RELATES TO:
KRS
205.520,
205.5605,
205.5606,
205.5607,
42 C.F.R. Part 460, 42 C.F.R.
489.100 -
489.104, 42
U.S.C. 1396a, 1396b, 1396d, 1396n
NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and
Family Services, Department for Medicaid Services, has responsibility to
administer the Medicaid Program.
KRS
205.520(3) authorizes the
cabinet, by administrative regulation, to comply with any requirement that may
be imposed, or opportunity presented, by federal law to qualify for federal
Medicaid funds. 42 C.F.R. Part 460 establishes the federal requirements for
PACE to provide comprehensive, capitated health services that enhance the lives
of frail, older adults, and enable those adults to live in the community as
long as medically and socially feasible. This administrative regulation
establishes the department's coverage and reimbursement for Programs of
All-Inclusive Care for the Elderly (PACE).
Section
1. Definitions.
(1) "Emergency
medical condition" is defined by
42 C.F.R.
460.100(c).
(2) "PACE" means Programs of All-Inclusive
Care for the Elderly.
(3) "PACE
program agreement" means an agreement that:
(a) Is between a PACE organization, the
Centers for Medicare and Medicaid Services (CMS), and the department for the
operation of a PACE program; and
(b) Meets the requirements of Section 7 of
this administrative regulation.
(4) "Participant" means an individual who is
enrolled in a PACE program.
Section 2. PACE Participant Eligibility,
Enrollment, Disenrollment, and Reinstatement.
(1) To be eligible to enroll in a PACE
program, an individual shall:
(a) Be
fifty-five (55) years of age or older;
(b) Be determined by the department to meet a
nursing facility level of care determination, pursuant to
907
KAR 1:022;
(c) Reside in the service area of a PACE
organization;
(d) Be able to live
in a community setting without jeopardizing the participant's health or safety;
and
(e)
1. Be eligible for Medicaid services pursuant
to 907 KAR Chapter 20;
2. Pay the
full capitation payment if not eligible for Medicaid or Medicare; or
3. Pay the Medicaid portion of the capitation
payment if eligible for Medicare but not Medicaid.
(2) The PACE program enrollment
process shall be in accordance with
42 C.F.R.
460.152.
(3) In order to enroll in a PACE program, a
participant shall sign an enrollment agreement, which shall include all
information required by
42 C.F.R.
460.154.
(4) Upon enrollment, a participant shall
receive the following information from the PACE organization:
(a) A copy of the enrollment agreement, which
shall:
1. Be explained to the participant or
their representative or caregiver in a manner that they understand;
and
2. If there are any changes, be
updated and provided to the participant, with an explanation as required by
subparagraph 1. of this paragraph.
(b) A PACE membership card as required by
42 C.F.R.
460.156; and
(c) Emergency information, which shall also
be posted in the participant's home, identifying the individual as a PACE
participant and explaining how to access emergency
services.
(5) Enrollment
in a PACE program shall be effective on the first day of the calendar month
following the date the PACE organization receives the signed enrollment
agreement.
(6) Enrollment shall be
continued in accordance with
42 C.F.R.
460.160.
(7) A participant shall have the right to
voluntarily disenroll from the program at any time without cause. Any
disenrollment shall:
(a) Be processed on the
monthly enrollment cycle; and
(8) Involuntary disenrollment shall:
(a) Be reviewed by the department to
determine that the PACE organization has acceptable grounds for disenrollment,
pursuant to
42 C.F.R.
460.164; and
(b) Be in accordance with
42 C.F.R.
460.166.
(9) If a participant is disenrolled from a
PACE program, the PACE organization shall:
(a) Make appropriate referrals and ensure
medical records are made available to new providers within thirty (30) days;
and
(b) Work with CMS and the
department to reinstate the participant in other Medicaid programs for which
the participant is eligible.
(10) A previously disenrolled participant
shall not be precluded from being reinstated in a PACE program.
Section 3. PACE Covered Services.
(1) Pursuant to
42 C.F.R.
460.90, if an eligible Medicaid participant
elects to enroll in a PACE program:
(a)
Medicare and Medicaid benefit limitations and conditions relating to amount,
duration, scope of services, deductibles, copayments, coinsurance, or other
cost-sharing shall not apply; and
(b) The participant, while enrolled in the
PACE program, shall receive Medicare or Medicaid benefits solely through the
PACE organization.
(2)
Pursuant to
42 C.F.R.
460.92, the following shall be included in
the PACE benefits package and provided to participants as applicable:
(a) All Medicare-covered goods and services
for which the participant would otherwise qualify;
(b) All Medicaid-covered goods and services
for which the participant would otherwise qualify; and
(c) Other services that are necessary, as
determined by the interdisciplinary team, to improve and maintain the
participant's overall health status.
