[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Rules and Regulations]
[Pages 83822-83830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28483]
[[Page 83822]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 51c
RIN 0906-AB25
Implementation of Executive Order on Access to Affordable Life-
Saving Medications
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule implements an Executive Order requiring
entities funded under section 330(e) of the Public Health Service Act
(PHS Act or the Act), whether by receiving a federal award or a
subaward, and that also participate in the 340B Drug Pricing Program
(340B Program) must establish practices to provide access to insulin
and injectable epinephrine to low-income health center patients at the
price the health center purchased these two drugs through the 340B
Program. The Executive Order supports the improved access to these
life-saving medications by low-income individuals who do not have
access to affordable insulin and injectable epinephrine due to either
lack of insurance or high cost sharing requirements.
DATES: This final rule is effective on January 22, 2021.
FOR FURTHER INFORMATION CONTACT: Jennifer Joseph, Director, Office of
Policy and Program Development, Bureau of Primary Health Care, Health
Resources and Services Administration, 5600 Fishers Lane, Rockville,
Maryland 20857; email: jjoseph@hrsa.gov; telephone: 301-594-4300; fax:
301-594-4997.
SUPPLEMENTARY INFORMATION:
I. Public Participation
On September 28, 2020, HHS published a notice of proposed
rulemaking (NPRM) in the Federal Register (85 FR 60748) to implement
Executive Order 13937 (Executive Order) of July 24, 2020, by amending
the regulations implementing Section 330 of the Public Health Service
Act (PHS Act or the Act), to require entities funded under Section
330(e) of the Act to establish practices to provide insulin and
injectable epinephrine to low-income patients at the price the health
center purchased these two drugs through the 340B Program. The NPRM
provided for a 30-day comment period, and HHS received 226 comments.
HHS carefully considered all comments in developing this rule, as
outlined in Section V below, and presents a summary of all significant
comments and HHS responses.
II. Background
As discussed in the NPRM, on March 13, 2020, President Trump
declared the COVID-19 pandemic of sufficient severity and magnitude to
warrant an emergency declaration for all states, territories, and the
District of Columbia. With the COVID-19 emergency, many low-income
individuals are experiencing significant economic hardship. These low-
income individuals who are dependent upon the life-saving medications
of insulin and/or injectable epinephrine are now less able to access
these drugs at an affordable price. On July 24, 2020, President Trump
issued Executive Order 13937 to direct health centers that receive
grants under section 330(e) of the PHS Act to support the improved
access to certain life-saving medications by low-income individuals. As
provided in the Executive Order, it is the policy of the United States
to enable Americans without access to affordable insulin and injectable
epinephrine through commercial insurance or federal programs, such as
Medicare and Medicaid, to purchase these pharmaceuticals from a health
center at the same price at which the health center acquired the
medication through the 340B Program. This final rule aligns with the
goals of the President's mandate.
Through the Executive Order, the President directed the Secretary
of Health and Human Services (the Secretary) to take action, to the
extent permitted by law, to ensure all future grants available under
section 330(e) of the PHS Act, as amended, 42 U.S.C. 254b(e), are
conditioned upon health centers having established practices to make
insulin and injectable epinephrine available at the discounted price
paid by the health center grantee or subgrantee under the 340B Program
(plus a minimal administration fee) to individuals with low incomes, as
determined by the Secretary, who:
(a) Have a high cost sharing requirement for either insulin or
injectable epinephrine;
(b) Have a high unmet deductible; or
(c) Have no health care insurance.
Under section 330(k)(3) of the Act, the Secretary may not approve
an application for a grant under subparagraph (A) or (B) of subsection
(e)(1) unless the Secretary determines that the entity for which the
application is submitted meets the requirements enumerated in section
330(k)(3)(A)-(N). Section 330(k)(3)(N) requires that ``the center has
written policies and procedures in place to ensure the appropriate use
of Federal funds in compliance with applicable Federal statutes,
regulations, and the terms and conditions of the Federal award.''
Through this final rule, and consistent with the Act, HRSA will include
in the Terms section of applicable Notices of Award (NOAs) issued under
section 330(e) grant awards, the requirement that health center
awardees comply with the discounted price provisions described herein.
This regulation applies to new grants and new project periods for
service area, new access point, supplemental, and expanded services
awards issued under section 330(e) of the PHS Act.
III. Statutory Authority
The statement of authority for 42 CFR part 51c continues to read
section 330 of the PHS Act (42 U.S.C. 254b) and section 215 of the PHS
Act (42 U.S.C. 216).
IV. Summary of This Rule
Overview
This rule codifies the proposed requirement described in the
September 2020 NPRM implementing the Executive Order issued to support
the improved access to certain life-saving medications for low-income
individuals. This rule establishes a requirement for awarding new
grants under section 330(e) of the PHS Act (42 U.S.C. 254b) that the
awardee have established written practices to make insulin and
injectable epinephrine available at or below the discounted price paid
by the health center grantee or subgrantee under the 340B Program (plus
a minimal administration fee) to health center patients with low
incomes who: (a) Have a high cost sharing requirement for either
insulin or injectable epinephrine, (b) have a high unmet deductible, or
(c) have no health insurance. This final rule also provides definitions
relevant to this requirement.
Through this final rule, the requirement for all grant awards under
section 330(e) of the PHS Act is as follows:
Under Executive Order 13937, issued July 24, 2020, if your health
center or a subrecipient receives section 330(e) funding, is enrolled
in the 340B Program and purchases, is reimbursed, or provides
reimbursement to other entities for insulin and injectable epinephrine,
whether obtained using federal or non-federal funds, your health center
must have established practices to make insulin and injectable
epinephrine available to low-income health center patients (defined
herein as
[[Page 83823]]
those individuals or families with annual incomes at or below 350
percent of the Federal Poverty Guidelines (FPG))--who either have
insurance with a high cost sharing requirement for either insulin or
injectable epinephrine, as applicable, a high unmet deductible, or who
have no health insurance--at or below the price the health center paid
through the 340B Program, plus a minimal administration fee. You are
not required to charge third-party payors this discounted price.
