An Act To Increase the Quality of Care and Reduce Administrative Burdens in the Pharmacy Prior Approval Process
Maine Legislature, Session 122, LD 1404
Committee: Health and Human Services
Sponsors: BRENNAN, BRAUTIGAM, MAYO, MILLS, MITCHELL, STRIMLING, BARSTOW, NUTTING, PERRY, TARDY
Amends: 22 MRSA §254

Legislative Document 
No. 1404 
S.P.493 
In Senate, March 22, 2005 
An Act To Increase the Quality of Care and Reduce Administrative 
Burdens in the Pharmacy Prior Approval Process 
Reference to the Committee on Health and Human Services suggested and ordered printed. 
Presented by Senator BRENNAN of Cumberland. 
Cosponsored by Representative BRAUTIGAM of Falmouth and 
JOY J. O'BRIEN 
Secretary of the Senate 
Senators: MAYO of Sagadahoc, MILLS of Somerset, MITCHELL of Kennebec, STRIMLING 
of Cumberland, Representatives: BARSTOW of Gorham, NUTTING of Oakland, PERRY of 
Calais, TARDY of Newport. 
Printed on recycled paper 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1. 22 MRSA §254, sub-§II-A, as enacted by PL 2001, c. 
691, §1 and affected by §6, is amended to read: 
II-A. 
Retention of eliqibility. 
A person wbo was eligible 
for the program at any time from August 1, 1998 to July 31, 1999 
and who does not meet the requirements of subsection 10 retains 
eligibility for the program if that person is a 
member of a 
household of an eligible person; aHe. 
Sec. 2. 22 MRSA §254, sub-§12, as enacted by PL 1999, c. 73l, 
Pt. TT, §10, is amended to read: 
12. 
Funds not to lapse. 
Funds 
appropriated 
from 
the 
General Fund to carry out the purpose of this section may not 
lapse but must carry from year to yearT~ 
Sec.3. 22 MRSA §254, sub-§13 is enacted to read: 
13. 
Procedures. 
Procedures 
for 
prior authorization of 
benefits under the program or preferred drug lists within the 
program 
must 
melt 
thl 
nguirlmlnts 
Istablishld 
for 
prior 
authorization and prefer rid drug lists in the MaineCare program 
under slction 3174-GG. 
Sec. 2. 22 MRSA §§3174-GG and 3174-HH are enacted to read: 
S3174 GG. 
Pharmacy benefit procedures 
Thl rl<;{uiremlnts set out in this section apply to procedures 
for prior authorization of pharmacy benefits or preferred drug 
lists undlr thl MainlCan program and thl eldlrly low-cost drug 
program undlr section 254. 
As 
used in this section "member" 
mlans a Plrson rlcliying benefits under the MaineCare program or 
the elderly low-cost drug program. 
The dlpartment shall adopt 
rulls to impllmlnt this section. 
RullS adopted pursuant to this 
slction are routinl tlchnical rulls as defined in Title 5, 
chaptlr 37~, subchapter 2-A. 
1. 
Preferred drug lists. 
In the adoption of any preferred 
drug lists, the provisions of this subsection apply. 
A. 
Thl departmlnt shall adopt rulls specifying the number 
and classes of prefer rid drugs that must bl determined to be 
clinically inappropriate or ineffective before permitting 
the use of a nonpreferred drug. 
B. 
The department shall adopt rules establishing preferred 
drug lists for off label use of prescription drugs 
for 
children through qn approval process that is determined in 
accordance with the requirements of 42 United States Code, 
Section l396(r)(5). 
2. 
Prior authorization. 
In the 
adoption of 
any prior 
authorization process for pharmacy benefits, the provisions of 
this subsection apply. 
A. 
The 
department shall adopt rules providing clinical 
exemptions from the prior authorization process for at least 
the following groups of persons: 
il) Members who are unable to adequately communicate 
their health condition as a result of dementia or other 
cognitive or physical impairment; 
(2) 
Members who reside in health care or residential 
care facilities; 
(3) 
Members who have acute psychiatric conditions that 
have been stabilized on a nonpreferred drug and who, in 
~e judgment of 
the 
t~g health care provider, 
would suffer an adverse health effect as a result of 
~nging that drug; 
(4) 
Members 
whose 
medical 
condition 
has 
been 
stabilized 
on 
a 
nonpreferred 
drug 
during 
hospitalization 
or 
who 
have 
been 
prescribed 
a 
nonpreferred 
drug 
upon 
discharge 
so 
that 
they 
may 
continue to receive the drug following hospitalization 
for a transition period of at least 90 daysi 
(5) 
Members 
for 
whom 
the 
abrupt termination of 
a 
certain prescribed drug may cause serious hqrmi and 
(6) 
Members 
who 
are frail or medically vulnerable, 
~luding those diagnosed with HIV or AIDS, for whom 
exclusion 
from 
prior 
authorization 
is 
clinically 
appropriate. 
B. 
The 
department 
shall 
adopt 
rules 
that 
provide 
for 
dispensing drugs on an emergency basis. 
