Opioid and methamphetamine data system
The bill requires DOA to issue a request for proposals to establish and maintain
an opioid and methamphetamine data system to collect, format, analyze, and
disseminate information on opioid and methamphetamine use as specified in the bill.
DOA must collaborate with and collect data from DHS, DOC, DOJ, DSPS, and DCF
and any other applicable agencies for the opioid and methamphetamine data system.
Under the bill, DOA administers the contract with a vendor to operate the opioid and
methamphetamine data system, has access to the data contained in the opioid and
methamphetamine data system, and works with the vendor to disseminate
information and advanced analytics from the opioid and methamphetamine data
system in as close to real time as possible. The opioid and methamphetamine data
system must allow the state agencies that submit data to the opioid and
methamphetamine data system access to the data in the opioid and
methamphetamine data system as appropriate for the agency to fulfill its functions
and as allowed by state and federal confidentiality laws. The bill requires DOA to
submit a report to the governor and appropriate standing committees of the
legislature summarizing the information from the opioid and methamphetamine
data system and analyzing trends in that information across years of data collection.
Behavioral health technology grants
The bill appropriates general purpose revenue to DHS to provide grants to
behavioral health providers to implement electronic health records systems and
connect to health information exchanges.
Medication-assisted treatment grants
The bill directs DHS, as part of the grants DHS is required to award for
community programs, to award up to $500,000 in grants in fiscal year 2021-22 and
then up to $1,000,000 annually thereafter to develop or support entities that offer
medication-assisted treatment. Medication-assisted treatment addresses opioid
use disorder and opioid dependence.
Substance use harm reduction grant
The bill allows DHS, as part of the grants DHS is required to award for
community programs, to annually award up to $250,000 to organizations with
comprehensive harm reduction strategies for the development or support of
substance use harm reduction programs, as determined by DHS.
Addiction treatment platform
The bill directs DHS to contract in fiscal year 2022-23 for the development of
a substance use disorder treatment platform that allows for the comparison of
substance use disorder treatment programs in the state. Substance use disorder
treatment programs treat individuals for substance use disorder by offering services
including counseling, medication management, and recovery coaching. The bill
requires that DHS may spend no more than $300,000 on the contract.
Training for methamphetamine addiction treatment
The bill appropriates general purpose revenue to DHS to provide grants to
provide trainings to substance use disorder treatment providers on treatment
models for methamphetamine addiction.
General health and human services
Making references in the statutes gender neutral
The bill recognizes same-sex marriage by making references in the statutes to
spouses gender neutral, with the intent of harmonizing the Wisconsin Statutes with
the holding of the U.S. Supreme Court in Obergefell v. Hodges, 135 S. Ct. 2584, 192
L. Ed. 2d 609 (2015), which recognizes that same-sex couples have a fundamental
constitutional right to marriage. The bill also recognizes legal parentage for
same-sex couples under certain circumstances and adopts gender neutral parentage
terminology.
The bill provides that marriage may be contracted between persons of the same
sex and confers the same rights and responsibilities on married persons of the same
sex that married persons of different sexes have under current law. The bill defines
“spouse" as a person who is legally married to another person of the same sex or a
different sex and replaces every reference to “husband" or “wife" in current law with
“spouse." The bill makes applicable to married persons of the same sex all provisions
under current law that apply to married persons of different sexes. These provisions
relate to such diverse areas of the law as income tax, marital property, inheritance
rights, divorce, child and spousal support, insurance coverage, family and spousal
recreational licenses, consent to conduct an autopsy, domestic abuse, and eligibility
for various types of benefits, such as retirement or death benefits and medical
assistance.
In addition to making statutory references to spouses gender neutral, the bill
specifies ways in which married couples of the same sex may be the legal parents of
a child and, with some exceptions, makes current references in the statutes to
“mother" and “father," and related terms, gender neutral.
Under current law, all of the following may adopt a child: a husband and wife
jointly, a husband or wife whose spouse is the parent of the child, and an unmarried
adult. Because the bill makes references in the statutes to spouses gender neutral,
same-sex spouses jointly may adopt a child and become the legal parents of the child,
and a same-sex spouse of a person who is the parent of a minor child may adopt the
child and become the legal parent of his or her spouse's child.
