feedback on the assigned point values in the 
distribution, which are proposed to be as follows:

------------------------------------------------------------------------
              Population-to-provider ratio                    Points
------------------------------------------------------------------------
Ratio >=6,000:1, or No CNMs or OB-GYNs and Population                  5
 (Pop) >=500............................................
6,000:1 >Ratio >=5,000:1, or No CNMs or OB-GYNs and Pop                4
 >=400..................................................
5,000:1 >Ratio >=3,000:1, or No CNMs or OB-GYNs and Pop                3
 >=300..................................................
3,000:1 >Ratio >=2,000:1, or No CNMs or OB-GYNs and Pop                2
 >=200..................................................
2,000:1 >Ratio >=1,500:1, or No CNMs or OB-GYNs and Pop                1
 >=100..................................................
Ratio <1,500:1, or No CNMs or OB-GYNs and Pop <100......               0
------------------------------------------------------------------------

Score for Percentage of Population With Income at or Below 200 Percent 
of the Federal Poverty Level

    HRSA proposes to incorporate poverty data from the U.S. Census 
Bureau into the MCTA composite score, as the majority of commenters 
highlighted the disparities that women living in poverty face in 
accessing necessary maternity health services. The percentage of people 
living in the service area at or below 200 percent of the FPL will be 
used to score MCTAs, based on recommendations from commenters and 
poverty data from the U.S. Census Bureau. Maternal health literature 
demonstrates a high correlation between low income, low health status, 
and poor maternal health outcomes.\6\
---------------------------------------------------------------------------

    \6\ Aftab., et al. ``Effects of Poverty on Pregnant Women.'' 
Department of Gynae and Obstetrics, Dow University of Health 
Sciences, Lyari General Hospital, Karachi, vol. 51, no.1 (2012). 
March of Dimes, ``Nowhere to Go: Maternity Care Deserts Across the 
US,'' (2018), available at https://www.marchofdimes.org/materials/Nowhere_to_Go_Final.pdf.
---------------------------------------------------------------------------

    HRSA is seeking feedback on the assigned point values in the 
distribution, which are proposed as follows:

------------------------------------------------------------------------
    Population with income at or below 200% FPL ratio         Points
------------------------------------------------------------------------
Percentage of population with income at or below 200%                  6
 FPL >=55%..............................................
55% >Percentage of population with income at or below                  5
 200% FPL >=50%.........................................
50% >Percentage of population with income at or below                  4
 200% FPL >=45%.........................................
45% >Percentage of population with income at or below                  3
 200% FPL >=40%.........................................
40% >Percentage of population with income at or below                  2
 200% FPL >=35%.........................................
35% >Percentage of population with income at or below                  1
 200% FPL >=30%.........................................
Percentage of population with income at or below 200%                  0
 FPL <30%...............................................
------------------------------------------------------------------------

Score for Travel Distance/Time to Nearest Source of Accessible Care 
Outside of the MCTA

    Several of the commenters highlighted the barriers in travel time 
and transportation that many women face in accessing maternity care 
services, particularly in rural and underserved areas. In keeping with 
this feedback, HRSA will incorporate the travel time and distance to 
the Nearest Source of Care into the MCTA composite score. The Nearest 
Source of Care is defined as the closest provider location where the 
residents of the area or designated population have access to 
comprehensive maternity care services. Scientific literature presented 
by the American Academy of Pediatrics Committee on Fetus and Newborn 
and the American College of Obstetricians

[[Page 53327]]

and Gynecologists Committee on Obstetric Practice established that an 
individual's proximity to care can affect health outcomes.\7\ 
Specifically for maternity care, the literature indicates that 
decision-to-incision time for emergency cesarean delivery is 30 
minutes.\8\
---------------------------------------------------------------------------

    \7\ Kilpatrick, Sarah J., et al. Guidelines for Perinatal Care. 
8th ed., American Academy of Pediatrics, 2017.
    \8\ Roa, Lina et al., ``Travel Time to Access Obstetric and 
Neonatal Care in the United States.'' Obstetrics and Gynecology (New 
York. 1953) vol. 136, no. 3 (2020): 610-612.
---------------------------------------------------------------------------

    HRSA is seeking public comment on the assigned point values in the 
distribution, which are proposed as follows:

