[Federal Register: October 2, 2002 (Volume 67, Number 191)]
[Rules and Regulations]
[Page 61955-61974]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc02-21]
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Part II
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Part 457
State Children's Health Insurance Program; Eligibility for Prenatal
Care and Other Health Services for Unborn Children; Final Rule
[[Page 61956]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
42 CFR Part 457
[CMS-2127-F]
RIN 0938-AL37
State Children's Health Insurance Program; Eligibility for
Prenatal Care and Other Health Services for Unborn Children
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: In order to provide prenatal care and other health services,
this final rule revises the definition of ``child'' under the State
Children's Health Insurance Program (SCHIP) to clarify that an unborn
child may be considered a ``targeted low-income child'' by the State
and therefore eligible for SCHIP if other applicable State eligibility
requirements are met. Under this definition, the State may elect to
extend eligibility to unborn children for health benefits coverage,
including prenatal care and delivery, consistent with SCHIP
requirements.
EFFECTIVE DATE: These regulations are effective on November 1, 2002.
FOR FURTHER INFORMATION CONTACT: Kathleen Farrell, (410) 786-1236.
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I. Background
Section 4901 of the Balanced Budget Act, (Pub. L. 105-33), as
amended by Public Law 105-100, added title XXI to the Act. Title XXI
authorizes the State Children's Health Insurance Program (SCHIP) to
assist State efforts to initiate and expand the provision of child
health assistance to uninsured, low-income children. Under title XXI,
States may provide child health assistance primarily for obtaining
health benefits coverage through (1) a separate child health program
that meets the requirements specified under section 2103 of the Act;
(2) expanding eligibility for benefits under the State's Medicaid plan
under title XIX of the Act; or (3) a combination of the two approaches.
To be eligible for funds under this program, States must submit a State
child health plan (State plan), that meets the applicable requirements
of title XXI and is approved by the Secretary.
Benefits under SCHIP are jointly financed by the Federal and State
governments and are administered by the States. Within broad Federal
guidelines, each State determines the design of its program,
eligibility groups, benefit packages, payment levels for coverage, and
administrative and operating procedures. Under section 2102(b) of the
Act, States have discretion to adopt eligibility standards that are
related to age, and thus may extend SCHIP eligibility only to certain
age groups of targeted low-income children (who must be under age 19).
SCHIP provides a capped amount of funds to States on a matching basis
for Federal fiscal years (FY) 1998 through 2007. Regulations
implementing SCHIP are set forth at 42 CFR 457.
II. Provisions of the Proposed Regulations
On March 5, 2002, we published a proposed rule in the Federal
Register that proposed to revise the definition of ``child'' under the
SCHIP program (67 FR 9936). In the interest of providing necessary
prenatal care and other health services to children, we proposed to
clarify and expand the definition of the term ``child'' so that a State
may elect to make individuals in the period between conception and
birth eligible for coverage under the State plan. Specifically, we
proposed to revise the definition at Sec. 457.10 to clarify that
``child'' means an individual under the age of 19 and may include any
period of time from conception to birth up to age 19. In this rule, we
explained that while a pregnant woman under age 19 could be eligible as
a targeted low-income child, and her child would benefit from needed
prenatal care and delivery services by virtue of the mother's
eligibility status, a pregnant woman over age 19 could not be eligible
as a targeted low-income child.
We stated that the proposed definition would provide States with
the option to consider an unborn child to be a targeted low-income
child and therefore eligible for SCHIP if other applicable State
eligibility requirements are met. This would permit States to ensure
that needed services are available to benefit unborn children
independent of the mother's eligibility status. We also discussed in
detail the Department's 1999 report, Trends in the Well-Being of
America's Children and Youth, which describes the benefits of prenatal
care for the mother and the child. We stated that our proposed
revisions were intended to benefit both the unborn children and their
mothers by promoting continuity of important medical care.
In order to protect against the substitution of title XXI enhanced
payments for Medicaid payments, we proposed to add a new paragraph
(a)(3) to Sec. 457.626(a), Prevention of duplicate payments, to
clarify that payment is not available under title XXI when payment may
be reasonably expected to be made under Medicaid on the basis of the
Medicaid eligibility or enrollment of the pregnant woman.
With regard to maintenance of effort requirements, we proposed that
if a State elects to include unborn children in the SCHIP definition of
children, the State must also apply that same interpretation in
assessing compliance with the Medicaid maintenance of effort provision
of section 2105(d)(1) of the Act. Specifically, we proposed to revise
Sec. 457.622, Rate of Federal Financial Participation (FFP) for State
expenditures, to provide that the State does not adopt eligibility
standards and methodologies for purposes of determining a child's
eligibility under the Medicaid State plan that were more restrictive
than those applied under policies of the State plan in effect on June
1, 1997. This limitation applies also to more restrictive standards and
methodologies for determining eligibility for services for a child
based on the eligibility of a pregnant woman.
We also stated that, a State that defines children under SCHIP to
include unborn children would need to apply the same definition in the
screen-and-enroll process described in SCHIP regulations at Sec.
457.350, Eligibility screening and facilitation of Medicaid enrollment.
We proposed to add a new Sec. 457.350(b)(2) to clarify that screening
[[Page 61957]]
procedures must identify any applicant or enrollee who would be
potentially eligible for Medicaid services based on the eligibility of
his or her mother under one of the poverty level groups described in
section 1902(l) of the Act, section 1931 of the Act, or a Medicaid
demonstration project approved under section 1115 of the Act.
We noted that under our proposed regulation, States would continue
to have the authority to set eligibility requirements under their State
plans, including age limits so long as the age limit is under 19 years
of age. Hence, States would not be required to extend coverage to this
population. States that opt to extend eligibility to unborn children
must submit a State plan amendment in accordance with Sec. 457.60.
States can use the preprinted application template for the State
Children's Health Insurance Program, sections 4.1.2 and 4.4, and the
preprinted budget template in submitting this State plan amendment.
III. Analysis of and Responses to Public Comments
We received and accepted 7,783 comments. The majority of these were
form letters that were part of write-in campaigns. Because of possible
residual delays in the Washington, DC mail, resulting from new security
procedures, we accepted comments that were postmarked up to and
including May 13, 2002. All public comments have been summarized and
are discussed in detail in the following discussion.
1. General Comments
In this section, we have summarized and responded to general public
comments on the program or the proposed rule as a whole and not to any
particular provision of this rule. All other public comments are
addressed below in the context of the particular subpart.
Comment: We received a great number of comments from people who
viewed the proposed rule as having a hidden agenda of providing unborn
children with formal legal rights as the first step in abolishing
abortion.
Commenters stated that since the child in the womb would be
recognized as a patient, there would never be a case where abortion is
justified. Another commenter stated that the unborn child's status as a
patient in need of health care has long enjoyed international
recognition and cited the United Nations Declaration on the Rights of
the Child and the 1990 Convention implementing its principles, which
declared that the child needs special safeguards and care, including
appropriate legal protection, before as well as after birth. Other
commenters viewed the proposed rule as empowering lower-income women to
choose life for their children and enhance their ability to raise their
families with dignity.
Many commenters expressed opposing views on this issue, saying that
this is an anti-choice proposal disguised as a health care proposal.
Commenters considered the proposal as the Administration's attempt to
create legal precedent for viewing unborn children as separate physical
and legal entities, which they believe devalues women as persons and is
counterproductive to the health and well being of both women and
children. Commenters stated that the underlying purpose of the proposed
rule is to advance fetal personhood and deny the right of every woman
to determine the direction of her own life. They believe the proposed
rule would undermine the foundation of the right to choose abortion and
threatens a woman's reproductive freedom. They said the proposed rule
would lay the legal groundwork for an adversarial relationship between
a woman and her unborn child.
Commenters expressed the opinion that the proposed rule is a tactic
for extending the rights of a person under the constitution to an
unborn child through the regulatory process as a means of circumventing
the legislative process where it can be debated and voted on openly by
elected representatives. Many commenters considered the proposed rule
an attempt to provoke controversy over Roe v. Wade and provide the
groundwork for having it overturned with the long-term goal of having
abortion declared illegal.
Response: CMS does not believe that this revised definition of
``child'' is inconsistent with the United Nations Declaration on the
Rights of the Child or with Roe v. Wade.
At the core of a number of commenters' arguments against the rule
is a fundamental misconception that this rule would set up an
adversarial relationship between the mother and her unborn child that
might threaten the mother's autonomy.
Such reasoning overlooks the reality that the SCHIP program is a
voluntary assistance program that begins when an individual applies for
the benefit. If the woman did not want the health insurance coverage
offered by the State's SCHIP program, she simply would not apply for it
or would discontinue her participation in the program.
This rule, rather than limiting an uninsured woman's choices in
fact expands them by offering important health care that may not
otherwise be available to her.
In general, patient education literature affirms that prenatal care
benefits both the mother and the unborn child. For example, the Web
site of the American College of Obstetricians and Gynecologists (ACOG)
provides excerpts from its patient education material. ACOG Education
Pamphlet AP098--Special Tests for Monitoring Fetal Health explains
that, ``[e]arly prenatal care gives your doctor a chance to check on
your health and the progress of your pregnancy. Based on the results of
routine prenatal care, your doctor may suggest tests to check the
health of the baby. Most of the time, these tests help assure you and
your doctor that all is going well. Monitoring helps you and your
doctor during your pregnancy by telling more about the well being of
the baby. Monitoring may be done during pregnancy to help assess the
health, activity level, and growth of the unborn child. Some of the
tests used for monitoring check the movement, heartbeat, blood flow,
and rate of growth of the unborn child. If so, the baby may need
special care or may need to be delivered right away.''
In another article, ``Nutrition During Pregnancy,'' available
through the Medem.com Web site, ACOG explains that, ``[a] balanced diet
is a basic part of good health at all times in your life. During
pregnancy, diet is even more important. The foods you eat are the main
source of the nutrients for your baby. As your baby grows, you will
need more of most nutrients.''
This rule reflects the common understanding that prenatal care
benefits both mother and child and therefore does not create tension
between them.
It is also useful to bear in mind that these generally are children
who will otherwise be eligible for their respective SCHIP program in a
State at birth. It only makes sense, and indeed is medically obvious
that establishing eligibility during the prenatal stage advances the
likelihood of a healthy pregnancy, healthy birth, and healthy life.
