1

August 27, 2010

Office of Consumer Information and Insurance Oversight

Department of Health and Human Services

Attention: OCIIO‐9994‐IFC, RIN 0991‐AB69

P.O. Box 8016

Baltimore, Maryland  21244‐1850

Office of Health Plan Standards and Compliance Assistance

Employee Benefits Security Administration. Room N‐5653

U.S. Department of Labor

200 Constitution Avenue NW

Washington, DC  20210

Attention:  RIN1210‐AB43

Internal Revenue Service

CC: PA: LPD: PR, Room 5025

P.O. Box 7604 Ben Franklin Station

Washington, DC  20044

Attention: REG‐120399‐10

RE: File Code OCIIO‐9994‐IFC, RIN 0991‐AB69/ RIN 1210–AB43/REG–120399‐10. Requirements for

Group Health Plans and Insurance Issuers under the Patient Protection and Affordable Care Act

Relating to Pre‐Existing Condition Exclusions, Lifetime and Annual Limits, Rescission, and Patient

Protections, Final Rule and Proposed Rule

Dear Sir or Madam:

The undersigned organizations, representing millions of consumers, thank you for the opportunity to

comment on the interim regulations pertaining to patient protections under the Affordable Care Act.  

The protections addressed in these regulations are essential to people who face serious illnesses. They

will provide children with access to coverage this year, and provide all people with access to coverage

regardless of their health status in 2014; ensure that coverage continues to protect people who face

serious and costly illnesses; prevent abusive retroactive cancellations of coverage; help people choose

providers that will ensure  continuous and coordinated care; and improve coverage for people who face

an emergency and must obtain treatment out‐of‐network. We appreciate the thought and care with

which the Departments have addressed these important issues and offer the following comments on

additional protections that should be built into these rules.

Pre‐Existing Condition Exclusions (26 CFR  54.9801‐2 and 54.9815‐2704T1

, 29 CFR 2590.701‐3 and

2590.715‐2704, 45 CFR 147.108 and 147.126)

                                                           

1

 All references to Department of Treasury temporary rules in this comment letter are also intended as comments on 

the proposed rules with the same text and similar numbers published in the June 28 Federal Register. 
2

We are pleased that the interim final rule (IFR) clearly prohibits the denial of coverage based on health

status and the exclusion of coverage of specific benefits associated with a pre‐existing condition for

children under 19 in plan years beginning on or after September 23, 2010 and for adults in plan years

beginning on or after January 1, 2014. The rule provides immediate and critical new protections for

families with children with preexisting conditions who are purchasing coverage in the small group and

individual markets. In order to strengthen the protections and to fulfill the promise of the Affordable

Care Act (ACA), we recommend the following improvements to the interim final rule:

 The final rule should include excessive waiting periods in the definition of pre‐existing

condition exclusions. An excessive waiting period should be defined as any period longer than

90 days, in line with the ACA provision that will go into effect on January 1, 2014. Without such

an inclusion, children with pre‐existing conditions will continue to face delays in access to

necessary coverage and care for their health conditions.2

 The final rule should explicitly allow the Secretary of Health and Human Services to use her/his

regulatory authority under Section 2794 to prohibit unreasonable premium increases and/or

excessive premiums for families with children with pre‐existing conditions. Without such

authority, insurers may charge newly covered children with pre‐existing conditions excessively

high premiums or significantly increase premiums for currently covered children based on their

health status, making coverage unaffordable and unattainable for families. Allowing such high

premiums and premium increases goes against the intention of this provision of the ACA, to

expand health coverage to more children.  

If states allow limited open enrollment periods for children, they should be required to have special

enrollment periods in individual market policies as well as group policies. On July 28, the

Administration issued new guidance regarding the sale of health plans to children with pre‐existing

conditions that permits open enrollment periods in the individual market, as allowed under state law.

We appreciate this new guidance and request that for states without laws on the timing and duration of

open enrollment periods, the final rule should, at a minimum, establish special enrollment period rules

for the individual market, paralleling the rules of the group market. Special enrollment periods will

provide families the opportunity to learn about and understand their coverage options and make

educated decisions. Moreover, during the first year in which coverage is available to children without

regard to pre‐existing conditions, plans should not restrict enrollment periods or should allow liberal

exemptions to any open enrollment periods, since it will take time for many families to learn about their

new rights to coverage and seek enrollment.  

