National Partnership for Women & Families Issues Public Comment on Centers for Medicare & Medicaid Services Rule

WASHINGTON, July 11 -- The National Partnership for Women and Families has issued a public comment on the Centers for Medicare and Medicaid Services' rule entitled "Medicare and Medicaid Programs, Basic Health Program, and Exchanges: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program". The comment was written on July 7, 2020, and posted on July 8, 2020:

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The National Partnership for Women & Families (National Partnership) submits these comments in response to an Interim Final Rule (IFR) issued by the U.S. Department of Health and Human Services (Department) to make certain policy and regulatory changes in response to the coronavirus disease 2019 (COVID-19) pandemic./1

In particular, we would like to address the IFR's 60-day delay in implementation of the "Separate Billing Rule," a recently-released regulation that will require issuers on the Affordable Care Act (ACA) individual exchanges to bill separately for most abortion coverage, as well as require policy holders to pay for that coverage in separate transactions./2

The National Partnership has long worked to improve access to affordable, quality health care - including abortion care - that authentically meets the needs of all women and families and that reduces inequities in health. A core part of this work is ensuring the integrity of the ACA and of the health care exchanges.

To that end, we have been engaged in the legislative and rulemaking process surrounding the ACA, including rulemakings related to the implementation of the ACA's Section 1303, which permits private marketplace plans to cover abortion care but prevents issuers offering such plans in the individual market from paying for those services with federal dollars that are otherwise prohibited for spending on abortion.

The National Partnership continues to oppose the Separate Billing Rule. As we previously identified in our comments to the Department in January 2019, the rule undermines the statutory intent of the ACA, is unworkable in practice, and will impose unnecessary burdens on both issuers and consumers. Moreover, the rule will result in loss of health insurance benefits and increased insurance premiums for people across the country; eviscerate abortion coverage in ACA marketplaces; and threaten the health, well-being and economic security of more than a million individuals across the country./3

The rule's harms will also fall disproportionately on people with low and moderate incomes, Black and Latina women, and immigrants.

The National Partnership submits these comments to make clear that the Department's recent IFR, which provides a sixty-day delay in implementation of the Separate Billing Rule, is woefully inadequate to address the rule's severe, negative effects on consumers, which the COVID-19 pandemic and recession have exacerbated. In light of these additional harms, we call on the Department to immediately suspend the Separate Billing Rule's implementation, at least until the COVID-19 pandemic is over and the U.S. economy has recovered. Instead of wasting agency, patient, issuer, and state time in implementing this misguided rule, the Department should focus its energy on expanding, not threatening, access to health insurance and care that people across the country need now more than ever.

I. ACCESS TO COMPREHENSIVE, AFFORDABLE HEALTH INSURANCE IS ESPECIALLY CRITICAL DURING THE COVID-19 PANDEMIC AND RECESSION

ACA marketplaces offering individual health plans have helped reduce the number of uninsured people by making health insurance available to individuals and families who may not have access to a group-sponsored health plan or public insurance program. Federal subsidies have also helped to make those exchange plans more affordable for people with low and moderate incomes. As a result of the individual marketplaces and other ACA reforms, nearly nine in ten women between 19 and 64 were insured in 2018./4

And by the start of the 2020 Plan Year, 11.4 million people had enrolled in an individual-market exchange plan,/5 one-third of whom lived in states where one or more plans in the ACA marketplace include abortion coverage./6

During the COVID-19 pandemic, the Department has an obligation to take steps not just to maintain this level of coverage but to expand access, including for the newly uninsured population. To date, more than 2 million COVID-19 cases have been diagnosed in the United States. Treatment for the disease can require extended hospital stays and substantial, costly medical interventions. For individuals without health coverage, these costs could be financially devastating and they will discourage individuals from seeking care. Individuals who have been hospitalized for COVID-19 care have reported receiving hospital bills for up to hundreds of thousands of dollars, and in one instance, over one million dollars./7

The need to protect coverage during the pandemic is also critically important to minimizing the disproportionately negative effect that COVID-19 is having on Black and brown communities due to systemic racism and barriers to coverage and care./8

According to CDC data, Black and Latinx individuals are disproportionately dying from COVID-19./9

Moreover, due to environmental racism and decades of neglect, communities of color are more likely to suffer from chronic conditions that raise the risk of developing severe COVID-19 symptoms, such as asthma, cardiovascular disease, and diabetes./10

Maintaining and strengthening coverage through the individual marketplaces is also crucial for individuals who have so far been healthy but are suffering the economic impact of what has now officially become a U.S. recession./11

Since the beginning of the pandemic, more than 40 million people have lost their jobs./12

For these newly unemployed individuals, ACA marketplaces offering individual plans provide a critical lifeline to health insurance.