Comment: Many of the commenters asserted that if the intent of the
proposed regulation is to provide additional health care to pregnant
women, it could be done through existing regulations. Commenters were
concerned that the designation of the unborn child as a child would
raise legal and operational issues that would take years to resolve,
resulting in litigation that would prevent many pregnant women from
receiving needed
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health care. For this reason, numerous commenters recommended the
withdrawal of this rule. One commenter mentioned that for States to
adopt this rule, they would be required to act through their State
legislatures to redefine a ``child'' as being from conception through
age 19, which would cause enormous tension in State capitals across the
country and unproductive bipartisan politics, which would not further
the health care needs of pregnant women or children.
Since States already have the means to cover pregnant women, the
commenter urged HHS to facilitate the process and not complicate it and
many commenters stated that they believe the regulation is unnecessary.
As examples, commenters cited the States of New Jersey and Rhode Island
that have applied for and received section 1115 waivers to expand
coverage to low-income women. They noted that SCHIP waivers are
relatively easy for States to secure since under the existing SCHIP
waiver program, the Federal government does not require ``budget
neutrality'', States can spend additional funds up to the State's
unspent SCHIP allotment and there is already a template in place to
streamline the waiver application process.
Commenters suggested alternative options to HHS rather than
implementing the rule that included: use options under Medicaid to
provide comprehensive prenatal and pregnancy-related care to women; use
the existing authority of approving waivers and implement a process for
expediting the approval of waiver applications; amend the SCHIP statute
to provide prenatal care for pregnant women by expanding eligibility to
the woman rather than to the unborn child; and support and work with
the Congress to approve pending legislation that would provide access
to prenatal care for uninsured women as well as additional funding for
States.
Response: This regulation bridges a gap in eligibility between the
Medicaid and the SCHIP programs that has now existed for five years.
Members of the Congress have also recognized this gap and have
introduced various pieces of legislation over the years to address this
gap. The opportunity to expand vital health insurance coverage during a
critical time is at hand.
We welcome all of these suggestions for expanding health insurance
coverage and indeed States and the Secretary have already used the
flexibility in current regulations. However, there are still gaps. We
also welcome support for the actions of the Secretary in granting
waivers to States that expand eligibility for individuals who would not
otherwise be eligible for Medicaid or SCHIP. But the Secretary's
ability to intervene through one mechanism (a waiver) should not be the
sole option for States and may in fact be an inferior option. Waivers
are discretionary on the part of the Secretary and time limited while
State plan amendments are permanent, and are subject to allotment
neutrality.
Commenters recognize that certain low-income pregnant women are not
currently eligible for coverage under either Medicaid or SCHIP. We
recognize that States already have the ability to provide prenatal care
to pregnant women through expanding their title XIX coverage of
pregnant women either through an amendment to their approved State Plan
or through a demonstration project under section 1115 of the Act.
However, States have been reluctant to do so under the regular Medicaid
match rate. It is the enhanced match under title XXI that has proven to
be the incentive for States to increase eligibility.
The approval process for a SCHIP demonstration project to extend
coverage to pregnant women under section 1115 is a relatively
streamlined process. However, as the commenters also acknowledge, only
five States have applied to cover pregnant women (Colorado, Maryland,
Michigan, New Jersey and Rhode Island) of which two have been approved
as of July 2002 (New Jersey and Rhode Island).
States may decide not to pursue this option because of the local
political climate, the need for State legislative modifications or a
variety of other reasons. Our regulation is simply an option to make it
faster and easier for States that want to use SCHIP funds to expand
prenatal services for low-income women and to do so without having to
go through the 1115 process or wait for the passage of legislation.
With respect to comments relating to potential legislative changes
to the Medicaid and SCHIP statute, discussion of such changes are
beyond the scope of this regulation.
Comment: One commenter said that another way the Administration
could help ensure prenatal care was to change the Medicaid system to
make it less confusing and more accessible, by reducing the complexity
of the eligibility process, the burdensome application forms and by
addressing the lack of knowledge surrounding access and other
regulatory barriers that prevent women from accessing this health care
insurance.
Response: Many States in fact have taken action to lower barriers
to enrollment, renewal, and access. Barriers to enrollment have been
one of the major areas CMS has worked on with States in recent years.
States were given significant flexibility to simplify the eligibility
process in the SCHIP statute and regulations, and CMS has encouraged
States to take similar steps within the framework of Medicaid
requirements. States have the option to provide presumptive eligibility
for pregnant women and the Medicaid regulations have mandated
simplification and streamlining of the enrollment process. It is the
State's option how they choose to accomplish this. However,
administrative simplification has its limits and cannot bridge the
eligibility gap as the proposed regulation would.
Comment: A commenter noted that the unborn child was a feature of
the Medicaid program until 1986 when it was replaced with a coverage
category tied directly to the woman's pregnancy status (Pub. L. 99-509,
the Budget Reconciliation Act of 1986). The commenter considered that
option to be an invaluable means of permitting coverage of certain
children whose mothers could not for a variety of reasons qualify for
Medicaid coverage. The commenter believes that the recognition of this
option in SCHIP at least partially restores this State flexibility,
which was lost 16 years ago, and positions State programs to extend
public health insurance to pregnant women who are currently unqualified
in their own right.
Response: We appreciate the commenter's support and agree that the
intent of this regulation is to provide States with flexibility in
selecting the options that are available to them in providing this
vital care.
The proposed regulation in fact would restore flexibility that the
previous Federal policy provided that allowed welfare and Medicaid
coverage for not-yet-born children.
As early as 1941, the Bureau of Public Assistance, a predecessor
agency within the Department of Health, Education and Welfare (HEW),
determined that unborn children could be covered under the Social
Security Act of 1935. It was determined that under the Act, Federal
funds could be provided to the States for the aid of unborn children.
The Agency's 1946 Handbook of Public Assistance Administration
permitted the inclusion of unborn children among those eligible for
State-plan aid ``on the basis of the same eligibility conditions as
apply to other children.'' The operating policy remained unchanged
through 1971. The option remained with State welfare plans to determine
whether to include unborn children as
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dependents. At the time of the institution of the Medicaid program,
many State social service agencies adopted similar eligibility
definitions for the purposes of qualifying for Medicaid under a State
plan. The approaches were later changed through a decision by the HEW
Secretary. While this change was in part a reaction to the
determination with respect the historic Aid to Families with Dependent
Children program in Burns v. Alcala, 420 U.S. 575 (1975) that States
were not required to extend eligibility based on unborn children, this
decision is not applicable to the SCHIP statute and does not reflect
the congressional intent to provide broad State flexibility under SCHIP
to expand the provision of child health assistance. These precedents
are important as we look for ways for all women to receive prenatal
care.
Comment: A commenter noted that several States have sought and
obtained waivers allowing them to provide SCHIP coverage to unborn
children as beneficiaries of SCHIP and felt that this offers in itself
a strong argument for making that inclusion uniform among the States
and independent of the waiver process.
Response: We agree with the commenter, but note that States still
retain the option to apply for section 1115 waivers to provide prenatal
coverage to low-income pregnant women.
Comment: A commenter noted that the U.S. House of Representatives
also recognizes the value of Secretary Thompson's decision and has,
therefore, drafted a Congressional Resolution (H.R. Res. 346)
commending the decision to recognize that pregnant mothers and unborn
children are deserving of concern about their health and well being.
Another commenter mentioned the bills currently being considered by the
Congress that would allow States to provide low-income women with
prenatal coverage under SCHIP, specifically the ``Start Healthy, Stay
Healthy Act of 2001 (S. 1016/H.R. 3729), the ``Mothers and Newborns
Health Insurance Act of 2001 (S. 724/H.R. 2610), and the ``Legal
Immigrant Children's Health Improvement Act of 2001 (S. 582/H.R. 1143)
on which the Congress has yet to schedule action. The commenters said
that absent the change in statute, they are pleased that, once
finalized, the proposed CMS regulation will allow States to extend
coverage to pregnant women without delay. Commenters concluded that
extending eligibility for SCHIP coverage to unborn children, including
prenatal care and delivery, as consistent with SCHIP requirements, is
the best way to provide needed medical care to those low-income
children and pregnant women that would otherwise be without health
insurance.
Response: We agree and appreciate the commenters' support.
2. Definition of Targeted Low-Income Child
Comment: The commenters expressed their belief that life begins at
conception and unborn children are human beings who should be eligible
for health care. The commenters asserted that any threshold for
eligibility other than conception is inevitably arbitrary, because
conception is the point when an individual human life comes into
existence. Commenters stated that the proposed rule reflects the
medical reality that the life of a child begins before birth at
conception, and is thoroughly consistent with precedent, according
legal significance to, and protecting the life of the unborn child. The
commenters stated that the proposed rule's definition of ``child'' is
consistent with a vast body of scientific literature, and with modern
medical practice, which recognizes that the life of a child begins at
conception and continues until adulthood.
The commenters mentioned that the statute defines the maximum age
of eligibility for services as 19, but specifies no minimum age. Thus,
without this regulatory clarification, it is possible that many
otherwise eligible children would not receive prenatal care under this
program, and might suffer severe health consequences as a result.
Another commenter noted that Pediatrics, Vol 81, 5, May 1988,
p. 736, defines commitment to the health of the individual as beginning
at conception. The commenter supported the proposed rule based on the
importance of ensuring adequate health care for children, both before
and after birth, and the health of their mothers.
Response: We appreciate all of the comments as important
contributions to the public record, which helps shape the Secretary's
decision-making. We recognize that while the intent of this rule is to
extend health insurance coverage, policy determinations are often
carried into other important public discussions. We agree with these
commenters that conception can be a logical point to recognize a
targeted low income child, and thus, we are retaining our revised
definition to permit States the option in administering the SCHIP
program.
Comment: Commenters stated that the proposed rule has ample legal
precedent. Outside the abortion context, they stated that unborn
children are often recognized as persons who warrant the law's
protection. As examples, the commenters said that most States allow
recovery in one form or another for prenatal injuries. Thus, several
commenters cited Roe v. Wade, 410 U.S. 113, 161-2 (1973) and an article
by Paul Benjamin Linton, Planned Parenthood v. Casey, 13 St. Louis U.
Public Law Rev. 15, 46-64 (1993). Another commenter noted that roughly
half the States criminalize fetal homicide. Commenters said that unborn
children have long been recognized as persons for purposes of
inheritance, Roe, 410 U.S., at 162, and a child unborn at the time of
his or her father's wrongful death has been held to be among the
children for whose benefit a wrongful death action may be brought, 22A
Am.Jur.2d death Sec. 99 (1988). A commenter cited a Kansas bill
(HB2797) that would treat a fetus as ``an unborn child'' and declare
the ``unborn child'' to be a ``person or human being'' so as to allow,
under State criminal law, prosecution following the ``death or injury
of a fetus.'' (See Hanna, AP/Topeka Capital-Journal, April 2, 2002.)