Lifetime and Annual Limits (26 CFR 54.9815‐2711T, 29 CFR 2590.715‐2711, 45 CFR 147.126)

Adequacy of Transitional Annual Limits

The rules will phase out the use of annual dollar limits over the next three years, until 2014 when the

Affordable Care Act bans annual limits on essential benefits. Plans issued or renewed beginning

September 23, 2010 will be allowed to set annual limits no lower than $750,000. We understand the

                                                           

2

 There is precedent in existing rules for considering a waiting period as part of a pre-existing condition exclusion 

period – see the definition of enrollment date for purposes of calculating the maximum pre-existing condition 

exclusion period in the group market (45 CFR 146.111.). 
3

                                                           

need for a transitional period to phase out annual limits and believe that while the first year limit of at

least $750,000 is reasonable it is still on the low side.  There will still be cases when individuals may find

themselves with significant out of pocket expenses.  For instance, the estimated average U.S. billed

charges for the first year following a heart transplant were nearly $788,000 in 2008. Likewise, average

first year billed charges for a heart‐lung transplant were $1.1 million in 2008.3 As these costs illustrate,

patients undergoing such transplants may still be left with significant out‐of‐pocket costs, even with a

$750,000 annual limit.

Modify Transitional Period:

Although we believe the transitional annual limit amounts are reasonable overall, we recommend that

the rules provide further clarification regarding the timing of when annual limits are fully prohibited. The

statute generally requires this section of the law to be effective six months after enactment (Section

1004) and provides that “with respect to plan years beginning prior to January 2014” plans can establish

restricted annual limits as defined by the Secretary (Section  1001). To simplify the marketplace for

consumers and to ease oversight and enforcement, it would be extremely helpful to clearly prohibit

annual limits in all plans beginning on January 1, 2014. Thus, we suggest that the Secretary restrict

annual limits for the 2013 plan year in such a way that any allowed limits expire on December 31, 2013.

The rule should clarify that, for example, although an insurer may have a plan year that begins in

October and may be able to apply an annual limit of $2 million from October 2013 to December 2013,

once 2014 starts, the plan must not impose an annual limit of any value.   

Decreases in annual limits should be prohibited, not just result in a loss of grandfathered status. We

are concerned that the temporary rule (section d) and the rules on grandfathering4 both allow a health

plan to establish an annual limit when it had neither an annual nor lifetime limit before.  As currently

drafted, adding a new annual limit or lowering an annual limit would result only in the loss of

grandfathering status. While we understand the need for a transitional period prior to 2014 in order to

keep plans on the market and avoid large premium increases, this transition should pertain only to plans

that previously had lifetime or annual limits. Under the statute, the Secretary is to “ensure that access to

needed services is made available with a minimal impact on premiums.”  Therefore, 1) plans that did not

previously have limits should not be permitted to decrease their coverage by imposing new restrictions;

2) plans that previously had lifetime limits but not annual limits should be prohibited from adopting an

annual limit that is lower than the dollar value of their previous lifetime limit; and 3) plans should be

prohibited from decreasing their annual limits. Any of these changes would decrease access to needed

services.

Clarify application of transitional annual limits and prohibited annual limits. Regarding the transitional

annual limits that plans may apply in years before 2014, we recommend that the rule clarify that the

permitted limits may only be applied collectively—that is, that dollar “sublimits” on specific services are

prohibited. For example, the rules should make clear that a plan that imposes a $750,000 limit for the

coming plan year comprised of individual service limits that add up to $750,000 (for example, $10,000

for prescription drugs, $300,000 for hospital services, etc.) would not be in compliance with the ACA.

3

 Milliman Inc., 2008 U.S. Organ and Tissue Transplant Cost Estimates and Discussion (Brookfield, WI: Milliman 

Inc, April 2008). 