(3) Emergency medical services shall be
covered as applicable and pursuant to Section 4 of this administrative
regulation.
Section 4.
Emergency Services.
(1) A PACE organization
shall:
(a) Establish and maintain a written
plan to handle emergency care that provides for services including:
1. An on-call provider, available twenty-four
(24) hours per day to address participant questions about emergency services
and respond to requests for authorization of urgently needed out-of-network
services and post stabilization care services following emergency services;
and
2. Coverage of urgently needed
out-of-network and post stabilization care services if:
a. The services are preapproved by the PACE
organization; or
b. The services
are not preapproved by the PACE organization because the PACE organization did
not respond to a request for approval within one (1) hour of being contacted or
cannot be contacted for approval;
(b) Ensure that the following are held
harmless if the PACE organization does not pay for emergency services:
1. PACE participants;
2. CMS; and
3. The department; and
(c) Ensure that the participant, caregiver,
or both, understand when and how to get access to emergency services and that
prior authorization is not needed.
(2) Emergency services shall:
(a) Be provided if:
1. Services are needed immediately because of
an injury or sudden illness; and
2.
The time to reach the PACE organization or one (1) of its contract providers
would cause risk of permanent damage to the participant's health; and
(b) Include inpatient and
outpatient services that:
1. Are furnished by
a qualified emergency services provider, other than the PACE organization or
one (1) of its contract providers, either in or out of the PACE organization's
service area; or
2. Are needed to
evaluate or stabilize an emergency medical condition.
Section 5. Exclusions to
PACE Covered Services. The following services shall not be covered under a PACE
program:
(1) Any service that is not
authorized by the interdisciplinary team, unless the service is deemed to be an
emergency service;
(2) In an
inpatient facility:
(a) Private room and
private duty nursing services, unless medically necessary; and
(b) Nonmedical items for personal
convenience, unless specifically authorized by the interdisciplinary team as
part of the participant's plan of care;
(3) Surgery that is purely cosmetic in nature
and purpose, and does not meet an exception pursuant to
42 C.F.R.
460.96(c);
(4) Experimental medical, surgical, or other
health procedures; or
(5) Services
furnished outside of the United States, except:
(b) As otherwise permitted
pursuant to Title 907 KAR.
Section 6. PACE Organization Requirements. A
PACE organization shall:
(1) Have an
agreement as required by
42 C.F.R.
460.30 with CMS and the department in order
to provide services pursuant to this administrative regulation;
(2) Meet all requirements established in 42
C.F.R.
460 Subpart E, 460.60 to 460.86;
(4) Not provide services designated as
excluded from the program pursuant to Section 5 of this administrative
regulation;
(5) Establish and
implement a written plan to furnish care that meets the needs of each
participant in all care settings for twenty-four (24) hours a day, every day of
the year and provide services pursuant to
42 C.F.R.
460.98;
(6) Provide at each PACE center, at a
minimum:
(a) Primary care;
(b) Social services;
(c) Restorative therapies, including physical
and occupational therapy;
(d)
Personal care and supportive services;
(e) Nutritional counseling;
(f) Recreational therapy; and
(g) Meals;
(7) Operate at least one (1) PACE center in
or contiguous to its defined service area with sufficient capacity to allow
routine attendance by participants;
(8) Ensure accessible and adequate services
to meet participant needs;
(9)
Establish a written participant bill of rights, which shall:
(a) Be displayed:
1. In English and any other principal
languages of the community as required by
42 C.F.R.
460.116(c)(1); and
2. In a prominent place within the PACE
center; and
(b) Include
all rights specified in
42 C.F.R.
460.112;
(10) Ensure that the rights specified in
subsection (9) of this section, as well as the participant's responsibilities
and appeal rights, are conveyed to the participant in writing and explained in
a manner understood by the participant or their representative upon enrollment
pursuant to
42 C.F.R.
460.116 and
42 C.F.R.
460.124;
(11) Protect and provide for the exercise of
the participant's rights;
(12)
Pursuant to
42 C.F.R.
460.118, establish documented procedures to
respond to and rectify a violation of a participant's rights;
(13) Pursuant to
42
C.F.R.
460.114, limit the use of restraints
to the least restrictive and most effective method available, regardless of
whether the restraint is physical or chemical in nature;
(14) Ensure that any restrained participant
be continually assessed, monitored, and reevaluated;
(15) Meet the following conditions if the
interdisciplinary team determines that a restraint is needed to ensure the
participant's physical safety or the safety of others:
(a) The restraint shall be imposed for a
defined, limited time, and based upon the assessed needs of the
participant;
(b) The restraint
shall be imposed in accordance with safe and appropriate restraining
techniques;
(c) The restraint shall
be imposed only if other less restrictive measures have been found to be
ineffective to protect the participant or others from harm; and
(d) The restraint shall be removed or ended
at the earliest possible time;
(16) Establish, implement, maintain, and
evaluate an effective, data-driven quality improvement program, in writing,
pursuant to
42
C.F.R.
