[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39179-39181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14042]


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DEPARTMENT OF DEFENSE

Office of the Secretary


Establishing a TRICARE Low Back Pain and Physical Therapy 
Demonstration

AGENCY: Department of Defense.

ACTION: Notice of demonstration project.

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SUMMARY: The Director, Defense Health Agency (DHA), has approved the 
creation of a demonstration to waive cost-sharing for up to three 
physical therapy (PT) visits for TRICARE beneficiaries with low back 
pain (LBP). The purpose of the demonstration is to encourage the uptake 
of PT services for the treatment and management of LBP and to 
incentivize beneficiaries towards higher-value care and away from 
lower-value care. This demonstration will operate in 10 states, test 
whether waiving cost-sharing increases the uptake of PT services among 
patients with LBP, and measure the impact of LBP on lower-value 
services such as imaging, opioids, and surgery.

DATES: This demonstration project will be effective January 1, 2021, 
through December 31, 2023, unless terminated earlier by the Director, 
DHA, or designee.

FOR FURTHER INFORMATION CONTACT: Ms. Erica Ferron, Medical Benefits and 
Reimbursement Section, TRICARE Health Plan, telephone (303) 676-3626. 
[email protected]. Questions regarding payment of specific 
claims should be addressed to the appropriate

[[Page 39180]]

TRICARE contractor (contact information is available at https://tricare.mil/contactus).

SUPPLEMENTARY INFORMATION:

A. Background

    LBP is a common symptom that may be caused by a variety of 
underlying conditions, including muscle strains, disc degeneration, 
sciatica, scoliosis, arthritis, and fibromyalgia. Risk factors include 
age, fitness level, weight, pregnancy, genetics, and occupation. Acute 
LBP includes pain lasting up to four weeks from onset of symptoms, 
subacute LBP refers to pain lasting from 4 to 12 weeks, and chronic LBP 
persists beyond 12 weeks. With rest and self-care, most cases of LBP 
resolve within six weeks of onset of symptoms, although approximately 
20 percent of cases of acute LBP transition to chronic LBP and require 
additional interventions. Due largely to its high prevalence, LBP 
results in significant costs. According to a 2016 review by Dieleman et 
al. published in the Journal of the American Medical Association, low 
back and neck pain accounted for $87.6 billion in estimated health care 
spending in 2013 (the third-highest spending category behind diabetes 
and ischemic heart disease). Combined direct and indirect costs (e.g., 
lost wages, inability to work, and decreased productivity) of LBP are 
estimated to be over $100 billion per year, according to a 2006 study 
by JN Katz published in the Journal of Bone and Joint Surgery.
    Many national professional medical associations, national expert 
opinion organizations, and providers have developed treatment 
guidelines and best practices for treating LBP. These guidelines are 
intended to maximize patient outcomes and quality of life, as well as 
increase the value of LBP treatments and diagnostic services. 
Increasing the value of health care refers to improving patients' 
quality of care and outcomes, improving patients' access to care, and 
reducing overall costs of care. In contrast, low-value care refers to 
interventions that: Are not proven to benefit patients; may harm 
patients; result in unnecessary costs; or waste health care resources. 
Several types of LBP treatments and diagnostic services are classified 
as low-value or inappropriate care in the absence of red-flag symptoms, 
such as imaging services (e.g., x-rays, computed tomography scans, and 
magnetic resonance imaging scans) before six weeks from onset of 
symptoms, surgery for non-specific back pain, opioids as a first- or 
second-line treatment, and prolonged bedrest. Use of low-value services 
increases health care costs and patients who receive low-value, 
inappropriate care for LBP may experience worse outcomes than patients 
who receive conservative, higher-value measures such as PT. Low-value 
care is particularly pernicious for LBP patients, as low-value 
interventions, such as imaging, may lead to further low-value care, 
such as surgery, with the accompanying potential for negative outcomes 
or side effects. Likewise, the use of low-value care such as opioids 
instead of higher-value care, such as PT, may cause the patient to 
transition from acute pain to chronic pain and may lead to opioid use 
disorder.
    This demonstration was created, in part, due to a TRICARE Health 
Plan (THP) analysis that found TRICARE beneficiaries who attended PT 
and occupational therapy (OT) did so at the same rate across 
beneficiary classes and age groups (i.e., similar proportions attended 
1 to 3 visits, 3 to 5 visits, more than 12 visits, etc.); that is, 
beneficiaries who attended at least one therapy visit tended to attend 
additional visits at the same rate. However, the percentage of 
beneficiaries who attended at least one therapy visit varied across 
beneficiary classes: Active Duty Service members (ADSMs) attended PT or 
OT at a rate of 65 percent, Active Duty family members (ADFMs) at a 
rate of 42 percent, and non-active duty dependents (NADDs), which 
includes retirees and all non-ADFM or non-ADSM beneficiaries, at a rate 
of 38 percent. Notably, NADD beneficiaries have the highest cost-
sharing requirements for PT and OT, and the lowest rates of use. 
Therefore, this demonstration hypothesizes that incentivizing PT 
services for patients with LBP will result in an increase in the 
initial and total use of PT services among TRICARE beneficiaries 
currently subject to cost-sharing. Additionally, the demonstration 
hypothesizes that this increase in PT uptake will reduce low-value 
interventions for LBP, reduce the overall cost of treating LBP, and 
improve patient outcomes.