4

 See 26 CFR 54.9815-1251T (g). 
4

Additionally, insurance consumers often find themselves with inadequate access to care because of non‐

dollar service limits imposed by their health plans. We believe that the rules should clarify that these

arbitrary limits, such as those on the number of hospital days, outpatient specialist visits, or other

services, are not permitted under the ACA. Without such a clarification, we are concerned that

insurance plans will simply replace their current dollar limits with annual service limits, nullifying the

effects of this important consumer protection: limits on hospital days, for example, are easily translated

into a monetary value and can be a subterfuge for annual dollar limits on care. Instead of allowing

arbitrary service caps, the rules should clarify that medical necessity is the criteria upon which insurers

must base their claim payment decisions. This standard will ensure that consumers receive timely,

appropriate, and effective care. In order to control utilization, a plan might require prior authorization of

visits that go beyond some amount that is based on typical treatment protocols, but should not ban

additional visits all together. Services in the essential benefit package should be adequate in scope to

achieve their purpose. 5

Waiver of Annual Limit Restrictions for Certain Health Plans

The rules provide that the Secretary of Health and Human Services may grant a waiver from annual limit

restrictions to plans for which the application of the requirements “would result in a significant decrease

in access to benefits or a significant increase in premiums.” The rules state that future guidance will be

provided on the scope and process of such a waiver. Such future guidance should clarify what is meant

by “a significant decrease in access to benefits” and should also include specific criteria for what

qualifies as a “significant increase in premiums.” Guidance should further provide for notice to affected

consumers and an opportunity for consumers to comment on proposed waivers.  

The preamble to the rules discusses mini‐med plans as being possibly subject to future waivers. While

we understand the need to protect people who have already enrolled in these policies until they have

access to another affordable plan in 2014, we are concerned that many consumers enroll in these plans

without understanding how unprotected they are against major medical expenses.  Consumers in these

plans have found themselves without access to care and/or in debt when they experience illness. The

Secretary should consider whether consumers are likely to get anything of value for their premium for a

mini‐med policy before granting a waiver. The Secretary should require prominent warnings to

consumers and employers, including information on what essential benefits are not covered or are

limited and information about how to find more comprehensive coverage. (See p. 6 for a discussion of

waivers and dependent coverage.)

Notice Needed When Reaching an Annual Limit

The rule does not address notice requirements when a person is nearing an annual limit. We suggest

that the insurer or health plan be required to notify enrollees when they are close to reaching an

allowed annual limit (for example, when the plan has already paid out 75 percent of the amount of the

annual limit). This may allow consumers time to plan financially, if possible, for the high out‐of‐pocket

costs they may face for their treatments later in the year. In addition, the notice should include:  contact

information for enrollees who believe there is an error in calculating their health expenses or in the

application of the limit; notice that they may be eligible for Medicaid or Medicare if they have a

permanent disability and the government’s webportal address (www.healthcare.gov) for further

                                                           

5

 Until essential benefits are further defined, you could use a standard similar to Medicaid’s standard that services be 

sufficient in amount, duration, and scope to reasonably achieve their purpose (42 CFR 440.230(b)). 
5

                                                           

information about their options;  the date on which they will again be eligible for benefits under the

health plan; and general information that the annual limit will be higher in future years.  

Notice and Re‐Enrollment Opportunity for Individuals Who Have Hit Lifetime Caps   

Section (e) provides for notice and an enrollment opportunity for people who previously reached a

lifetime limit. This notice should meet plain language standards and be furnished in Spanish as well as

English and in other languages upon request. Also, it should clarify whether the 30 day enrollment

period begins on the date the notice was postmarked or the date the notice was received.  Following is

an example of a consumer‐friendly notice6

:   

If you (or a family member) lost health coverage because you reached your plan's lifetime limits,

you can now re‐enroll. XXX plan no longer limits the dollar value of benefits it will cover over

your lifetime. Individuals have 30 days to enroll after [receiving this notice? the date or

postmark date on this notice?]. For more information, contact [plan administrator or issuer] at

[phone number].  

Additionally, we believe that clarification is needed regarding which former plan enrollees are eligible to

re‐enroll in under the prohibition on lifetime limits, particularly in the individual market.  An example

clarifying which individual market enrollees would be eligible and which, if any, would not be eligible

would make it easier to understand who can benefit from this protection.  

Premiums for Enrollees Who Have Reached Limits

We are concerned that the rules do not provide guidance on the premiums that insurers may charge to

individuals who have the right to re‐enroll in a plan due to a previous lifetime limit. The rule should

clarify that such individuals cannot be subject to new underwriting and should be charged using no

higher health status or claims history underwriting than when they were last enrolled in the plan.