Unemployed individuals who previously had employer-sponsored health coverage may seek an individual-market plan now because it is more affordable or accommodating than continuing group coverage under COBRA./13

And many unemployed people will turn to the exchanges mid-year because job loss is a basis for special enrollment in an ACA exchange throughout the plan year.

Furthermore, due to systemic structures that limit the ability of Black and brown people to access education and high-paying jobs, people of color make up the majority of low-wage earners economically harmed by the COVID-19 pandemic./14

In addition, although women make up nearly fifty percent of the workforce, they account for most of the job losses related to COVID-19./15

In this time of crisis, it is unconscionable that the Department is actively advancing a policy that will reduce access to care for all people, and especially for those who most need it now.

II. THE SIXTY-DAY DELAY IN IMPLEMENTATION DOES NOT ACCOUNT FOR THE SEPARATE BILLING RULE'S NEW COSTS

In the original Separate Billing Rule, the Department significantly under-estimated the costs the rule would impose on both issuers and consumers. In this IFR, the Department anticipates that the rule's costs in the coming year will be lower than expected because of the sixty-day delay in implementation and asks commenters to help identify the value of those cost savings.

However, the National Partnership objects to the assumptions underlying the Department's request for comment. The Department cannot simply assess "cost savings" from the delayed implementation period it selected without simultaneously evaluating the actual original costs and addressing the significant new costs to consumers, patients, issuers, and states that are associated with implementing the Separate Billing Rule in the middle of a global pandemic and recession. In light of these new costs, it is apparent that the 60-day delay in implementation is woefully inadequate to address the needs of stakeholders.

A. The Department must address the Separate Billing Rule's additional costs for consumers and patients if implemented during a pandemic and recession

In announcing the sixty-day implementation delay, the Department completely ignored the interests of consumers and patients and did not explain how they could possibly be prepared by August 2020 to comply with the Separate Billing Rule's requirement that they pay their abortion-related premium portion in a separate transaction.

First, the Department concluded in December 2019 that the Separate Billing Rule would affect more than three million enrollees around the country./16

But millions of people have lost their jobs in the past few months, and many of those people will turn to the ACA's individual marketplaces to obtain health coverage. Accordingly, to assess the cost impact of a delay in implementation, the Department must recalculate the number of affected enrollees, which is likely to be far greater than the three million identified by the Department in the original rule.

Second, the IFR fails to account for the additional costs to consumers of implementing the Separate Billing Rule at a time when people are dealing with new and substantial upheaval in their lives - from COVID-19 infection, deaths of family members, job loss, loss of health insurance, an inability to obtain child care as schools and daycare centers are closed, potential eviction or other consequences from their inability to pay bills, and COVID-related changes in residence that may delay receipt of mail. The Department has acknowledged that the Separate Billing Rule will lead to inadvertent non-initiation and termination of coverage for some individuals confused about whether and how to pay the abortion-related portion of the premium./17

At a minimum, the Department must address the increased likelihood of these non-initiations and terminations among consumers whose lives have been further complicated by the pandemic and recession. It should also address the fact that lapses in health insurance coverage carry even greater potential for economic hardship today because of COVID-19 than they did when the Separate Billing Rule was adopted.

Third, in assessing delayed implementation, the Department must account for consumers' rising inability to weather premium increases at this time. The Department has conceded that the Separate Billing Rule is likely to result in increases of up to one percent annually for consumers./18

However, the COVID-19 pandemic is also likely to lead to premium increases as plans around the country experience deep losses attributable to the disease.