------------------------------------------------------------------------
                Travel time and distance                      Points
------------------------------------------------------------------------
Time >=105 min, or Distance >=105 miles.................               6
105 min >Time >=90 min or 105 miles > Distance >=90                    5
 miles..................................................
90 min >Time >=75 min, or 90 miles > Distance >=75 miles               4
75 min >Time >=60 min, or 75 miles > Distance >=60 miles               3
60 min >Time >=45 min, or 60 miles > Distance >=45 miles               2
45 min >Time >=30 min, or 45 miles > Distance >=30 miles               1
Time <30 min, and Distance <30 miles....................               0
------------------------------------------------------------------------

Score for Fertility Rate

    HRSA proposes to include fertility rate as a criteria for the MCTA 
score to reflect the increased need for maternity care services among 
populations which experience a higher rate of births. Women of 
childbearing age will be derived from the American Community Survey and 
births will be derived from the National Vital Statistics System.
    HRSA is seeking public comment on the assigned point values in the 
distribution, which are proposed as follows:

------------------------------------------------------------------------
                     Fertility rate                           Points
------------------------------------------------------------------------
Fertility Rate >=90th Percentile........................               2
90th Percentile >Fertility Rate >=50th Percentile.......               1
Fertility Rate <50th Percentile.........................               0
------------------------------------------------------------------------

Score for Social Vulnerability Index

    Several MCTA commenters highlighted associations between adverse 
maternal health outcomes and non-clinical factors such as poverty, 
unemployment, lack of adequate housing and transportation, minority 
status, and English language proficiency. The Agency for Toxic 
Substances and Disease Registry's Geospatial Research, Analysis and 
Services Program within the Centers for Disease Control and Prevention 
(CDC) created databases to help emergency response planners and public 
health officials identify and map communities that will most likely 
need support before, during, and after a hazardous event. Per the CDC, 
Social Vulnerability refers to the resilience of communities when 
confronted by external hazards such as natural or human-caused 
disasters, or disease outbreaks.
    One such database is the Social Vulnerability Index (SVI), which 
uses U.S. Census data to determine the social vulnerability of every 
census tract based on the following four themes: Socioeconomic status, 
household composition and disability, minority status and language, and 
housing type and transportation. Each tract receives a separate 
percentile ranking which is represented by a number between zero and 
one for each of the four themes, as well as an overall ranking. These 
themes take into account various factors ranging from educational 
attainment and unemployment to multi-unit structures and single parent 
households.
    Public health literature supports the correlation between low 
English proficiency and late initiation of prenatal care as well as 
adverse perinatal outcomes due to lack of communication between the 
provider and patient.9 10 Currently, literature is not 
available that evaluates the use of the entire SVI to specifically 
quantify maternal health outcomes. However, many of the individual 
factors within the SVI are known social determinants of health. Social 
determinants of health are the conditions in the environment in which 
people are born, live, learn, work, play, worship, and age that affect 
a wide range of health, functioning, and quality-of-life outcomes and 
risks. These social determinants of health as represented within the 
SVI, are critical in understanding external factors that affect the 
need for maternity care services.
---------------------------------------------------------------------------

    \9\ Pope, Charlene. ``Addressing Limited English Proficiency and 
Disparities for Hispanic Postpartum Women.'' Journal of Obstetric, 
Gynecologic & Neonatal Nursing, vol. 34, no. 4, 2005, pp. 512-20. 
Crossref, doi:10.1177/0884217505278295.
    \10\ Vinson, Abigail, et al. ``131: Maternal Language, Severe 
Maternal Morbidity and Access to Prenatal Care.'' American Journal 
of Obstetrics and Gynecology, vol. 222, no. 1, 2020, pp. S99-100. 
Crossref, doi:10.1016/j.ajog.2019.11.147.
---------------------------------------------------------------------------

    A score for overall social vulnerability will be incorporated into 
the MCTA composite score to reflect the increased need for maternity 
care services among populations which experience a higher rate of 
social vulnerability using the CDC's SVI. HRSA is seeking public 
comment on the assigned point values in the distribution, which are 
proposed as follows:

------------------------------------------------------------------------
               Social Vulnerability Index                     Points
------------------------------------------------------------------------
Social Vulnerability >=75th Percentile..................               2
75th Percentile > Social Vulnerability >=50th Percentile               1
Social Vulnerability <50th Percentile...................               0
------------------------------------------------------------------------


[[Page 53328]]