One commenter said that Federal statute similarly recognizes the
unborn child as a human subject deserving protection from harmful
research as soon as pregnancy is confirmed, 42 U.S.C. 289g(b); 45 CFR
part 46 Sec. Sec. 46.203 et seq. Therefore, the commenters did not
consider it to be an innovation to treat an unborn child as a human
individual for the purpose of providing quality prenatal care to the
child and his or her mother.
Response: We appreciate all of the comments as important
contributions to the public record, which helps shape the Secretary's
decision-making. We recognize that while the intent of this rule is to
extend health insurance coverage, policy determinations are often
carried into other important public discussions. We agree with these
commenters that unborn children are often recognized for other purposes
under State law, and thus are retaining our revised definition to
permit States such an option in administering the SCHIP program.
Comment: Commenters said that defining unborn children as children
is not an appropriate administrative decision. Commenters considered
defining a child in this way to be arbitrary and they asserted that
most of this country's population does not agree with this position.
The commenters go on to say that this approach will enforce a minority
point of view, is highly political, and is not in the best interests of
women and their children. One commenter noted that the government
should not be in the business of
[[Page 61960]]
deciding when life begins. Another commenter noted that to define
childhood as beginning at conception is an idea not universally held by
religious or medical experts and imposes a particular theological view
on the American public. Another commenter noted that the proposed rule
is both cynical and futile given the widespread disagreement and
confusion about what constitutes life and when an unborn child becomes
a person. They went on to say that there is no ethical or medical
justification for expanding the definition of ``child'' to include the
unborn under the SCHIP provisions, when all medical services offered to
an unborn child must be performed on a pregnant woman. Another
commenter noted that it is inconceivable that a child be defined as
``from conception to 19 years of age.'' If all of the world's greatest
theologians, sociologists and scientists and other great minds cannot
determine when life begins, the commenter asserted, then DHHS certainly
cannot. Another commenter expressed concern that these rules have the
hidden agenda of attempting to define ``when life beings''--a deeply
divisive issue around which the American public has not achieved
consensus. The commenter stated that the fact of existence outside the
body of its mother has consistently been the point at which legal
personhood (including the ability to receive benefits) has been
distinguished from the unborn child, which is not yet a legal person.
The commenter believes that changing this understanding by an executive
department must inevitably lead to Constitutional challenges.
Response: We appreciate all of the comments as important
contributions to the public record, which helps shape the Secretary's
decision-making. We recognize that while the intent of this rule is to
extend health insurance coverage, policy determinations are often
carried into other important public discussions. We disagree with these
commenters' contention that there is only one appropriate
interpretation of the statutory term at issue, and we believe the range
of comments supports our view that States should have the option to
include unborn children as eligible targeted low income children. We
are therefore retaining a revised definition that does not attempt to
define when life begins but permits States maximum flexibility in
extending SCHIP eligibility.
Comment: The commenters said that in their view, unborn children
are not children who should be deemed eligible for health care. The
commenters stated that until birth occurs, mother and the unborn child
are one and not two different people. Another commenter said that the
proposed change would make an arbitrary separation between a woman and
her developing unborn child and goes onto say that such a separation
can only be a concept, for the unborn child is a functioning part of
the mother, sharing physical systems. Other commenters noted that the
unborn child is a part of the mother's body that cannot survive without
the use of the mother's heart, the mother's lungs and so forth. The
commenters asserted that as a society we must allow women to control
their own bodies and not turn them into mere holding vessels for an
unborn child. The commenters believe that the emphasis should be placed
upon the pregnant woman on whom the unborn child's health care is
completely dependent. They believe that life begins at birth, not at
conception and noted that defining childhood as beginning at conception
is not an idea universally held by religious or medical experts.
Response: We appreciate all of the comments as important
contributions to the public record, which helps shape the Secretary's
decision-making. We recognize that while the intent of this rule is to
extend health insurance coverage, policy determinations are often
carried into other important public discussions. We disagree with these
commenters that extending SCHIP eligibility to unborn children would
work to the disadvantage of, or devalue the role of, the mother.
Indeed, we believe the extension of SCHIP eligibility will be in the
best interest of both mother and child, and thus are retaining our
revised definition to permit States such an option in administering the
SCHIP program.
Comment: Two commenters asked what the status of zygotes held in
infertility clinics would be. They asked if such clinics would be faced
with criminal suits for the practice of destroying embryos? Another
commenter asked why sperm are not classified as children so sexually
active men could receive funding to maintain the health of their sperm.
The commenters asked who will arbitrate when a third party decides the
interests of the woman conflict with those of the unborn child she is
carrying? And, will the State decide whether to save the life of the
mother or her unborn child? Commenters also asked if another person
could be appointed the guardian of an unborn child?
Response: While the questions raised by the commenters are
interesting, they are well beyond the issue of providing eligibility
under a publicly funded health insurance program. The important medical
and ethical issues raised in the comments existed prior to the
promulgation of the proposed regulation and are resolved separately
from the specific issue of eligibility for a publicly funded health
insurance program. Guardianship is established through legal
proceedings and is unlikely to be an issue in the routine application,
enrollment, and participation process.
Comment: Commenters discussed the language of the majority in Roe
v. Wade that they believe clearly States ``the word `person' as used in
the 14th Amendment does not include the unborn.'' The commenters
asserted that the Administration does not have the right to reverse
this clear and unambiguous statement unilaterally in a regulation. The
commenters stated that the unborn child is not recognized as a person
in our legal system, where mothers and fathers are responsible for
decision making when it comes to health care for their offspring.
Response: While we understand the views of the commenters, we do
not believe that limiting the definition of child is consistent with
the flexibility that Congress accorded to States under the SCHIP
statute. We believe that the range of comments supports our view that
States should have the option to include unborn children as eligible
targeted low income children. We are therefore retaining a revised
definition that permits States maximum flexibility in extending SCHIP
eligibility.
We appreciate all of the comments as important contributions to the
public record, which helps shape the Secretary's decision-making. We
recognize that while the intent of this rule is to extend health
insurance coverage, policy determinations are often carried into other
important public discussions.
Comment: Commenters asked if defining the unborn child as a person
means that we will restructure the National Census and tax forms to
include this new population of citizens? They asked if we will rethink
our welfare policies to consider unborn children in deciding an
individual's or family's benefits? Commenters expressed concern that
the proposed rule will lay the legal groundwork for an adversarial
relationship between a woman and her unborn child by defining the
unborn child as a person, who would then have full legal status, equal
to that of the woman. A commenter noted that an unborn child is not
given a social security number; it is not a Medicaid beneficiary;
pregnant women do not receive an exemption on their income taxes for
the unborn child;
[[Page 61961]]
and census-takers count only born individuals.
Response: These comments extend beyond the scope of this
regulation, which concerns only the ability of States to extend SCHIP
eligibility to unborn children, and would not change any other Federal
programs. The only government forms affected are those directly
connected to the SCHIP program.
Comment: Commenters expressed concern that for women of color,
distinguishing the needs of the unborn child from those of the mother
has more than once resulted in adverse consequences for the mother. The
commenters referred to Ferguson v. City of Charleston, 532 U.S. 67
(2001), where the Supreme Court considered issues related to a South
Carolina hospital that, pursuant to State law, reported women, all of
color, to the police because her unborn child in the third trimester or
her newborn tested positive for drugs. Consequently, the commenters
asked us to reconsider the definition in this rule.
Response: We appreciate all of the comments as important
contributions to the public record, which helps shape the Secretary's
decision-making. We recognize that while the intent of this rule is to
extend health insurance coverage, policy determinations are often
carried into other important public discussions.
While we understand the commenters' concern, we do not agree that
extending SCHIP eligibility to unborn children would work to the
disadvantage of, or devalue the role of, the mother. Indeed, we believe
the extension of SCHIP eligibility will be in the best interest of both
mother and child. Furthermore, we believe that it is consistent with
congressional intent to provide broad State flexibility under SCHIP to
expand the provision of child health assistance.
Comment: Commenters stated that language in SCHIP suggests that the
term ``child'' does not include an unborn child because the statute
makes reference to the State in which the child ``resides,'' 42 U.S.C.
section. 1397jj(b)(1)(ii)(III). Commenters asserted that in ordinary
usage, an unborn child is not considered to have a ``reside[nce].''
And, the commenters continued that Federal courts have ruled that in
other Federal benefits programs, including AFDC and Medicaid, that the
term ``child'' does not include a fetus. Therefore, the commenters
asserted, the same reasoning applies here, and it is clear that the
Congress did not intend the phrase ``individual under 19 years of age''
to include the ``unborn.''
Response: As previously mentioned, recognition of the unborn child
in Federal assistance programs can be traced back more than half a
century. Currently some Federally funded programs such as Medicaid
include, (or as in SCHIP, provide States with the option to include),
the unborn child in the size of a family for purposes of determining
eligibility for members of that family. Eligibility for some families
may indeed rest on counting the unborn child.
Comment: The commenter stated that in numerous cases related to
child abuse statutes, courts have ruled that the term ``child'' does
not include ``unborn children'' and as such, this rule's
``clarification'' is without merit. In support of this argument, the
commenter cited U.S. v. Spencer, 839 F.2d 1341 (9th Cir. 1988) in which
the defendant's infliction of injuries on an unborn child, who was born
alive, but died as a result of such injuries, was within the Federal
statutory definition of murder. The commenter mentioned that the key to
the holding in that case was that the unborn child was born alive.
Under the Uniform Code of Military Justice, the term ``human being''
was defined as a child that was ``born alive.'' U.S. v. Nelson, 53 M.J.
319 (U.S. Armed Forces, 2000). Moreover, in numerous other cases,
courts have held that the term ``child'' contained in a State's child
abuse statute does not include ``unborn children.'' As an example,
commenters cited In re Unborn Child, 18 P.3d342 (Okla.2001) (holding
fetus is not a ``child'' for purposes of State children's code); State
v. Dunn, 916 P.2d 952 (Wash. Ct. App.1996) (dismissing child
mistreatment charges, finding that the legislature did not intend to
include unborn children within the scope of the term ``child,'' which
was defined as a ``person under eighteen years of age''); Reinesto v.
Superior Court, 894 P.2d 733, 735 (Ariz. Ct. App. 1995) (ordinary
meaning of ``child'' does not include ``activity that affects
fetuses''); State v. Gray, 584 N.E. 2d 710, 711-713 (Ohio 1992) (same).
Response: We recognize there is not a single, uniform standard for
treating an unborn child under all State and Federal statutes. We do
not agree with the commenter's basic premise that the interpretation of
the term ``child'' under SCHIP must be controlled by the interpretation
of that term under other, unrelated statutes that deal with criminal
issues or other purposes. Thus we are retaining our revised definition
in this final rule.