Under current law, if a woman is artificially inseminated under the supervision
of a physician with semen donated by a man who is not her husband and the husband
consents in writing to the artificial insemination of his wife, the husband is the
natural father of any child conceived. Under the bill, one spouse may also consent
to the artificial insemination of his or her spouse and is the natural parent of the child
conceived. The artificial insemination is not required to take place under the
supervision of a physician, but, if it does not, the semen used for the insemination
must have been obtained from a sperm bank.
Under current law, a man is presumed to be the father of a child if he and the
child's natural mother 1) were married to each other when the child was conceived
or born or 2) married each other after the child was born but had a relationship with
each other when the child was conceived and no other man has been adjudicated to
be the father or is presumed to be the father because the man was married to the
mother when the child was conceived or born. The paternity presumption may be
rebutted in a legal action or proceeding by the results of a genetic test showing that
the statistical probability of another man's parentage is 99.0 percent or higher. The
bill expands this presumption into a parentage presumption, so that a person is
presumed to be the natural parent of a child if he or she 1) was married to the child's
established natural parent when the child was conceived or born or 2) married the
child's established natural parent after the child was born but had a relationship
with the established natural parent when the child was conceived and no person has
been adjudicated to be the father and no other person is presumed to be the child's
parent because he or she was married to the mother when the child was conceived
or born. The parentage presumption may still be rebutted by the results of a genetic
test showing that the statistical probability of another person's parentage is 99.0
percent or higher. Expanding on current law, the bill allows for a paternity action
to be brought for the purpose of rebutting the parentage presumption, regardless of
whether that presumption applies to a male or female spouse.
Current law provides that a mother and a man may sign a statement
acknowledging paternity and file it with the state registrar. If the state registrar has
received such a statement, the man is presumed to be the father of the child. Under
current law, either person who has signed a statement acknowledging paternity may
rescind the statement before an order is filed in an action affecting the family
concerning the child or within 60 days after the statement is filed, whichever occurs
first. Under current law, a man who has filed a statement acknowledging paternity
that is not rescinded within the time period is conclusively determined to be the
father of the child. The bill provides that two people may sign a statement
acknowledging parentage and file it with the state registrar. If the state registrar
has received such a statement, the people who have signed the statement are
presumed to be the parents of the child. Under the bill, a statement acknowledging
parentage that is not rescinded conclusively establishes parentage with regard to the
person who did not give birth to the child and who signed the statement.
The bill defines “natural parent" as a parent of a child who is not an adoptive
parent, whether the parent is biologically related to the child or not. Thus, a person
who is a biological parent, a parent by consenting to the artificial insemination of his
or her spouse, or a parent under the parentage presumption is a natural parent of
a child. The definition applies throughout the statutes wherever the term “natural
parent" is used. In addition, the bill expands some references in the statutes to
“biological parent" by changing the reference to “natural parent."
Gender neutral references on birth certificates
Generally, the bill substitutes the term “spouse" for “husband" in the birth
certificate statutes and enters the spouse, instead of the husband, of the person who
has given birth on the birth certificate at times when a husband would currently be
entered on a birth certificate. The name of the person who has given birth is entered
on a birth certificate when the person gives birth to a child, and current law specifies
when another name should be entered on the birth certificate. Current law requires
that if a birth mother is married at any time from the conception to the birth of a
child, then her husband's name is entered on the birth certificate as the legal father
of the child. Under the bill, if a person who gives birth is married at any time from
the conception to the birth of the child, then that person's spouse's name is entered
as a legal parent of the child. The bill also specifies that, in the instance that a second
parent's name is initially omitted from the birth certificate, if the state registrar
receives a signed acknowledgement of parentage by people presumed to be parents
because the two people married after the birth of the child, the two people had a
relationship during the time the child was conceived, no person is adjudicated to be
the father, and no other person is presumed to be the parent, then the state registrar
must enter the name of the spouse of the person who gave birth as a parent on the
birth certificate.
Health information exchange grants
The bill requires DHS to provide a grant of $655,000 in each of fiscal years
2021-22 and 2022-23 to support health information exchange activities. Health
information exchange, generally, is the sharing of patient information between
health care providers or health care systems. The bill allows DHS to transfer moneys
appropriated for these grants between fiscal years.