Consistent with the Executive Order, this Term only applies to
health centers receiving section 330(e) grant funds that participate in
the 340B Program (42 U.S.C. 254b and 256b). This requirement is limited
to increasing affordable access to insulin and injectable epinephrine.
The requirement to make insulin and injectable epinephrine available at
or below the same price paid through the 340B Program does not apply to
other 340B drugs. Health centers subject to this requirement are
expected to provide drugs in these two categories at or below the price
paid through the 340B Program to health center patients only, and only
to those health center patients identified as low-income, as described
below. An individual will not be considered a ``patient'' of the health
center for this purpose if the only health care service received by the
individual from the health center is the dispensing of a drug or drugs
for subsequent self-administration or administration in the home
setting. See Notice Regarding Section 602 of the Veterans Health Care
Act of 1992 Patient and Entity Eligibility, 61 FR 55,156 (Oct. 24,
1996). Nothing in this Program Term or the actions described in this
final rule prohibits or otherwise restricts a health center from
setting the price for insulin or injectable epinephrine lower than the
price the health center paid through the 340B Program.
This Program Term will be included on all Notices of Award issued
to health centers receiving grant funds under section 330(e) of the
Act.
The Executive Order states that future grants under section 330(e)
should be conditioned upon health centers or subrecipients
participating in the 340B Program, including through contract pharmacy
arrangements, having established practices to make insulin and
injectable epinephrine accessible at an affordable price to low-income
patients. To implement this requirement, all future awards made
available under section 330(e) will include the requirement that health
centers participating in the 340B Program comply with the regulation as
described in the Program Term in order to receive a grant award.
Specifically, these funding opportunities will require health centers
that participate in the 340B Program to have established practices that
implement the Executive Order by offering insulin and injectable
epinephrine to low-income health center patients at no more than the
price the health center paid through the 340B Program plus a minimal
administration fee. In particular, these practices will provide
information to health center patients in an easily understandable
format regarding their administration fees, and the low-income, high
cost sharing, and high unmet deductibles standard as described in this
regulation. Health centers that have one or more subgrantees that
participate in the 340B Program must demonstrate such subgrantees have
established practices to offer health center patients these 340B
discounted drugs as described in this final rule.
Through this final rule, HRSA defines the following terms to assist
health centers in complying with and implementing the Executive Order.
1. ``Established practices'': The health center demonstrates
through its written policies, procedures, and/or other relevant
documents that it has established practices to offer insulin and
injectable epinephrine at no more than the discounted price paid by the
health center under the 340B Program plus a minimal administration fee.
2. ``Health center grantee or subgrantee'': The Executive Order
cites section 1905(l)(2)(B)(i) and (ii) of the Social Security Act, as
amended (42 U.S.C. 1396d(l)(2)(B)(i) and (ii)). These two subparagraphs
refer to organizations receiving an award under section 330 of the PHS
Act (health centers) directly or as a subrecipient of grant funding.
For purposes of this final rule, this definition of health center
grantee or subgrantee is defined as organizations receiving funding
under section 330(e) of the PHS Act.
3. ``Minimal administration fee'': This final rule establishes that
health centers receiving funding under section 330(e) of the PHS Act
are expected to offer insulin and injectable epinephrine at or below
the price the health center paid through the 340B Program, plus a
minimal administration fee. As the Executive Order does not allow any
other charge for these two categories of drugs, the minimal
administration fee is expected to include any dispensing fee,
counseling costs, and any other charges associated with the patient
receiving the medication. As the fee must be ``minimal,'' consistent
with the stated policy of the Executive Order, the administration fee
should not create a barrier to low-income health center patients
accessing these drugs, and health centers should make every reasonable
effort to keep the fee as low as possible. Health centers may consider
referring to the Medicaid dispensing fee in their state \1\ as a
comparison for what may be considered a minimal administration fee.
Please note that when there is a separate fee associated with provision
of the pharmaceutical service, such as a dispensing fee, health centers
must apply a sliding fee discount to that fee. The Health Center
Program Compliance Manual's Sliding Fee Discount Program Chapter
specifies the requirements of a health center's sliding fee discount
program for in-scope services including pharmaceutical services.\2\
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\1\ Please see https://www.medicaid.gov/medicaid/prescription-drugs/state-prescription-drug-resources/medicaid-covered-outpatient-prescription-drug-reimbursement-information-state/index.html for
further information.
\2\ Please see https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-9.html#titletop for further information.
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4. ``Individuals with low incomes'': This final rule defines
individuals with low incomes as individuals and families with annual
incomes of no greater than 350 percent of the Federal Poverty
Guidelines.
5. ``High cost sharing requirement'': For purposes of this final
rule, cost sharing refers to a patient's out-of-pocket costs,
including, but not limited to, deductibles, coinsurance, and
copayments, or similar charges. More specifically, a cost sharing
requirement that exceeds twenty percent of the amount the health center
is charging its patients for the drug would be considered a high cost
sharing requirement.
6. ``High deductible'': High deductible refers to a deductible
amount that is not less than the amount required for a high deductible
health plan as defined in section 223(c)(2)(A) of the Internal Revenue
Code, which, for 2020, is any plan with a deductible of at least $1,400
for an individual or $2,800 for a family, with out-of-pocket costs not
to exceed $6,900 for an individual and $13,800 for a family for in-
network services. For 2021, the deductible limits would remain the
same, while the limits for out-of-pocket costs would increase to $7,000
for self-only coverage and $14,000 for family coverage. When the
Internal Revenue Service (IRS) updates these figures, HRSA will post
the updated high deductible amounts on the Health Center Program
website.
7. ``High unmet deductible'': High unmet deductible refers to the
amount
[[Page 83824]]
a patient owes toward their high deductible at any time during a plan
year in which the portion of the patient's high deductible for the plan
year that has not yet been met exceeds 20 percent of the deductible.
8. ``Health insurance'': Health insurance refers to private
insurance, State and exchange plans, employer-funded plans, and
coverage under titles XVIII, XIX, and XXI of the Social Security Act.