Comment: Commenters stated their belief that the statutory language
is clear regarding the age determination as post-birth. Commenters
asserted that the Congress does not mention care for unborn children in
SCHIP and that, by omission, Congress has spoken on this issue.
Commenters cited Chevron v. Natural Resources Defense Council, Inc. et
al., for the proposition that, in constructing a statute, primary
weight must go to whether Congress has spoken on the issue and only
when Congress has not spoken is weight given to a permissible agency
construction of the statute.'' Commenters cited State of Wyoming v.
United States of America et al., 279 F. 3d 1214, 1230 (10th Cir. 2002)
and said the ``question of whether Federal law authorized certain
Federal agency action is one of congressional intent.'' The commenters
asserted that it cannot be assumed that the Congress would have
intended ``child'' to mean a fertilized egg, embryo or fetus unless it
had been explicitly discussed. As an example, commenters cited State v.
Ashley, 701 So.2d 338, 342-43 (Fla. 1997) (rejecting homicide
prosecution of a woman who shot herself in the abdomen while pregnant,
causing premature birth and the subsequent death of her unborn child).
The commenters stated that in the months leading up to the creation
of the SCHIP program there was extensive discussion in the Congress
about the need for a comprehensive children's health insurance program.
And, the commenters said that when describing the problem of uninsured
children, the very first statistic Senator Daschle used was that ``[e]
very 48 seconds a child is born without insurance'' [emphasis added].
Commenters mentioned that in the House, Congresswoman Furse promoted as
a model an Oregon policy that ``cover[ed] a child from birth to 18
years.'' The commenters asserted that not once in the legislative
history does the Congress mention including fetuses or embryos as
beneficiaries of a children's health insurance program, and the
problems it identified were problems afflicting children, not embryos
and fetuses. Commenters continued, that when the Congress spoke of the
need for health insurance for prenatal care, ``uninsured pregnant women
were specifically mentioned.''
The commenters continued by stating that an examination of the
Congress' intent in passing the SCHIP statute demonstrates that the
Secretary's action in promulgating this rule is ultra vires. They
asserted that although the Secretary's interpretation of the term
``child'' is consistent with a possible legal meaning of the word, it
is entirely inconsistent with the legislative history and the structure
of the legislation.
[[Page 61962]]
First, they asserted, there is no evidence from any of the
Congressional debates on the SCHIP statute that the Congress intended
to extend SCHIP benefits to include ``unborn children.'' And, they
stated, it seems unlikely that the Congress would have intended the
statute to cover this group unless it had been explicitly discussed.
The commenters argued that this is further supported by the fact
that the Congress deliberately chose to include ``well-baby and well-
child care'' in the list of benefits that must be included in a basic
benefit package to determine actuarial equivalence under SCHIP. If the
Congress had intended that the children covered by this statute would
include ``unborn children'' then including these specific benefits
would have been unnecessary. The commenters said that it seems unlikely
that coverage for unborn children was intended because it was not
included on the list.
Furthermore, the commenters noted that the Balanced Budget Act of
1997 (BBA), contains other sections that explicitly use the term
``unborn child.'' Title IV of that Act amended sections of the Medicare
and Medicaid statutes to define the term ``emergency medical
condition'' as a medical condition which ``place[es] the health of the
individual) or, with respect to a pregnant woman, the health of the
woman or her unborn child) in serious jeopardy. BBA of 1997, Pub. L.
No. 105-33, Sec. Sec. 4001, 4704, 111 Stat. 251, 290, 496 (1997)
(codified as amended at 42 U.S. C. Sec. 1395w-22(d)(3)(B)(i) and 42
U.S.C. 1396u-2(b)(2)(C)(i)) [emphasis added].
The commenters asserted that if the Congress intended to include a
fetus as a ``child'' eligible for SCHIP, it would have explicitly used
the term ``unborn child'' in this section of the Act as it did in the
Medicare and Medicaid sections of the same statute. The proposed
amendment to the SCHIP regulations is therefore unauthorized. The
commenters concluded by stating that the proposed change appears to use
a rule change to advance an ideological position on the ``personhood''
of an unborn `` a position never contemplated by the Congress during
debate on this program.
Response: We do not believe that Congress directly spoke to the
issue of whether the term ``child'' could include unborn children,
because the statute contains no limitation on such an interpretation.
We believe the commenters effectively conceded that point by focusing
on congressional silence and raising peripheral issues and statements
by individual legislators taken out of context. The argument that
Congress explicitly used the term ``unborn child'' in a number of
legislative enactments and did not do so in SCHIP goes both ways,
because while Congress did not expressly include unborn children,
Congress did not exclude them either. Instead, Congress clearly sought
to provide a maximum level of State flexibility under SCHIP. Thus we do
not see a compelling reason to change our proposed interpretation in
this final rule.
The reference to ``well child'' benefits in the statute simply
means that the Congress chose to specify some benefits rather than
others as it gave States wide latitude and broad authority to establish
what benefits would be offered to those enrolled in the program. The
suggestion that the Congress limited benefits to those expressly
defined is wrong as indicated by the language of section 2103 (c)(3),
``Nothing in this subsection shall be construed as preventing a State
child health plan from providing coverage of benefits that are not
within a category of services described in paragraph (1) or (2).''
Furthermore, the definition of ``child health assistance'' at section
2110(a)(9) expressly includes prenatal care.
The construction of title XXI is a broad delegation of authority to
the Secretary and the States. The Congress considered various forms of
expanding health insurance including one limited solely to the
expansion of Medicaid. The Congress chose not to duplicate the Medicaid
program, but rather constructed a program that left a great deal of
authority up to the Secretary and the States to design eligibility and
benefits.
Comment: Commenters stated that no regulation or Federal statute
currently on the books treats the unborn child as the equivalent of a
person and no Federal regulation should do so. The commenters asserted
that the SCHIP statute nowhere states or suggests that ``child'' as
used in the statute includes a fetus and they asserted that defining a
``child'' to include a fetus is inconsistent with the plain and
ordinary meaning of the term.
Commenters mentioned that Federal courts have been asked to rule on
whether AFDC and Medicaid apply to fetuses and in both contexts,
Federal courts have concluded that the term ``child'' does not include
a fetus. In Burns v. Alcala, 420 U.S. 575 (1975), the Supreme Court
held that the term ``dependent child,'' as used in the AFDC statute,
does not include ``unborn children.'' 420 U.S. at 580-81. Likewise, the
commenters asserted, in Lewis v. Grinker, 794 F. Supp. 1193
(E.D.N.Y.1991), aff'd on other grounds, 965 F.2d 1206 (2d Cir. 1992),
the Federal district concluded that fetuses are not eligible for
Medicaid. 794 F. Supp.at 1198. Commenters stated that it held that in
all events, the phrase ``individuals under the age of 21'' does not
easily apply to unborn children under ordinary usage. The unborn are
not ``persons'' under the Constitution. Roe v. Wade, 410 U.S. 113, 93
S. Ct. 705, 35 L. Ed.2d 147 (1973).
In addition, one commenter noted that the ``age'' of any individual
is normally computed from birth. The commenter asserted that while the
statute does not require calculation of the precise age ``under 21,''
it is apparent that any construction of the phrase ``individuals under
the age of 21,'' which will accommodate the unborn is not ordinary
usage. Accordingly, this commenter concluded that the Congress did not
intend the phrase ``individuals under the age of 21'' to include the
unborn.
Other commenters asserted that the same reasoning applies here:
under ordinary rules of statutory construction, it is clear that the
Congress did not intend the phrase ``individual under 19 years of
age,'' within the meaning of the SCHIP statute, to include the
``unborn.''
For this reason, commenters asserted that the Secretary lacks the
authority to promulgate the proposed regulation. The commenters
contended that the definition can only be changed by amending the
current statute and that is far beyond the reach of the Department. The
commenters went onto say that what the Department calls a
``clarification'' of the definition is an attempt to change what the
Congress intended to include in the definition of child for the
purposes of SCHIP eligibility.
Response: As noted above, the SCHIP statute is silent on the issue
of eligibility for unborn children, and we do not believe that the
interpretation of the term ``child,'' is appropriately controlled by
the cases cited, which involved other programs and situations. We
believe instead that Congress had a broader purpose under title XXI,
which included maximizing State flexibility in offering access to child
health assistance under SCHIP.
There is little doubt that the purpose of title XXI is to provide
access to health insurance. This regulation would provide eligibility
at an earlier point in time that is also one of the most critical times
in the lifecycle.
The statute clearly established an age ceiling of 19 that could not
be circumvented absent a waiver. However, other broad eligibility
standards were
[[Page 61963]]
left to the States. A State has the authority to target to different
ages below age 19. For example, Federal statute requires Medicaid
eligibility at 133 percent of the Federal poverty level up to age 6.
After age 6, the Federal minimum is 100 percent of poverty. To fill the
gap in Medicaid eligibility, a State could have used the enhanced
funding provided by title XXI and designed their SCHIP program to
simply cover children at 133 percent of poverty between the ages of 6
and 19.
A State could target resources to younger children as an early
childhood development program and thus create an eligibility category
at higher income levels specifically for infants and children up to age
4 for example.
Many commenters who oppose this rule have indicated their belief
that the Secretary does have authority to extend eligibility to a
pregnant woman who is over the age limit set by statute and indeed have
indicated support for such a waiver. We believe the Secretary's
authority extends to the adoption of definitions through the rulemaking
process.
Comment: One commenter suggested that the Secretary might be
exceeding his authority by applying the revised SCHIP definition of
child in assessing compliance with the Medicaid maintenance of effort
provision of section 2105(d)(1), as stated in the preamble to the
proposed rule at 67 FR 9938.
Response: We disagree with the commenter because we believe the
Secretary's authority clearly extends to the interpretation of
statutory terms such as the SCHIP term ``child.'' Furthermore, in this
instance, we have used rulemaking procedures to ensure that we have
fully considered the issues. We clarify that we interpret the
maintenance of effort provision at 2105(d)(1) for purposes of the SCHIP
statute, consistent with our overall definition of the term ``child.''
Thus, because a State may extend SCHIP eligibility to unborn children,
we will review compliance with SCHIP maintenance of effort provisions
by including unborn children in our review. The provision at issue is a
SCHIP provision, and it ensures that SCHIP funds will not be used to
replace Medicaid coverage.