(1) 
The rules must apply if a prescribing provider 
fails 
to 
submit 
a 
completed 
application 
for 
prior 
authorization or to attach the required documentation. 
(2) 
The rules must authorize the pharmacy to dispense, 
in accordance with applicable licensing standards and 
professional judgment, a one-time supply for 34 days of 
the prescribed drug. 
(3) 
The rules must allow the department to authorize 
refills of the drug on a case-by-case basis at the end 
of 
the 
34-day 
dispensed 
supply if the 
prescribing 
provider has not submitted the reguired information at 
that time. 
(4) 
The rules must provide that receipt of a 
day 
supply under this subparagraph does not relieve the 
prescribing provider of the duty to submit all reguired 
information and does not entitle the member to receive 
benefits pending appeal in the event 
a 
reguest for 
prior authorization is ultimately denied. 
C. 
The 
department 
shall 
adopt 
rules 
to 
minimize 
the 
administrative burdens imposed on prescribing providers. 
(1) 
The 
rules 
must 
allow 
a 
provider 
to 
sign 
a 
statement on the prior authorization form certifying 
that the prescribed drug is medically necessary, 
is 
supported by the clinical records of the provider and 
does not exceed the medical needs of the member. 
The 
rules must provide for acceptance of this certification 
and may not reguire attachment of clinical records if 
certification has been completed. 
The rules must allow 
the department's surveillance and utilization review 
unit to determine. on a case-by-case basis, whether a 
proyid,r is not subject to this provision. 
(2) 
The rules must provide for the adoption of a prior 
authorization form that clearly indicates all of the 
clinical 
criteria 
reguired 
for 
approval 
of 
a 
nonpreferred 
drug 
and 
must 
solicit the 
information 
necessary to determine whether the clinical criteria 
have been met. 
(3) 
The 
rules 
must 
prohibit 
disapproval 
by 
the 
department solely because the department does not have 
a 
record in its files of a prior prescription for a 
nonpreferred drug if a provider certifies that the drug 
has previously been prescribed for or provided to the 
member. 
(4) 
The 
rules must establish procedures 
to advise 
providers of changes in the preferred drug list within 
hours of the change, 
by electronic or facsimile 
notice. 
(5) 
The rules must establish a method of electronic 
submission 
of 
prior 
authorization 
forms, 
certifications, documentation and necessary information. 
(6) 
The rules must define "clinical records." 
(7) 
The rules must provide an exemption to the prior 
authorization process for a period of 
months for a 
provider if the provider routinely prescribes drugs 
from 
the preferred drug list or if the provider's 
requests for prior authorization have been routinely 
approved in the past. 
D. 
The 
department shall adopt rules 
to streamline the 
~ppeals process for the prior authQrization process. 
(1) 
The 
rules must provide for 
a 
decision by the 
commissioner or the commissioner's designee. 
llL 
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commissioner or the commissioner's designee is final 
agency action. 
(3) 
The rules must provide for final decision on a 
request for a fair hearing within 90 days of the date 
of request for the hearing and, if a decision is not 
made within 90 days and the delay past 90 days is not a 
result of a request, fault or consent of the member, 
for 
tempo~ary approval of a prior authorization request 
until a final decision is made. 
(4) The rules must provide for approval of the prior 
authorization request if the hearing officer determines 
that the notice of decision provided by the department 
fails to substantially comply with the department's 
rules regarding the content of notices and the hearing 
Q1.t"icer determines that further delay would prejudice 
the rights of the member. 
E. 
The department shall adopt rules establishing a consumer 
information 
sheet 
on 
prior 
authorization 
of 
pharmacy 
benefits. 
The information sheet must include a telephone 
number for the member to call for assistance in accessing 
pharmacy benefits. The rules must require the information 
sheet to be available at pharmacies and to be given to a 
member 
when 
the 
department 
refuses 
to 
grant 
prior 
authorization. 
§3174-BB. 
Drug utilization review committee 
The drug utilization review conunittee, referred to in this 
section 
as 
"the 
committee," 
is established to 
review data, 
maintain 
a 
best 
practices 
protocol 
and 
analyze 
department, 
provider, pharmacy and member experience with the preferred drug 
lists adopted by the department under the MaineCare program and 
the elderly low-cost drug program. 
The committee shall review on 
a quarterly basis nonpreferred drugs for which the prior approval 
rate is high to determine whether they should be categorized as 
preferreg drugs. 
The committee shall meet at least twice per 
year. 
1. 
Membership. 
The Director of 
the 
Bureau of Medical 
Services shall appoint the committee from nominations solicited 
from 
the 
appropriate 
interest 
groups 
by 
the 
director 
when 
vacancies 
exist. 
At 
least half of 
the 
membership 
must 
be 
appointees unger paragraphs A and B, not incluging a ph,ysician 
employeg by or unger contract with, the State. 
The membership 
must include: 
A. 
At least 4 allopathic physicians who are licensed and 
actively practice medicine in the State. 
Nominations for 
these members must be solicited from a statewide association 
of allopathic physicians, 
the 
committee, 
other statewide 
megical societies and an association of nursing facility 
medical girectors: 
B. 
At least one osteopathic physician who is licensed and 
actively practices megicine in the State. 