Without these standards, individuals with a right to re‐enroll in coverage may be priced out of the

market, undermining the intended protection. Similarly, the rules should also clarify that insurers may

not subject those who have hit an allowed annual cap, but who will start coverage again at the

beginning of the next plan year, to new underwriting.  

Relationship between Dependent Coverage Extension and the Patient’s Bill of Rights

The regulations prohibit health plans from setting annual benefit caps below certain dollar values,

starting at $750,000 in 2010.7 However, they also allow the Secretary to waive annual cap restrictions

for certain plans, including mini‐med plans, if doing so would avoid a major reduction in benefits or

increase in premiums.8 These waivers could cause unintended problems for young adults who might

otherwise be eligible for meaningful insurance as a dependent on a parent’s plan. Accordingly, the

regulations should clarify how such waivers will affect the dependent coverage extension.  

The Affordable Care Act (ACA) requires all plans providing dependent coverage to extend that coverage

to any dependent under the age of 26.9 However, until 2014, grandfathered plans may choose not to

6

 You may wish to get more guidance from literacy experts as you finalize your model notices. 

7

 26 C.F.R. § 54.9815-2711T(d). 

8

 26 C.F.R. § 54.9815-2711T(d)(3). 

9

 Patient Protection and Affordable Care Act of 2010 § 1001(5); see also 26 C.F.R. § 54.9815-2714T. 
6

                                                           

cover adult dependents who are eligible to enroll in their own employer‐sponsored insurance.10 If a

young adult’s employer offers a mini‐med plan, a type of plan that often provides extremely limited caps

and benefits, the plan must generally comply with the Patients’ Bill of Rights, and current regulations

would bar the young adult access to a parent’s health plan. However, if the Secretary decides to grant a

waiver to the employer’s mini‐med plan, the young adult would be limited to sub‐standard health care

regardless of what might be otherwise available through a parent’s plan. That result would lock young

adults into insurance plans that do not comply with the ACA’s fundamental protections, running

contrary to Congress’s clear intent to ensure meaningful health care for as many Americans as possible.  

Therefore, the regulations on the Patient’s Bill of Rights should clarify that a health plan receiving a

waiver from annual cap restrictions does not qualify as eligible employer‐sponsored insurance for the

purposes of determining eligibility for the dependent coverage extension. A young adult with access to

a plan with a waiver should still be allowed to join a parent’s grandfathered plan.

Applicability to Student Health Plans

The Patients’ Bill of Rights should expressly apply to student health plans. Further, when evaluating

waivers from annual caps for those plans, the Secretary should carefully consider the consequences of

withholding this basic protection from students on plans with minimal benefits.  

Rules have not yet been issued regarding how student health insurance plans will be regulated. For now,

it is unclear whether they will be considered group plans, individual plans, or a separate type of plan

altogether.11 However, the regulations on the Patients’ Bill of Rights only expressly apply to group and

individual health plans. According to 2006 Census data, nearly 20 million students were enrolled in a

college or university.12 Millions, of those are insured through student or individual market plans.13 Those

students should be able to rely on the basic protections provided for in the Affordable Care Act.

Accordingly, the regulations should clarify that those protections will be available under any student

plan.  

The ban on restrictive annual limits is one of the most important protections for students. The Secretary

has the discretion to waive these limits in order to preserve the viability of existing plans.14 While we

agree that student health plans should remain available, we strongly believe that those plans should be

more than insurance in name only. A recent report by New York’s attorney general found that, along

with kickbacks to universities and very low per‐illness limits, some student plans have annual benefit

caps of $25,000 or less.15 Because students pay hundreds or thousands of dollars for this type of

coverage, many will incorrectly believe that they will be covered if they get sick or injured. Furthermore,

10 Health Care and Education Affordability Reconciliation Act of 2010 § 2301(a)(4)(B)(ii); see also 26 C.F.R. § 

54.9815-2714T(g). 

11 See Patient Protection and Affordable Care Act of 2010 § 1560(c) (“Nothing in this title . . . shall be construed to 

prohibit an institution of higher education . . . from offering a student health insurance plan, to the extent that such 

requirement is otherwise permitted under applicable Federal, State, or local law”). 12 United States Department of Commerce, US Census Bureau (2008, August) School Enrollment in the US: 2006. 

