30218 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

2.0 ppm. The Agency revised this 

tolerance level based on analysis of the 

residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. 

Finally, the Agency has revised the 

tolerance expression to clarify: (1) That, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of NAA not specifically 

mentioned; and (2) that compliance 

with the specified tolerance levels is to 

be determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of NAA, 1- 

naphthaleneacetic acid, in or on 

avocado at 0.05 ppm; fruit, pome, group 

11–10 at 0.15 ppm; sapote, mamey at 

0.05 ppm; mango at 0.05 ppm; and 

rambutan at 2.0 ppm. This regulation 

additionally removes the tolerance in or 

on fruit, pome, group 11 at 0.15 ppm 

and the time-limited tolerance in or on 

avocado at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 14, 2013. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.155 is revised to read 

as follows: 

§ 180.155 1-Naphthaleneacetic acid; 

tolerances for residues. 

(a) General. Tolerances are 

established for the residues of 1- 

naphthaleneacetic acid, including its 

metabolites and degradates in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only 1-naphthaleneacetic 

acid and its conjugates, calculated as the 

Stoichiometric equivalent of 1- 

naphthaleneacetic acid, in or on the 

commodity. 

Commodity Parts per 

million 

Avocado ................................ 0 .05 

Cherry, sweet ....................... 0 .1 

Fruit, pome, group 11–10 ..... 0 .15 

Mango ................................... 0 .05 

Olive ...................................... 0 .7 

Orange .................................. 0 .1 

Pineapple1 ............................ 0 .05 

Potato ................................... 0 .01 

Rambutan ............................. 2 .0 

Sapote, mamey .................... 0 .05 

Tangerine .............................. 0 .1 

1There are no U.S. registrations since 1988. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2013–12207 Filed 5–21–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 152 

[CMS–9995–IFC3] 

RIN 0938–AQ70 

Pre-Existing Condition Insurance Plan 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period sets the payment rates 

for covered services furnished to 

individuals enrolled in the Pre-Existing 

Condition Insurance Plan (PCIP) 

program administered directly by HHS 

beginning with covered services 

furnished on June 15, 2013. This interim 


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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30219 

final rule also prohibits facilities and 

providers who, with respect to dates of 

service beginning on June 15, 2013, 

accept payment for most covered 

services furnished to an enrollee in the 

federally-administered PCIP from 

charging the enrollee an amount greater 

than the enrollee’s out-of-pocket cost for 

the covered service as calculated by the 

plan. The PCIP program was established 

under Section 1101 of Title I of the 

Patient Protection and Affordable Care 

Act (Affordable Care Act). 

DATES: Effective date: This interim final 

regulation is effective on June 15, 2013. 

Comment date: To be assured 

consideration, written comments must 

be received at one of the addresses 

provided below, no later than 5 p.m. on 

July 22, 2013. Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. 

ADDRESSES: In commenting, please refer 

to file code CMS–9995–IFC3. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed). 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9995–IFC3, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9995–IFC3, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

4492 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://regulations.gov. 

Follow the search instructions on that 

Web site to view public comments. 

Comments received timely will be 

also available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Simpson, Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, (410) 786– 

0017. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Patient Protection and Affordable 

Care Act, (Pub. L. 111–148) was enacted 

on March 23, 2010; the Health Care and 

Education Reconciliation Act of 2010 

(Reconciliation Act), (Pub. L. 111–152) 

was enacted on March 30, 2010 

(collectively, ‘‘Affordable Care Act’’). 

Section 1101 of the Affordable Care Act 

directs the Secretary of Health and 

Human Services (HHS) to establish, 

either directly or through contracts with 

states or nonprofit private entities, a 

temporary high risk health insurance 

pool program to provide access to 

affordable health insurance coverage to 

eligible uninsured individuals with preexisting conditions. A number of states 

elected to contract with HHS to 

establish and administer a high risk 

pool using PCIP funds. HHS directly 

established and administers a high risk 

pool in the remaining states and the 

District of Columbia. (Hereafter, we 

generally refer to this program as the 

Pre-Existing Condition Insurance Plan 

program, or the PCIP program. We refer 

to the PCIP program administered by 

HHS as the ‘‘federally-administered 

PCIP’’ or the ‘‘Plan’’ and a PCIP program 

administered by a state or its designated 

entity as a ‘‘state-based PCIP.’’) The 

PCIP program is intended to provide 

health insurance coverage to eligible 

uninsured individuals with pre-existing 

conditions until 2014. Beginning in 

2014, most health insurance issuers will 

be required to offer coverage to all 

individuals, regardless of pre-existing 

conditions, pursuant to section 2704 of 

the Public Health Service Act. Eligible 

individuals will be able to obtain health 

insurance coverage either by enrolling 

in a qualified health plan offered 

through the new Health Insurance 

Exchanges (also called Marketplaces) 

established under section 1311 or 1321 

of the Affordable Care Act, or by 

enrolling in health insurance coverage 

offered in the individual or group 

market outside of the Exchanges. 

As a temporary bridge to the 

provisions that go into effect beginning 

in 2014, the PCIP program was designed 

to provide coverage to eligible 

individuals who have been locked out 

of the insurance market due to their 

health status. Since enrollment began in 

July 2010, the PCIP program has 

experienced significant and sustained 

growth, enrolling more than 135,000 

otherwise uninsured individuals with 

pre-existing conditions. Many PCIP 

enrollees have serious health conditions 

that require immediate and ongoing 

medical treatment including severe or 

life threatening conditions such as 

cancer. In 2012, the average annual 

claims cost paid per enrollee was 

$32,108. This cost per enrollee exceeds 

even that of state high risk pools that 

predate the Affordable Care Act for 

several reasons. Like other high risk 

pools, PCIP enrollees are limited to 

people that were previously considered 

uninsurable due to high expected claims 

cost. In contrast to many state high risk 

pools, PCIP enrollees also do not 


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30220 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

experience any waiting periods or preexisting condition exclusions upon 

enrollment in the program. 