For example, in March, Covered California predicted that one-year projected costs in the commercial market, which includes individual insurance plans, would "range from $34 billion to $251 billion for testing, treatment and care specifically related to COVID-19."/19

It concluded that premiums in individual and employer markets in 2021 "could be 40 percent or more solely because of these unexpected COVID-19 costs in the absence of federal action, as insurers would seek to recoup unplanned losses from 2020 and budget for pandemic-related costs in 2021."/20

Any consideration of implementing the Separate Billing Rule during the pandemic must consider the compounding effect of the rule's premium increases alongside COVID-related premium increases. Taken together, these increases are likely to impose even greater hardship on consumers and result in more enrollees dropping coverage or selecting cheaper plans that do not fully meet their needs.

Fourth, the Department must address the impact of implementing the Separate Billing Rule at a time when individuals' needs for comprehensive and affordable health care are increasing. Most obviously, any lapses in health insurance coverage caused by the Separate Billing Rule will have potentially catastrophic effects on the health and economic stability of individuals diagnosed with COVID-19. At least 700,000 people who have contracted COVID-19 reside in states whose individual marketplaces require plans to offer abortion coverage./21

Another 450,000 live in states that permit abortion coverage in their individual exchanges, and where one or more plans do in fact include that coverage./22

In total, more than half of all COVID-19 cases have occurred in states where at least one individual marketplace plan will be affected by the Separate Billing Rule./23

In addition, the Department must contend with the increasingly negative impact that the Separate Billing Rule will have on people in need of sexual and reproductive health care. As the American College of Obstetricians and Gynecologists told the Department in a comment seeking delay of the Separate Billing Rule's implementation, the rule will result in more uninsured individuals, and compromise the ability of Americans to obtain access to care during this public health crisis. The IFR did not even acknowledge this letter, much less attempt to reconcile its 60-day implementation delay with the letter's concerns.

More recent data confirms ACOG's concerns. One new study conducted by the Guttmacher Institute found that more than one-third of women reported that they wanted to delay having a child or limit future births because of the pandemic./24

It is more critical now than ever that people have access to health insurance that makes birth control and abortion affordable, yet the Department has acknowledged that some enrollees will lose their health insurance coverage because of the Separate Billing Rule./25

As the Guttmacher Institute found, "the number of women who will need to access abortion care may increase" because of the pandemic and changing fertility preferences./26

Many people report that raising funds for their abortion delayed obtaining care./27

Such delay is likely to only exacerbate cost, as abortion care is more expensive later in pregnancy./28

In one study, the total out-of-pocket costs (including abortion and travel) of obtaining abortion care were equivalent to more than one-third of monthly personal income for more than half of participants./29

Those numbers are undoubtedly amplified in an economic downturn like the one we are experiencing now.

For individuals for whom such costs are or become prohibitive, the negative impact of being unable to access abortion care is significant and long-lasting. Being denied a wanted abortion results in economic insecurity for women and their families for years to come, including nearly four-times-higher odds of being below the Federal Poverty Line./30

Women denied abortion care also report more chronic pain and rate their overall health as worse than those who are able to obtain abortions./31

Instead of addressing these harms, the Department has recognized that issuers may respond to the Separate Billing Rule by dropping abortion coverage from their plans, where permitted by state law, which will force people to pay out of pocket for this care/32 - or not get this needed care at all.

B. The Department must evaluate the costs to issuers and states of requiring implementation of the Separate Billing Rule during the pandemic and recession.

The Department's selection of a 60-day implementation delay is also at odds with the needs of issuers and states. Even before the COVID-19 pandemic, most issuers would have needed far longer for implementation than the Separate Billing Rule or the IFR would provide.

Blue Cross Blue Shield Association, for example, told the Department that "most issuers would need up to two years for implementation."/33

America's Health Insurance Plans likewise conducted a survey of plans and concluded that two-thirds would need at least eighteen months to comply./34

In particular, issuer representatives explained that implementation in the middle of the 2020 plan year would increase consumer confusion and leave issuers without a sufficient amount of time to test new systems required to comply with the rule and to train customer service staff./35

The National Association of Insurance Commissioners echoed that concern, explaining that "[c]onsumers can more easily adapt to new payment arrangements at the beginning of a plan year, when they expect premiums to be different and other changes to their plan to occur."/36