Retrieved from: http://www.census.gov/prod/2008pubs/p20-559.pdf. 13 United States Government Accountability Office (2008, March) Health Insurance: Most College Students Are 

Covered through Employer-Sponsored Plans, and Some Colleges and States Are Taking Steps to Increase Coverage. 

Retrieved from: http://www.gao.gov/new.items/d08389.pdf. 14 26 C.F.R. § 54.9815-2711T(d)(3). 

15 Andrew M. Cuomo, Office of the Attorney General of New York, Letter to Schools (2000). 
7

many student plans have extremely low medical loss ratios—sometimes with as little as 30 cents of

every dollar going towards medical care—suggesting that those plans could offset the costs of increased

benefit caps by achieving reasonable medical loss ratios.16 Accordingly, the Secretary should carefully

consider how withholding annual limit protections would affect students and should especially scrutinize

claims that a waiver would be required to preserve the viability of student plans.

Rescissions (26 CFR 54.9815‐2712T, 29 CFR 2590.715‐2712, 45 CFR 147.128)

The regulation prohibits plans from rescinding coverage “unless the individual (or a person seeking

coverage on behalf of the individual) performs an act, practice, or omission that constitutes fraud, or

unless the individual makes an intentional misrepresentation of material fact, as prohibited by terms of

the plan or coverage.” [45 CFR § 147.128(a)(1)] This addresses—and will hopefully end—the practice of

insurers retroactively cancelling coverage based on mistakes or unintentional omissions on an enrollee’s

application. While the incidence of rescission is relatively low at an estimated 10,700 per year, the

consequences can be devastating, usually happening at a time when a patient has accumulated a

significant medical bill.  

We appreciate the clarification that more protective federal or state laws may apply without

preemption and the admonition in the regulation’s preamble that the Department will be watching for

“attempts in the marketplace to subvert these rules.” This watchfulness is necessary given insurers’

continued battle over rescission rules in the states. For example, the Association of California Life and

Health Insurance Companies (ACLHIC), an industry trade association of life and health insurance

companies, filed a lawsuit on August 16 in the Sacramento Superior Court, two days before a new anti‐

rescission regulation was to go into effect in California.

Clarify “Material Fact”  

Since rescission is such a drastic action, the terms used to describe the circumstances in which rescission

is still possible should be clear to consumers. As such, the term “material fact” needs clarification and

should be narrowly defined. Consumers otherwise may not be clear what information is material to the

issuance of a health insurance policy.  

Clarify Burden of Proof

In addition, the regulation should explicitly note that insurers bear the burden of proving that a

consumer has committed fraud or intentional misrepresentation of a material fact. Consumers should

be informed that the insurer bears the burden of proof in the 30‐day advance notice of rescission that

plans must provide them.

Standards Regarding Health Questionnaires

One way for insurers to collect health information on prospective plan enrollees is through a health

questionnaire. Potential enrollees should be informed in writing that information collected on a health

questionnaire by an insurer, or an employer on an insurer’s behalf, can potentially be cited as evidence

of fraud or intentional misrepresentation at the time of application or at any time during the life of the

policy.  

                                                           

16 Id.
8

In addition, the regulation should set minimum standards for the content of health questionnaires.

Without commonsense protections, a confusing, ambiguous, or misleading questionnaire may be set as

a trap for consumers and allow insurers to violate the spirit of the rescission restrictions. At a minimum,

questionnaires should use clear, unambiguous, lay‐person language in discussing a prospective

enrollee’s medical history. Questions should only elicit medical information that is reasonable and

necessary for medical underwriting, and each question should clearly state the time frame covered.

Also, questions should not require an applicant to guess what symptoms are significant to the health

insurer or to understand the medical significance of symptoms or conditions. Applicants should also

have the opportunity to indicate where they are unsure of an answer.

30‐Day Advance Notice of Rescission

In the past, many consumers have faced rescission without the benefit of any advance notice, so a 30

calendar‐day window in which to begin the process of contesting the insurer’s decision or to find

alternative coverage is a good start. The notice should be delivered by certified mail with return receipt

requested, or by similar timely method that provides proof of delivery, to ensure the notice arrives in

the hands of the enrollee. The 30‐day clock should begin when the enrollee receives the notification, not

when it is sent.  

The regulation should also make clear what kind of information must be contained in the 30‐day notice.