Comment: Commenters stated that by defining an egg as a child and
consequently, when life begins, DHHS is imposing a religious belief on
all women. The commenters stated that for each group of people whose
religion teaches them that an unborn child is a child at any stage of
development, there is another whose religion teaches them precisely the
contrary. One commenter mentioned that forcing people to proceed
against their religious beliefs in order to access a public benefit is
almost certainly illegal and to dangle prenatal care in front of needy
women who do not happen to share a particular religious viewpoint would
not only be illegal, it would be morally reprehensible.
In support of this position, one of the commenters stated that the
Supreme Court found as much in the seminal case of Sherbert v. Verner,
374 U.S. 398 (1963), while more recently holding that a State may deny
unemployment benefits for illegal conduct, even if that conduct is
religiously motivated.
The commenter continued by saying, that the free exercise of
religion means, first and foremost, the right to believe and profess
whatever religious doctrine one desires. Thus, the commenter asserted
that the First Amendment obviously excludes all ``governmental
regulation of religious beliefs as such'' and cited Sherbert v. Verner,
supra, at 402. The commenter asserted that the government may not
compel affirmation of religious belief, and cited several cases in
support of this argument, including Torcaso v. Watkins, 367 U.S. 488
(1961), United States v. Ballard, 322 U.S. 78, 86-88 (1944), McDaniel
v. Paty, 435 U.S. 618 (1978); Fowler v. Rhode Island, 345 U.S. 67, 69
(1953); cf. Larson v. Valente, 456 U.S. 228, 245 (1982), Presbyterian
Church in U.S. v. Mary Elizabeth Blue Hull Memorial Presbyterian
Church, 393 U.S. 440, 445-452 (1969); Kedroff v. St. Nicholas
Cathedral, 344 U.S. 94, 95-119 (1952); Serbian Eastern Orthodox
Diocese1 v. Milivojevich, 426 U.S. 696, 708-725 (1976), Employment Div.
of Oregon v. Smith, 494 U.S. 872, 877 (1990).
The commenter stated that in the Sherbert case, a person was denied
unemployment benefits on the basis of work related misconduct because
she refused to work on her Sabbath. The Court ruled that forcing a
person to choose between following her religious beliefs and receiving
a public benefit violates the First Amendment, and in the absence of
criminal behavior, that remains the statute today.
The commenter contended that the regime proposed by CMS will
confront many pregnant women with just such a choice in that they must
either be willing to publicly declare the unborn child they are
carrying to be a human being, even if their religion teaches them
otherwise, or they must forego perhaps prenatal care and delivery
services. The commenter asserted that CMS would be attempting to ``lend
its power to one or the other side in controversies over religious
authority or dogma.'' Smith, supra at 877.
Response: Application for SCHIP benefits is voluntary, and there is
nothing in the SCHIP statute that forces a mother to accept SCHIP
benefits. While it is certainly possible that acceptance of SCHIP
benefits for an unborn child may be contrary to some women's religious
beliefs, we do not believe this should preclude States from offering
such benefits. If a woman has a religious objection, she simply would
not accept SCHIP benefits.
Comment: Commenters stated that by establishing eligibility
benefits from the point of conception, a woman's right to make
decisions about her health care is undermined. The commenters pointed
out that the U.S. Supreme Court has consistently ruled that women's
health interests may not be supplanted by State or fetal health
interests and cited the following cases: in Stenberg v. Carhart, the
Court struck down a State law imposing government restrictions on
abortion that failed to provide an adequate exception for preservation
of the woman's health; and in Colautti v. Franklin, the Court
invalidated a statute that failed to guarantee that a woman's health
would always prevail over the life and health of her unborn child.
The commenters believe that this rule opens up the possibility for
the government or others to claim the right to represent such fetal
interests, and thus the right to make decisions about a woman's
pregnancy over her objections. The commenters asserted that amending
the definition of a covered ``child'' to include ``the period from
conception to birth,'' thereby allowing health insurance coverage for a
zygote, embryo and fetus in utero has legal and practical problems and
could actually undermine the health of the pregnant woman. The
commenters stated that current constitutional statute allows States to
place limited restrictions on a woman's access to abortion, but a
pregnant woman holds an absolute right to make decisions about her
pregnancy during the first trimester, including decisions about her
health care.
The commenters believe the proposed regulation is inconsistent with
the constitutionally protected right of a woman to determine the course
of her pregnancy.
Response: As stated previously, enrollment and participation in the
SCHIP program is voluntary. There is no conflict as the services to be
provided benefit both mother and child.
Comment: One commenter stated that the term ``conception'' should
be understood to mean at the time of
[[Page 61964]]
fertilization when the new genetically complete and unique individual
begins his or her existence. The commenter said it would be good to
define clearly what is meant by ``conception'' since there are other
potentially confusing definitions being used.
Response: We do not generally believe there is any confusion about
the term ``conception.'' To the extent that there is, however, we
believe States should have flexibility to adopt any reasonable
definition of that term.
3. Program Eligibility
Comment: Several commenters asked about when coverage of the unborn
child would begin, given the logistical difficulties in establishing
the exact date of conception. These commenters also asked whether or
not the pregnancy would need to be medically verified, and whether
coverage could be retroactive to the date of conception.
Response: Under title XXI, States have discretion in adopting
administrative procedures regarding eligibility for coverage. States,
at their option, may elect to offer retroactive coverage or may require
medical confirmation of the pregnancy before any prenatal care would be
provided. If the application had been filed prior to such confirmation
and it turned out that the woman was not pregnant, the costs of the
pregnancy test could be paid as an administrative cost, at the State's
option. If the pregnancy were confirmed, the cost of the pregnancy test
and any prenatal care subsequently provided could be treated as child
health assistance.
Comment: One commenter asked whether Medicaid rules should be
applied to SCHIP. A few commenters asked about whose income would be
used to determine the unborn child's eligibility. One specifically
asked whether States would need the mother's income and resource
information. Another asked whether income from the parents of an unwed
pregnant teen living at home should be counted, as would be the case if
the teenager were applying for coverage as a pregnant woman under
Medicaid. This commenter also asked whether child support enforcement
requirements apply to the unborn child or to the mother.
Response: Medicaid eligibility rules only apply when a State has
implemented its SCHIP through a Medicaid expansion program. Medicaid
eligibility rules do not apply to separate child health programs.
States have broad discretion in defining ``family income'' for purposes
of determining eligibility under a separate child health program.
States have discretion to determine whose income shall be considered in
determining a child's eligibility. Similarly, States have broad
discretion on whether to have a resource test for their separate child
health program and, if so, whose resources to count. Thus, in the
example cited by one commenter, a State could opt to count the income
and/or resources of a pregnant teen's parents in determining
eligibility. However, it is not required to do so.
There are no Federal child support enforcement requirements for
separate child health programs. Thus, while States can impose such
requirements, they are not required to do so.
Comment: One commenter asked whether the baby would be eligible for
a year of presumptive eligibility.
Response: In general, infants born to mothers who were eligible for
and receiving Medicaid at the time of the infant's birth automatically
are eligible for Medicaid for one year. It is unclear whether this
commenter is asking if babies, who were covered by SCHIP while in
utero, would be covered by this rule, or whether the commenter is
asking if such babies would be eligible for one year of presumptive
eligibility under SCHIP. We will respond to both questions.
Under 42 CFR 457.350(b) regarding the SCHIP regulation's screen and
enroll requirements, if a mother is Medicaid eligible, the unborn child
cannot be eligible for SCHIP. Conversely, if the unborn child is
covered under SCHIP, that means that the State determined, in the
screening and eligibility process, that the mother was not eligible
for, or receiving, Medicaid. Accordingly, the automatic one-year
eligibility enjoyed by infants born to mothers on Medicaid would not
apply to infants covered by SCHIP while in utero.
If a State has adopted presumptive eligibility for its separate
child health program, an unborn child could be determined to be
presumptively eligible, to the same extent as any other child,
consistent with the regulations at 42 CFR 457.355. However, presumptive
eligibility cannot be applied to a child once the child has been
determined to be eligible for coverage under SCHIP. This basic
principle is true for a child determined eligible for coverage while in
utero, as well as one who is first determined eligible after birth.
This does not mean, however, that an infant eligible in utero loses
coverage at birth. Under current regulations at 42 CFR 457.320(e)(2),
States have the flexibility to establish an eligibility period of up to
12 months. A child's eligibility for a separate child health program
must be redetermined at the end of the eligibility period adopted by
the State. Between regularly scheduled redeterminations, States are not
required to reevaluate a child's continued eligibility, regardless of
changes in circumstances (other than the child turning 19).
Under this regulation, the term ``targeted low-income child'' is
defined to include an unborn child, who otherwise meets the State's
income eligibility criteria. Thus, whatever period of eligibility the
State has adopted for children covered under its separate child health
program also would apply to an unborn child. Birth in and of itself
does not alter the baby's status as a ``targeted low-income child.''
Thus, once born, the infant would remain eligible for coverage under
the separate child health program until the next regularly scheduled
redetermination.
For example, suppose that a State has adopted a 12-month
eligibility period and that an unborn child was determined eligible for
SCHIP three months prior to birth. At birth, the infant would remain
eligible for coverage under the State's separate child health program
for 1 year from the date of initial eligibility, or, in this case, nine
months from the date of birth.
Note that, at any point a parent or other caretaker has the right
to file a Medicaid application on behalf of the infant. If such an
application were filed, the State then would be required to determine
the infant's eligibility for Medicaid.
Comment: One commenter asked if the continuous eligibility afforded
to pregnant women by Medicaid `` under which pregnant women retain
eligibility for the duration of their pregnancy and postpartum period
regardless of changes in income--would be available to unborn children
eligible for SCHIP under this regulation.
Response: No. As explained above, Medicaid rules do not apply to
separate child health programs. However, as also explained above, under
current regulations at 42 CFR 457.320(e)(2), States can adopt
continuous eligibility for children eligible for their separate child
health program, with an eligibility period of up to 12 months. A
child's eligibility must be redetermined at the end of the eligibility
period adopted by the State. Between regularly scheduled
redeterminations, States are not required to reevaluate a child's
continued eligibility, regardless of changes in income or other
circumstances (other than the child turning 19).
[[Page 61965]]
Comment: One commenter asked whether an unborn child could be
eligible for SCHIP if the mother is not eligible for Medicaid because
she does not satisfy the State's residency requirement.
Response: Subject to the provisions of 42 CFR 457.320(d), States
may establish residency requirements for their separate child health
programs. An application for an unborn child for this program would be
treated the same as any other application for coverage. Thus, it also
would be subject to the residency requirements established by the
State.
Comment: One commenter asked whether States would need the mother's
social security number (SSN).