V. Public Comments and Responses
HRSA received a total of 226 comments from the public, including
individuals requiring insulin or injectable epinephrine and their
family members, associations and organizations representing health
centers and other stakeholders, health center staff and clinical
professionals, health insurance issuers, and pharmaceutical
manufacturers. The vast majority of commenters identifying themselves
as individuals or the family members of those who rely on insulin or
injectable epinephrine (22) were in favor of the proposed rule,
although several suggested the proposed rule did not go far enough in
reducing prices of these two medications. Many commenters (175),
including many health centers, strongly urged that the proposed rule
either not be finalized or be delayed in implementation, although most
of these comments shared in the Administration's goal of ensuring
access to these two life-saving medications. Most of the comments
opposing implementation of the rule or suggesting delaying
implementation also recommended changes to the language of the NPRM if
it were to be implemented.
All comments were considered in developing this final rule. This
section presents a summary of all major issues raised by commenters,
grouped by subject, as well as responses to the comments. Commenters
used the terms ``Federally Qualified Health Centers (FQHCs)'' and
``health centers'' interchangeably. For consistency, and as this rule
applies to health centers funded under Section 330(e) of the PHS Act,
and not to other FQHCs, this final rule uses ``health center''
throughout.
1. Support for the Proposed Rule
Approximately 23 commenters expressed support for the proposed
rule. Commenters cited a number of reasons for their support, including
the high cost of insulin and injectable epinephrine and concern over
increasing costs of medications. Commenters also stated that lower cost
medications lead to higher medication patient adherence and, as such,
lower the costs to the overall health system. One commenter noted that
the proposed rule would mostly benefit those between 200 percent and
350 percent of the FPG.\3\ Many of these commenters felt the proposed
rule should be expanded to include more medications and patients beyond
those served by health centers.
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\3\ The FPG are a federal poverty measure issued each year in
the Federal Register by HHS. The guidelines are used for
administrative purposes, such as for determining financial
eligibility for certain federal programs. They are available at
https://aspe.hhs.gov/poverty-guidelines.
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Additionally, one commenter requested that HRSA include the
proposed rule's requirements in all grants establishing 340B
eligibility, and that the proposed rule's requirements should also
apply to health centers' contract pharmacy arrangements.
Response: HRSA appreciates the commenters' support for the rule.
Consistent with the direction provided to HHS in the Executive Order,
HRSA is not expanding this final rule beyond health centers receiving
grants under Section 330(e) of the PHS Act, to drugs beyond insulin and
injectable epinephrine, or otherwise beyond the parameters identified
in the proposed rule. As a clarification, health centers utilizing
contract pharmacy arrangements must also adhere to this final rule.
2. Concerns Regarding the Proposed Rule's Enforceability
Two commenters expressed concerns with the proposed rule's
enforceability. Commenters suggested that a rule implementing the
Executive Order could be easily circumvented and could be challenging
to enforce. More specifically, commenters stated that without explicit
codes for documenting which health centers participate in the 340B
Program, it would be difficult to monitor and enforce compliance.
Another commenter suggested HRSA clearly identify which health centers
are participating in the 340B Program to help private sector partners
support the implementation of the proposed rule. In addition, the
commenter stated that HRSA should specify methods that would be used to
verify income and insurance status in order to successfully operate the
program.
One commenter also included suggestions for ensuring compliance and
eliminating loopholes, including: (1) Providing receipt information for
the monetary exchange between patients and providers, (2) comparing the
manufacturer's drug price against the price charged to patients, and
(3) using incentives to ensure compliance beyond the loss of section
330(e) funding awards (e.g., loss of medical license for non-
compliance).
Response: HRSA appreciates these comments. HRSA provides oversight
of all covered entities in the 340B Program, including health centers,
and HRSA declines to add these suggested compliance requirements. In
particular, the suggestion that non-compliance should result in the
loss of a medical license is outside of HRSA's purview.
With regard to the other suggestions for monitoring compliance with
the final rule, HRSA will monitor the ongoing implementation of this
final rule and will make changes as appropriate to ensure its effective
implementation.
3. Final Rule Is Not Needed as the 340B Program Is Operating as
Intended
Approximately 52 commenters stated that the 340B Program is
operating as intended when originally created and changes are not
needed. Many of these commenters stated that health centers already
provide discounted drugs to patients, regardless of their ability to
pay. Commenters also noted that health centers are required by law to
use 340B savings to expand access to health care for the underserved,
and these savings are crucial to enabling health centers to offer other
services to their patients in addition to providing discounts for
drugs.
One commenter called on HRSA to take a more holistic approach to
realign the 340B Program with its original intent and scope and support
health centers' access to the 340 Program.
Response: HRSA acknowledges that health centers use 340B Program
savings to benefit their patient population, as required by the Health
Center Program, and many health centers provide discounted medications
to their patients. Consistent with the Executive Order, this final rule
applies only to insulin and injectable epinephrine and does not address
other drugs health centers purchase through the 340B Program.
4. The Executive Order Reflects a Misunderstanding of Health Centers'
Mission and Operations
Approximately 175 commenters suggested that the Executive Order, on
which the NPRM is based, reflects fundamental misunderstandings about
health centers' mission and operations, and does not recognize the
essential role that health centers play in ensuring access to
affordable pharmaceuticals for medically vulnerable populations. The
commenters expressed concern with the
[[Page 83825]]
Executive Order provision that suggested that health centers are
benefiting inappropriately from the 340B Program at the expense of
their vulnerable patients. The commenters argued that health centers do
much more than pass on the 340B discount to their low-income patients,
and often discount drug prices below the 340B price to ensure they are
affordable. Additionally, commenters stated that all health centers are
required to invest all 340B savings into activities that expand access
to care for low-income populations, and that health centers are already
part of the solution to unaffordable drug prices, and not part of the
problem. Commenters also stated that health centers are widely praised
for their strong track record of compliance with both the letter and
the spirit of the 340B statute.
Response: The final rule implements the goals and intent of the
Executive Order to make insulin and injectable epinephrine more
affordable. HRSA acknowledges that health centers play a crucial role
in providing access to comprehensive, high quality primary health care
to all patients regardless of ability to pay. Further, HRSA is
cognizant of health centers' compliance with the 340B statute and
strong track record of using the savings generated to benefit patients.