At a minimum, the notice should include:

 a detailed explanation of the reason for rescission, including the legal standard for rescission

and the ways in which the insurer believes the consumer has committed fraud or intentional

misrepresentation of a material fact;

 a statement acknowledging that the insurer, not the beneficiary, bears the burden of proof;  

 an affirmation of the beneficiary’s right to obtain copies of any and all information used in

making this determination and an explanation of how this documentation can be obtained;

 a description of any federal or state consumer protections that exist, such as the right to an

appeal;  

 a description of how an appeal can be initiated and of the levels of appeal available to the

consumer;  

 a statement that tells the consumer about his/her right to fight the insurer’s decision to rescind

in court;

 a clear indication of the date the rescission decision takes effect and the date of the retroactive

loss of coverage; and  

 an itemized accounting of pending or previously‐reimbursed medical expenses that will be

recouped by the insurer, with provider’s name and contact information.  

Guarantee the Right to External Review of a Rescission

The regulation cross‐references PHS Act section 2719 on appeal rights. The interim final regulations for

section 2719 [45 CFR § 147.136 (c)] raise questions about the level of appeal available to consumers

facing a rescission. In that regulation, rescission of coverage is specifically listed as an adverse benefit

determination, regardless of whether or not there is an adverse effect on any particular benefit at that

time, and is subject to internal administrative appeal. However, with respect to external review, the

regulation allows states to maintain their current external review processes as long as they meet the
9

minimum standards of the NAIC Uniform Model Act. The NAIC Uniform Model Act does not explicitly

include rescission under the definition of “adverse determination.” Therefore, states maintaining their

own external review process rather than adopting the federal standard (likely most states) do not

appear to be required to give consumers the right to external appeal of rescissions.  

A consumer whose plan has been rescinded should have the right to an external appeal to a third party.

Questions of whether an omission constitutes fraud, whether information is “material,” and whether a

misstatement was “intentional” seem ideally suited for third party review since health plans have a clear

interest in reading those terms broadly. The reviewer should have the legal expertise to review the issue

of whether there was intentional misrepresentation of a material fact or fraud, not just medical

expertise. Coverage should remain in place pending the outcome of the review. Without the availability

of an external review process, the health plan has the final say unless a consumer bears the expense and

burden of a court case.

Provider Access

Choice of Health Care Professional (26 CFR 54.9815‐2719AT, 29 CFR 2590.715‐2719A, 45 CFR 147.138)

Improve Notice to Consumers

We generally support this section of the regulations. Federal rules about choice of health care

professionals have been very helpful in the Medicaid managed care context, and we expect that they

will assist other consumers as well. However, we suggest that the model notice be improved to be in

plain language, translated into Spanish, and also available in other languages. New enrollees should

receive prominent notice about any provider assignment—it should not be buried in a subscriber

contract. In addition, the plan should be required to explain how to find participating providers and

should regularly update their lists of participating primary care providers. Plans should explain

consumers’ right to choose providers and pediatricians in any web listing of providers and any provider

directories as well as in initial enrollment materials.  

Below is one suggestion of how to make the model notice more readable. 17

In XX plan, you must have a primary care doctor [or nurse]. You [and your family members] have

the right to choose any primary care doctor in our network, as long as that doctor serves people

in your age group and is taking new patients. You can get a list of primary care doctors in our

network at [web address and/or phone number]. Tell us who you have picked. Until you choose

your doctor, we have chosen a doctor who has agreed to serve you. This doctor is: ____ , but

you can switch to a different doctor at any time. For more information, contact y.

  

Alternatively, if the plan does not make an immediate provider assignment, the last sentences

would read:

Please choose a primary care provider by (insert date).  If you do not choose a provider we will

assign one to you.  Once you have picked your primary care provider please let us know by

calling XXX‐XXX‐XXXX.  But you can switch to a different doctor at any time. For more

information, contact y.  

                                                           

17 You may wish to get more guidance from literacy experts as you finalize your model notices. 
10

Designation of Pediatrician As Primary Care Provider

We support the new rule that requires plans to allow a parent/guardian to designate a participating

pediatrician as their child’s primary care provider. We suggest two additions to the regulations:

1) Require notice to consumers of this right (similar to the notice requirements we have described

above), including information about how to find participating pediatricians. Plans should

regularly update their lists of participating pediatricians.  