The combined effect of the number of 

individuals enrolled in the program, 

particularly very sick individuals, their 

high utilization of covered services, and 

the statutory limitations on enrollee 

cost-sharing (which limits the maximum 

amount an enrollee pays out-of-pocket 

for covered services to $6,250 in 2013) 

has led to a situation where the overall 

cost of the PCIP program is higher than 

originally projected. While the actuarial 

estimates that HHS relies on to manage 

the program fluctuate as new claims 

data is received and processed, given 

the current enrollment projections and 

the current rate of claims payment, the 

aggregate amount needed for the 

payment of the expenses of the PCIP 

program is estimated to exceed the 

amount of remaining funding 

appropriated by Congress to pay for 

such expenses until the statutory end to 

the program in 2014, unless we 

implement the policy changes being 

announced in this interim final rule. 

We have already taken measures to 

contain costs, with the intent of 

sustaining the program until 2014. In 

May of 2012, the federally-administered 

PCIP ceased paying referral fees to 

agents and brokers in connection with 

enrolled individuals they had referred 

to the program and began requiring that 

applications for enrollment include 

documentation showing that the 

individual had been denied health 

insurance coverage due to the existence 

of a pre-existing condition. On August 

1, 2012, the federally-administered PCIP 

switched provider networks, reducing 

both its negotiated and out-of-network 

payment rates to providers. This 

network change was followed by a 

targeted effort to negotiate additional 

discounts from in-network inpatient 

facilities that were treating a large 

number of PCIP enrollees. Additionally 

in 2012, the federally-administered PCIP 

limited the specialty drug benefit such 

that the plan would only cover specialty 

drugs dispensed by in-network 

pharmacies. 

Beginning January 1, 2013, the 

federally-administered PCIP 

implemented additional cost 

containment measures, including—(1) 

The elimination of two of three former 

plan options in favor of a single plan 

option; (2) an increase in the maximum 

out-of-pocket limit from $4,000 to 

$6,250 for in-network services; and (3) 

an increase in coinsurance, once the 

deductible has been met, from 20 

percent to 30 percent of the plan 

allowance for in-network covered 

services. Furthermore, on February 15, 

2013, the federally-administered PCIP 

suspended its acceptance of new 

enrollment applications until further 

notice. 

State-based PCIPs suspended their 

acceptance of new enrollment 

applications received after March 2, 

2013. Additionally, a number of statebased PCIPs have taken measures to 

constrain costs in their programs, for 

example, by renegotiating their facility 

and physician reimbursement rates or 

by setting their payment rates at levels 

similar to the rates paid by Medicare. 

Lastly, in May 2013 HHS began 

negotiations with state-based PCIPs on a 

final program contract, with a period of 

performance running from June 1, 2013 

through December 31, 2013. The 

contract HHS will offer to state-based 

PCIPs will be a cost reimbursement 

contract up to, but not exceeding, the 

funding obligated in the contract. 

Based on estimates, HHS believes it is 

prudent and necessary to make 

additional adjustments in the federallyadministered PCIP with respect to 

payment rates for covered services in 

order to ensure that there is sufficient 

funding available to provide coverage to 

currently enrolled individuals until the 

program ends in 2014. 

II. Provisions of the Interim Final Rule 

This interim final rule specifies that 

we are using our authority under section 

1101(g)(2) of the Affordable Care Act to 

set the payment rates for covered 

services in the federally-administered 

PCIP for dates of service beginning on 

June 15, 2013. As explained below, with 

the exception of covered services 

furnished under the prescription drug, 

organ/tissue transplant, dialysis and 

durable medical equipment benefits, 

covered services furnished to enrollees 

in the federally-administered PCIP 

program will be paid at—(1) 100 percent 

of Medicare payment rates, or (2) where 

Medicare payment rates cannot be 

implemented by the federallyadministered PCIP, 50 percent of billed 

charges or a rate generated pricing 

methodology using a relative value scale 

which is generally based on the 

difficulty, time, work, risk and resources 

of the service. (Hereafter, we generally 

refer to this pricing methodology as 

‘‘relative value scale’’ pricing.) These 

rates will become the new plan 

allowances for the covered services, 

with the Plan being responsible for 

reimbursing the facility or a provider for 

a portion and the enrollee being 

responsible for reimbursing the facility 

or provider for the remainder, as 

calculated by the Plan using the current 

cost sharing rules described in the Plan 

brochure. 

Furthermore, to protect enrollees in 

the federally-administered PCIP from 

having to shoulder potentially 

significant costs that could be shifted to 

them as a result of this new payment 

policy, we are also adopting a policy 

that prohibits any facility or provider 

who, with respect to dates of service 

beginning on June 15, 2013, accepts 

payment for a covered service provided 

to an enrollee in the federallyadministered PCIP (excepting only the 

four benefit categories discussed below) 

from charging the enrollee an amount 

greater than the enrollee’s out-of-pocket 

cost for the covered service as 

calculated by the Plan based on the plan 

allowance for the covered service. In 

other words, as a condition of accepting 

payment for most covered services, 

facilities and providers will be 

prohibited from ‘‘balance billing’’ 

enrollees in the federally-administered 

PCIP for the difference between the plan 

allowance for those covered services 

and the charge for the covered service 

that they might otherwise bill to a 

patient who is not a federallyadministered PCIP enrollee. 

Presented below is a discussion of the 

specific regulatory provisions set forth 

in this interim final rule. 

A. Insufficient Funds (§ 152.35(c)) 

Section 1101(g)(2) of the Affordable 

Care Act states that ‘‘[i]f the Secretary 

estimates for any fiscal year that the 

aggregate amounts available for the 

payment of the expenses of the high risk 

pool will be less than the actual amount 

of such expenses, the Secretary shall 

make such adjustments as are necessary 

to eliminate such deficit.’’ We have 

codified this provision at 45 CFR 

152.35(b). 