Response: States are not permitted to require the SSN of anyone,
other than the child applying for coverage, as a condition of
eligibility. This rule does not change that situation. Thus, States may
not require that the unborn child's mother provide her SSN. However,
States would likely assign a unique identifier to every unborn child
that is found eligible for coverage and enrolled in a separate child
health program in order to perform normal administrative functions. The
mechanism used to assign such an identifier is left to the discretion
of each State.
As in current practice, a State may request the pregnant woman's
SSN as long as the State makes it clear for what purpose her SSN would
be used; and that she is not required to provide her SSN and that
eligibility will not be affected if she does not do so.
Comment: One commenter asked whether either parent would be able to
submit an application on behalf of the unborn child.
Response: Under title XXI of the Social Security Act, States have
broad discretion to adopt administrative procedures governing the
filing and processing of applications. Thus, States can, but are not
required, to place restrictions on who can file an application on
behalf of a child. There is nothing in this regulation, however, that
would permit any individual to compel another to seek or use health
care services.
Comment: A few commenters asked whether an unborn child would have
to be issued a SSN or other unique identifier. These commenters also
asked what method the State would use to track services provided to the
unborn child.
Response: We are not aware of any circumstances in which the Social
Security Administration assigns a SSN to an individual prior to birth.
This rule does not request, let alone require, that it do so.
Therefore, we do not anticipate that an unborn child that is
determined to be eligible for coverage under a separate child health
program would be given a SSN. Consequently, it will be necessary for
States to assign a unique identifier to appropriately process claims.
The mechanism used to assign the identifier is left to the discretion
of each State.
The data collection and reporting requirements for separate child
health programs are set forth at 42 CFR subpart G. Regulations
governing payment for and verification of services provided are found
at 42 CFR 457.950 and 42 CFR 457.980. States are required to comply
with these requirements with respect to coverage of all enrolled
individuals. This rule does not impose any additional requirements on
States with respect to services provided to an unborn child.
Comment: In the March 5, 2002 proposed rule, we explained that this
regulation will give States the option to consider an unborn child to
be a targeted low-income child and therefore eligible for SCHIP ``if
other applicable eligibility criteria are met.'' One commenter asked
whether the ``other eligibility criteria'' applies to the unborn child
or the pregnant woman.
Response: The ``other eligibility criteria'' pertain to the unborn
child.
Comment: One commenter emphasized the importance of the screen and
enroll requirements.
Response: We agree with the commenter that the screen and enroll
requirements are very important. As we explained in the March 5, 2002
proposed rule, the purpose of the rule is to encourage States to
increase the availability of prenatal care. In order to ensure that
funding for prenatal care under SCHIP does not replace funding for
prenatal care under Medicaid, we explained that States must apply the
screen and enroll process described in the SCHIP regulations at 42 CFR
457.350. Consistent with the terms of that regulation, States must
screen the unborn child's mother for Medicaid eligibility. If the State
determines that the mother is potentially eligible for Medicaid, then
the State must assist her in completing the Medicaid application
process, again, consistent with the requirements set forth in 42 CFR
457.350.
Comment: One commenter asked whether a State could include this
group in an existing Medicaid waiver, such as the family planning and
Healthy Start waivers.
Response: Section 1115 waivers are demonstration projects awarded
to States at the Secretary's discretion on a case by case basis. As
such, consideration of this eligibility group could be considered for
inclusion in an existing waiver but a sufficient rationale would need
to be provided by the State. Also, it may not make sense to include
this group, as in the case of family planning waivers, for example.
Comment: Two commenters said that all States should be required to
cover the unborn child.
Response: We cannot require States to cover unborn children. The
statute does not require that States cover all children who meet the
definition of a targeted low-income child. Section 2102(b)(1) of the
Act and implementing regulations at 42 CFR 457.320(a)(2) specifically
permit States to adopt eligibility standards based on age. Thus, we are
precluded from mandating that all States cover unborn children.
4. Immigration Status
Comment: Commenters stated that the proposed regulations do not
address how the unborn child will be classified in determining its
citizenship or immigration status. Many commenters urged the Department
to make clear in the final rule that unborn children will be eligible
for SCHIP benefits under the rule, regardless of the immigration status
of their mothers. The commenters asserted that since no unborn child is
a citizen or a qualified immigrant, there is no basis for making
distinctions among unborn children on nationality and immigration
status grounds.
Commenters stated that low-income pregnant women who are either
recent legal immigrants (subject to the 5 year bar on receipt of
Federal public benefits) or are undocumented immigrants are often
unable to secure prenatal care, and such an exclusion is likely to
result in serious harm to the unborn child.
Yet, commenters noted, the babies born to these women in the United
States will become citizens immediately upon their birth. Commenters
asserted that effective health care for these children, no less than
others, must begin with access to prenatal care. In addition, this
would provide effective coverage for the maximum number of unborn
children. One commenter noted that the proposed regulation would permit
States to ensure that essential prenatal services are available ``to
benefit unborn children regardless of the mother's eligibility
status.'' (67 FR 9937) The commenter noted that this position is
consistent with existing statute and practice since many children whose
parents would not be eligible for SCHIP are currently enrolled in the
SCHIP program. These include children whose
[[Page 61966]]
parents are subject to the 5-year bar. The commenter states that with
the exception of income available to the child, parents' eligibility
for SCHIP is irrelevant. They noted that SCHIP eligibility is based
upon the age, immigration status, insurance coverage and other factors
specific to the child. 42 U.S.C. 1397bb(b)(1)(A); 42 CFR 457.320, as
amended by interim final rule published at 66 FR 33810 (June 25, 2001).
The commenters stated that HHS should amend the proposed regulation
to clarify that all unborn children will be treated equally for SCHIP
eligibility purposes. One commenter specifically requested that we
amend Sec. 457.320(b)(6) to state that ``In establishing eligibility
standards and methodologies a State may not exclude individuals based
on citizenship or nationality to the extent that the children are U.S.
citizens, which includes unborn children from conception to birth who
upon birth will be U.S. citizens, U.S. nationals or qualified aliens.''
Commenters contended that if the regulation were adopted, treating all
unborn children as constructively born in the U.S. would be the most
straightforward way to accomplish this end and cited Lewis v. Thompson,
252 F.3rd 567, 581 (2d Cir. 2001), (discussing the ``constructive
birth'' provisions of 42 U.S.C. 1396d(n)(1)(A), which treats a
childless pregnant woman as a parent with one child for TANF
eligibility purposes.)
Response: We agree with the commenters that requiring exclusion of
unborn children on the basis of immigration status is neither legally
mandated nor desirable. Unborn children do not have immigration status
as ``aliens'' and thus are not precluded from receiving Federal means-
tested benefits under the provisions of Title IV of the Personal
Responsibility and Work Opportunity Reconciliation Act of 1996
(PRWORA), Public Law No. 104-193. Under PRWORA, these restrictions
apply only to ``aliens'' who are not ``qualified aliens''; since unborn
children are not ``aliens,'' they are not within the scope of this
preclusion nor are unborn children subject to the 5-year bar.
Furthermore, as we stated in the preamble to the proposed rule, the
goal is to permit States to ensure that needed services are ``available
to benefit unborn children independent of the mother's eligibility
status'' (67 FR 9937). Because prenatal care is a key element to
ensuring healthy infants and children, this goal would maximize the
availability of prenatal care and, consequently, promote the overall
health of infants and children. It would be inconsistent with this goal
to tie services for prenatal care to the immigration status of the
mother.
We do not, however, believe that it is necessary to explicitly
amend the proposed rule to express this interpretation of applicable
law. Since unborn children would not be precluded from receiving
benefits under applicable law, there is no reason to further address
the issue in the regulation text.
Comment: One commenter noted that the unborn child of an ineligible
immigrant woman is indistinguishable from that of any other woman
present in that State. In the real world, upon birth, that unborn child
becomes a child and a U.S. citizen. This commenter asked, ``But if CMS
adopts a position that deems that fetus a ``child'' in utero, then what
possible justification could there be for denying SCHIP benefits to
such a ``child''?'' Another commenter recommended that the proposed
regulation should not be clarified to deny coverage to the unborn
children of immigrant women merely because the women would themselves
be ineligible to receive benefits under Federal statute. This commenter
stated that any clarification of the regulation should make explicit
that the woman's immigration status is irrelevant to the provision of
SCHIP benefits. If the proposed regulation is adopted, there is no
principal basis on which to distinguish the unborn children of
immigrant women from the unborn children of citizen women. The
commenter said that although Federal statute provides that ``an alien
who is not a qualified alien is not eligible for any Federal public
benefit * * *'' 8 U.S.C. 1611(a), an unborn child has no citizenship or
immigration status whatsoever, and is therefore not made ineligible for
coverage by reason of 8 U.S.C. 1611(a) or any other immigration-related
eligibility restriction. The commenter stated that any exclusion of the
unborn children of ineligible immigrant women would thus have to be
accomplished by altering the proposed regulation to exclude such unborn
children explicitly. The commenter contended that such a change would
be contrary to the avowed purpose of the proposed regulation and would
have no basis in logic, given that the regulation is premised entirely
on the unborn child's status and not the woman's and in support of this
position cited Plyler v. Doe, 457 U.S. 202, 220 (1982) (invalidating
State law denying public schooling to the children of undocumented
immigrants because the denial ``directed the onus of a parent's
misconduct against his children'').
Response: We agree that it is does not make sense to try to impute
an immigration status to an unborn child based on the status of the
mother. As discussed above, an unborn child is not an alien, and the
status of the child is not necessarily tied to the status of the
mother. Moreover, to do so would not be consistent with the purpose of
providing States with the flexibility to maximize the availability of
prenatal care to ensure healthy infants and children.
Comment: Commenters stated that the rule should be clarified to
make clear that undocumented immigrants may not be reported to
immigration authorities for seeking medical care for their unborn
children. Commenters were concerned that in the absence of such a
protection, undocumented immigrant mothers may not seek medical care,
and their unborn children will not receive care they need to help
ensure a healthy birth and are entitled to as a U.S. citizen.
Commenters stated that since the pregnant woman will never be the
recipient, it would seem that a State, pursuant to the ``Tri-Agency
Guidance'' issued by the Departments of Health and Human Services and
Agriculture (on 9/21/00), would be prohibited from inquiring about her
immigration status.
Response: Nothing in this regulation alters section 434 of the 1996
welfare reform statute, which prohibits the Federal government from
restricting State or local government entities from sending to or
receiving from the Immigration and Naturalization Service information
regarding the immigration status of an alien in the U.S. Further,
nothing in this regulation alters the Tri-Agency Guidance with respect
to inquiries about immigration status of nonapplicants.