Nominations for 
this member must be soliciteg from a statewide association 
Qf Qsteopath~c physicians, the cQmmittee ang oth,er statewide 
megical societies: 
C. 
Three 
community 
pharmacists 
who 
are 
licensed 
and 
actively practice 
in the 
State. 
Nominations 
for 
these 
members must be solicited from the committee or a statewide 
association Qf pharmacists: 
D. 
The Director of the Bureau of Medical Services or a 
persQn designateg by the girector as a pharmacy physician 
cQnsultant; 
E. 
A hospital pharmacist who 
is licensed and actively 
practices in the State or a pharmacist with pharmacy benefit 
management 
experience. 
The 
required 
level 
of 
hospital 
pharmacy background must be determined by the Director of 
the Bureau of Medical Services. 
NominatiQns for this member 
must be solicited from a statewide association of hospital 
pharmacists: 
F. 
The pharmacy programs manager for the Bureau of Medical 
Services; 
G. 
An assistant pharmacy programs manager for the Bureau of 
Medical Services; 
H. 
A pharmacist employed by the entity that holds the 
contract with the department for drug utilization review; 
I. 
Two 
consumers of MaineCare services. 
Nominations for 
these members must be solicited from the committee that 
advises the commissioner on the MaineCare program; and 
J. 
A psychiatrist who is licensed and actively practices in 
the State. 
Nominations for this member must be solid ted 
from 
a 
statewide 
association 
of 
psychiatrists, 
other 
statewide medical societies and the committee. 
2. 
Specialty committees. 
The committee may appoint members 
to specialty committees to offer advice to the committee as 
needed. 
3. 
Conduct of meetings. 
The department shall adopt rules 
governing the conduct of meetings of the committee. 
The rules 
must r~ire that all meetings be open to the public unless they 
are permitted to be held in executive session by Title 1, section 
405. 
The rules must provide for an adequate period of time for 
public 
comment during the meetings of the committee, 
to 
be 
divided 
egually 
among 
attendees 
from 
the 
general 
public, 
Maine<;:are members and their representatives, MaineCare providers 
and representatives of the pharmaceutical industry. 
4. 
Notice of action. 
The department shall provide notice 
to committee members within 48 hours of taking action regarding a 
matter on which the committee has provided a recommendation to 
the department. 
5. 
Rulemaking. 
The 
department 
shall 
adopt 
rules 
to 
implement 
this 
section. 
Rules 
adopted 
pursuant 
to 
this 
subsection are routine technical rules as defined in Title 5, 
chapter 375, subchapter 2-A. 
Sec. 4. MaineCare handbook. 
The Department of Health and 
Human Services shall develop a MaineCare handbook for applicants 
for and recipients of benefits under the MaineCare program. 
The 
handbook must provide current basic program information including 
information 
about 
the 
prior 
authorization 
process. 
The 
department shall provide easy access to the handbook 
on the 
department's 
publicly accessible site 
on 
the 
Internet. 
The 
department shall provide the handbook to MaineCare providers in 
sufficient numbers for their patients. 
Sec. 5. Prior authorization study and survey. 
The Department of 
Health and Human Services shall contract with an 
independent 
entity 
to 
study 
the 
efficacy 
and 
impact 
of 
the 
prior 
authorization process on program benefits and costs and conduct a 
survey of MaineCare members. 
1. 
Study. 
The 
study 
shall 
examine 
at 
a 
minimum 
the 
following issues: 
A. 
The 
number 
of 
prescriptions 
not 
being 
filled 
by 
recipients of prescription drug benefits under the MaineCare 
program as a result of the prior authorization process: 
B. 
The percentage of denied requests from providers who do 
not later file an additional request for prior authorization: 
C. 
The percentage of denied requests for which a generic 
drug was substituted: 
D. 
The percentage of denied requests for which no drug was 
substituted; and 
E. 
The extent to which adverse health effects or the use of 
additional MaineCare services resulted from not receiving a 
nonpreferred drug. 
2. 
Random 
sample 
survey. 
By 
Oc tobe r 
1, 
2005, 
the 
department shall conduct 
a 
random 
sample survey of MaineCare 
members to examine the impact of the prior authorization process 
on members. 
The survey must be designed to determine whether 
members are receiving clinically appropriate, medically necessary 
drugs with reasonable promptness and must explore the extent to 
which, as a result of the prior authorization process, members 
may have encountered barriers to care or adverse health effects 
or 
may 
have 
incurred additional 
health 
care 
costs 
for 
the 
MaineCare program. 
3. 
Report. 
By March 1, 2006, the department shall report 
to the Joint Standing Committee on Health and Human Services on 
the results of the study and the survey under this section. 
SUMMARY 
This bill establishes prior authorization pharmacy benefit 
procedures for the MaineCare and elderly low-cost drug programs. 
The bill establishes a drug utilization review committee within 
MaineCare. 
The bill requires the Department of Health and Human 
Services to publish a MaineCare handbook and to contract for a 
MaineCare study and survey and to report the results to the Joint 
Standing Committee on Health and Human Services by March 1, 2006.