Hepatitis from NY State Health Department Perspective

25
(2) proof
of appropriate and adequate insurance for the duration of the project; and
(3) a statement signed by the contractor or a person duly authorized to sign for the
contractor that the work will be done in a workmanlike manner, using materials suitable for
pu
rposes of the project and the safety of the enrollee and household members, and will comply
with all applicable building and zoning laws.
(
h)
If less than three bids are submitted, a written explanation of why three acceptable
bids were not obtained must
be provided, as well as a written explanation of how the
determination was made that the one or two bids being considered are reasonably priced.
(
i
) If the two lowest comparable bids are within ten percent of each other, the enrollee or
his or her legall
y authorized representative may choose one of the two lowest bids.  If there is
more than a ten percent difference between the two lowest comparable bids, the Fund
Administrator shall choose the bid that represents the best value for both the Fund and the
enrollee based on factors including not only the price offered by each bidder but also the quality,
durability, extent of any warranties provided, safety of the product itself, and workmanship
offered by each bidder.  The successful bidder will be notified
after the Fund Administrator or a
designee of the Fund Administrator (1) discusses the bids received with the enrollee or the
person authorized to act on the enrollee’s behalf and the reasons why a particular bid is chosen
by the Fund Administrator, and (
2) obtains the written consent of the enrollee or the person
authorized to act on the enrollee’s behalf to have the Emod constructed or installed by that
bidder.  If the enrollee or the person authorized to act on the enrollee’s behalf disagrees with the
F
und Administrator’s decision, the enrollee or his or her authorized representative can request a
review of the Fund Administrator’s decision.
26
(
j
)  Any change from either the specifications in terms of alternative or substitute
equipment or the scope of
work involved in the modification that will result in a cost increase
from the bid price will require approval from the Fund Administrator.
(
k
) Payment for the Emod shall include the cost of the comprehensive evaluation of the
proposed project,
the evalua
tion of required bids if the Fund Administrator finds it necessary to
engage an outside expert,
the evaluation of the completed Emod, a one year maintenance
contract, if deemed appropriate by the Fund
Administrator
, as well as the cost of construction or
i
nstallation of the Emod itself.
§ 69
-
10.
9
Prior Approval Requests for Vehicle Modifications.
(a)  A vehicle modification request may only be made for a vehicle owned by the enrollee
or a member of the enrollee’s household who has consistent and ongoing c
ontact with the
enrollee and provides unpaid primary, long
-
term support to the enrollee.  Proof of ownership of
the vehicle by the enrollee or the enrollee’s legal representative must be provided to the Fund
Administrator
.  A modification will be approved
only if the vehicle is the primary source of
transportation for the participant and is used to access services and supports in the community
and to improve the enrollee’s independence and inclusion in the community.
(b) The vehicle modification request mu
st be accompanied by a Vehicle Modifications
and Equipment Ev
aluation, based on the enrollee’
s needs, that has been obtained from a Driver
Rehabilitation Specialist who has been certified by the Association of Driver Rehabilitation
Specialists.  The evalua
tion must specify the most cost effective and least complicated vehicle
modification that will ensure safe transportation, and exit from and entrance into the vehicle for
the participant, and include a detailed scope of work and specifications.
27
(c) Modifi
cations can only be made to vehicles that are registered, insured and meet state
inspection standards before and after the modifications are completed.
(d) Modifications may be made  either to a vehicle that is being purchased by the enrollee
or a member
of the enrollee’s household or to a vehicle that is structurally sound, not in need of
mechanical repair as determined by the vehicle modifier, and is less than five years old or
registers less than 50,000 miles.
(e) Modifications to a vehicle that the en
rollee will not be driving are limited to
modifications that are necessary to ensure safe transportation and safe access into and out of the
vehicle.
(
f
)
Only contractors that meet Acces
-
VR’s qualifications or
,
if the enrollee lives in the
District of Columbia or a state other than New York, the qualifications required by the district or
other state for performing vehicle modifications
,
may submit bids for modifications.
(
g
)
Once the initial request has been r
eviewed by the Fund
Administrator
, the Fund
Administrator
shall notify the enrollee or person authorized to act on the enrollee’s behalf in
writing which services or items have been approved and/or denied and inform the enrollee or
person authorized to act
on the enrollee’s behalf of the bidding process that is required prior to
the Fund Administrator approving payment for the vehicle modification.  The enrollee or person
authorized to act on the enrollee’s behalf is then required to obtain a
minimum of thr
ee
acceptable bids
from qualified contractors. 