Since enrollment began in July 2010, 

the PCIP program has experienced 

significant and sustained growth, 

providing affordable health care 

insurance to more than 135,000 of the 

sickest and most vulnerable uninsured 

individuals with pre-existing 

conditions. As a result, claims paid by 

the PCIP program are, on average, 2.5 

times higher than claims paid by state 

high risk pools that predate the PCIP 

program. Based on enrollment and 

claims data, current HHS estimates 

indicate that the aggregate amount 

needed to pay for PCIP program 

expenses may be greater than the 

remaining funding appropriated by 

Congress to pay for such expenses until 

coverage under the program ends in 

2014. Thus, to ensure that there is 

sufficient funding to pay for the 

expenses of the PCIP program until 

2014, as directed by the statute, we are 

adding a new § 152.35(c) to our 


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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30221 

regulations. This new section states that 

with the exception of covered services 

furnished under the prescription drug, 

organ/tissue transplant, dialysis and 

durable medical equipment benefits, the 

payment rates for covered services in 

the federally-administered PCIP with 

dates of service beginning June 15, 2013 

will be paid at—(1) 100 percent of 

Medicare payment rates; or (2) where 

Medicare payment rates cannot be 

implemented by the federallyadministered PCIP, 50 percent of billed 

charges or a rate using relative value 

scale pricing methodology. For purposes 

of implementing this interim final rule, 

we presume that (for covered services 

paid at 50 percent of billed charges) a 

facility or provider’s billed charge will 

be reasonable. Such charges are subject 

to review. The benefit and premium 

provisions codified at 45 CFR part 152 

Subpart D will not change. In addition, 

as the new payment rates will become 

the new plan allowances for the covered 

services, we note that the Plan will be 

responsible for reimbursing the facility 

or a provider for a portion of these rates, 

and the enrollee will be responsible for 

reimbursing the facility or provider for 

the remainder, as calculated by the Plan 

using the current cost sharing rules 

described in the Plan brochure. 

HHS chose to index the new payment 

rates that will apply to most covered 

services to the Medicare payment rate 

because Medicare rates are widely 

accepted, familiar, and publicly 

available. Since Medicare payment rates 

are well known by facilities and 

providers, we believe using a rate 

indexed to Medicare best informs them 

of what the payment rate for most 

covered services will be. Based on 

enrollment and claims data, current 

HHS estimates indicate that 

implementing a payment rate that is 

100% percent of Medicare will allow us 

to ensure that there is sufficient funding 

to pay for the claims and administrative 

expenses of the PCIP program until 

coverage under the program ends in 

2014. 

Since the federally-administered PCIP 

utilizes a third party administrator to 

administer the Plan, there are a few 

instances where Medicare rates cannot 

serve as the basis for indexing the new 

Plan rates. The payment rate for these 

covered services will be 50 percent of 

billed charges or calculated using a 

relative value scale pricing 

methodology. We have chosen to adopt 

a different payment rate in such 

instances to ensure that the services 

currently covered under the Plan can 

continue to be covered by the federallyadministered PCIP while also 

addressing the need to further contain 

program costs. These rates were chosen 

because the federally-administered PCIP 

can immediately operationalize them. 

Given the short remaining life of the 

program, and the limited number of 

covered services to which these 

payment rates would apply, we believe, 

it would be inefficient and too costly for 

HHS to operationalize other payment 

rates that could be applied to these 

covered services. We note that a facility 

or provider will be able to contact the 

federally-administered PCIP directly to 

determine the plan allowance for one of 

these covered services before providing 

the service to a federally-administered 

PCIP enrollee. Below, we discuss the 

specific covered services for which 

payment will be 50 percent of billed 

charges or a rate generated using a 

relative value scale pricing 

methodology. 

To the extent to which these covered 

services are non-pharmaceutical 

services, the payment rate will be 

calculated using a the relative value 

scale payment methodology that uses a 

relative value scale generally based on 

the difficulty, time, work, risk and 

resources of the service. For 

pharmaceutical services other than 

those administered under the current 

Plan prescription drug benefit, the 

relative value scale payment 

methodology is similar to the pricing 

methodology used for Medicare Part B 

drugs based on published acquisition 

costs or average wholesale price for 

pharmaceuticals as published in the Red 

Book by RJ Health Systems, Thomson 

Reuters. In these cases the plan 

allowance will be based on the above 

described relative value scale pricing 

methodology and subject to the 

prohibition on balance billing 

(discussed below). If no Medicare 

payment rate or relative value scale 

pricing methodology is available, the 

federally-administered PCIP will apply 

the 50 percent of billed charges payment 

rate. In these cases, the plan allowance 

is also subject to the prohibition on 

balance billing (discussed below). 

Other instances where covered 

services will be paid at 50 percent of 

billed charges are—(1) Professional 

services where there are no comparable 

CPT codes; (2) facility based services 

where the facility does not participate in 

Medicare and therefore has no Medicare 

ID; (3) facility-based services where 

Medicare rates are not yet available or 

not yet incorporated into the payment 

software; (4) facility-based services 

provided in a free-standing facility for 

skilled nursing facilities, long-term 

acute care facilities, rehabilitation 

facilities, mental health and substance 

abuse facilities; (5) facility-based 

services where all data elements 

required to calculate the Medicare 

payment rate are not provided; (6) 

facility-based services for home health 

providers (UB billers only); and (7) 

covered services that are not covered by 

Medicare. In these cases the plan 

allowance will be based on 50 percent 

of billed charges and subject to the 

prohibition on balance billing 

(discussed below). Enrollees will, 

however, remain responsible for paying 

any applicable cost-sharing amounts, as 

calculated by the Plan. 

We are adopting these new payment 

rates for the federally-administered PCIP 

based on current enrollment projections 

and the current rate of claims payment. 

If these enrollment and claims 

projections change after this interim 

final rule goes into effect, HHS may opt, 

through future rulemaking, to change 

the payment rate. 

Given the changes we have already 

made to the prescription drug benefit in 

the federally-administered PCIP as 

previously discussed, we believe that 

establishing new payment rates for 

prescription drugs is not 

administratively feasible or cost 

effective. Therefore, the current plan 

allowances that apply to the 

prescription drug benefit in the 

federally-administered PCIP will not be 

affected by this interim final rule and 

will continue to apply. Similarly, we 

will not apply the new payment rates to 

covered services furnished under the 

organ/tissue transplant benefit to ensure 

that enrollees continue to have access to 

the federally-administered PCIP’s 

network of transplant centers of 

excellence, which we believe will lead 

to fewer complications, shorter lengths 

of stay, fewer readmissions, better 

health outcomes, and lower costs. 

Accordingly, the current plan 

allowances for covered services 

furnished under the organ/tissue 

transplant benefit will remain the same. 