Issuers also described the tasks necessary to ensure compliance with the rule, including "changes to nearly every aspect of the enrollment and billing processes to identify impacted enrollees, generate and send multiple accurate invoices, collect multiple payments, and reconcile payment amounts."/37

In the IFR, the Department stated that it was delaying implementation in light of the "immediate need for . . . issuers to devote resources to respond to" the emergency caused by the pandemic./38

The delay had the effect of providing issuers eight months, instead of six, to implement the Separate Billing Rule. This 60-day delay is not meaningfully different and still fails to address the challenges issuers face in implementing the rule to begin with, let alone in the middle of the pandemic. The majority of issuers will still be required to comply with the Separate Billing Rule in the middle of a plan year, which runs from January 1 to December 31, and at least ten months before most issuers have indicated that they would be prepared to comply. And now issuers will have to do so in the middle of what the Department has conceded is a pandemic presenting "extraordinary circumstances,"/39 which, thanks in large part to the Department's failure to take necessary steps to control it, is only going to get worse.

The Department must address the cost impact of requiring implementation by August 2020. In particular, the Department estimated in the Separate Billing Rule that issuers would pay a 50 percent premium to prepare for implementation by the original deadline./40

That estimate likely undercounted the costs for compliance; but even assuming it was accurate when made, it is most certainly an underestimate now - even with the 60-day delay - because issuers and their vendors are also dealing with new IT and operational demands associated with the pandemic.

The IFR also failed to address the unique interests of state exchanges and agencies during this time; impacts to these stakeholders also bear on the costs associated with implementation of the Separate Billing Rule during the pandemic and recession. For example, the Department's IFR failed to acknowledge, much less contend with, critical points made in a letter from seven state attorneys general, all of whom urged the Department to delay implementation until the COVID-19 pandemic is contained and the economy has recovered./41

The attorneys general highlighted the experience of state health and insurance regulators to justify this delay, explaining that these civil servants are focused "on the mission-critical functions of assuring access to and maintenance of health coverage for treatment and testing of COVID-19."/42

At a minimum, the Department must explain how the imposition of the Separate Billing Rule on state exchanges and regulators at this time affects the Department's cost assessment involved in selecting the period of delayed implementation.

CONCLUSION

The National Partnership believes that the Separate Billing Rule should be withdrawn in its entirety, as it is contrary to the legislative intent of the ACA, overly burdensome to issuers, and undermines the health, economic security, and well-being of people in the United States. At a minimum, though, implementation of the rule must be suspended for the duration of the COVID-19 pandemic and accompanying recession. During this moment of crisis, the Department should focus its time and efforts on trying to stem the pandemic and save lives, not on denying people access to essential sexual and reproductive health services.

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Footnotes:

1/ See Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program, Interim Final Rule, 85 Fed. Reg. 27,550 (May 8, 2020).

2/ See Patient Protection and Affordable Care Act; Exchange Program Integrity, Final Rule, 84 Fed. Reg. 71,674 (Dec. 27, 2019) (to be codified at 45 C.F.R. pts. 155, 156); Patient Protection and Affordable Care Act; Exchange Program Integrity, Notice of Correction, 85 Fed. Reg. 2,888 (Jan. 17, 2020).

3/ One in four women in the U.S. will have an abortion by age 45. Jones RK and Jerman J, Population group abortion rates and lifetime incidence of abortion: United States, 2008-2014, AM. JOURNAL OF PUBLIC HEALTH, 2017, doi:10.2105/AJPH.2017.304042.

4/ Kaiser Family Found., Women's Health Insurance Coverage (2020), https://www.kff.org/womens-health-policy/fact-sheet/womenshealth-insurance-coverage-fact-sheet/.

5/ Kaiser Family Found., Marketplace Enrollment, 2020, https://www.kff.org/health-reform/state-indicator/marketplaceenrollment/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D.

6/ Calculated by summing the marketplace enrollment numbers, Kaiser Family Found., supra note 4, for the states listed in notes 9 and 10, infra.

