Nurse-Family Partnership National Service Office Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 19 -- Sarah McGee, chief policy and government affairs officer of the Nurse-Family Partnership National Service Office, Denver, Colorado, has issued a public comment on the Department of Health and Human Services proposed rule entitled "Securing Updated and Necessary Statutory Evaluations Timely". The comment was written on Dec. 4, 2020, and posted on Dec. 8, 2020:

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Thank you for the opportunity to provide comments on the Department of Health and Human Services' (HHS) proposed rule, "Securing Updated and Necessary Statutory Evaluations Timely" (hereinafter referred to as the "Regulations Rule").

Nurse-Family Partnership(R) (NFP) is a community health program that provides critical services and supports to families of first-time mothers, across the perinatal period - beginning early in pregnancy and continuing until the child is 2 years old. Our programs aim to achieve the following goals:

1. Improve maternal health and pregnancy outcomes and reduce maternal mortality by helping women engage in positive preventive care practices during the perinatal period, including seeking regular prenatal care, maintaining a healthy diet and lifestyle, and, if needed, seeking behavioral health services and/or treatment;

2. Improve the health and development of infants by providing families with the information and resources needed to support a sensitive, responsive, and competent parenting style; and

3. Improve the economic self-sufficiency of families by helping parents address the various factors impacting their health (e.g. social determinants of health), like connecting families to housing supports, food assistance programs, family and pregnancy-related resources, behavioral health services, and employment training programs.

Randomized controlled trials of the NFP model have shown the following positive impacts on maternal and child health outcomes:

* 35% fewer cases of pregnancy-induced hypertension/1

* 18% fewer preterm births/2

* 79% reduction in preterm delivery among women who smoke cigarettes/3

* 31% reduction in very closely spaced (<6 months) subsequent pregnancies/4

* 19% increase in the number of babies with up-to-date vaccinations/5

* 67% fewer behavioral and intellectual problems in children at age 6/6

* 48% reduction in child abuse and neglect/7

The proposed rule would retroactively impose an expiration provision on most HHS regulations and establish "assessment" and "review" procedures to determine which, if any, regulations should be retained or revised. The Regulations Rule is an ill-conceived proposal that would create tremendous administrative burden for HHS and would wreak havoc across a broad swath of Department programs such as Medicaid and regulated entities such as the Center for Medicaid and CHIP Services (CMCS). We also strongly object to the truncated 30day comment period, which is insufficient for a rule of this broad scope with potentially harmful effects. We urge HHS to immediately withdraw this proposed rule.

HHS asserts that the Regulations Rule will promote "accountability, administrative simplification [and] transparency. . . ."/8

In fact, the proposed rule would create a significant administrative burden that would divert resources from critical work, including efforts to address the COVID-19 pandemic. HHS itself estimates that the proposed rule would cost nearly $26 million dollars over 10 years, needing 90 full-time staff positions to undertake the required reviews./9

Within the first two years, HHS estimates the need to assess at least 12,400 regulations that are over 10 years old./10

However, these estimates likely underestimate the time and money involved in the review process, and do not accurately account for complications that may arise.

The Regulations Rule would adversely affect HHS's ability to focus on the administration of current programs, to issue new regulations, and appropriately review current regulations that need modification. We believe prioritizing efforts to improve programs like Medicaid and administer them more effectively and efficiently is a better use of resources and staff time.

For example, NFP has requested clarification from CMCS on how to appropriately blend and braid federal funds for evidence-based home visiting programs. Many of the public and nonprofit entities that deliver NFP services rely on some Medicaid reimbursement, in combination with other private and public funding sources, to fund the program. However, lack of clarity has hindered state action in effectively leveraging Medicaid to support home visiting services. As a result, NFP has encouraged CMCS to build upon its 2016 Joint Informational Bulletin on this topic to clearly articulate how Medicaid dollars can be blended and braided appropriately to reach eligible families, provide streamlined coverage options for services, and how to cover specific components of home visiting programs. Lastly, especially during crisis situations like COVID-19, it is critically important that HHS have the flexibility and bandwidth to shift focus and respond quickly to immediate needs.