Also, we will not apply a new payment 

rate to the dialysis services provided 

under the diagnostic and treatment 

services benefit because we are unable 

to operationalize a Medicare payment 

rate. We believe that the current 

negotiated rates with dialysis providers 

result in payments that are likely to be 

less than 50 percent of billed charges. 

Therefore, we believe maintaining our 

current in-network payment rate for this 

service is more competitive than if we 

were to implement a new payment rate 

at 50 percent of the billed charge. 

Finally, we will not apply the new 

payment rates to covered services 

furnished under the durable medical 

equipment benefit, which currently is 

provided to enrollees in the federallyVerDate Mar<15>2010 14:58 May 21, 2013 Jkt 229001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\22MYR1.SGM 22MYR1

pmangrum on DSK3VPTVN1PROD with RULES
30222 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

administered PCIP on an in-network 

basis only. We believe that the rates 

currently paid for durable medical 

equipment are at least as competitive as 

Medicare payment rates. 

This interim final rule establishes 

new payment rates for most covered 

services furnished in the federallyadministered PCIP. The federallyadministered PCIP is administered 

directly by HHS. We note that HHS can 

implement this interim final rule 

quickly and efficiently. The state-based 

PCIPs have previously indicated to HHS 

that they are unable to implement new 

facility and provider rates quickly. 

Therefore, we have taken the 

contracting strategy outlined herein 

with state-based PCIPs. 

B. Premiums and Cost-Sharing 

(§ 152.21(c)) 

Section 1101(c)(2)(D) of the 

Affordable Care Act requires that a PCIP 

program established under this section 

meet ‘‘any other requirements 

determined appropriate’’ by the 

Secretary. We are using this authority to 

adopt a new requirement for the 

federally-administered PCIP that 

conditions a facility or provider’s 

acceptance of the new payment rates 

discussed above for most covered 

services on the facility or provider’s 

agreement not to balance bill the 

enrollee for an amount greater than the 

cost-sharing amount calculated by the 

Plan. 

Balance billing is a term generally 

used to describe the practice of billing 

a patient for the difference between the 

plan allowance for a covered service 

and the amount that the facility or 

provider would otherwise charge for the 

service. Although the federallyadministered PCIP currently contracts 

with a network of facilities and 

providers that have agreed not to 

balance bill, it may not be able to 

sustain that contractual arrangement as 

it currently exists, or otherwise enter 

into new contracts with networks that 

will accept as payment in full the 

payment rates we are adopting in this 

interim final rule. Thus, the federallyadministered PCIP may operate without 

a network for most covered services, 

and the corresponding protection 

against balance billing that has, to date, 

been available to enrollees who choose 

to use network facilities and providers. 

Without such protection, enrollees in 

the federally-administered PCIP could 

become liable to pay significant out-ofpocket costs for many covered services. 

We understand that facility and 

provider charges will often be higher 

than the rates we are setting in this 

interim final rule. Allowing this 

financial liability to transfer to the 

enrollee could leave federallyadministered PCIP enrollees no better 

off than they would have been if they 

had no PCIP coverage, and runs counter 

to the entire PCIP concept, which is to 

provide affordable health insurance 

coverage to those who need it most. 

Also, we believe that the payment rates 

we are setting in this interim final rule 

are still better than the alternative, 

which is leaving facilities and providers 

with the possibility of having to decide 

whether to furnish uncompensated care. 

Accordingly, to safeguard federallyadministered PCIP enrollees from 

experiencing potentially significant 

increases in their out-of-pocket costs 

due to balance billing, we are adding a 

new § 152.21(c) to our regulations. 

Beginning with June 15, 2013 dates of 

service, this new section requires all 

facilities and providers that accept 

payment from the federallyadministered PCIP for furnishing a 

covered service to an enrollee (with the 

exception of covered services furnished 

under the prescription drug, organ/ 

tissue transplant, dialysis and durable 

medical equipment benefits) to accept 

as payment in full the plan allowance 

for the covered service, which includes 

the cost-sharing amount calculated by 

the Plan for the covered service. With 

respect to these covered services, 

facilities or providers may not bill the 

enrollee for an amount greater than the 

amount determined by the Plan to be 

the enrollee’s cost-sharing amount for 

the covered service. 

The prohibition on balance billing 

will not apply to covered services 

furnished under the prescription drug, 

organ/tissue transplant, dialysis and 

durable medical equipment benefits 

because, as explained above, covered 

services furnished under these benefits 

will continued to be paid at the existing 

in-network payment rates. We do not 

apply the balance billing prohibition to 

these covered services because it is our 

desire to encourage federallyadministered enrollees to continue to 

seek treatment for these covered 

services from in network facilities and 

providers for the cost-containment 

reasons described above. 

III. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

IV. Waiver of Proposed Rulemaking 

and the 60-Day Delay in the Effective 

Date 

Under the Administrative Procedure 

Act (APA) (5 U.S.C. 551, et seq.), a 

notice of proposed rulemaking and an 

opportunity for public comment are 

generally required before promulgation 

of a regulation. We also ordinarily 

provide a 60-day delay in the effective 

date of the provisions of a rule in 

accordance with the APA (5 U.S.C. 

553(d)), which requires a 30-day 

delayed effective date and the 

Congressional Review Act (5 U.S.C. 

801(a)(3)), which requires a 60-day 

delayed effective date for major rules. 

However, this procedure can be 

waived if the agency, for good cause, 

finds that notice and public comment 

and delay in effective date are 

impracticable, unnecessary, or contrary 

to the public interest and incorporates a 

statement of the finding and its reasons 

in the rule issued. 5 U.S.C. 553(d)(3); 5 

U.S.C. 808(2). 

HHS has determined that issuing this 

regulation in proposed form, such that 

it would not become effective until after 

public comments are submitted, 

considered, and responded to in a final 

rule, would be impracticable and 

contrary to the public interest. The PCIP 

program is intended to provide benefits 

to eligible uninsured individuals with 

pre-existing conditions until 2014. 