7/ See, e.g., Danny Westneat, Coronavirus Survival Comes with a $1.1 Million, 181-Page Price Tag, Seattle Times, June 13, 2020, https://www.seattletimes.com/seattle-news/inspiring-story-of-seattle-mans-coronavirus-survival-comes-with-a-1-1-million-dollarhospital-bill/; Adi Guajardo, Evans Man Shocked by $139,254 Medical Bill for COVID-19 Treatment, Denver 7 ABC, May 30, 2020, https://www.thedenverchannel.com/news/local-news/evans-man-shocked-by-139-254-medical-bill-for-covid-19-treatment; Joseph Goldstein, She Survived the Coronavirus. Then She Got a $400,000 Medical Bill, N.Y. Times, June 14, 2020, https://www.nytimes.com/2020/06/14/nyregion/coronavirus-billing-nyc.html.

8/ William J. Barber II & William J. Barber III, Racism and COVID-19 Are a Lethal Combination, The Nation, Apr. 21, 2020, https://www.thenation.com/article/activism/environmental-racism-death-coronavirus/.

9/ Ctrs. for Disease Control & Prevention, COVID-19 in Racial and Ethnic Minority Groups (June 4, 2020), https://www.cdc.gov/ coronavirus/2019-ncov/need-extra-precautions/racial-ethnic-minorities.html; J. Edward Moreno, Black, Latino Communities Suffering Disproportionately from Coronavirus, Statistics Show, The Hill, Apr. 7, 2020, https://thehill.com/homenews/state-watch/491518-blacklatino-communities-suffering-disproportionately-from-coronavirus.

10/ Ctrs. for Disease Control & Prevention, People Who Are at Higher Risk for Severe Illness (May 14, 2020), https://www.cdc.gov/ coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html.

11/ Nat'l Bureau of Econ. Research, Determination of the February 2020 Peak in US Economic Activity (June 8, 2020), https://www.nber.org/cycles/june2020.pdf.

12/ Patricia Cohen, 'Still Catching Up': Jobless Numbers May Not Tell Full Story, N.Y. Times (updated June 4, 2020), https://www.nytimes.com/2020/05/28/business/economy/coronavirus-unemployment-claims.html.

13/ Rachel Garfield et al., Kaiser Family Found., Eligibility for ACA Health Coverage Following Job Loss (May 13, 2020), https://www.kff.org/coronavirus-covid-19/issue-brief/eligibility-for-aca-health-coverage-following-job-loss/. The extent to which an individual who was uninsured before job loss qualifies for a special enrollment period after job loss depends on the individual's state of residence. Id.

14/ Janell Ross, As Economy Struggles Amid Coronavirus, Low-Wage Workers of Color Taking a Major Hit, NBC News, Mar. 25, 2020, https://www.nbcnews.com/news/nbcblk/economy-struggles-amid-coronavirus-low-wage-workers-color-taking-major-n1168731.

15/ Renee Monrad, Why Are COVID-19-Related Job Losses Hitting Women Harder Than Men?, Forbes, Apr. 30, 2020, https://www.forbes.com/sites/reneemorad/2020/04/30/why-are-covid-19-related-job-losses-hitting-women-harder-than-men/#463599e61296.

16/ Patient Protection and Affordable Care Act; Exchange Program Integrity, Final Rule, 84 Fed. Reg. at 71,706.

17/ Id. at 71,686 (HHS conceding that "even with fulsome outreach and education efforts to explain the billing scheme to the policy holder, consumer confusion could still lead to inadvertent coverage losses."); see also id. at 71,703 (projecting annual issuer costs to manage "the grace period process for a higher volume of enrollees who enter a non-payment grace period," including costs related to carrying out "termination[s]" for non-payment).

18/ Id. at 71,701 (citing "[i]ncrease in premiums beginning in plan year 2021"); id. at 71,704.

19/ Covered Cal., Covered California Releases the First National Projection of the Coronavirus (COVID-19) Pandemic's Cost to Millions of Americans With Employer or Individual Insurance Coverage (Mar. 24, 2020), https://www.coveredca.com/newsroom/newsreleases/2020/03/24/covered-california-releases-the-first-national-projection-of-the-coronavirus-covid-19-pandemics-cost/.

20/ Id.