Comment: The commenter was concerned about the additional cost of
covering all unborn children conceived in the United States by illegal
immigrant women. The commenter believes that under this rule, the
unborn child should be eligible for benefits if (she is conceived in
the United States. The commenter was concerned that if women are
permitted to self-declare whether conception occurred in United States
that the Administration's cost estimate is too low because of the large
numbers of undocumented immigrants who would be receiving coverage.
Response: The question of where conception occurred is irrelevant
to the question of the unborn child's immigration status or this final
rule. This regulation provides states with the flexibility to assure
essential prenatal care to the maximum number of unborn children,
regardless of the immigration
[[Page 61967]]
status of their mothers. States, in deciding whether or not to adopt
this option under their title XXI state plan, will certainly weigh,
along with numerous other factors, the potential costs associated with
providing coverage to unborn children since States cannot receive
Federal funding that exceeds title XXI allotment.
Comment: One commenter stated that prenatal care is even more
important among Latinas, who suffer from higher rates of pregnancy-
induced hypertension and maternal mortality. The commenter noted that
12 States offer prenatal care to immigrant women who are ineligible for
Federally funded medical assistance, which has lessened the effects of
PRWORA. The commenter stated that if the new regulation explicitly
covers children of undocumented immigrants, it would increase the
number of States that provide prenatal care services to pregnant
immigrant women and provide an incentive for those States that have
seen a large influx of Latina immigrants in recent years.
Response: This rule ensures that States have maximum flexibility to
extend SCHIP eligibility to unborn children, independent of the
immigration status of the mother. We believe that this rule addresses
the concerns of the commenter since the intent of this rule is to
benefit both the unborn child and their mothers by promoting continuity
of important medical care.
5. Benefits
Comment: Commenters, whether in favor of this rule or not,
expressed their belief that all women should receive regular and
adequate prenatal care because there is overwhelming data that shows
that there are still too many women who receive no or less than
adequate care during pregnancy. Commenters agreed that health care
should be provided from the prenatal stage.
Many commenters, in support of this rule, expressed their belief
that all women should be able to receive prenatal services that
increase the chances of every child being born healthy. This regulation
would allow pregnant women and unborn children to receive the medical
treatment they need. Commenters noted that the lack of prenatal care
results in increased health costs for taxpayers in caring for problems
and complications after birth, and some noted that coverage of the
unborn child may result in the incidental improvement in the health of
the mother. But, all too often proper prenatal care has been cost
prohibitive to low-income women, and the commenters view this proposal
as assisting the millions of women of childbearing age who lose or lack
health insurance. Proper prenatal care can prevent avoidable birth
defects. Fetal surgery is able to correct many life-threatening
congenital disorders. There is no reason the unborn child should be
denied the lifesaving procedures that will permit him or her to live a
full, normal life after birth, particularly with the recent medical
advances that will continue to develop and evolve. Providing this care
is a benefit, not only for the unborn child, but for women and families
as well. Commenters stated that this policy provides a way for the
mother to make positive choices with regard to caring for her unborn
child and herself.
Some commenters noted that coverage would decrease infant mortality
rates. Two commenters cited a DHHS report, ``Trends in the Well-Being
of America's Children & Youth 2000,'' that indicated prenatal care can
improve birth outcomes and decrease health costs. Two commenters also
cited an American Academy of Pediatrics (AAP) policy that indicates ``*
* * physical and psychosocial growth, development, and health of the
individual begins prior to birth when conception is apparent * * * the
responsibility of pediatrics may therefore begin with the fetus * * *
.''
Commenters expressed a concern that it is in the public's interest
to assure that expectant mothers have access to quality prenatal health
care coverage as highlighted in Healthy People 2010. Additionally,
commenters noted that it is less expensive to care for healthy babies
than unhealthy babies and that access to prenatal care means long-term
reduction in the cost of health care for these children. Expanding
Federal health programs to give more low-income pregnant women access
to prenatal care is an important step in making sure children get a
healthy start in life.
Response: We appreciate the commenters' support of our goal in
developing this rule. By providing States with the option of ensuring
that needed prenatal care is available under SCHIP to benefit unborn
children, uninsured low-income women, who are less likely to receive
prenatal care, would be able to access crucial services that they may
not otherwise be able to receive. This regulatory clarification is
intended to benefit both the unborn child and the mother by promoting
continuity of important medical care. We agree that healthy pregnancies
should also result in significant savings in public expenditures over a
child's lifetime.
Comment: While commenters agreed with the importance of prenatal
care as essential for the mother and child, many disagreed with the
mechanism this Administration has taken for accessing that care. They
feel very strongly that eligibility should be extended to the pregnant
woman and not to the unborn child. Several commenters opposed this
approach as a false separation of the woman and child. Commenters were
concerned that the medical needs of the embryo would take precedence
over the needs of the mother and stressed their belief that the benefit
should be conferred to the woman and not to the unborn child. They
expressed concern that this regulation may create a conflict of
interest between the woman and the unborn child.
They believe that a crucial question is whose needs take priority?
Many felt that treating the unborn child as if it exists separately and
should be considered before and above the health of the woman carrying
the unborn child is a false separation that would ultimately prove
detrimental to the health of many women as well as to their unborn
children or newborns. They believe that this proposal interferes with
women's autonomy to make medical care decisions and represents an
arbitrary separation of the woman and child (since one cannot be cared
for without the other also receiving care). One commenter indicated
that conflicts of interest between the mother and child would not arise
if the woman was determined the patient, as under the Medicaid program
(42 U.S.C. 1396a(a)(10)(A)(i)(III), (IV), (VI), (VII), (A)(ii) and
(1).)
Response: We understand the commenters' concerns. The intent of
this rule is to maximize the availability of SCHIP benefits in the
interest of both pregnant women and unborn children. The statutory
provisions of title XXI are very clear that only targeted low-income
children can be eligible for the program. Although, under Sec.
457.1010 States do have the option of applying for a variance to
purchase family coverage through which a pregnant woman over the age of
19 could be determined SCHIP eligible.
States do have options available if they wish to expand eligibility
to a pregnant woman over the age of 19 whose income is over the current
Medicaid income guidelines rather than to the unborn child, which
include: a title XIX expansion under one of their poverty groups; or a
section 1115 waiver demonstration. However, absent a
[[Page 61968]]
waiver, eligibility can only be conferred to the targeted low-income
child.
That being said, nothing in this rule is intended to affect the
traditional relationship between the pregnant mother and the physician.
Questions of medical treatment for the pregnant woman and/or her unborn
are a decision between the pregnant woman and her physician and nothing
in this rule would circumvent or alter that relationship.
Comment: Commenters were concerned that a woman could possibly be
denied medical treatments such as prescription drugs, psychotropic
medications to treat psychiatric illnesses, and life-saving radiation
or chemotherapy treatments because of the effects they would have on
the unborn child.
Commenters asked if the pregnant woman would be denied other care
that might be harmful to the unborn child, thus effectively pitting her
needs against those of the unborn child? One commenter asked whether
the State would be subjecting women to drug and alcohol tests on the
alleged ground that it is protecting its patient-beneficiary? Several
commenters referred to this policy as medically unsound, ethically
unacceptable, and/or poor public policy. Commenters questioned if
physicians would be required to consult with the unborn child's father
or another legal guardian if these types of issues exist. Several
questioned what entities would have the authority to assert the rights
of the unborn child (such as, State, Federal government, physician,
pregnant woman, father?).
To illustrate their point, two commenters cited a court case (In re
A.C., 573 A. 2d 1235, 1235 (D.C.1990) in which a woman was compelled by
the court to undergo a caesarean section, following which both the
mother and unborn child died (Veronica E. B. Kolder et. al, Court-
Ordered Obstetrical Interventions, 316, New Engl. J. Med. 1192, 1195
(1987).
Several commenters also raised the question as to what happens in
cases where continuing the pregnancy itself endangers the life of the
mother, since the assumption made by the commenters is that the life of
the unborn child would take precedence over the life of the mother or
that both would be allowed to die.
Response: These comments extend beyond the scope of this
regulation, which concerns only the ability of States to extend SCHIP
eligibility to unborn children. As in Medicaid, nothing in this rule is
intended to affect the traditional relationship between the pregnant
mother and the physician. Questions of medical treatment for the
pregnant woman and/or her unborn are a decision between the pregnant
woman and her physician and nothing in this rule would circumvent or
alter that relationship.
Comment: Commenters expressed concern that certain benefits that
would provide comfort for the pregnant women would not be covered, such
as epidurals or anesthesia during delivery.
Response: Within the options for benefit coverage selected by a
State, as described at Sec. 457.410, a State selecting this SCHIP
option has the flexibility in defining its benefit package to provide
benefits it deems necessary.
Regarding the specific question asked by the commenters, while
analgesia given as an epidural and/or intramuscular intravenous
injections of pain relievers, and/or anesthesia given as regional or
general anesthesia is primarily provided during labor and delivery to
relieve the mother's pain from uterine contractions or to perform
surgery, that is, C-section, if a woman's pain during labor and
delivery is not reduced or properly relieved, adverse and sometimes
disastrous effects can occur for the unborn child. There is no question
that analgesia/anesthesia is required in order to perform a C-section
and such a procedure cannot even be considered if some form of pain
relief is not provided. In terms of vaginal deliveries, without
relieving the mother's pain from uterine contractions, the progress and
labor may be interrupted and not efficient, which in turn can cause
fetal complications, such as fetal distress and infection from
prolonged labor and prolonged rupture of membranes and other
complications. Therefore, we would expect that this coverage would be
provided.
Comment: Several commenters were concerned about whether States
would have the flexibility to use enhanced Federal funds to provide
comprehensive benefits to pregnant women and stated that the failure to
provide a comprehensive range of services for all of a pregnant woman's
health care needs and treatment of some stated diseases, could
compromise her health, as well as, that of the unborn child.
Although many commenters supported expanded access to prenatal care
among low-income, uninsured women, many believed that the benefit
should be given to the woman, in addition to or instead of her unborn
child. One commenter stated that one cannot effectively treat an unborn
child without treating the woman carrying it, believing that a healthy
pregnancy resulting in the delivery of a healthy baby requires a
healthy mother. One commenter stated that low-income women deserve
actual, not merely incidental, health insurance coverage that covers
all of their health needs. Several commenters indicated that women
deserve comprehensive care, not simply care related to the unborn
child, and several referred to the proposal as ``reducing women to
vessels.''
Commenters also felt that extending comprehensive care to the
mother would result in women who are healthier and ultimately would
result in better birth outcomes. One commenter felt that targeting
coverage for the unborn child, not the mother raised ethical issues and
puts the mother's health at risk by providing inadequate coverage.