Home care provider registry
The bill requires DHS to conduct a one-year pilot program to create a home care
provider registry to support home and community-based long-term care support
programs and clients and vendors of care services. DHS is required to use its
competitive request-for-proposals procedures to select a vendor of the software
platform for the registry.
housing
Homelessness
Priority for homeless children
The bill creates a two-year pilot program that gives priority to homeless
children and their families, as defined under federal law, on the waiting list that
WHEDA, or a public housing agency or other entity that contracts with WHEDA,
maintains under the federal Housing Choice Voucher Program. Under the bill,
WHEDA is required to develop policies and procedures for the pilot program.
Report on homeless children and youths
The bill requires DPI to annually submit a report to the legislature on the
number of homeless children and youths in the public schools of this state. Under
the bill, “homeless children and youths” is defined by reference to federal law
providing homeless assistance.
Rental assistance grants for homeless veterans
The bill requires DOA to award grants to each continuum of care organization
in Wisconsin for the purpose of providing tenant-based rental assistance to homeless
veterans. A continuum of care organization is an organization designated by the
federal Department of Housing and Urban Development that provides funding and
services to alleviate homelessness.
Eliminating employment grants program
Under current law, DOA may award grants of up to $75,000 to counties, cities,
villages, or towns to be used to connect homeless individuals with permanent
employment. The bill eliminates that grant program.
Landlord-tenant
Notification of building code violations
Under current law, before entering into a lease with or accepting any earnest
money or a security deposit from a prospective tenant, a landlord must disclose to the
prospective tenant any building code or housing code violations of which the landlord
has actual knowledge if the violation presents a significant threat to the prospective
tenant's health or safety. The bill eliminates the condition that the landlord have
actual knowledge of such a violation and that the threat to the prospective tenant's
health or safety be “significant”; under the bill, the landlord must disclose to a
prospective tenant a building code or housing code violation, regardless of whether
the landlord has actual knowledge of the violation, if the violation presents a threat
to the prospective tenant's health or safety.
Terminating a tenancy on the basis of criminal activity
Current law allows a landlord, upon providing notice to a tenant, to terminate
the tenant's tenancy, without an opportunity to cure the tenant's default, if the
tenant, a member of the tenant's household, or a guest of the tenant 1) engages in any
criminal activity that threatens the health or safety of other tenants, persons
residing in the immediate vicinity of the premises, or the landlord; 2) engages in any
criminal activity that threatens the right to peaceful enjoyment of the premises by
other tenants or persons residing in the immediate vicinity of the premises; or 3)
engages in any drug-related criminal activity on or near the premises. The bill
eliminates these provisions.
General housing
Low income housing tax credit
Under current law, WHEDA may certify a person to claim, for a period of up to
six years, a state tax credit if the person has an ownership interest in a low-income
housing project in Wisconsin and qualifies for the federal low-income housing tax
credit program. Current law limits the amount of credits WHEDA may annually
authorize to $42,000,000. The bill increases the period for which the credit may be
claimed to 10 years and increases the amount of credits that WHEDA may annually
authorize to $100,000,000. The bill also requires that the project be allocated the
federal credit and be financed with tax-exempt bonds that are not subject to the
federal credit's volume cap, as opposed to any tax-exempt bonds as required under
current law, and allows WHEDA to waive these requirements to the extent that
WHEDA anticipates that sufficient tax-exempt private activity bond volume cap
under federal law will not be available to finance low-income housing projects in any
year.
Housing quality standards grants
The bill requires DOA to award grants to owners of rental housing units in
Wisconsin for purposes of satisfying applicable housing quality standards.
Affordable housing grants
The bill requires DOA to award grants to municipalities for the purpose of
increasing the availability of affordable workforce housing within the
municipalities.
Water utility assistance program for low-income households
The bill creates a water utility assistance program for low-income households
that is administered by DOA. Under the program, low-income households may
apply for assistance from the state to help pay the cost of their water utility bills.
Although the program is administered by DOA, DOA may contract with a county
department, another local governmental agency, or a private nonprofit organization
for processing applications and making assistance payments. DOA must establish
a payments schedule for the program. If the number of household applicants exceeds
the number anticipated to apply, payments to households may be reduced and DOA
may suspend additional applications for assistance. Under the bill, a household
eligible for water utility assistance may also be eligible for a crisis assistance
payment if the household is experiencing or at risk of experiencing a water
utility–related emergency, as defined by DOA.
insurance
Pharmacy benefit manager and prescription drug benefit regulation
The bill generally requires pharmacy benefit managers to be licensed with the
commissioner of insurance or to have an employee benefit plan administrator license
under current law. The bill also establishes certain requirements on pharmacy
benefit managers and certain health plans regarding their interactions with
pharmacies and pharmacists. Under the bill, a pharmacy benefit manager is an
entity that contracts to administer or manage prescription drug benefits on behalf
of an insurer, a cooperative, or another entity that provides prescription drug
benefits to Wisconsin residents.