HRSA values its partnerships with all health centers and commends their
efforts to ensure access to affordable drugs for all of their patients.
5. The Executive Order Reflects a Misunderstanding of the 340B Program
Approximately 161 commenters suggested that the Executive Order on
which the NPRM is based reflects a fundamental misunderstanding of the
340B Program, and if implemented as written would decrease some
patients' access to affordable drugs. The commenters argued that this
misunderstanding of 340B pricing would result in some patients paying
more for insulin, dramatic fluctuations in insulin costs from one
quarter to another and requiring quarterly changes to a patient's
prescription to keep them on the most affordable insulin brand
available.
The commenters also disagreed with the Executive Order's statement
that health centers pay only one penny for a month's supply of insulin
or injectable epinephrine. The commenters suggested that this statement
was not universally true given drug pricing fluctuations, with prices
for drugs often varying from one penny in one quarter to over $100 in
another quarter. These commenters stated that health centers cannot
guarantee that the price of the insulin or injectable epinephrine that
a patient will pay on a certain day is the exact 340B price. This 340B
price fluctuation from quarter to quarter can create an undue
administrative compliance burden on health center staff.
One commenter suggested that the drug price charged to the health
center patient should be the average 340B drug price to account for the
quarterly variations in pricing.
Response: The rule implements the goals and intent of the Executive
Order to make insulin and injectable epinephrine more affordable. HRSA
recognizes that health centers have a strong history of compliance with
the 340B statute and that many already significantly discount drugs for
their patients, either through in-house pharmacies or via 340B contract
pharmacies.
Drug prices are set quarterly based on prices manufacturers submit
to the Centers for Medicare & Medicaid Services. Although insulin and
injectable epinephrine prices may vary from quarter to quarter, the
final rule allows health centers to offer these drugs at lower than the
340B price despite these fluctuations. Given this flexibility, and
consistent with the intent of the Executive Order, HRSA will not change
the final rule to allow for the averaging of 340B prices.
6. Differences Between the Executive Order and NPRM
Approximately 143 commenters noted that the language in the
proposed rule departs from language in the Executive Order.
Specifically, the proposed rule would allow health centers to make
insulin and injectable epinephrine available ``at or below'' the price
the health center paid through the 340B Program, whereas the Executive
Order requires that health centers make such medications available ``at
the discounted price.'' Commenters suggested that the Executive Order
prohibits health centers from providing these drugs at prices below the
340B Ceiling Price. The commenters agreed with the need to allow
flexibility in providing further discounts to patients but expressed
concern that the discrepancy in language between the Executive Order
and proposed rule demonstrates the inappropriateness of both.
Response: HRSA intends to proceed with language in the proposed
rule requiring health centers to make insulin and injectable
epinephrine available ``at or below'' the price paid by the health
center through the 340B Program. This final rule will allow a health
center to provide either of these two medications to patients at a
price below the 340B Price. The language in this rule is consistent
with the intent of the Executive Order.
7. Change Proposed Definition of ``Low-Income''
Approximately 164 commenters requested that HRSA change its
proposed definition of ``low-income'' from 350 percent of the FPG to
200 percent of the FPG to better align with definitions used by other
federal programs and private entities. Commenters noted that income
assessments are not typically conducted by clinical staff, and those
who conduct the assessments do not and should not have access to the
personal health information that would be required for them to conduct
a separate income analysis for patients who require insulin or
injectable epinephrine. Additionally, commenters stated that such staff
may not be competent to determine which patients may need such drugs
now or in the future. Commenters specifically argued that using a low-
income definition different from the 200 percent of the FPG required by
the Health Center Program would create significant burden on health
center staff to determine eligibility for health center discounts
differently from eligibility for the pricing created by the proposed
rule. This discrepancy would also create potential burden when using a
contract pharmacy, where staff may be unfamiliar with evaluating
patient income and may be unwilling to do so. Commenters further noted
HHS, the United States Census Bureau, and private groups use 200
percent of the FPG to define low-income for research purposes.
Commenters stated that for every federal program with income
eligibility thresholds, low-income is defined as 250 percent of the FPG
or less. While the Patient Protection and Affordable Care Act uses a
ceiling above 350 percent to identify those eligible for premium tax
credits on the Exchanges, this is not a definition of low income, as
premium tax credits are designed for both lower and middle class
individuals. Finally, commenters argued that a 350 percent FPG
threshold could eliminate health centers' ability to retain 340B
savings from privately insured patients due to health insurance issuers
frequently requiring health centers to bill no more than their usual
and customary (U&C) rate. While health centers have been successful
resisting issuers' attempts to define U&C rates as discounted rates
provided to patients at or below 200 percent FPG, the commenters
expressed concern that
[[Page 83826]]
defining low-income as 350 percent FPG will cover most health center
patients, making it very difficult to argue that the 340B price for
insulin and injectable epinephrine is not the health center's U&C rate.
This change would effectively transfer the 340B benefit from health
centers to private health insurance issuers.
Response: HRSA intends to proceed with the language in the proposed
rule requiring health centers to make insulin and injectable
epinephrine available at or below the price paid by the health center
through the 340B Program to health center patients that have incomes at
or below 350 percent FPG and that otherwise meet the criteria described
in this rule. While HRSA appreciates the feedback on the definition of
``low income'', we do not agree that it is too burdensome to implement
as written. The language in this rule is consistent with the intent of
the Executive Order.
8. Clarify Eligible Patients Under the Rule
Approximately 162 commenters requested clarification of the
regulatory language that only those patients who meet the 340B patient
definition are eligible for the 340B (or lower) price. Commenters
argued that the regulatory language must clearly state that the health
center is required to charge the 340B price (or less) only to those
low-income individuals who meet the definition of ``FQHC patient''
under the 340B Program. Without such language, health centers could be
forced to provide 340B pricing (or less) to individuals who are not
eligible to receive 340B-priced drugs from the health center.
Commenters used the example that low-income individuals could demand
the health center provide them with discounted insulin, without
permitting the health center to assume responsibility for their care (a
necessary step for 340B eligibility). In such situations, 340B
compliance would require the health center to purchase the insulin at
the regular price, while this regulation would require that the
individual be charged the 340B price or lower--an outcome that would be
both expensive and administratively burdensome for the health center.