460.130 and
460.132
and containing, all requirements contained in
42 C.F.R.
460.134;
(17) Ensure that the quality improvement plan
complies with
42
C.F.R.
460.130 and reflects the full range of
services offered by the PACE organization, and take actions that result in
improvements in the organization's performance in all types of care, including
all requirements established in
42 C.F.R.
460.136;
(18) Pursuant to
42 C.F.R.
460.138, establish one (1) or more committees
with community input to:
(a) Evaluate data
collected pertaining to quality outcome measures;
(b) Address the implementation of, and
results from, the quality improvement plan; and
(c) Provide input related to ethical decision
making, including:
1. End-of-life issues;
and
2. Implementation of the
Patient Self Determination Act pursuant to
42 C.F.R.
489.102;
(19) Comply with all requirements for the
PACE organization in the enrollment process, disenrollment process, and
reinstatement process pursuant to Section 2 of this administrative
regulation;
(20) Establish and
maintain a procedure to document the reasons for all voluntary and involuntary
disenrollments, and that documentation shall be available for review by CMS and
the department;
(21) Utilize the
information received under subsection (20) of this section relating to
voluntary disenrollments in the quality improvement program;
(22) Pursuant to
42 C.F.R.
460.196, post a notice of the availability of
the results of the most recent review conducted pursuant to Section 9 of this
administrative regulation and any plan of correction or response to that
review, and make these results available for examination in a place readily
accessible to participants, their families, caregivers, or representatives;
and
(23) Maintain records, collect
all data, report all required data and information, and comply with all other
requirements contained in 42 C.F.R.
460 Subpart L, 460.200 to
260.210.
Section 7. PACE
Program Agreement Requirements.
(1) A PACE
program agreement shall meet the requirements for authorization pursuant to
42 C.F.R.
460.30.
(2) The PACE program agreement between the
department and a PACE organization shall include:
(a) All content required by
42 C.F.R.
460.32;
(b) The criteria used to determine if an
individual's health or safety would be jeopardized by living in a community
setting, pursuant to
42 C.F.R.
460.150(c)(2);
(c) The criteria for determining the
continuing eligibility of a participant, pursuant to
42 C.F.R.
460.160(b)(3)(ii).
(d) Pursuant to
42 C.F.R.
460.202 and
42 C.F.R.
460.32(a)(11), a
comprehensive list of data and information pertaining to the PACE
organization's provision of participant care:
1. Collected by the PACE organization;
and
2. To be furnished to CMS and
the department in the manner, and at the time intervals, specified by CMS and
the department.
(e) The
specific eligibility conditions pursuant to Section 2 of this administrative
regulation;
(f) Any additional
terms and conditions agreed to by the parties, subject to limitations pursuant
to
42 C.F.R.
460.32(b)(2); and
(g) Pursuant to
42 C.F.R.
460.32(a)(12), procedures
for any adjustments to account for the difference between the estimated number
of participants on which the prospective monthly payment was based and the
actual number of participants in that month.
(3) A PACE program agreement shall be
effective for one (1) contract year, but may be extended for additional
contract years in the absence of a notice by a party to terminate, pursuant to
42 C.F.R.
460.34.
(4) The department shall limit the number of
PACE program agreements pursuant to
42 C.F.R.
460.24.
Section 8. Interdisciplinary Team.
(1)
(a)
Each PACE organization shall establish an interdisciplinary team that fulfills
each of the positions described in paragraph (b) of this subsection at each
PACE center to comprehensively assess and meet the individual needs of each
participant.
(b) An
interdisciplinary team shall meet the composition requirements of
42 C.F.R.
460.102(b) and be composed
of at least a:
1. Primary care provider, who
shall:
a. Furnish primary medical care to a
participant; and
b. Be responsible
for managing a participant's medical needs and overseeing a participant's use
of medical specialists and inpatient care;
2. Registered nurse;
3. Master's-level social worker;
4. Physical therapist;
5. Occupational therapist;
6. Recreational therapist or activity
coordinator;
7.
Dietitian;
8. PACE center
manager;
9. Home care
coordinator;
10. Personal care
attendant or their representative; and
11. Driver or their representative.
(2) A PACE organization
shall assign each participant to an interdisciplinary team functioning at the
PACE center that the participant attends.
(3) A PACE organization shall establish,
implement, and maintain documented internal procedures pursuant to
42 C.F.R.
460.102(f) and consistent
with the confidentiality requirements of
42 C.F.R.
460.200(e).
(4) An interdisciplinary team that complies
with the requirements of
42 C.F.R.
460.102 shall be responsible for the initial
assessment, periodic reassessments, plan of care pursuant to
42
C.F.R.