The bill requires a pharmacy benefit manager to be licensed either as a
pharmacy benefit manager or as an employee benefit plan administrator, which is
an existing license under current law, in order to perform the activities of a pharmacy
benefit manager. The bill specifies that an entity that is both an employee benefit
plan administrator and a pharmacy benefit manager need only have a single license
as an administrator. To obtain a license, the pharmacy benefit manager must pay
the applicable fee; supply a bond; provide its federal employer identification number;
and show to the commissioner that the pharmacy benefit manager intends to act in
good faith in compliance with applicable laws, rules, and commissioner's orders
through certain competent and trustworthy individuals, to designate an individual
to directly administer the prescription drug benefits, and, if not organized in
Wisconsin, to agree to be subject to the jurisdiction of the commissioner and
Wisconsin courts. Under the bill, pharmacy benefit manager licenses may be
limited, suspended, or revoked for the same reasons as for employee benefit plan
administrator licenses, which include that the pharmacy benefit manager is
unqualified; repeatedly or knowingly violates laws, rules, or commissioner's orders;
endangers enrollees or the public; or has inadequate financial resources. After a
pharmacy benefit manager's license is ordered suspended or revoked, the
commissioner may allow the pharmacy benefit manager to continue to provide
services for the purpose of providing continuity of care to existing enrollees. In
addition to powers the commissioner has, generally, to implement and enforce
insurance-related laws, the bill allows the commissioner to examine, audit, or accept
an audit of a pharmacy benefit manager in the same manner as employee benefit
plan administrators and insurers and to promulgate any rules to implement
licensure of pharmacy benefit managers.
Unless federal law requires otherwise, a pharmacy benefit manager is
prohibited in the bill from retroactively denying a pharmacist's or pharmacy's claim
unless the original claim was fraudulent, the payment of the original claim was
incorrect, the pharmacy services were not rendered by the pharmacist or pharmacy,
the pharmacist or pharmacy violated state or federal law, or the reduction is
permitted by contract and is related to a quality program. The bill limits recovery
for an incorrect payment to the amount that exceeds the allowable claim. The bill
requires every pharmacy benefit manager to submit annual transparency reports
containing information specified in the bill to the commissioner. The bill sets
requirements on a pharmacy benefit manager; insurer; defined network plan, such
as a health maintenance organization; or a self-insured governmental health plan
that is conducting an audit of a pharmacist or pharmacy.
Certain health plans, or pharmacy benefit managers on behalf of health plans,
may require a pharmacy to fulfill certification or accreditation requirements in order
to participate in the plan's network of providers. The bill requires a pharmacy benefit
manager or a representative of a pharmacy benefit manager to provide to a
pharmacy, within 30 days of receipt of a written request from the pharmacy, written
notice of the certification or accreditation requirements as a determinant of network
participation. The bill prohibits a pharmacy benefit manager or representative from
changing its accreditation requirements more frequently than once every 12 months.
Current law requires pharmacy benefit managers to agree in their contracts to
make certain disclosures regarding prescription drug reimbursement, including
updating maximum allowable cost pricing information for prescribed drugs or
devices at least every seven business days, reimbursing pharmacies or pharmacists
subject to the updated maximum allowable cost pricing, and modifying information
in the maximum allowable cost information in a timely fashion. Pharmacy benefit
managers currently must also include in each contract with a pharmacy a process
to appeal, investigate, and resolve pricing disputes in accordance with the specifics
in current law. These current law requirements are unchanged by the bill.