Commenters recommended an addition to the regulatory text to clarify
that only eligible health center patients should be able to access
these drugs at the 340B price.
Response: The intent of the rule is to provide insulin and
injectable epinephrine at no more than the 340B price to health center
patients and not to individuals who are not health center patients.
HRSA understands commenters' concerns, and the language in 42 CFR
51c.303(w)(1) has been revised to clarify that the final rule applies
only to ``health center patients.'' HRSA also notes that the NPRM
states that a ``patient'' for purposes of this subsection means only
health center patients who receive in-scope health center services
beyond dispensing of drugs that are self-administered or administered
at home. This definition is also being finalized in this rule.
9. Address Potential Conflict With Third-Party Payor Contract Terms
Approximately 161 commenters requested that HRSA add regulatory
language ensuring that health centers are not forced to provide
discounts to underinsured patients if doing so would violate the terms
of their insurance contracts. These commenters noted that many health
insurance issuers prohibit providers from charging patients less for a
service or supply than the amount due under their deductible or cost
sharing requirements.
Response: HRSA acknowledges that health centers need to comply with
the terms of their contracts with third-party payors. HRSA clarifies in
the final rule that provision of insulin and injectable epinephrine at
or below the 340B discounted price is subject to potential restrictions
in contracts with third-party payors. The language of the final rule
reflects this clarification.
10. Change Definitions of ``High Cost Sharing Requirement,'' ``High
Deductible'' and ``High Unmet Deductible''
Approximately 161 commenters requested HRSA clarify its definitions
of ``high cost sharing requirement.'' Commenters specifically noted
confusion surrounding the definition of ``high cost sharing
requirement'' and asked whether it means that a low-income patient
should be charged the lesser of their cost sharing amount, or the
amount they would be charged under the proposed rule if they were
uninsured. In addition, two commenters argued that health centers
already provide their patients with medications at significant
discounts and are thus concerned about defining ``high cost sharing
requirement'' as 20 percent of an already discounted price. The two
commenters noted that it is unlikely that a private health insurance
issuer would define a charge that is 20 percent of an already
discounted price as a ``high cost sharing requirement.'' Commenters
requested the definition be rewritten to reflect that 20 percent of an
already discounted price is not a high cost sharing requirement. One
commenter requested clarification as to how ``high cost sharing'' would
be calculated for a patient with an insurance plan that ties the
patient's cost sharing to a deductible or co-insurance that may change
over the course of a plan year and suggested that this kind of
fluctuation in cost sharing would require communication with payors and
should be worked out before a final rule is promulgated.
Two commenters requested that ``high deductible'' and ``high unmet
deductible'' be changed to a specifically defined amount so that health
center and contract pharmacy staff could determine eligibility from a
patient's insurance card. They specifically noted the proposed
definition of ``high deductible'' points to a section in the Internal
Revenue Code and that it would be burdensome for intake staff to
determine if a patient has a ``high deductible'' or a ``high unmet
deductible'' using this definition. One commenter requested further
clarification of ``high unmet deductible,'' asking if once a patient
meets 80 percent of their deductible they are no longer eligible for
the proposed rules' pricing. The commenter noted that, if so, the
patient's deductible payments would need to be tracked throughout the
plan year and made available at the point of sale through the claims
adjudication process. Additionally, medical claims may need to be
factored into the unmet deductible amount, which could be challenging
due to the delays in processing medical claims for patients with a dual
pharmacy/medical deductible.
Response: HRSA appreciates the feedback surrounding the definition
of ``high cost sharing requirement.'' The rule does not state that a
low-income patient should be charged the lesser of their cost sharing
amount or the amount they would be charged under the proposed rule if
they were uninsured. Rather, the rule states that such patients should
be provided access to insulin and injectable epinephrine at no more
than the price at which the health center purchased the drug through
the 340B program. While HRSA appreciates the feedback on the definition
of ``high cost sharing requirement,'' we do not agree that it is too
burdensome to implement as written. HRSA also notes that health centers
may choose to charge their patients less than the discounted price at
which the health center purchased the drug through the 340B Program,
regardless of the patient's insurance out-of-pocket costs or insurance
status.
HRSA appreciates the feedback that the proposed rule may be
difficult to implement for patients whose cost
[[Page 83827]]
sharing changes throughout the plan year. HRSA will monitor
implementation of the final rule and will modify it if we determine
that a modification is warranted.
HRSA appreciates the feedback that it will be difficult for health
center intake staff to determine eligibility for the final rule's
pricing on insulin and injectable epinephrine because the rule's
definition of ``high deductible'' references the Internal Revenue Code
definition. As reflected in the preamble of the NPRM, HRSA will publish
the Internal Revenue Code definition of high deductible on the Health
Center Program website. Such eligibility determinations may be
integrated into existing processes utilized by health centers.
Furthermore, it is HRSA's understanding that many insurance cards do
print the deductible on their cards, and we agree that the ability to
evaluate whether a plan has a ``high deductible'' based on such
information may make evaluation less burdensome on health center staff.
However, HRSA does not have the authority to require health insurance
issuers to place deductible amounts on the proof of insurance cards
they provide to patients.
HRSA appreciates the feedback on the definition of ``high unmet
deductible'' and the potential difficulty with implementing this
provision of the rule. To clarify, HRSA does intend that once a patient
meets 80 percent of a high unmet deductible, the health center would no
longer be required to provide that patient with insulin or injectable
epinephrine at the 340B price as described by this rule, unless such
patient separately meets the definition of either having a ``high cost
sharing requirement'' or having no insurance. We realize this may have
the potential to create additional burden on health centers and their
contract pharmacies to ascertain a patient's eligibility for pricing
under this rule. HRSA will monitor implementation of this final rule
and will modify it if it is deemed that a modification is warranted.