460.106, and coordination of
twenty-four (24) hour care delivery, and shall meet all requirements of
42 C.F.R.
460.104.
(5) Each member of the interdisciplinary team
shall:
(a) Regularly inform the
interdisciplinary team of the medical, functional, and psychosocial condition
of each participant;
(b) Remain
alert to pertinent input from other team members, participants, and caregivers;
and
(c) Document changes of a
participant's conditions in the participant's medical record consistent with
documentation policies established by the medical
director.
Section
9. PACE Organization Monitoring.
(1) The department, in cooperation with CMS,
shall conduct continued reviews of PACE organizations as appropriate, and shall
take into account the quality of care furnished and the organization's
compliance with all requirements of 42 C.F.R.
460, and Title 907 KAR.
(2) Continued reviews shall include on-site
visits at least every two (2) years.
(3) The department, in cooperation with CMS,
shall monitor the effectiveness of actions taken to correct deficiencies
identified during a review pursuant to Section 10 of this administrative
regulation.
(4) The results of a
review conducted under this section shall be:
(a) Promptly reported to the PACE
organization, along with recommendations for changes to the organization's
program; and
(b) Made available to
the public upon request.
Section 10. Corrective Actions Regarding the
PACE organization.
(1) The department shall
have the authority, upon a determination by CMS or the department that the PACE
organization is not in substantial compliance with 42 C.F.R. Part
460 , to:
(a) Condition the continuation of the PACE
program agreement upon timely execution of a corrective action plan;
(b) Withhold some or all payments under the
PACE program agreement until the organization corrects the deficiency;
or
(c) Terminate the PACE program
agreement.
(2)
Termination of the PACE program agreement by the department, including
termination for cause, shall comply with
42 C.F.R.
460.50, as appropriate.
(3) If a PACE program agreement is being
terminated, the PACE organization shall:
(a)
Follow all procedures regarding termination pursuant to the PACE program
agreement; and
(b) Provide
transitional care to participants and comply with all other requirements
established pursuant to
42 C.F.R.
460.52.
Section 11. PACE Organization Payments.
(1) The department shall make a monthly
payment to a PACE organization. The payment shall be:
(a) A prospective payment, based upon the
estimated number of participants a PACE organization will provide services to
in the relevant month; and
(b)
Subject to adjustment based on the estimated and actual number of participants
who received services from the organization in a given month, as provided in
the PACE program agreement.
(2) The amount of the department's monthly
payment to the PACE organization shall:
(a)
Be less than the amount that the department would have otherwise paid for a
participant under other state plan services providing the same level of
care;
(b) Take into account the
comparative frailty of PACE participants;
(c) Be a fixed amount, regardless of changes
in a participant's health status; and
(d) Be open to renegotiation on an annual
basis.
(3) A PACE
organization shall:
(a) Accept the negotiated
payment as payment in full for Medicaid participants; and
(b) Not bill, charge, collect, or receive any
other form of payment from the department or from, or on behalf of, the
participant, except a:
1. Payment with
respect to any applicable liability under
42
C.F.R.
435.121 and
42 C.F.R.
435.831 and any amounts due under the
post-eligibility treatment of income process under
42 C.F.R.
460.184; or
2. Medicare payment received from CMS or from
other payers, in accordance with
42 C.F.R.
460.180(d).
(4) A PACE organization shall not charge a
premium to a participant who is eligible for Medicaid.
Section 12. Appeals and Grievances.
(1) An appeal of a department decision
regarding a participant or applicant relating to the delivery of PACE services
shall be in accordance with
907
KAR 1:563.
(2) An appeal of a department decision
regarding the eligibility of an individual for Medicaid services shall be in
accordance with
907
KAR 1:560.
(3) The following shall not be considered a
sanction against a PACE organization and shall not be appealable:
(a) A voluntary moratorium;
(b) A decision not to renew a
certification;
(c) A citation;
or
(d) Denial of an initial
certification.
(4) A PACE
organization's appeals shall be in accordance with
42 C.F.R.
460.122.
(5) A PACE participant may register any
grievance or complaint regarding a PACE service provision or a PACE
organization by contacting the department via:
(a) Email at dmsweb@ky.go.; or
(b) Mail at Department for Medicaid Services,
Division of Policy and Operations, 275 E. Main Street 6W-D, Frankfort, Ky.
40621.
Section
13. Federal Approval and Federal Financial Participation. The
department's coverage and reimbursement of services pursuant to this
administrative regulation shall be contingent upon:
(1) Receipt of federal financial
participation for the coverage and reimbursement; and
(2) Centers for Medicare and Medicaid
Services' approval of the coverage and reimbursement.
Section 14. Use of Electronic Signatures. The
creation, transmission, storage, or other use of electronic signatures and
documents shall comply with the requirements established in
KRS
369.101 to
369.120.