However, the funding available to pay 

claims against, and the administrative 

costs of, the PCIP program is limited by 

statute, and HHS estimates that, at the 

current rate of expenditure, the 

aggregate amount needed for the 

payment of program expenses may be 

greater than the amount of remaining 

funding appropriated by the Congress to 

pay such expenses. Moreover, for 

individuals with pre-existing conditions 

enrolled in the PCIP program, the 

program may be their only available 

source of health coverage before 

prohibitions on discrimination by 

health insurance issuers based on preexisting conditions go into effect in 

January 2014. It is critical to the 

continued sustainability of the program 

that the new payment rates go into effect 

as soon as operationally possible. A 

delay in the implementation of the new 

reimbursement rates beyond June 15, 

2013 would risk program funds being 

exhausted prior to 2014. 

We also believe that it would be 

impracticable and contrary to the public 

interest to delay the implementation of 

a policy that prohibits facilities and 

providers from billing federallyVerDate Mar<15>2010 14:58 May 21, 2013 Jkt 229001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\22MYR1.SGM 22MYR1

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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30223 

administered PCIP enrollees for the 

difference between the plan allowance 

for most covered services and the 

amount they would otherwise charge for 

the covered services. The PCIP program 

is a program of last resort for 

individuals who, because of their preexisting conditions, are either denied 

coverage in the individual market 

altogether, or can only obtain coverage 

that excludes their pre-existing 

condition (often at substantially higher 

premium rates than those paid by other 

individuals). The Affordable Care Act 

not only makes coverage available to 

these individuals until the more general 

pre-existing condition protections 

become available in 2014, but does so at 

a lower cost than they otherwise would 

likely have to pay if they did not have 

health coverage. Furthermore, if the 

network currently in place in the 

federally-administered PCIP became 

unavailable as a result of the new 

payment rates being set in this interim 

final rule, we are concerned that the 

balance billed charges could cause 

irreparable financial harm to enrollees 

and deter them from seeking services at 

all. Because we want not only to 

preserve the program benefit structure 

as intended by the Congress, but also 

meet the needs of enrollees in the 

federally-administered PCIP who expect 

that their out-of-pocket costs will be 

limited, we believe that it would be 

impracticable and contrary to the public 

interest to create a situation in which 

these enrollees are either deterred from 

seeking covered benefits under the 

program altogether, or are forced to pay 

substantially higher out-of-pocket costs 

than they would have otherwise had to 

pay absent our adoption of a policy 

prohibiting balance billing in this 

interim final rule. 

For the foregoing reasons, we find 

good cause to waive the notice of 

proposed rulemaking and 60-day delay 

in the effective date and to issue this 

final rule on an interim basis. 

We are providing a 60-day public 

comment period, and this regulation 

will be effective on June 15, 2013. 

V. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

We are not soliciting public comment 

on these issues addressed in this interim 

final rule because we are not making 

changes to the information collections 

associated with this program, which are 

covered under OMB Control Number 

OMB–0938–1100. 

VI. Regulatory Impact Analysis 

A. Summary and Need for Regulatory 

Action 

Section 1101 of Title I of the 

Affordable Care Act requires that the 

Secretary establish, either directly or 

through contracts with states or 

nonprofit private entities, a temporary 

high risk pool program to provide 

affordable health insurance benefits to 

eligible uninsured individuals with preexisting conditions. The Affordable Care 

Act envisions that this program will 

provide coverage to eligible uninsured 

individuals with preexisting conditions 

until 2014, when these individuals will 

begin to have access to a broader range 

of affordable health coverage options, 

including qualified health plans offered 

through new Health Insurance 

Exchanges established under sections 

1311 or 1321 of the Affordable Care Act. 

An interim final rule published July 10, 

2010 (75 FR 45014) set forth and 

addressed key issues regarding 

administration of the program, 

eligibility and enrollment, benefits, 

premiums, funding, appeals rules, and 

enforcement provisions related to antidumping and fraud, waste, and abuse. 

This interim final rule sets forth new 

payment rates that apply to most 

covered services with dates of service 

beginning June 15, 2013, in the 

federally-administered PCIP. Payment 

rates for covered services—with the 

exception of covered services furnished 

under the prescription drug, organ/ 

tissue transplant, dialysis and durable 

medical equipment benefits will be—(1) 

100 percent of Medicare payment rates; 

or (2) where Medicare payment rates 

cannot be implemented by the federallyadministered PCIP, 50 percent of billed 

charges or a rate generated using a 

relative value scale pricing 

methodology. This interim final rule is 

an exercise of our authority to make 

program changes that we have 

determined are prudent and necessary 

to ensure that there is sufficient funding 

to pay for program expenses until 2014. 

Additionally, to protect federallyadministered PCIP enrollees from 

potentially becoming financially liable 

to pay significant costs for covered 

services as an unintended consequence 

of this interim final rule, we are 

adopting a policy that prohibits 

facilities and providers from billing an 

enrollee for the difference between the 

plan allowance for a covered service 

(with the exception of covered services 

furnished under the prescription drug, 

organ/tissue transplant, dialysis and 

durable medical equipment benefits) 

and the amount that they would 

otherwise charge for the covered 

service. In other words, facilities and 

providers that furnish covered services 

to federally-administered PCIP enrollees 

must accept, as payment in full, the 

plan allowance for most of those 

covered services (as determined by the 

Plan) and not bill the enrollee for an 

amount greater than the cost-sharing 

amount that the federally-administered 

PCIP has calculated for the covered 

service. 

Executive Order 12866 explicitly 

requires agencies to take account of 

‘‘distributive impacts’’ and ‘‘equity.’’ 

Setting the federally-administered PCIP 

payment rates applicable to most 

covered services with dates of service 

beginning on June 15, 2013, is prudent 

and necessary to ensure the PCIP 

program continues to provide benefits to 

enrolled individuals with pre-existing 

conditions who cannot obtain health 

coverage in the existing insurance 

market until 2014, when these 

individuals will begin to have access to 

a broader range of coverage options, 

including qualified health plans offered 

through new health insurance 

marketplaces established under sections 

1311 or 1321 of the Affordable Care Act. 

Based on enrollment and claims data, 

current HHS estimates indicate that the 

aggregate amount needed to pay for 

PCIP expenses may be greater than the 

remaining funding appropriated by 

Congress to pay for such expenses until 

coverage under the program ends in 

2014. Therefore, it is critical that we set 

the new payment rates and prohibit 

balance billing under the federallyadministered PCIP as soon as 

operationally possible so that we can 

ensure that funding remains available to 

provide benefits to PCIP enrollees until 

2014 and enrollees are protected from 

potentially significant out-of-pocket 

costs. 