11. Clarify Definition of ``Minimal Administration Fee''
Approximately 161 commenters requested clarification that, as a
result of this rule, the ``minimal administration fee'' for insulin and
injectable epinephrine will differ from the fees (if any) associated
with dispensing other pharmaceuticals. Commenters noted that this rule
will create significant additional administrative burdens for health
centers, beyond the costs regularly associated with dispensing,
counseling, and 340B compliance. One commenter requested that if the
eligibility threshold under this rule is not aligned with the 200
percent of the FPG established for discounts to health center services
under the Health Center Program, that HRSA define ``minimal
administration fee'' to include costs associated with dispensing, 340B
compliance, and the additional administrative work required to identify
patients. Furthermore, they requested that HRSA clarify that this fee
is unique to the dispensing of insulin and injectable epinephrine.
One commenter requested clarification that administration fees may
include limited per prescription fees associated with operationalizing
an overall 340B Program or contract pharmacy network. Because health
centers often have arrangements with third-party vendors and/or
contract pharmacies that include a per prescription fee, and such fees
are often minimal, changes to how these fees are calculated and
administered could cause patients to lose access to some pharmacies.
Response: The final rule defines ``minimal administration fee'' as
a fee that may not create a barrier to low-income patients' access to
insulin and injectable epinephrine. It would be inconsistent with the
intent of the Executive Order and the rule to define ``minimal
administration fee'' in a way that could create a barrier to accessing
these drugs. A definition that included potential costs related to
compliance could be seen as accepting that health centers will charge
patients a higher fee to purchase insulin and injectable epinephrine
than for other pharmaceuticals.
As all health centers are required to collect information regarding
patient income, HRSA does not anticipate the need for a separate
eligibility review. Entities participating in the 340B Program already
manage different prices for 340B drugs on a quarterly basis. This final
rule has clarified that only health center patients are eligible for
insulin and injectable epinephrine at the prices set under this rule,
and HRSA does not anticipate health centers incurring additional costs
related to non-health center patients receiving these drugs. Monitoring
and reporting compliance with this rule is not anticipated to be
significant.
HRSA recognizes that the minimal administration fee described in
the rule does not occur with other pharmaceuticals, including other
340B drugs, where multiple fees are listed separately. The rule defines
the term, and states that health centers may, but are not required to,
charge such a minimal administration fee for insulin and injectable
epinephrine. HRSA acknowledges that this minimal administration fee is
unique to this rule and insulin and injectable epinephrine as covered
here, and that this rule does not create a new term that applies to the
340B Program beyond this rule. As noted in the rule, all definitions
are provided ``for purposes of this paragraph exclusively.'' Therefore,
HRSA declines to make revisions to this section.
12. Clarify ``Established Practices''
One commenter requested that HRSA clarify and provide additional
guidance on the proposed rule's requirement for ``established
practices.'' Because not all covered entities have mechanisms in place
to adjudicate 340B claims for uninsured or underinsured patients, the
commenter noted that many will have to take affirmative steps to
develop systems and processes to support the provisions of the proposed
rule, which have cost and time implications. These additional
administrative costs could lead to reduced patient access to health
center services or discounted drugs.
The commenter requested HRSA clarify that to the extent that 340B
covered entities have existing contracts with third-party
administrators or vendors regarding established practices, deference be
given to the practices in those existing contracts. However, for those
covered entities that do not have established practices in place, the
commenter requested that HRSA provide clear guidance on how covered
entities should notify contract pharmacies so that they are aware which
patients are eligible for the discounted prices.
Response: HRSA proposed a definition of ``established practices''
in the NPRM and finalizes that definition in this rule. We understand
that some health centers will have to establish new practices to ensure
compliance with the requirements of this rule; however, HRSA does not
anticipate that the administrative costs of establishing such practices
will be substantial.
13. Suggested Technical Edits to (w)(1)
One commenter suggested several edits to the NPRM language proposed
at 42 CFR 51c.303(w)(1). Specifically, they suggested that the
regulatory language in subsection 51c.303(w)(1), as proposed in the
NPRM, be edited to replace ``through a written agreement'' with
``indirectly.'' They argued that some 340B covered entities either do
not have written agreements with contract pharmacies, or do not abide
by such agreements. They further suggested
[[Page 83828]]
that ``discounted price paid by the health center'' be replaced with
``340B Ceiling Price,'' arguing that ``ceiling price'' be more clearly
defined. They also suggested several typographical edits.
Response: As the commenter noted, health centers should have
written agreements with contract pharmacies used for dispensing 340B
drugs. HRSA believes that the use of ``written agreements'' as proposed
in the NPRM will provide greater clarity for health centers in
complying with this rule. It is HRSA's intent that a health center
choosing to participate in the 340B Program must provide the two life-
saving medications identified in this rule either directly or through a
written agreement. Other forms of ``indirect'' distribution of the drug
would not be compliant with the rule. HRSA will monitor implementation
of this final rule and will modify it if it is deemed that a
modification is warranted.
HRSA will not at this time use ``340B Ceiling Price'' as suggested
by the commenter. The Executive Order intended for low-income patients
to access insulin and injectable epinephrine at no more than the price
paid by the health center through the 340B Program. As it is possible
that the health center may have paid less than the 340B Ceiling Price,
the language proposed in the NPRM is finalized in this rule.
HRSA appreciates the commenter's identification of several
typographical edits and accepts those suggestions, which are reflected
in the final rule.
14. Concern Regarding Market Distortions
Two commenters expressed concern regarding market distortions. One
commenter argued that the proposed rule could exacerbate market
distortions, as well as create new ones. Another commenter noted that
applying this policy to the insured could deflect costs from insurance
plans to patients and that the policy could perpetuate a situation
whereby patients with insurance may be unable to utilize the benefit in
a meaningful way. The commenter argued that allowing patients with
insurance to access 340B Program pricing creates a perverse incentive
for insurance plans to continue shifting out-of-pocket costs for 340B
drugs to patients. They argued that this undermines the purpose of
insurance, and that to the extent more patients remain in the
deductible phase of the benefit for all if not most of the year, the
health insurance issuer does not provide any coverage for the patient's
prescription.
Response: HRSA appreciates the concern expressed in these comments.
However, the purpose of the Executive Order and the rule is to reduce
the cost of insulin and injectable epinephrine to patients. Therefore,
HRSA will finalize the rule as described.