Score for Maternal Health Indicators

    Many of the comments HRSA received raised concerns about social 
determinants of health that have an impact on women's health outcomes, 
not only during and after pregnancy, but also before and in between 
pregnancies. In order to address these concerns, HRSA is seeking public 
comment on the use of maternal health indicators as scoring criteria 
for MCTAs. MCTA scores will consider health indicators that are 
associated with poor maternal health outcomes by looking at various 
data points related to pre-pregnancy health status and when prenatal 
care began. Scores will consider pre-pregnancy obesity, diabetes, and 
hypertension, as well as whether prenatal care began in the first 
trimester, as these are all conditions which may require additional 
workforce capacity to adequately address community needs. Only women of 
childbearing age will be considered for these indicators. HRSA will use 
the National Vital Statistics System as the data source to determine 
the sub-score for each of these four (4) maternal health indicators.
    Public health literature demonstrates that higher rates of obesity, 
diabetes, or hypertension, and later onset of prenatal care are all 
associated with poorer maternal health outcomes and will help identify 
the need for additional health professionals. A 2018 Centers for 
Disease Control and Prevention report on preconception health 
surveillance identified priority indicators for adverse maternal health 
outcomes.\11\ The study reviewed 50 preconception health indicators and 
prioritized those indicators that are most suitable for surveillance 
purposes. Weight, diabetes, and hypertension were all among the top 10 
preconception health indicators recommended for surveillance.\12\
---------------------------------------------------------------------------

    \11\ Robbins, Cheryl L., et al. ``Preconception Health 
Indicators for Public Health Surveillance.'' Journal of Women's 
Health, vol. 27, no. 4 (2018): 430-43.
    \12\ Ibid.
---------------------------------------------------------------------------

    HRSA also considered incorporating maternal mortality data into the 
MCTA score. However, due to data suppression for privacy reasons, this 
data is not readily available publicly or to HRSA below the state 
level. As both HPSAs and MCTAs are designed to be able to provide 
meaningful differentiation of need between communities at a local 
level, HRSA decided not to incorporate maternal mortality data at this 
time. If this data eventually becomes available to HRSA at the county 
level or below, HRSA may include it in future MCTA score calculation.
    HRSA is seeking public comment on the proposed criteria and point 
scale distributions below. Service areas may receive one point each for 
meeting the criteria.

 Pre-Pregnancy Obesity

    Pre-pregnancy obesity is defined as having a Body Mass Index of 30 
or higher. One point will be awarded if the prevalence of pre-pregnancy 
obesity in the area is greater than or equal to the 75th percentile 
among all counties in the United States. If the prevalence of pre-
pregnancy obesity in the area is less than the 75th percentile among 
all counties, zero points will be awarded.

------------------------------------------------------------------------
                  Pre-pregnancy obesity                       Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy obesity >=75th percentile...               1
Prevalence of pre-pregnancy obesity <75th percentile....               0
------------------------------------------------------------------------

 Pre-Pregnancy Diabetes

    One point will be awarded if the prevalence of pre-pregnancy 
diabetes in the area is greater than or equal to the 75th percentile 
among all counties in the United States. If the prevalence of pre-
pregnancy diabetes in the area is less than the 75th percentile among 
all counties, zero points will be awarded.

------------------------------------------------------------------------
                 Pre-pregnancy diabetes                       Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy diabetes >=75th percentile..               1
Prevalence of pre-pregnancy diabetes <75th percentile...               0
------------------------------------------------------------------------

 Pre-Pregnancy Hypertension

    One point will be awarded if the prevalence of pre-pregnancy 
hypertension among women in the area is greater than or equal to the 
75th percentile among all counties in the nation. If the prevalence of 
pre-pregnancy hypertension among women in the area is less than the 
75th percentile among all counties, zero points will be awarded.

------------------------------------------------------------------------
               Pre-pregnancy hypertension                     Points
------------------------------------------------------------------------
Prevalence of pre-pregnancy hypertension >=75th                        1
 percentile.............................................
Prevalence of pre-pregnancy hypertension <75th                         0
 percentile.............................................
------------------------------------------------------------------------

 Prenatal Care Initiation in the 1st Trimester

    One point will be awarded if the prevalence of women who did not 
initiate prenatal care in the first trimester of their pregnancy is 
greater than or equal to the 75th percentile among all counties in the 
nation. Zero points will be awarded if the prevalence of women who did 
not initiate prenatal care in the first trimester of their pregnancy is 
less than the 75th percentile among all counties.

------------------------------------------------------------------------
            Prenatal care in first trimester                  Points
------------------------------------------------------------------------
Prevalence of No Prenatal Care in First Trimester >=75th               1
 percentile.............................................
Prevalence of No Prenatal Care in First Trimester <75th                0
 percentile.............................................
------------------------------------------------------------------------



[[Page 53329]]

Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-20855 Filed 9-24-21; 8:45 am]
BILLING CODE 4165-15-P