2) Explain that pediatric subspecialists can also be designated as primary care providers, if they

are willing, for a child who needs that subspecialty. For some children with serious chronic

conditions, pediatric subspecialists (such as a pediatric oncologist) oftentimes provide children

with their routine and ongoing care, and families should be afforded the ability to designate

them as the primary care provider.

Patient Access to Obstetric and Gynecological Care

We are pleased to see that the interim final rule reflects the protections provided in the Affordable Care

Act that allow for direct patient access without referral to obstetric and gynecological care (“ob/gyn”),

and provide the following comments and suggestions to strengthen this rule.   

We commend the Departments for specifying in the Interim Rule that the self‐referral provision applies

to all medical professionals authorized by a state to provide ob/gyn care, not just physicians. Given that

there are many types of medical professionals providing ob/gyn care for women, this important

provision will help ensure that women have meaningful access to the ob/gyn provider of their choice.   

To further ensure that women enjoy the full protections envisioned in the Affordable Care Act, we

recommend the final regulations clarify and reflect the following points.  

 The Federal law provides a floor, not a ceiling. According to the American Congress of

Obstetricians and Gynecologists (ACOG), 43 states currently have some type of law providing for

direct access or self‐referral to ob/gyn care.  To ensure that the federal law does not pre‐empt

any state laws providing greater protections, and that women in these states do not lose any

additional rights afforded by these state laws, the final regulations should clarify that the rule

imposes a federal floor, not a ceiling, that does not pre‐empt any state law providing greater

access to such care.   

 The right of direct access/self‐referral applies without regard to the insured’s age. The final

regulations should specify that direct access rights apply to all women – without regard to age.  

We are concerned that without this important clarification, plans may attempt to impose an age

limitation on the self‐referral rule.  

 Plans may not impose different limits on self‐referral ob/gyn visits than those that would

apply to other types of care, such as primary care. Without clarification, we are concerned that

plans may impose limits on the number of self‐referral visits that may differ from other limits

imposed on other types of care. To prevent plans from imposing such limits that would

undermine this important protection, the final regulations should specify that direct access

rights apply to all women without limit—meaning that plans cannot impose limits on the
11

number of direct access visits that are different than any other limits imposed on visits to access

primary care providers. Similarly, the final regulations should specify that plans cannot limit the

type of ob/gyn care for which a woman may self‐refer. Rather, a woman should be able to self‐

refer or have direct access to an ob/gyn provider for any type of ob/gyn care that is within that

provider’s state authorized scope of practice.   

 An insured woman must be allowed her choice of provider. The final regulations should specify

that similar to the protections for the designation of a primary care provider, a woman may self‐

refer to an ob/gyn provider of her choice (participating in the plan network).    

 Plans may not impose higher cost‐sharing on women who self‐refer for ob/gyn care than on

women who are referred to an ob/gyn by their physician.  Without this protection, plans may try

to discourage women from using self‐referrals by increasing their cost‐sharing.  Cost‐sharing

should be either a flat copayment that is the same whether the woman self‐refers or not, or a

coinsurance amount that is based on the cost of the visit, and preventive care as detailed in

Section 2713 cannot be subject to cost‐sharing.

Emergency Services  

We support the definition of emergency services, consistent with EMTALA, that encompasses medical

screening and stabilization services. People who experience an emergency are often admitted to the

hospital for stabilization, and they should continue to receive these emergency stabilization services

without higher cost‐sharing.   

Section (v) (A) says that emergency services are provided “without regard to any term or condition of

coverage, other than the exclusion of or coordination of benefits.” This language is confusing. Do you

mean to say that the plan cannot apply any additional coverage requirements or restrictions to out‐of‐

network emergency services? Or is this section meant to refer to emergency services generally, whether

they are in or out‐of‐network? Permitting “exclusion of benefits” is overly broad. Plans should not be

permitted to exclude benefits for emergency services unless those benefits are also excluded in a non‐

emergency setting.