Under the bill, a health insurance policy or a governmental self-insured health
plan may not, and a policy or plan must ensure that a pharmacy benefit manager
does not, restrict a pharmacy from or penalize a pharmacy for informing an enrollee
under the policy or plan of any differential between the out-of-pocket cost of a drug
to the enrollee under the policy or plan and the cost an individual would pay for the
drug without using insurance. Health insurance policies are referred to in the bill
as disability insurance policies. The bill prohibits a policy, plan, or pharmacy benefit
manager from requiring an enrollee under the policy or plan to pay more for a covered
drug than either the cost-sharing amount for the prescription drug under the policy
or plan or the amount the enrollee would pay for the drug without using insurance,
whichever amount is lower.
The bill requires pharmacies to post a sign describing the pharmacist's ability
to substitute a less expensive drug product equivalent or interchangeable biological
product for the prescribed drug or biological product unless the consumer or the
prescribing practitioner indicates otherwise. Under current law, a pharmacist is
required to dispense either the prescribed drug or biological product or, if lower in
price, a drug product equivalent or interchangeable biological product. The
pharmacist is currently required to inform the consumer of the options available in
dispensing the prescription. The bill requires each pharmacy to have available for
the public a listing of the retail price, updated monthly or more often, of the 100 most
commonly prescribed prescription drugs available for purchase at the pharmacy.
The bill also requires pharmacies to make available for the public information on
how to access a list, created by the Pharmacy Examining Board, of the 100 most
commonly prescribed generic drugs with the corresponding brand name, and the
federal Food and Drug Administration's list of currently approved interchangeable
biological products, to which the Pharmacy Examining Board currently has to
provide a link on its website.
The bill requires a health insurance policy, governmental self-insured health
plan, or pharmacy benefit manager to provide advanced written notice to an enrollee
of a formulary change that either removes a prescription drug from the formulary or
reassigns a prescription drug to a higher benefit tier. A higher benefit tier is a tier
with a higher deductible, copayment, or coinsurance than the tier the prescription
drug had been assigned. The advanced notice required by the bill must be provided
no fewer than 30 days before the expected formulary change, must include
information on the procedure for the enrollee to request an exception to the
formulary change, and need only be provided to those enrollees who are using the
drug at the time the notification must be sent. A policy, plan, or pharmacy benefit
manager is not required to provide advanced written notice if the prescription drug
is no longer approved by the federal Food and Drug Administration; is the subject
of a notice, guidance, warning, announcement, or other statement from the FDA
relating to concerns about the safety of the drug; or is approved by the FDA for use
without a prescription. A policy, plan, or pharmacy benefit manager is also not
required to provide advanced written notice for the removal or reassignment of a
prescription drug if the policy, plan, or pharmacy benefit manager adds to the
formulary at the same or a lower benefit tier a generic prescription drug that is
approved by the FDA for use as an alternative to the prescription drug or a
prescription drug in the same pharmacologic class or with the same mechanism of
action. A lower benefit tier has a lower deductible, copayment, or coinsurance than
the prescription drug's current benefit tier.
The bill requires a pharmacist or pharmacy to notify an enrollee in a policy or
plan if a prescription drug for which an enrollee is filling or refilling a prescription
is removed from the formulary and the policy or plan or a pharmacy benefit manager
acting on behalf of a policy or plan adds to the formulary at the same or a lower
cost-sharing tier a generic prescription drug or a prescription drug in the same
pharmacologic class or with the same mechanism of action. If an enrollee has had
an adverse reaction to the prescription drug that is being substituted for an
originally prescribed drug, the bill allows the pharmacist or pharmacy to extend the
prescription order for the originally prescribed drug to fill one 30-day supply of the
originally prescribed drug for the cost-sharing amount that applies to the
prescription drug at the time of the substitution.
Fiduciary duty of pharmacy benefit managers
The bill imposes fiduciary and disclosure requirements on pharmacy benefit
managers. Specifically, the bill provides that a pharmacy benefit manager owes a
fiduciary duty to a plan sponsor and requires that a pharmacy benefit manager
annually disclose all of the following information to the plan sponsor:
1. The indirect profit received by the pharmacy benefit manager from owning
a pharmacy or service provider.
2. Any payments made to a consultant or broker who works on behalf of the plan
sponsor.
3. From the amounts received from drug manufacturers, the amounts retained
by the pharmacy benefit manager that are related to the plan sponsor's claims or
bona fide service fees.
4. The amounts received from network pharmacies and the amount retained
by the pharmacy benefit manager.