Commenters expressed concern or questioned whether care would be
extended to women for injury or disease not related to the pregnancy,
such as skin melanoma, emergencies, accidents, broken bones, or mental
illness. One commenter advocated for coverage of drug treatment
programs for mothers who were addicted.
Several commenters indicated that the focus should be on addressing
the health care needs of millions of uninsured women, and one advocated
expanded access to uninsured women to ``take care of those already
here.''
Response: The SCHIP statute provides States with broad flexibility
in defining those services for which they choose to provide coverage
under their State plan. States have the flexibility to define and
provide comprehensive services that are related to the pregnancy or to
conditions that could complicate the pregnancy. Under the regulation,
States would define what services would be included. Services related
to conditions that could complicate the pregnancy include those for
diagnosis or treatment of illnesses or medical conditions that might
threaten the carrying of the unborn child to full term or the safe
delivery of the unborn child. Within these parameters, States have
discretion in the services for which coverage can be provided.
However, SCHIP eligibility is limited by statute to targeted low-
income children and there must be a connection between the benefits
provided and the health of the unborn child.
We would point out that the regulation is intended to reach
individuals who are currently uninsured and who therefore lack access
to any services.
Comment: Commenters believe that, by permitting States to extend
SCHIP coverage to unborn children, this rule would effectively deny
women access to needed postpartum care. They felt that pregnancy-
related care should be
[[Page 61969]]
viewed as a continuum comprising three distinctly important periods:
prenatal, intrapartum (during labor and delivery), and postpartum care.
Commenters stressed that a woman's pregnancy-related health care needs
do not end the moment her child is born. The commenters stated that the
woman still requires many pregnancy-related services and optimal
maternal health is important for overall family health. Under the
proposed regulation, covered care would be available only during ``the
period from conception to birth.'' These commenters are concerned that
the moment after the birth of the child, a woman would lose any
incidental covered care that she had received as a result of having an
SCHIP-covered unborn child in utero. The commenters continued with
their concern that woman would therefore not be eligible for any care
during the postpartum period including but not limited to the treatment
of hemorrhage, infection, episiotomy repair, C-section repair, family
planning counseling, treatment of complications after delivery, and
postpartum depression. Several cited this proposal as bad public policy
that will ultimately result in increased health care costs.
One commenter questioned whether hospitals and practitioners would
be compelled to release women immediately after delivery due to lack of
maternal coverage. Others expressed concern that some women will leave
the hospital immediately after birth to avoid expenses, against ACOG
and AAP recommendations, while others will not attend the four to six
week recommended follow-up visits (resulting in decreased maternal
health).
Several commenters noted that if the mother is ill and does not get
the care she needs, she may not be able to take care of her children,
especially an infant, appropriately. This indirectly jeopardizes the
health of women, children and families, and will inevitably result in
compromised health outcomes for both the woman and the unborn child.
Commenters quoted ACOG and AAP's recommendation that four to six
weeks after delivery the mother should receive a postpartum review and
examination. Several commenters referenced Medicaid statute and
regulations as an illustration of how public programs rely on
established medical standards (Sec. 1902(1) of the Act as defined in
Sec. 1902(a)(10)(a) (clause VII).
One commenter also indicated that lack of family planning
counseling creates greater risk of unintended pregnancy with serious
social and economic costs to the woman, State, and community. Others
noted that maternal mortality represents a serious health problem,
particularly for African-American women.
One commenter stated that coverage for postpartum care and
assistance in enrollment in Medicaid or SCHIP should be a requirement
for States electing to implement this rule, even in cases where the
child is not born alive.
Commenters asked clarifying questions such as: would postpartum
follow-up be covered; would emergencies arising to the mother following
delivery be covered; and would benefits such as the 60 days postpartum
care available through Medicaid be provided?
Response: Again, the intent of this rule is to extend access to
individuals who are currently uninsured. We believe that the benefits
that would be available to the mother and unborn child are indeed
vital.
The SCHIP statute provides States with flexibility in defining
those services for which they choose to provide coverage under their
State plan. States have the flexibility to define and provide services
that are related to the pregnancy or to conditions that could
complicate the pregnancy. Within these parameters, States have
significant flexibility in the services for which coverage can be
provided.
Commenters are correct that care after delivery, such as postpartum
services could not be covered as part of the title XXI State Plan,
(unless the mother is under age 19 and eligible for SCHIP in her own
right), because they are not services for an eligible child.
Comment: One commenter expressed concern that there are those who
would define care to include abortion, which the commenter felt would
be a complete twisting of the term ``care.'' This commenter did not
want abortions covered by the government.
Response: FFP is available in expenditures for abortions under
SCHIP only as specifically authorized by the Congress in the statute
and this will not change with this regulation. Section 2105(c)(1) and
(c)(7) of the Act sets limitations on payment for abortion services
under SCHIP. Section 457.475 of the January 2001 SCHIP final
regulation, specifies that FFP is not available for expenditures for
abortion, or for expenditures for the purchase of health benefits
coverage that includes coverage of abortion services, unless the
abortion is necessary to save the life of the mother or the abortion is
performed to terminate a pregnancy resulting from an act of rape or
incest. Additionally, FFP is not available to a State for expenditures
of any amount under its title XXI plan to assist in the purchase, in
whole or in part, of health benefits coverage that includes coverage of
abortion other than to save the life of the mother or resulting from an
act of rape or incest.
Comment: Commenters asserted that fetal surgery saves lives, as in
the case of spina bifida or repair of heart defects and asserted that
this type of coverage should be offered to unborn children.
Response: We provided a discussion of ``fetal medicine'' or
``fetology'' in the preamble to this rule as an example of a distinct
and important medical specialty that represents emerging opportunities
for services specifically targeted to the care of the unborn child.
Consistent with section 2103 of the Act, States have flexibility in
defining the benefits that are included as part of the health coverage
provided to targeted low-income children. The specific prenatal and
pregnancy related benefits included in a State's benefit package would
be the decision of the State.
Comment: The commenters stated that the practices of ``fetal
surgery,'' as described in the March 5, 2002 proposed rule, have been
deeply plagued by both clinical and ethical problems. The commenters
wanted to make clear that there is no such thing as fetal surgery
independent of the mother, and that surgery on the unborn child occurs
only through the woman's body and can occur only with her consent.
Commenters stated that surgery on the fetus presents significant risks
to the pregnant woman's life and health and the impact this surgery can
have on pregnant woman should be recognized and strongly considered.
Commenters continued that modest improvements (or no improvements at
all) in the outcomes for fetuses with neonatal operations often happen
in conjunction with severe obstetrical complications for the woman.
In support of the medical and ethical controversy surrounding fetal
surgery, one commenter cited several articles: Bruner et al, Fetal
surgery for myelomeningocele and the incidence of shunt dependent
hydrocephalus JAMA 1999;282;1819-25; Sutton et al, Improvement in
hindbrain herniation demonstrated by serial fetal magnetic resonance
imaging following fetal surgery for myelomeningocele JAMA
1999;282:1826-31; Simpson JL, Fetal surgery for myelomeningocele:
Promise, progress, problems JAMA 1999;282;1873-4; Lyerly et al,
Attitudes of maternal-fetal specialists concerning maternal-fetal
surgery, American Journal of Obstetrics and Gynecology 2001;185;1052-8;
Lyerly et al, Toward the ethical evaluation and use of
[[Page 61970]]
maternal-fetal surgery. Obstetrics and Gynecology 2001;98;689-97. This
commenter also cited a National Institutes of Health conference
examining the scientific, clinical, and ethical issues related to
maternal-fetal surgery.
The commenters stressed that a review of the medical literature
shows that maternal-fetal surgery is still considered experimental or
investigational by such medical professional organizations as the
American College of Obstetricians and Gynecologists. One commenter
quoted a member survey of the Society for Maternal-Fetal Medicine,
which found that 57 percent of respondents believed that a moratorium
should be imposed on open fetal surgery for nonlethal conditions until
a multicenter controlled trial is completed. The commenter noted that
most of the conditions listed by the March 5, 2002 proposed rule are
exceptionally rare and the mortality rates following surgery have been
high. Another commenter indicated that current Medicaid programs and
most private insurers do not cover experimental procedures.
In addition, the commenters expressed concern that there is no
research or data to support the assertion that fetal surgery can
ultimately lower postpartum medical care costs. They indicated that
while long-term research in this field may someday produce such
results, the March 5, 2002 proposed rule's claims that cost-savings
currently exist is without support.
The commenters noted that despite the fact that fetal surgery is at
this stage largely experimental, the March 5, 2002 proposed rule states
that the ``Secretary would like to permit the States the flexibility to
pay for the medical expenses related to unborn children,'' suggesting a
departure from longstanding State and Federal policy regarding denying
coverage for experimental treatments. One commenter indicated that this
rule seems to signal a radical shift in policy regarding experimental
treatments, and if this is the case, there are many patients suffering
from cancer and other diseases who might benefit from an overall change
in policy regarding experimental treatments. The commenter refers to a
May 26, 1993, letter to State Medicaid Directors and cites the
following: Miller by Miller v. Whitburn, 10 F.3d 1315 (7th Cir. 1993);
Rush v. Parham, 625 F.2d 1150, 1156 (5th Cir. 1980); Weaver v. Reagan,
886 F.2d 194 (8th Cir. 1989).
In addition, commenters are concerned that since fetal surgery is
so new and lacking in proven benefits that it really should be
considered research. Commenters asserted that this would make it
appear, then, that this rule is promoting unreviewed and unapproved
research on pregnant human subjects, in conflict with statutes
regarding human subjects of medical research (Anne E. Drapkin Lyerly,
MD et al. Toward the Ethical Evaluation and Use of Maternal-Fetal
Surgery, 98 ACOG 689 (2001).) They also stated that fetal surgery is
experimental and it is highly unlikely that this would be covered by
Medicaid or any other insurance program (45 CFR 46.101 through 45 CFR
46.409, promulgated pursuant to the Health Research Extension Act, 42
U.S.C. 289.)
Response: As we have said previously, nothing in this rule is
intended to affect the traditional relationship between the pregnant
woman and her physician. Questions of medical treatment for the
pregnant woman and/or her fetus are a decision between the pregnant
woman and her physician and nothing in this rule would circumvent or
alter that relationship.
Additionally, we are not saying that States that choose to extend
coverage to the unborn child must provide fetal medicine or fetology.
Consistent with section 2103 of the Act, States have flexibility in
defining the benefits that are included as part of the health coverage
provided to targeted low-income children. As such, States have always
had the ability under SCHIP to provide treatments or surgery that may
be considered investigational or experim |
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