(
h
)  Once the Fund Administrator receives from the enrollee or person authorized to act
on the enrollee’s behalf a minimum of three acceptable bids from qualified contractors, the Fund
Administrator shall e
valuate the qualifications of each bidder and the content of each bid to
determine whether each bid is acceptable. 
If less than three are submitted, a written explanation
28
of why three accepted bids were not obtained must be provided, as well as a written
explanation
of how the determination was made that the one or two bids being considered are reasonably
priced.  In order to be acceptable, a bid must:
(1) be signed by the contractor or a person duly authorized to sign on behalf of the
c
ontractor;
(2) sp
ecify the scope of work and specifications of the work; and
(3) state that all work will be done in a workmanlike manner, using materials suitable for
purposes of the modification.
(
i
)
I
f the two lowest bids are within ten percent of each other, the en
rollee or his or her
legally authorized representative may choose
one of the two lowest bids
. 
I
f there is more than a
ten percent difference between the two lowest bids
,
the Fund
Administrator
shall choose the bid
that represents the best overall value fo
r the Fund and the enrollee
based on factors including not
only the price offered by each bidder but also the quality, durability, extent of any warranties
provided, and the safety of the product itself
. 
The successful bidder will be notified after the
Fund
Administrator
or a designee of the Fund
Administrator
(1) discusses the bids received with
the enrollee or the person authorized to act on the enrollee’s behalf
and the reasons why a
particular bid is c
hosen by the Fund Administrator,
and (2) obtains the written consent of the
enrolle
e
or the person authorized to act on the enrollee’s behalf to have the installation done by
that bidder.  If the enrollee or person authorized to act on the enrollee’s behal
f disagrees with the
Fund
Administrator
’s decision, the enrollee or person authorized to act on the enrollee’s behalf
can request a review of the decision. 
The Fund
Administrator
will authorize payment to the
successful bidder of
no more than
one
-
third of
the accepted bid amount
unless there are
extenuating circumstances about which the Fund
Administrator
receives advance notice such as a
29
project that can be completed in one day or involves the purchase of a product prior to
installation
.
(
j
) Any change f
rom the specifications in terms of alternative or substitute equipment or
the scope of work involved in the modification that will result in a cost increase from the bid
price will require approval from the Fund Administrator.
(
k
) No additional payment wi
ll be authorized until the Fund
Administrator
has received a
post
-
modification evaluation stating that the vehicle meets or exceeds Acces
-
VR Vehicle
Modification Standards and that the modifications meet the enrollee’s functional needs.
(
l
)
Payment for ve
hicle modifications shall include, in addition to the cost of the vehicle
modification itself, the cost of the Vehicle Modifications and Equipment Evaluation,
the
evaluation of required bids if the Fund Administrator finds it necessary to engage an outside
expert,
the post
-
modification evaluation, and reimbursement for travel in those instances in
which the enrollee and his or her informal supports must travel outside of the geographic area in
which the enrollee’s community commonly obtains its medical care
and services for fittings and
vehicle tests.
§ 69
-
10.
10
Prior Approval Requests for Assistive Technology
(AT)
.
(a) A request for AT, as defined in section 69
-
10.1 of this Subpart, will be considered to
include a request for AT services, which is
assistance provided to the enrollee in the selection,
acquisition, and use of the appropriate AT device and necessary training of the enrollee, the
enrollee’s informal supports, and any paid staff who provide assistance to the enrollee at a time
when he or
she will be using the AT.
30
(b) Providers of AT to enrollees of the Fund must meet one of the following
qualifications:
(1) be approved as provider pursuant to 18 NYCRR Part 504;
(2) be a provider of AT services to the Home and Community Based Services W
aiver
Program administered by the New York State Office for Persons with Developmental
Disabilities or, if the enrollee lives in the District of Columbia or a state other than New York, be
a provider for a similar waiver program in the district or other st
ate;
(3) be a licensed and registered pharmacist;
(4)  be a Durable Medical Equipment (DME) provider; or
(5)  for Personal Emergency Response Systems (PERS), be an approved PERS provider
with existing contracts with Local Social Services District
s
or, if provided in another state,
or the
District of Columbia
be approved by the appropriate state agency in that state
or in the District of
Columbia
.
(c) A person or organization providing assessments must be:
(1) a New York State Acces
-
VR approved pr
ovider of rehabilitation technology or the
equivalent in another state;
(2) a present or former Independent Living Skills Trainer for one or more of New York
State’s Home and Community Based Services Waivers; or
(3) another professional who is knowledgea
ble about the full range of devices and/or
technology available to assist individuals with disabilities.