B. Executive Order 12866 

Under Executive Order 12866 (58 FR 

51735), a ‘‘significant’’ regulatory action 

is subject to review by the Office of 

Management and Budget (OMB). 

Section 3(f) of the Executive Order 

defines a ‘‘significant regulatory action’’ 

as an action that is likely to result in a 

rule— (1) having an annual effect on the 

economy of $100 million or more in any 

one year, or adversely and materially 

affecting a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local or tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) creating 


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a serious inconsistency or otherwise 

interfering with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. OMB 

has determined that this regulation is 

economically significant within the 

meaning of section 3(f)(1) of the 

Executive Order, because it is likely to 

have an annual effect on the economy 

of $100 million in at least 1 year. 

Accordingly, OMB has reviewed this 

rule pursuant to the Executive Order. 

HHS provides an assessment of the 

potential costs, benefits, and transfers 

associated with this interim final 

regulation, summarized in the following 

table. 

TABLE 1.1— ACCOUNTING TABLE

Benefits: 

Qualitative: The reduction in per-claim 

costs paid by the federally-administered Pre-Existing Condition Insurance 

Plan will help to ensure that the PCIP 

program can continue providing benefits to current enrollees who were previously denied health coverage due to 

their pre-existing condition. Facilities 

and providers serving enrollees in the 

Plan will continue to receive payment 

for such care, rather than risk receiving no payment for such care should 

they choose to continue treating the 

enrollee and PCIP program funding is 

exhausted prior to 2014. 

Costs: 

Qualitative: Health care facilities and 

providers will get paid less by the Plan 

for the same covered services, although given the small number of 

PCIP enrollees and large amount of 

uncompensated care that might otherwise be sought by these enrollees, we 

estimate this cost is minimal. 

a. Estimated Number of Affected 

Entities 

This interim final rule sets new 

payment rates for most covered services 

in the federally-administered PreExisting Condition Insurance Plan 

(PCIP) furnished beginning on June 15, 

2013. It also prohibits a facility or 

provider from balance billing a 

federally-administered PCIP enrollee in 

most circumstances. 

Only facilities and providers 

furnishing covered services to federallyadministered PCIP enrollees will be 

affected by the new payment rates and 

prohibition on balance billing. Although 

payment rates will be reduced, facilities 

and providers choosing to continue to 

furnish covered services to PCIP 

enrollees will continue to receive 

payment, whereas in the absence of 

PCIP, they might not be able to continue 

treating the individuals unless they 

furnish uncompensated care. Although 

the federally-administered PCIP 

currently includes an in-network 

benefit, enrollees are also able to receive 

treatment out-of-network, thereby 

making it difficult to quantify the 

number of facilities and providers that 

will be affected by this interim final 

rule. 

b. Benefits 

A key premise for the establishment 

of the PCIP program was that those who 

are unable to purchase private health 

insurance coverage due to a pre-existing 

condition are potentially disadvantaged 

as a result of both poor health and loss 

of income. We expect that this interim 

final regulation will help more than 

100,000 current enrollees continue to 

receive coverage until 2014. According 

to the 2009 report entitled ‘‘Financial 

and Health Burden of Chronic 

Conditions Grow,’’ released by the 

Center for Studying Health System 

Change, about 60 percent of the 

uninsured who have chronic conditions 

delay care or did not fill a prescription 

due to cost. Lack of health coverage 

often leads to significant medical debt, 

and uncompensated and expensive care 

at sites such as emergency rooms, 

shifting these costs in the health system 

to people with insurance coverage to 

offset the cost of this uncompensated 

care. Given these potential 

consequences of PCIP enrollees losing 

coverage and becoming uninsured prior 

to the coverage protections that will go 

into effect in 2014, this interim final 

regulation could generate significant 

benefits to enrolled individuals, for 

whom it will be possible to continue to 

be enrolled in the PCIP program. Absent 

this interim final rule, the PCIP program 

could exhaust its $5 billion in 

appropriated funding before the end of 

the program in 2014. 

The Regulatory Impact Analysis 

included in the preamble to the 2010 

PCIP interim final regulation included a 

discussion of the PCIP program’s benefit 

to program-eligible individuals, as 

compared to the absence of the program. 

This interim final rule better ensures the 

continued existence of the program 

until 2014, as an alternative to the 

absence of the program during that time 

period. Therefore, we refer readers to 

the discussion of the benefits to 

program-eligible individuals that 

appears in the Regulatory Impact 

Analysis of the July 30, 2010 interim 

final regulation (75 FR 45026). These 

benefits could take the form of 

reductions in mortality and morbidity, 

reductions in medical expenditure risk, 

and increases in worker productivity. 

Each of these effects is described in that 

Regulatory Impact Analysis. 

c. Costs and Transfers 

Under Section 1101 of the Affordable 

Care Act, HHS is authorized to disperse 

$5 billion to pay claims and the 

administrative costs of the PCIP 

program that are in excess of premiums 

collected from enrollees. 

There will be administrative costs 

associated with this interim final rule. 

The federally-administered PCIP claims 

processing contractor will incur 

minimal administrative costs to 

implement the payment rates required 

by this regulation to ensure that its 

systems are properly coded to pay the 

payment rates established under this 

interim final rule. This cost will be 

minimal because the claims processing 

contractor has an existing system in 

place to adjust its payment rates to 

reduce the payment rates to the amount 

specified. 

This interim final rule will not 

increase or decrease costs to the federal 

government. The Congress appropriated 

$5 billion for the PCIP program, and 

HHS intends to spend that $5 billion for 

PCIP-related costs, although this 

regulation will change how a portion of 

the remaining $5 billion is distributed 

by spreading funding for the maximum 

period of time by setting new payment 

rates in the federally-administered PCIP. 

With respect to other parties, we lack 

data with which to quantify costs 

associated with this regulation. Setting 

new payment rates for most covered 

services under the federallyadministered PCIP program gives 

facilities and providers two choices. 