21/ Calculated by summing the case numbers as of June 22 in Maine, New York, Illinois, California, Oregon, and Washington. Ctrs. for Disease Control & Prevention, Coronavirus Disease 2019 (COVID-19), Cases in the U.S. (June 22, 2020), https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html [hereinafter "CDC Case Numbers"].

22/ Calculated by summing the case numbers as of June 22 in Vermont, New Hampshire, Massachusetts, Rhode Island, Connecticut, New Jersey, Maryland, Montana, Colorado, Alaska, Hawaii, and the District of Columbia. Ctrs. CDC Case Numbers. See also Laurie Sobel et al., Kaiser Family Found., The Status and Likely Impact of Final Regulations on Payments for Abortion Coverage in ACA Marketplace Plans (May 4, 2020), https://www.kff.org/womens-health-policy/issue-brief/the-status-and-likely-impact-of-finalregulations-on-payments-for-abortion-coverage-in-aca-marketplace-plans/ (identifying states with at least one marketplace plan that covers abortion care).

23/ Calculated by summing the case numbers as of June 22 in the seventeen states identified in footnotes 21 and 22 and the District of Columbia, and dividing by the total number of U.S. cases. See CDC Case Numbers.

24/ Laura Lindberg, et al., Guttmacher Inst., Early Impacts of the COVID-19 Pandemic: Findings from the 2020 Guttmacher Survey of Reproductive Health Experiences (2020), https://www.guttmacher.org/report/early-impacts-covid-19-pandemic-findings-2020guttmacher-survey-reproductivehealth?utm_source=Guttmacher+Email+Alerts&utm_campaign=a8beeef774PSRH+Covid+commentary+5-2020_COPY_01&utm_medium=email&utm_term=0_9ac83dc920-a8beeef774-260691229.

25/ Patient Protection and Affordable Care Act; Exchange Program Integrity, Final Rule, 84 Fed. Reg. at 71,688.

26/ Lindberg et al., supra note 24.

27/ See Sarah C.M. Roberts et al., Out-of-Pocket Costs and Insurance Coverage for Abortion in the United States, 24 Women's Health Issues e211 (2014).

28/ Jenna Jerman & Rachel K. Jones, Secondary Measures of Access to Abortion Services in the United States, 2011 and 2012: Gestational Age Limits, Cost, and Harassment, 24 Women's Health Issues e419 (2014) (In 2011 and 2012, the median cost for a procedural abortion at ten weeks gestation was $495, compared to $1,350 at twenty weeks gestation).

29/ Roberts et al., supra note 27.

30/ Diana Greene Foster et al., Socioeconomic Outcomes of Women Who Receive and Women Who Are Denied Wanted Abortios in the United States, 108 Am. J. Pub. Health 407 (2018); see also Sarah Miller et al., Nat'l Bureau of Econ. Res., Working Paper 26662: The Economic Consequences of Being Denied an Abortion (2020), https://www.nber.org/papers/w26662.pdf.

31/ Lauren J. Ralph et a., Self-Reported Physical Health of Women Who Did and Did Not Terminate Pregnancy After Seeking Abortion Services: A Cohort Study, 171 Annals Internal Med. 328 (2019).

32/ Patient Protection and Affordable Care Act; Exchange Program Integrity, Final Rule, 84 Fed. Reg. at 71,705.

33/ BCBSA Comment at 4 (Jan. 7, 2019), CMS-2018-0135-74025.

34/ AHIP Comment at 11 (Jan. 7, 2019), CMS-2018-0135-73991.

35/ See, e.g., AHIP Comment at 11; BCBSA Comment at 5.

36/ NAIC Comment at 1 (Jan. 8, 2019), CMS-2018-0135-73342.

37/ 84 Fed. Reg. at 71,697.

38/ 85 Fed. Reg. at 27,599; see also id. at 27,600.

39/ 85 Fed. Reg. at 27,599.

40/ Patient Protection and Affordable Care Act; Exchange Program Integrity, Final Rule, 84 Fed. Reg. at 71,689; id. at 71,697.

41/ See Att'y Gen. of N.Y., et al., Letter, IFR-AR 000153-56.

42/ Id. at 3, IFR-AR 000155; see also ACOG Letter at 1, IFR-AR 000157 (explaining that the rule would "increase costs to states ... during this public health crisis").

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The rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0047-0001

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