We applaud the Departments for establishing reimbursement standards for out‐of‐network emergency

services. These standards will help to minimize balance billing. However, we suggest the following

modifications:

1) Clarify that stronger state laws are not  pre‐empted. In (C)(3)(i) and in the preamble, clarify that

these rules do not pre‐empt state laws that prohibit balance billing. California, Colorado,

Delaware, Florida, Maryland, and West Virginia are examples of states that have further

protected consumers from balance billing by, for example, (a) requiring HMOs to hold

consumers harmless, or (b) requiring providers to accept a rate negotiated by the state as

payment in full, or (c) prohibiting a class of providers (such as hospitals) from billing the patient

more than the plan’s cost‐sharing amounts.18 Other states may have restricted billing through,

for example, hospital community benefit requirements. (See Families USA, Medical Debt: What

Are States Doing to Protect Consumers, 2009, http://www.familiesusa.org/assets/pdfs/medical‐

                                                           

18 California also uses a “reasonable person” standard for emergency care, rather than the “prudent layperson” in 

EMTALA (Health and Safety Code Sec. 1371.4). 
12

debt‐state‐protections.pdf, for a brief summary of these laws.) Where states have stronger

protections than the federal law for consumers who go out‐of‐network, these protections

should continue to hold. In order to allow for these stronger state laws, the rule should add a

3(D) to the reimbursement alternatives: “An amount set by state law.” (Maryland currently

requires reimbursement for various types of emergency services at various percentages above

Medicare rates, and as we understand it, providers receiving these rates cannot balance bill.)

2) Prohibit balance billing for all emergency services in network facilities. At a minimum, when

the consumer receives emergency services at an in‐network facility, and has been assigned

providers by the facility, the emergency providers should not be permitted to balance bill. At the

very least, a plan should be able to negotiate a contract with a hospital and with facility‐based

providers such that there are some emergency providers available at all times that are willing to

accept either the plan’s rates or the rates set forth in this rule as payment in full.

3) Require notice of the plan’s payment. Consumers need to receive notice about how their plan

paid an out‐of‐network provider so that they can dispute any remaining charges with either

their plan or the provider.  

4) Advise consumers of how to minimize balance billing. In most emergency cases, consumers will

not be able to do anything to find in‐network providers; they will be busy dealing with the

emergency at hand. However, occasionally, they, their family members, or hospital personnel

may be able to help connect them with in‐network providers at the facility for stabilization care,

for example, if they are aware of the issue and have an easy way to locate in‐network providers.

Therefore, plan materials should advise consumers of their rights when they receive emergency

services out‐of‐network, of any possibility of balance billing, and who to call at the plan in an

emergency for help coordinating care and minimizing these charges.

5) Count all out‐of‐pocket expenses for emergency services towards consumers’ in‐network

deductible. Plans use high out‐of‐network deductibles to discourage consumers from going out

of network. However, consumers should not be penalized for using out‐of‐network services

involuntarily, and they have little or no control in emergency situations. They purchase

insurance to guard against the risks of unforeseen illnesses and insurance does not do its job

when it leaves consumers unprotected against emergencies. Therefore, out‐of‐pocket expenses

for out‐of‐network emergency care should count toward a consumer’s in‐network deductible.

Balance billing is a serious and costly problem for consumers, and it is particularly appalling when the

consumer is in an emergency and can do nothing to avoid the charges. We urge the Departments to

revisit this issue in promulgating network adequacy standards for plans participating on the Exchange.

Expiration Date of Department of Treasury Temporary Rules and Proposed Department of Treasury

Rules

We do not understand the June 21, 2013 expiration date of various temporary rules (54.9815‐2704T, 54‐

9815.2711T, 54.9815‐2712T, 54.9815‐2719AT.) We want to be sure that there is no gap between the

time that temporary provisions expire and the plan year after January 2014 when permanent

protections go into effect. We request that you clarify this timing either in the rules themselves or in the

preamble. In fact, many of the rules listed as temporary will be needed even after 2014 so we are

baffled by this expiration date. The federal register of June 28 also publishes proposed rules with the

same text as the temporary rules. The register does not note a different effective date or expiration date

for the proposed rules so this does not clarify the matter.
13

Conclusion

Thank you for your work on these important issues. The statute and rules provide a strong, long‐sought

floor of consumer protection. The changes we suggest above will further clarify these protections and

help to assure that plans provide meaningful coverage.

Sincerely,

Families USA

AARP

American Diabetes Association

American Heart Association/American Stroke Association

Consumers Union

Health Care for America Now

National Partnership for Women and Families

National Women’s Law Center

Service Employees International Union

The Arc of the United States

United Cerebral Palsy

USAction

U.S. PIRG

Young Invincibles