(d) Any AT device or supply requested from the Fund must meet standards established by
Underwriters Laboratory and/or comply with any applicable Feder
al Communications
Commi
ssion
requirements, if applicable.  Any AT that would constitute a fixture in the enrollee’s
31
residence or on the premises of the residence must meet any applicable ADA, Fair Housing Act,
or other safety standards or guidelines that a
pply.
(e)   A request for an AT must include:
(1)  a written statement from the enrollee’s treating physician on the physician’s
letterhead explaining why the requested AT is medically necessary, including  how the specific
equipment being requested will
meet the needs and goals of the enrollee in terms of maintaining,
increasing or improving his or her functional capacities in a safe, efficient, and reasonably cost
effective manner;
(2) copies of all assessments made to determine the necessary AT, inclu
ding an
assessment of the enrollee’s unique functional needs and the intended purpose and expected use
of the requested AT.  Any assessment submitted must include:
(i) information about the individual’s expressed needs and preferences, functional
limitati
ons and prognosis;
(ii) information about the environment in and circumstances under which the AT will be
used;
(iii) the basis for selecting the particular AT being requested, including advantages over
other options, how it addresses the enrollee’s func
tional limitations, how it meets the enrollee’s
needs safely, maintenance expenses, and cost/benefits;
(iv)
a description of
the alternatives
to the particular AT that were
considered, including a
comparison of features, future expansion or adaptation cap
abilities, the safety of the enrollee, the
overall cost, and the reliability
,
and if
less than three options were considered, the reason for
considering less than three must be provided
; and
(
v
)
a
written explanation of why the AT requested was chosen. 
32
(f) Once the request has been reviewed by the Fund Administrator, the Fund
Administrator shall notify the enrollee or person authorized to act on the enrollee’s behalf in
writing which services o
r
items have been approved and/or denied and inform the enr
ollee or
person authorized to act on the enrollee’s behalf of the bidding process that is required prior to
the Fund Administrator approving payment for the requested AT.  The enrollee or person
authorized to act on the enrollee’s behalf is the
n
required t
o obtain a minimum of three
acceptable bids from qualified providers for the particular AT requested
, except as provided in
subdivision (i) of this section
.
(g)
If
the enrollee or person authorized to act on the enrollee’s behalf obtains
less than
three
bids for the requested AT
, a written explanation of why three acceptable bids were not
obtained must be provided as well as a written explanation of how the determination was made
that the one or two bids being considered are reasonably priced.
(
h
)
I
f the
two lowest bids are within ten percent of each other, the enrollee or his or her
legally authorized representative may choose
one of the two lowest bids
. 
I
f there is more than a
ten percent difference between the two lowest bids, the Fund
Administrator
s
hall choose the bid
that represents the best overall value for the Fund and the enrollee
based on factors including not
only the price offered by each bidder but also the quality, durability, extent of any warranties
provided,
and
safety of the product its
elf
.
The successful bidder will be notified after the Fund
Administrator
or a designee of the Fund
Administrator
(1) discusses the bids received with the
enrollee or the person authorized to act on the enrollee’s behalf and why a particular bid is
chosen
by the Fund
Administrator
and (2) obtains the consent of the enrollee or the person
authorized to act on the enrollee’s behalf to purchase that particular AT.  If the enrollee or person
authorized to act on
behalf of the
enrollee
disagrees with the Fund
Ad
ministrator
’s decision, the

48
§ 69
-
10.2
2
Residence of Qualified Plaintiffs and Enrollees.
(
a
) Eligibility for or continued enrollment in the Fund is not dependent on the current or
past residency of a qualified plaintiff or enrollee.
(
b
)
The Fund
Administrator shall advise e
nrollees to
notify
the Fund Administrator of
any changes in address within ten business days from the date of the move
in order to prevent
delays
.
49
REGULATORY IMPACT STATEMENT
Statutory Authority: 
Title 4 of Article 29 of
the Public Health Law (PHL) creates the New York State Medical
Indemnity Fund (Fund) to provide a source of funding for all future qualifying health care costs
of a plaintiff or claimant who sustained birth
-
related neurological injuries as the result of me
dical
malpractice in order to reduce premium costs for medical malpractice insurance coverage.
Subdivision 3 of section 2999
-
h of the PHL sets forth a broad definition of “qualifying
health care costs” for services and supplies provided to qualified plain
tiffs and provides authority
for the Commissioner of Health (Commissioner) to further define such qualifying health care
costs in regulation.