15. Concern Regarding Additional Burden on Contract Pharmacies
One commenter noted the NPRM expressly states there will be no
additional paperwork or reporting burden for health centers associated
with implementation. The commenter was concerned that implementation of
the proposed rule could lead to additional paperwork, reporting, and
regulatory burdens for independent pharmacies operating as contract
pharmacies for health centers. The commenter requested clarification in
the final rule that no additional burdens will be placed on contract
pharmacies.
Response: Health centers and contract pharmacies operate as private
entities and make independent decisions as to their contracting
arrangements. HRSA will continue to monitor the impact of this final
rule on health centers and their contract pharmacy arrangements and
will modify it if it is determined that a modification is warranted.
16. Rule Is Economically Significant
One commenter disagreed with the proposed rule and believed it was
economically significant and that it would have an impact on small
entities. The commenter requested that HRSA be required to further
evaluate the costs and benefits of finalizing the proposed rule and to
look at alternatives to implementing the rule.
Response: This comment is addressed in the Regulatory Impact
Analysis section of this final rule.
17. Legal Sufficiency of the NPRM
One commenter argued that the NPRM does not provide legal
justification and is therefore arbitrary and capricious and contrary to
the Administrative Procedure Act. The commenter requested that HRSA
withdraw the NPRM.
Response: HRSA has indicated the statutory authority for the NPRM
and final rule as Section 330 of the PHS Act (42 U.S.C. 254b) and
Section 215 of the PHS Act (42 U.S.C. 216), and is issuing the final
rule pursuant to Executive Order 13937. HRSA disagrees with the
commenter that the rule is arbitrary and capricious. HRSA stated in the
NPRM that the ongoing Coronavirus Disease COVID-19 pandemic has caused
significant hardship among many low-income individuals and, because of
this and consistent with the Executive Order, HRSA is attempting to
ensure two life-saving medications, insulin and injectable epinephrine,
are available at affordable rates. HRSA disagrees that the NPRM and
final rule are inconsistent with the Administrative Procedure Act.
18. Miscellaneous
Other commenters raised a variety of issues that do not pertain
directly to the implementation of Executive Order 13937 requiring
entities funded under Section 330(e) of the PHS Act to establish
practices to provide access to insulin and injectable epinephrine to
low-income health center patients at the price the health center
purchased these two drugs through the 340B Program, which was the focus
of the proposed rule. This final rule does not address those issues as
they are outside the scope of the proposed rule.
VI. Regulatory Impact Analysis
HHS has examined the effects of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 8, 2011), the Regulatory Flexibility Act (Pub. L. 96-354,
September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4), and Executive Order 13132 on Federalism (August 4, 1999). HHS
has also considered Executive Order 13771 (``Reducing Regulation and
Controlling Regulatory Costs''), and received public comments
describing new administrative costs for health centers. As a result,
OMB has determined this rule is regulatory for purposes of Executive
Order 13771.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 is supplemental to and reaffirms the principles,
structures, and definitions governing regulatory review as established
in Executive Order 12866, emphasizing the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. Section 3(f) of Executive Order 12866 defines
a ``significant regulatory action'' as an action that is likely to
result in a rule: (1) Having an annual effect on the
[[Page 83829]]
economy of $100 million or more in any 1 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 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. A regulatory impact analysis (RIA)
must be prepared for major rules with economically significant effects
($100 million or more in any 1 year), and a ``significant'' regulatory
action is subject to review by the Office of Management and Budget
(OMB).
HHS does not believe that this rule will have an economic impact of
$100 million or more in any 1 year, or adversely and materially affect
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or Tribal
governments or communities. Because this rule is limited in scope to
two classes of drugs that are of particular need and it aligns with the
mission for health centers to provide access to care for vulnerable
individuals and families, HHS believes it will have minimal economic
impact. The economic impact is also expected to be minimal given the
rule is limited to only two drug categories which are available under
the 340B Program at significantly reduced prices. Indeed, approximately
91 percent of patients at affected health centers have incomes at or
below 200 percent of FPG, and thus receive discounts on health
services. (In addition, health centers are required to reinvest any
income from the 340B Program into patient services.) Many commenters
noted that health centers already provide medications at reduced prices
to their patients. For example, some health centers reported charging
$7 for a 1-month supply of insulin for individuals below 200 percent of
poverty. As discussed earlier, in the summary of public comments, the
final rule leads to new administrative costs for health centers in
association with new processes and procedures. There are approximately
1,385 health center awardees that could experience these new costs.\4\
HRSA estimates that, on average, each health center would need one
additional full-time equivalent (FTE) eligibility assistance worker at
approximately $50,000 to support necessary additional administrative
processes, totaling approximately roughly $68,750,000. Therefore, OMB
has not designated this rule as ``economically significant'' under
section 3(f)(1) of the Executive Order 12866. HHS welcomed but received
no public comments that demonstrated this rule will have an economic
impact exceeding the threshold set by E.O. 12866.
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\4\ See https://data.hrsa.gov/tools/data-reporting/program-data/national.
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The Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the
Small Business Regulatory Enforcement and Fairness Act of 1996, which
amended the RFA, require HHS to analyze options for regulatory relief
of small businesses. If a rule has a significant economic effect on a
substantial number of small entities, the Secretary must specifically
consider the economic effect of the rule on small entities and analyze
regulatory options that could lessen the impact of the rule. HHS will
use an RFA threshold of at least a 3 percent impact on at least 5
percent of small entities.
For purposes of the RFA, HHS considers all health care providers to
be small entities either by meeting the Small Business Administration
(SBA) size standard for a small business, or for being a nonprofit
organization that is not dominant in its market. The current SBA size
standard for health care providers ranges from annual receipts of $8
million to $41.5 million. As of August 8, 2020, the Health Center
Program provides grant funding under section 330(e) of the PHS Act to
1,310 organizations to provide health care to medically underserved
communities. HHS has determined, and the Secretary certifies, that this
rule will not have a significant impact on the operations of a
substantial number of small health centers; therefore, we are not
preparing an analysis of impact for the RFA.
HHS welcomed comments concerning the impact of this proposed rule
on health centers and received one comment on this topic. The commenter
argued that the rule will have a significant economic impact on a
substantial number of small entities. The commenter argued that the
stress this rule will cause to health centers may result in reductions
in services, employment, and access to life-saving treatment.