One choice is to continue to treat 

federally-administered PCIP enrollees 

and accept the payment rates set by this 

regulation as payment in full. We 

acknowledge that facilities and 

providers would, in general, be paid less 

to treat PCIP enrollees but we believe 

such cost is minimal (relative to 

facilities and providers’ annual 

revenues). In the absence of this 

regulation, funding for the PCIP 

program may be exhausted prior to 

2014, causing enrollees to seek from the 

same facilities and providers 

uncompensated and expensive care. 

Facilities and providers who furnish 

covered services to individuals enrolled 

in the federally-administered PCIP, the 

anticipated reduction in PCIP revenue 

per claim will not, in the aggregate, 

eliminate their overall PCIP revenue. 


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Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 30225 

The other choice that facilities and 

providers have is to no longer treat PCIP 

enrollees. While we understand that the 

decision to no longer treat PCIP 

enrollees is possible, we believe and are 

hopeful that most facilities and 

providers will accept the new payment 

rates established in this interim final 

rule given the serious health conditions 

many federally-administered PCIP 

enrollees have and the prospect that 

such reduced payment is temporary 

until 2014 when no one can generally be 

denied health coverage because of a preexisting condition. Facilities or 

providers who choose to not accept the 

payment rates established in this 

interim final rule could limit a 

federally-administered PCIP enrollee’s 

ability to access health care services. 

However, this same possibility would 

occur if the PCIP program were to end 

before 2014. Lastly, because the PCIP 

program serves such a small population 

nationwide, and the program is 

temporary in nature, it is unlikely that 

a facility or provider’s annual revenue 

would be significantly impacted by 

continuing to treat PCIP enrollees at the 

new payment rate. Therefore, we believe 

that this interim final regulation has 

minimal cost to such providers and 

facilities. 

d. Conclusion 

Under section 1101 of the Affordable 

Care Act, HHS is authorized to spend $5 

billion for the purpose of funding the 

PCIP program. Implementing this 

interim final regulation, through which 

HHS is setting payment rates for most 

covered services under the federallyadministered PCIP program to 100 

percent of Medicare payment rates, may 

not impose any substantial financial 

costs on any parties. 

For facilities and providers, the 

anticipated reduction in PCIP revenue 

per claim will likely be offset by the cost 

of uncompensated care in the absence of 

the PCIP program, a cost that facilities 

and providers would frequently incur if 

the PCIP program terminated earlier 

than 2014, due to funds being 

exhausted. Therefore, this interim final 

regulation has, in aggregate, minimal 

cost to such facilities and providers. By 

ensuing that coverage continues through 

the end of the year, when new options 

become available, the payment rates set 

forth in this interim final regulation will 

likely have a significant, positive 

financial impact on individuals enrolled 

in the program. 

We anticipate that PCIP enrollees, 

who might otherwise lose their PCIP 

coverage will benefit from this interim 

final rule because they will be able to 

maintain their PCIP coverage. We also 

anticipate that ensuring the PCIP 

program’s existence through 2014 will 

reduce the burden on local and state 

governments to pay health care facilities 

and providers for uncompensated care 

and prevent shifting of uncompensated 

care costs in the health system to people 

with insurance coverage to offset the 

cost of such uncompensated care. 

VII. Other Sections 

Regulatory Alternatives 

Under the Executive Order, we must 

consider alternatives to issuing 

regulations and alternative regulatory 

approaches. This interim final rule sets 

payment rates for covered services in 

the federally-administered PCIP with 

dates of service beginning June 15, 2013 

to reduce the rate of expenditures in 

order to eliminate the potential funding 

deficit estimated to occur in calendar 

year 2013. While other program 

modifications, as previously 

summarized, have been implemented to 

contain program costs, no other viable 

alternatives were identified that could 

substitute for the changes included in 

this interim final rule. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

requires agencies that issue a regulation 

to analyze options for regulatory relief 

of small businesses if a rule has a 

significant impact on a substantial 

number of small entities. The RFA 

generally defines a ‘‘small entity’’ as— 

(1) A proprietary firm meeting the size 

standards of the Small Business 

Administration (SBA); (2) a nonprofit 

organization that is not dominant in its 

field; or (3) a small government 

jurisdiction with a population of less 

than 50,000. States and individuals are 

not included in the definition of ‘‘small 

entity.’’ The Secretary certifies that this 

interim final rule will not have 

significant impact on a substantial 

number of small entities. 

Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates would require 

certain spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2013, that 

threshold is approximately $141 

million. 

UMRA does not address the total cost 

of a rule. Rather, it focuses on certain 

categories of cost, mainly those ‘‘federal 

mandate’’ costs resulting from—(1) 

Imposing enforceable duties on state, 

local, or tribal governments, or on the 

private sector; or (2) increasing the 

stringency of conditions in, or 

decreasing the funding of, state, local, or 

tribal governments under entitlement 

programs. 

Under the Affordable Care Act, states 

(or their designated nonprofit, private 

entities) chose to contract with HHS to 

administer PCIP and receive federal 

funding for doing so. If they did not 

choose to administer a PCIP, HHS 

established a PCIP in the state. Thus, 

this interim final rule does not impose 

an unfunded mandate on states. 

Enrolled individuals have to pay a 

premium and other out-of-pocket 

expenses to maintain their enrollment 

in a PCIP. However, individuals are free 

to disenroll based on their evaluation of 

the costs and benefits of remaining in 

the program. There is no automatic 

enrollment and no requirement to enroll 

or remain enrolled in a PCIP. Thus, this 

interim final rule does not impose an 

unfunded mandate on the private sector. 

Federalism (Executive Order 13132) 

Under the specific provisions of the 

Affordable Care Act, States or Statedelegated non-profit entities are 

contractors of the HHS in the 

implementation of the PCIP program. 

HHS has given those contractors 

flexibility within the parameters 

provided by the Affordable Care Act and 

within the budgetary capacity of the 

program. 

Congressional Review Act 

This proposed regulation is subject to 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq) and has been 

transmitted to the Congress and 

Comptroller General for review. 

V. Statutory Authority 

This interim final rule is adopted 

pursuant to the authority contained in 

section 1101 of the Patient Protection 

and Affordable Care Act (Pub. L. 

111–148). 