Application of manufacturer discounts
Health insurance policies and plans often apply deductibles and out-of-pocket
maximum amounts to the benefits covered by the policy. A deductible is an amount
that enrollees in the policy must pay out of pocket before attaining the full benefits
of the plan. An out-of-pocket maximum amount is a limit specified by the policy or
plan on the amount that enrollees have paid themselves, and once this limit is
reached, the policy or plan covers the benefit entirely. The bill requires health
insurance policies that offer prescription drug benefits and self-insured health plans
to apply the amount of discounts that a manufacturer of a brand name drug provides
to reduce the amount of cost-sharing that is charged to any enrollee for those brand
name drugs to this out-of-pocket maximum amount and deductible for the enrollee.
This requirement applies for brand name drugs that have no generic equivalent and
for brand name drugs that have a generic equivalent but that the enrollee has prior
authorization or physician approval to obtain. Health insurance policies are referred
to in the bill as disability insurance policies.
Reimbursement to federal drug pricing program participants
The bill prohibits any person from reimbursing certain entities that participate
in the federal drug pricing program, known as the 340B program, for a drug subject
to an agreement under the program at a rate lower than that paid for the same drug
to pharmacies that are similar in prescription volume. The bill also prohibits a
person from imposing any fee, charge back, or other adjustment on the basis of the
entity's participation in the 340B program. The entities covered by the prohibitions
under the bill are federally qualified health centers, critical access hospitals, and
grantees under the federal Ryan White HIV/AIDS program, as well as these entities'
pharmacies and any pharmacy with which any of the entities have contracted to
dispense drugs through the 340B program.
Drug margin data reporting by hospitals in the 340B program
The bill requires each hospital participating in the 340B program to report to
OCI the per unit margin for each drug covered under the 340B program dispensed
in the previous year, the total margin, and how the margin revenue was used. OCI
is required under the bill to publicly post the information submitted and publish a
report analyzing the data. The 340B program limits the pricing of prescription drugs
paid by entities that are covered by the program due to agreements between
prescription drug manufacturers and the federal government.
Prescription drug affordability review board
The bill creates a prescription drug affordability review board, whose purpose
is to protect Wisconsin residents and other stakeholders from the high costs of
prescription drugs. The board consists of the commissioner of insurance and the
following members, all of whom are appointed by the governor for four-year terms:
1. Two members who represent the pharmaceutical drug industry, at least one
of whom is a licensed pharmacist.
2. Two members who represent the health insurance industry.
3. Two members who represent the health care industry, at least one of whom
is a licensed practitioner.
4. Two members who represent the interests of the public.
The bill requires the board to meet in open session at least four times per year
to review prescription drug pricing information. The board must provide at least two
weeks' public notice of its meetings, make the meeting's materials publicly available
at least one week prior to meeting, and provide the opportunity for public comment.
The bill imposes conflict of interest requirements for the board relating to recusal
and public disclosure of certain conflicts. The bill directs the board to access and
assess drug pricing information, to the extent practicable, by accessing and assessing
information from other states, by assessing spending for the drug in Wisconsin, and
by accessing other available pricing information.
Under the bill, the board must conduct drug cost affordability reviews. The first
step in such reviews is for the board to identify prescription drugs whose increase in
wholesale acquisition cost exceeds specified thresholds and other prescription drugs
that may create affordability challenges for the health care system in Wisconsin. For
each identified prescription drug, the board must determine whether to conduct an
affordability review by seeking stakeholder input and considering the average
patient cost share for the drug. During an affordability review, the board must
determine whether use of the prescription drug that is fully consistent with the
labeling approved by the federal Food and Drug Administration or standard medical
practice has led or will lead to an affordability challenge for the health care system
in Wisconsin. In making this determination, the bill requires the board to consider
a variety of factors, which include the following:
1. The drug's wholesale acquisition cost.
2. The average monetary price concession, discount, or rebate the
manufacturer provides, or is expected to provide, for the drug to health plans.
3. The total amount of price concessions, discounts, and rebates the
manufacturer provides to each pharmacy benefit manager for the drug.
4. The price at which therapeutic alternatives have been sold and the average
monetary concession, discount, or rebate the manufacturer provides, or is expected
to provide, to health plan payors and pharmacy benefit managers for therapeutic
alternatives.
5. The costs to health plans based on patient access consistent with federal
labeled indications and recognized standard medical practice.
6. The impact on patient access resulting from the drug's cost relative to
insurance benefit design.