Section 2999
-
i of the PHL requires the Superintendent of Insurance (Superintendent) to
administer the Fund and th
e Commissioner of Taxation and Finance to be the custodian of the
Fund for which a special account is created pursuant to section 99
-
t of the State Finance Law. 
Subdivision 2 of section 2999
-
i of the PHL authorizes the Superintendent to enter into a contr
act
to administer the Fund (Administrator) and subdivision 6 requires the Superintendent to conduct
actuarial calculations of the estimated liabilities of the Fund and suspend enrollment in the Fund
if the estima
ted liabilities equal or exceed
80% of the F
und’s assets.
Section 2999
-
j of the PHL governs payments from the Fund and includes broad standards
for the Fund enrollment process, payment of costs by collateral sources, rates to be paid to
providers of qualifying health care services, prior authorizat
ion for certain services, and the
claims processing requirements for reimbursement of qualifying health care costs.  Subdivision 2
of section 2999
-
j of the PHL requires any applicable prior authorization requirements to be
50
promulgated by the Commissioner i
n regulation and subdivision 4 of such section requires the
Commissioner to define in regulation “the basis of one hundred percent of the usual and
customary rates” to be paid for services provided by private physician practices and for all other
services,
any rates of payment to be paid on a basis other than Medicaid rates.
Lastly, subdivision 15 of section 2999
-
j of the PHL specifically states that the
Commissioner, in consultation with the Superintendent, “ shall promulgate . . . all rules and
regulatio
ns necessary for the proper administration of the fund in accordance with the provisions
of this section, including, but not limited to those concerning the payment of claims and
concerning the actuarial calculations necessary to determine, annually, the t
otal amount to be
paid into the fund as otherwise needed to implement this title.”
Legislative Objectives: 
The Legislature delegated the details of the Fund’s operation to the Department of
Financial Services (DFS) and the Department of Health (DOH), th
e two State agencies that have
the appropriate expertise to develop, implement and enforce all aspects of the Fund’s operations. 
These proposed regulations reflect the collaboration of both agencies in providing the
administrative details of the manner in
which the Fund will operate.  Specifically, the regulations
provide a clear process for enrollment of plaintiffs or claimants who sustained birth
-
related
neurological injuries as the result of medical malpractice.  And they create standards governing
the
qualifying health care costs to be paid by the Fund and the rates at which they will be paid,
keeping in mind the two Legislative objectives of lifetime coverage for all current and future
enrollees and reducing premium costs for medical malpractice insura
nce coverage.
51
Needs and Benefits:
These regulations are needed because Title 4 of Article 29 of the PHL provides only
broad standards governing operation of the Fund, some of which include a specific requirement
to further define criteria in regulatio
n, and to provide the details necessary to make the Fund
operationally successful for all parties, including qualified plaintiffs, Fund enrollees, providers of
qualifying health care services, the Administrator, and the two agencies charged with operating
the Fund.  All parties will benefit from specific standards governing their respective roles
regarding the Fund by providing: (1) a smooth application and enrollment process, including
specific requirements for the actuarial calculations to be made by DFS
and any ensuing
suspension of enrollment in the Fund; (2) a clear concept of the qualifying health care costs for
which the Fund will pay and their applicable rates of payment; (3) a step
-
by
-
step prior approval
process required only for certain costly serv
ices, including environmental modifications, vehicle
modifications, assistive technology, private duty nursing, transportation for medical care and
services, treatment with a specialty drug, and experimental treatment; (4) a claims submission
process that
allows timely payment to providers; and (5) a fair review process if an enrollee’s
claims or prior authorization requests are denied, including document based reviews and
hearings conducted by DOH.
Costs to Regulated Parties:
There are no costs imposed on
regulated parties by these regulations.  Qualified plaintiffs
will not incur any costs in connection with applying for enrollment in the Fund or coverage by
the Fund.
52
Costs to the Administering Agencies, the State, and Local Governments:
Costs to admi
nistering agencies and the State associated with the Fund will be covered by
applicable appropriations, as provided in subdivisions 3 through 5 of section 2999
-
i of the PHL.
There are no costs imposed on local governments by these regulations.
Local Govern
ment Mandates:
The proposed regulations do not impose any new programs, services, duties of
responsibilities upon any county, city, town, village, school district, fire district or other special
district.