Specifically, the commenter stated that the rule will have the impact
of (1) dramatically reducing 340B savings for health centers, (2)
likely increasing the cost of life-saving medications nationwide, and
(3) creating enormous administrative burdens for health centers,
specifically because the NPRM proposed defining ``low-income'' as at or
below 350 percent of the FPG, a different income threshold than the 200
percent used by the Health Center Program.
HHS acknowledges the commenter's concerns. However, HHS has not
changed its determination that the RFA does not apply to this rule. The
comment did not demonstrate that a reduction in 340B savings would meet
the threshold of a 3 percent impact on 5 percent of small entities. A
reduction in 340B savings is limited to those related to these two
medication categories, and only when provided to low-income patients
that are uninsured, or who have a high cost sharing requirement or high
unmet deductible. The comment did not demonstrate or explain how this
rule will increase the cost of medications nationwide. To the contrary,
the rule will increase the access of certain low-income patients to
affordable insulin and injectable epinephrine.
Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year.'' In 2019, that threshold level was
approximately $164 million. HHS does not expect this rule to exceed the
threshold.
Executive Order 13132--Federalism
HHS has reviewed this rule in accordance with Executive Order 13132
regarding federalism, and has determined that it does not have
``federalism implications.'' This rule would not ``have substantial
direct effects on the States, or on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This rule
would not adversely affect the following family elements: Family
safety, family stability, marital commitment; parental rights in the
education, nurture, and supervision
[[Page 83830]]
of their children; family functioning, disposable income or poverty; or
the behavior and personal responsibility of youth, as determined under
section 654(c) of the Treasury and General Government Appropriations
Act of 1999.
Paperwork Reduction Act of 1995
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that OMB approve all collections of information by a federal agency
from the public before they can be implemented. This rule is projected
to have no impact on current reporting and recordkeeping burden for
health centers. This rule would result in no new reporting burdens. HHS
welcomed but did not receive comments that this rule would result in
new reporting burdens for health centers.
List of Subjects in 42 CFR Part 51c
Grant programs--Health, Health care, Health facilities, Reporting
and recordkeeping requirements.
Dated: December 16, 2020.
Thomas J. Engels,
Administrator, Health Resources and Services Administration.
Dated: December 17, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
Accordingly, by the authority vested in me as the Secretary of
Health and Human Services, and for the reasons set forth in the
preamble, 42 Code of Federal Regulations Part 51c is amended as
follows:
PART 51c--GRANTS FOR COMMUNITY HEALTH CENTERS
0
1. The authority statement for part 51c is revised to read as follows:
Authority: 42 U.S.C. 254b (Sec. 330, Public Health Service Act);
42 U.S.C. 216 (Sec. 215, Public Health Service Act,).
0
2. Section 51c.303 is amended by adding paragraph (w) to read as
follows:
Sec. 51c.303 Project elements.
* * * * *
(w)(1) Provision. To the extent that an applicant for funding under
Section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) has
indicated that it plans to distribute, either directly, or through a
written agreement, drugs purchased through the 340B Drug Pricing
Program (42 U.S.C. 256b), and to the extent that such applicant plans
to make insulin and/or injectable epinephrine available to its
patients, the applicant shall provide an assurance that it has
established practices to provide insulin and injectable epinephrine at
or below the discounted price paid by the health center grantee or
subgrantee under the 340B Drug Pricing Program (plus a minimal
administration fee) to health center patients with low incomes, as
determined by the Secretary, who have a high cost sharing requirement
for either insulin or injectable epinephrine; have a high unmet
deductible; or have no health insurance.
(2) Definitions. For purposes of this paragraph (w) exclusively:
(i) Established practices. The health center has written policies,
procedures, and/or other relevant documents that it has established
practices to offer insulin and injectable epinephrine at no more than
the discounted price paid by the health center under the 340B Drug
Pricing Program plus a minimal administration fee. Such established
practices may reflect that provision of insulin and injectable
epinephrine at or below the 340B discounted price is subject to
potential restrictions through contracts with third-party payors.
(ii) Health center grantee or subgrantee. Organizations receiving
an award under section 330(e) of the PHS Act (i.e., health centers)
directly or as subgrantees of section 330(e) grant funding.
(iii) Minimal administration fee. The minimal administration fee
includes any dispensing fee, counseling costs, and any other charges
associated with the patient receiving the medication. The
administration fee may not create a barrier to low-income health center
patients accessing these drugs, and health centers should make every
reasonable effort to keep the fee as low as possible. Health centers
may refer to the Medicaid dispensing fee in their state as a reference
for minimal administration fees. When there is a separate fee
associated with provision of the pharmaceutical service, such as a
dispensing fee, health centers must apply a sliding fee discount to
that fee.
(iv) Individuals with low incomes. Individuals and families with
annual incomes no greater than 350 percent of the Federal Poverty
Guidelines.
(v) High cost sharing requirement. A cost sharing requirement that
exceeds twenty percent of the amount the health center charges its
patients for the drug is a high cost sharing requirement. Cost sharing
refers to a patient's out-of-pocket costs, including, but not limited
to, deductibles, coinsurance, and copayments, or similar charges.
(vi) High deductible. High deductible refers to a deductible amount
that is not less than the amount required for a high deductible health
plan as defined in section 223(c)(2)(A) of the Internal Revenue Code,
as implemented by the Internal Revenue Service.
(vii) High unmet deductible. High unmet deductible refers to the
amount a patient owes toward their high deductible at any time during a
plan year in which the outstanding deductible portion exceeds 20
percent of the total deductible for the plan year.
(viii) Health insurance. Health insurance refers to private
insurance, State and exchange plans, employer-funded plans, and
coverage under titles XVIII, XIX, and XXI of the Social Security Act.
(ix) ``Patient.'' an individual is not be considered a ``patient''
of the health center if the only health care service received by the
individual from the health center is the dispensing of a drug or drugs
for subsequent self-administration or administration in the home
setting.
[FR Doc. 2020-28483 Filed 12-22-20; 8:45 am]
BILLING CODE 4165-15-P