List of Subjects in 45 CFR Part 152 

Administrative practice and 

procedure, Health care, Health 

insurance, Penalties, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, the Department of Health and 

Human Services amends 45 CFR subtitle 

A, subchapter B, part 152 as set forth 

below: 


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30226 Federal Register / Vol. 78, No. 99 / Wednesday, May 22, 2013 / Rules and Regulations 

PART 152—PRE–EXISTING 

CONDITION INSURANCE PLAN 

PROGRAM 

■ 1. The authority citation for part 152 

continues to read as follows: 

Authority: Sec. 1101 of the Patient 

Protection and Affordable Care Act (Pub. L. 

111–148). 

■ 2. Section 152.21 is amended by 

adding paragraph (c) to read as follows. 

§ 152.21 Premiums and cost-sharing. 

* * * * * 

(c) Prohibition on balance billing in 

the PCIP administered by HHS. A 

facility or provider that accepts payment 

under § 152.35(c)(2) for a covered 

service furnished to an enrollee may not 

bill the enrollee for an amount greater 

than the cost-sharing amount for the 

covered service calculated by the PCIP. 

■ 3. Section 152.35 is amended by 

adding paragraph (c) to read as follows. 

§ 152.35. Insufficient funds. 

* * * * * 

(c) Payment rates for covered services 

furnished beginning June 15, 2013 to 

enrollees in the PCIP administered by 

HHS. (1) Covered services furnished 

under the prescription drug, organ/ 

tissue transplant, dialysis and durable 

medical equipment benefits will be paid 

at the payment rates that are in effect on 

June 15, 2013. 

(2) With respect to all other covered 

services, the payment rates will be— 

(i) 100 percent of Medicare payment 

rates; or 

(ii) Where Medicare payment rates 

cannot be implemented by the federallyadministered PCIP, 50 percent of billed 

charges or a rate using a relative value 

scale pricing methodology. 

Dated: May 15, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Dated: May 16, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–12145 Filed 5–17–13; 4:15 pm] 

BILLING CODE 4150–03–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 14 

[CG Docket No. 10–213; WT Docket No. 96– 

198; and CG Docket No. 10–145; FCC 13– 

57] 

Accessibility Requirements for Internet 

Browsers 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission adopts rules to implement 

section 718 of the Communications Act 

of 1934 (the Act), as amended, which 

was added to the Act by the TwentyFirst Century Communications and 

Video Accessibility Act of 2010 (CVAA). 

Section 718 of the Act requires Internet 

browsers built into mobile phones to be 

accessible to individuals who are blind 

or visually impaired. In this document, 

the Commission also affirms that section 

716 of the Act requires certain Internet 

browsers used for advanced 

communications services to be 

accessible to people with disabilities. 

DATES: Effective October 8, 2013. 

FOR FURTHER INFORMATION CONTACT: Eliot 

Greenwald, Consumer and 

Governmental Affairs Bureau, Disability 

Rights Office, at (202) 418–2235 or 

email Eliot.Greenwald@fcc.gov, or 

Rosaline Crawford, Consumer and 

Governmental Affairs Bureau, Disability 

Rights Office, at (202) 418–2075 or 

email Rosaline.Crawford@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Second 

Report Order, document FCC 13–57, 

adopted on April 26, 2013, and released 

on April 29, 2013, in CG Docket No. 10– 

213, WT Docket No. 96–198, and CG 

Docket No. 10–145. The full text of 

document FCC 13–57 will be available 

for public inspection and copying via 

ECFS, and during regular business 

hours at the FCC Reference Information 

Center, Portals II, 445 12th Street SW., 

Room CY–A257, Washington, DC 20554. 

It also may be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., Portals II, 

445 12th Street SW., Room CY–B402, 

Washington, DC 20554, telephone: (800) 

378–3160, fax: (202) 488–5563, or 

Internet: www.bcpiweb.com. Document 

FCC 13–57 can also be downloaded in 

Word or Portable Document Format 

(PDF) at http://www.fcc.gov/document/ 

section-718-accessibility-requirementsinternet-browsers-mobile. To request 

materials in accessible formats for 

people with disabilities (Braille, large 

print, electronic files, audio format), 

send an email to fcc504@fcc.gov or call 

the Consumer and Governmental Affairs 

Bureau at (202) 418–0530 (voice) or 

(202) 418–0432 (TTY). 

Final Paperwork Reduction Act of 1995 

Analysis 

Document FCC 13–57 does not 

contain new or modified information 

collection requirements subject to the 

Paperwork Reduction Act of 1995 

(PRA), Public Law 104–13. In addition, 

therefore, it does not contain any new 

or modified information collection 

burden for small business concerns with 

fewer than 25 employees, pursuant to 

the Small Business Paperwork Relief 

Act of 2002, Public Law 107–198, 44 

U.S.C. 3506(c)(4). 

Synopsis 

I. Introduction 

1. In document FCC 13–57, the 

Commission implements section 718 of 

the Act, which was added by section 

104 of the CVAA to ensure that people 

with disabilities have access to 

emerging and innovative advanced 

communications technologies. Section 

718 of the Act requires mobile phone 

manufacturers and mobile service 

providers that include or arrange for the 

inclusion of an Internet browser on 

mobile phones to ensure that the 

functions of the included browser are 

accessible to and usable by individuals 

who are blind or have a visual 

impairment, unless doing so is not 

achievable. In addition, in document 

FCC 13–57, the Commission affirms its 

previous conclusions regarding the 

coverage of Internet browsers used for 

ACS under section 716 of the Act, and 

retains the recordkeeping requirements 

and deadlines for entities covered under 

section 718 of the Act. 

II. Background 

2. On October 7, 2011, the 

Commission adopted rules, published at 

76 FR 82353, December 30, 2011, 

implementing section 716 of the Act 

(also added by the CVAA), which 

requires advanced communications 

services (ACS) and equipment used for 

ACS to be accessible to and usable by 

individuals with disabilities, unless 

doing so is not achievable. 47 U.S.C. 

617; 47 CFR 14.1—14.21 of the 

Commission’s rules. The Commission 

also adopted rules to implement section 

717, which establishes recordkeeping 

and enforcement requirements for 

entities covered under sections 255, 

716, and 718 of the Act. 47 U.S.C. 618; 

47 CFR 14.30—14.52 of the 

Commission’s rules. In addition, the 

Commission adopted a Further Notice of 


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