Paperwork:
The proposed regulations impose
paperwork requirements on regulated parties by
requiring (1) a qualified applicant, person authorized to act on behalf of a qualified applicant, or
certain defendants to submit an application and supporting documentation for a qualified
applicant’s enrollm
ent into the Fund; (2) an enrollee to submit electronic or manual claims for
reimbursement of qualified health care services, documentation to support any prior approval
request and payment thereof, a review request form for denial of a claim or prior appr
oval
request, and notice of a change in address; (3) DOH to issue a notice of hearing, if applicable;
and (4) DFS to issue a notice of any suspension or reinstatement of enrollment into the Fund.
Duplication:
There are no other State or Federal requirem
ents that duplicate, overlap, or conflict with
the statute and the proposed regulations.  Although some of the services to be provided by the
Fund are the same as those available under certain Medicaid waivers, the waivers have limited
slots and the Fund b
ecomes the primary payer for dually enrolled individuals.  Coordination of
benefits will be one of the responsibilities of the Fund Administrator.  Health care services,
53
equipment, medications or other items that any commercial insurer providing coverage t
o a
qualified plaintiff  is legally obligated to provide will not be covered by the  Fund (except for
copayments and/or deductibles) nor will the Fund cover any health care service, equipment, or
other item that is potentially available through another Sta
te or Federal program (except
Medicaid and Medicare) or similar program in another country, if applicable, such as the Early
Intervention Program or as part of an Individualized Education Plan unless the parent or guardian
can demonstrate that he or she ha
s made a reasonable effort to obtain such service, equipment or
item for the qualified plaintiff through the applicable program.
Alternatives:
DFS and DOH have considered multiple alternatives to the proposed regulatory
requirements and have made recent
changes to the Express Terms to reflect more reasonable
approaches to certain situations enrollees might face.  For example:
(1) In the case of divorced parents, the regulations used to allow environmental
modifications only to the primary residence of a
custodial parent.  The agencies considered the
limitation placed on a child’s ability to spend time at the home of the noncustodial parent and
changed the Express Terms to allow environmental modifications to the primary residence of a
noncustodial parent.
(2) When the Administrator received a request for approval of environmental
modifications to a home that had yet to be built, the regulations had no process to allow for such
approval.  The agencies considered the benefit to families in having adaptation
s built in for their
child making the home move
-
in ready on completion, in addition to the cost effectiveness of
environmental modifications made during construction, as opposed to after construction, and
changed the Express Terms to provide an approval pr
ocess for these types of requests.
54
(3) The prior approval process for assistive technology used to require 3 acceptable bids
for every item requested.  The agencies considered this process to be cumbersome for less costly
items, especially when prices are
readily available in catalogues or online, and changed the
Express Terms to allow for the submission of 3 prices in lieu of 3 bids for items costing less than
$2500.
Federal Standards: 
There are no minimum Federal standards regarding this subject.
Comp
liance Schedule:
The Fund was statutorily required to be operational by October 1, 2011.
Contact Person:
Katherine E. Ceroalo
New York State Department of Health
Bureau of House Counsel, Regulatory Affairs Unit
Corning Tower Building, Rm. 2438
Empire
State Plaza
Albany, New York 12237
(518) 473
-
7488
(518) 473
-
2019 (FAX)
REGSQNA@health.state.ny.us
55
STATEMENT IN LIEU OF
REGULATORY FLEXIBILITY ANALYSIS
No regulatory flexibility analysis is required pursuant to section 202
-
b(3)(a) of the State
Administrative Procedure Act.  The proposed amendment does not impose an adverse economic
impact on small businesses or local governments, and it does not impose reporting, record
keeping or other compliance requirements on small businesses or local govern
ments.
Cure Period:
Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other
opportunity for ameliorative action to prevent the imposition of penalties on the party or parties
subject to enforcement when developing a regulatio
n or explain in the Regulatory Flexibility
Analysis why one was not included.  This regulation creates no new penalty or sanction.  Hence,
a cure period is not necessary.
56
STATEMENT IN LIEU OF
RURAL AREA FLEXIBILITY ANALYSIS
No rural area flexibility
analysis is required pursuant to section 202
-
bb(4)(a) of the State
Administrative Procedure Act.  The proposed amendment does not impose an adverse impact on
rural areas, and it does not impose reporting, record keeping or other compliance requirements
on
public or private entities in rural areas.
57
STATEMENT IN LIEU OF
JOB IMPACT STATEMENT
No job impact statement is required pursuant to section 201
-
a(2)(a) of the State
Administrative Procedure Act.  It is apparent, from the nature of the proposed
amendment.