Regulations play an important role in implementing HHS policies and programs including safety net programs such as Medicaid and the Children's Health Insurance Program, which provide health coverage for over 75.5 million people, including 36.6 million children. More than 90 percent of NFP moms are enrolled in Medicaid. A strong regulatory framework provides states the clarity they need to run these programs on a day-to-day basis, gives providers and managed care plans guidance as to their obligations, and explains to beneficiaries what their entitlement means. The Regulations Rule would create legal uncertainty regarding the validity and enforceability of regulations throughout the review process.

The bigger danger posed by the Regulations Rule is that important regulations may be arbitrarily rescinded because there are simply not enough HHS staff or resources to undertake such a sweeping review process. Regulations that do not complete the complicated and time consumer review process would summarily expire, potentially leaving vast, gaping holes in the regulatory framework implementing HHS programs and policies.

We are concerned about the potential impact on the Medicaid regulations that outline the mandatory and optional benefits that States commonly use to finance home visiting services. Examples include (relevant sections of the Code of Federal Regulations or CFR included in parentheses):

* Extended pregnancy services (42 CFR Sec. 440.210, 42 CFR Sec. 440.220);

* Targeted case management (42 CFR Sec. 440.169(b));

* Medical or other remedial care by licensed practitioners (42 CFR Sec. 440.60);

* Early and Periodic Screening, Diagnostic and Treatment (42 CFR Sec. 440.40(b)(1)(2));

* Medicaid Administrative Claiming (42 CFR Sec. 433.15); and

* Managed care (42 CFR Part 438).

Furthermore, several states use Section 1115 waivers (42 CFR Subpart G) and South Carolina uses a 1915(b) waiver (42 CFR Sec. 438.1(a), 42 CFR Sec. 438.50(a)(1)(2)) to cover home visiting services and provide NFP to eligible moms. If these regulations were to simply disappear, programs would be free to redefine Medicaid benefits with no standards, consistency, or accountability. Arbitrarily rescinding large swaths of regulations would wreak havoc in HHS programs, leading to untold harm to the millions of people who rely on those programs, including the more than 40,000 families currently enrolled in NFP across the country.

The Regulations Rule claims that automatic expiration dates give HHS the incentive necessary to conduct regular assessments of existing regulations and comply with the Regulatory Flexibility Act (RFA). First, HHS agencies already commonly update regulations when needed. For example, in 2002 the Centers for Medicare & Medicaid Services (CMS) promulgated new regulations implementing statutory changes to Medicaid managed care./11

In 2015, CMS published a Notice of Proposed Rulemaking to update and modernize Medicaid managed care regulations./12

CMS took nearly a year to review and consider the 875 comments submitted, publishing the final rulemaking in May 2016./13

This administration undertook further rulemaking to revise Medicaid managed care regulations, to "relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care."/14

HHS' contention that it needs to "incentivize" regulation review by imposing a mandatory rescission is simply not supported by the facts./15

The current process works well for NFP and we are able to submit comments on proposed rules when they apply to our program.

Further, the RFA requires each agency to publish "a plan for the periodic review of the rules issued by the agency which have or will have a significant economic impact upon a substantial number of small entities."/16

However, nothing in this forty year-old law authorizes agencies to retroactively impose a blanket expiration date to rescind duly promulgated regulations.

In fact, this proposal is contrary to the Administrative Procedure Act's (APA) requirements for rulemaking. In the APA, Congress established clear procedures and standards for agencies seeking to modify or rescind a rule. The APA requires agencies to go through the same rulemaking process to revise or rescind a rule as they would for a new rule, with public notice and the opportunity to comment./17

HHS states it has authority under the APA to add end dates, or conditions whereby a previously promulgated rule would expire./18

We do not dispute that federal agencies can later amend existing regulations. However, the Regulations Rule would modify thousands of separate, distinct rules across HHS in a single stroke, in violation of the APA. HHS' attempt to apply a blanket amendment to 18,000 regulations violates the APA's requirements that review of an existing rule take place on an individual basis, requiring specific fact-finding relevant to the individual rule that the agency wants to amend.

While some HHS regulations may benefit from a periodic review and assessment, this blanket and extensive approach is dangerous and would create implementation challenges for current HHS programs, including Medicaid, a crucial funding source for NFP programs and health insurance option for NFP families around the country. Furthermore, states need stability and predictability to administer the Medicaid program effectively and efficiently, and providers and beneficiaries need Medicaid to work seamlessly and consistently. If the Regulation Rule is implemented, the disruption in the federal and state administration of the Medicaid program could cause irreparable harm.

Lastly, we are concerned that this rule will tie the hands of the incoming Administration by detracting from critical issues like the COVID-19 pandemic, to undertake this time-consuming process. We strongly oppose this rule, and we urge HHS to withdraw it immediately. Thank you for the opportunity to comment on this important issue. If you have further questions, please contact me at [email protected] or (303) 865-8384.

Sincerely,

Sarah McGee

Chief Policy & Government Affairs Officer

Nurse-Family Partnership National Service Office

[email protected]

(303) 865-8384

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Footnotes:

1/ Kitzman H, et al. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997

2/ Thorland, W., & Currie, D. Status of Birth Outcomes in Clients of the Nurse-Family Partnership - Supplemental Materials. Maternal and Child Health Journal. 2007

3/ Olds DL, Henderson CRJ, et al. Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. Pediatrics. 1986

4/ Kitzman H, Olds DL, et al. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000

5/ Thorland, B., Currie, D., et al (2017). Status of Birth Outcomes in Clients of the Nurse-Family Partnership. Maternal Child Health. 21:439-445; DOI 10.1007/s10995-016-2231-6

6/ Reanalysis Olds et al. Journal of the American Medical Association 1997 Aug 27;278(8):637-43

7/ Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey D, Henderson C, Hanks C, Bondy J, Holmberg J. Effects of nurse home visiting on maternal life-course and child development: age-six follow-up of a randomized trial. Pediatrics 2004;114:1550-9

8/ 85 Fed. Reg. 70104.

9/ 85 Fed. Reg. 70116.

10/ 85 Fed. Reg. 70112. To be specific, HHS states that "because the Department estimates that roughly five regulations on average are part of the same rulemaking, the number of Assessments to perform in the first two years is estimated to be roughly 2,480." Id.

11/ CMS, Medicaid Program; Medicaid Managed Care: New Provisions, RIN 0938-AK96, 67 Fed. Reg. 40989 - 41116 (June 14, 2002), https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/QuarterlyProviderUpdates/downloads/cms2104f.pdf.

12/ CMS, Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules, RIN 0938-AS25, 80 Fed. Reg. 31098-31296 (June 1, 2015), https://www.federalregister.gov/documents/2015/06/01/2015-12965/medicaid-and-childrens-health-insurance-programchipprograms-medicaid-managed-care-chip-delivered.

13/ CMS, Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Final Rule, RIN 0938-AS25, 80 Fed. Reg. 27498-27901 (May 6, 2016), https://www.federalregister.gov/documents/2016/05/06/201609581/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-delivered.

14/ CMS, Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care (Final Rule), RIN 0938-AT40, 85 Fed. Reg. 72754-72844, 72754 (Nov. 13, 2020), https://www.govinfo.gov/content/pkg/FR-2020-11-13/pdf/202024758.pdf.

15/ 85 Fed. Reg. 70099, 70106.

16/ 5 U.S.C. 610(a) (In the case of the RFA, periodically is defined as 10 years, unless such review is not feasible, in which case the review can be extended another 5 years).

17/ 5 U.S.C. Sec. 551(5);see also Maeve P. Carey, Specialist in Government Organization and Management, Can a New Administration Undo a Previous Administration's Regulations?, Congressional Research Service (Nov. 21, 2016), https://fas.org/sgp/crs/misc/IN10611.pdf ("In short, once a rule has been finalized, a new administration would be required to undergo the rulemaking process to change or repeal all or part of the rule."); Office of Information and Regulatory Affairs, Office of Management and Budget, The Reg Map 5 (2020) (noting that "agencies seeking to modify or repeal a rule" must follow the same rulemaking process they would under the APA).

18/ 85 Fed. Reg. 70104, fn 85 & 86, citing to separate, specific rulemakings modifying interim final rules implementing mental health parity and foreign quarantine provisions, respectively.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=HHS-OS-2020-0012-0001

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