B. Description of the Demonstration

    This demonstration waives cost-sharing for up to three PT visits 
for patients with LBP. To be eligible for the demonstration, TRICARE 
beneficiaries must have a primary diagnosis of LBP, reside and receive 
PT services in one of the selected demonstration states, and be 
referred by a TRICARE-authorized provider to receive PT services 
currently covered by TRICARE. TRICARE will promulgate a list of ICD-10 
diagnosis codes in the implementing instructions. Additionally, only 
new PT ``episodes'' will be eligible for waived cost-sharing (i.e., a 
patient who is receiving PT services before the beginning of the 
demonstration may not receive waived cost-sharing for those services 
once the demonstration starts). Provider reimbursement under this 
demonstration will follow current TRICARE reimbursement procedures for 
PT. Likewise, after the third PT visit with waived cost-sharing, 
beneficiary cost-sharing will follow current cost-sharing methodologies 
specified in the TRICARE Reimbursement Manual.
    There is no limitation on the number of weeks from onset of 
symptoms to receiving PT services under this demonstration (i.e., PT 
visits for acute, subacute, or chronic LBP may be eligible for waived 
cost-sharing), as early access to PT may result in overall lower health 
care utilization and LBP-related costs within the Military Health 
System. This supports the demonstration hypothesis that increased 
uptake of PT visits will reduce the proportion of beneficiaries who 
transition from acute and subacute LBP to chronic LBP, which may reduce 
costs while improving patient outcomes.
    Provider requirements under this demonstration shall include the 
following:
     Licensed physical therapists and physical therapist 
assistants may provide covered physical therapy services to eligible 
beneficiaries under this demonstration.
     To comply with existing statutory and regulatory 
requirements for TRICARE, physical therapy must be prescribed by a 
provider listed at title 32, Code of Federal Regulations, Sec.  
199.6(c)(3)(iii)(K)(2).
     Physical therapy services must be performed in a 
demonstration state to qualify for waived cost-sharing under this 
demonstration.
     When appropriate, physical therapists should schedule the 
next appointment immediately to encourage continued use of physical 
therapy visits.
     Cost-sharing shall be waived for in-network physical 
therapists.
    The following states were selected as demonstration states: 
Arizona, California, Colorado, Florida, Georgia, Kentucky, North 
Carolina, Ohio, Tennessee, and Virginia. These states were selected due 
to their high TRICARE retiree population (the category of beneficiaries 
with the highest cost-sharing for specialty care and are, therefore, 
the most likely to be impacted by this demonstration) and to create a 
comprehensive representation throughout the United States. If this 
demonstration is successful, the demonstration may be rolled out to the 
entire TRICARE population. This

[[Page 39181]]

ensures the demonstration meets ethical standards for experiments.
    If a beneficiary moves from a demonstration state to a non-
demonstration state, he is no longer eligible for the demonstration. 
However, if a beneficiary moves from a non-demonstration state to a 
demonstration state, he becomes eligible for the demonstration, 
provided he is beginning a new PT treatment (i.e., beneficiaries may 
not begin a PT treatment in a non-demonstration state, then receive 
three PT visits without cost-sharing as part of the same treatment plan 
after moving to a demonstration state). The goal of the demonstration 
is to determine if incentivizing starting PT has an impact on patient 
outcomes and the use of certain interventions; it is not to eliminate 
beneficiary burden for the entire cost of PT.
    This demonstration project will be effective January 1, 2021, 
through December 31, 2023, unless terminated earlier by the Director, 
DHA, or designee. DHA may terminate the demonstration early for any 
reason, including significantly-higher costs than anticipated or a 
clear failure to achieve any of the hypothesized outcomes in the 
demonstration states, via subsequent Federal Register notice.

C. Evaluation

    The primary goal of this demonstration is to incentivize the uptake 
of PT services. The demonstration will also test the below hypotheses 
using the respective outcome measures listed in Table 1:

         Table 1--Demonstration Hypotheses and Outcome Measures
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               Hypothesis *                      Outcome measure(s)
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Does waiving cost-sharing for up to three   Total number of initial PT
 PT visits increase the initial uptake of    visits; Proportion of
 PT visits among patients with LBP?          beneficiaries receiving an
                                             initial PT visit.
Does waiving cost-sharing for up to three   Average and median number of
 PT visits increase the overall number of    PT visits among
 PT visits among patients with LBP?          beneficiaries with LBP.
Does incentivizing the use of PT services   Average and median number of
 reduce the number of opioids prescribed     opioids prescriptions
 to patients with LBP?                       filled by beneficiaries
                                             with LBP.
Does incentivizing the use of PT services   Average and median number of
 reduce the amount of imaging services       imaging services (MRI, CT,
 provided to patients with LBP?              X-ray, and Ultrasound)
                                             provided to beneficiaries
                                             with LBP, stratified across
                                             the following time periods
                                             and measured from initial
                                             diagnosis of LBP: 0-6
                                             weeks; 6-12 weeks; >12
                                             weeks.
Does incentivizing the use of PT services   Proportion of beneficiaries
 reduce the number of back surgeries for     with a diagnosis for LBP
 patients with LBP?                          receiving back surgeries.
Does incentivizing the use of PT services   Average and median cost of
 reduce the total cost of care for a LBP     episode for LBP; Average
 episode?                                    and median cost of episode
                                             for LBP when beneficiary
                                             attends at least three PT
                                             visits; Average and median
                                             cost of episode for LBP
                                             when beneficiary attends
                                             fewer than three PT visits.
Does improved access to PT services         Proportion of patients
 prevent chronic LBP (i.e. do fewer          receiving services to treat
 patients transition from acute and          LBP after 12 weeks from
 subacute pain to chronic pain)?             initial diagnosis of LBP.
Does incentivizing the use of PT services   Average and median number of
 reduce the number of other low value        number of patients
 services or other LBP treatments?           receiving injections, etc.
------------------------------------------------------------------------
* The above hypotheses are intended to measure the correlational
  relationship; this evaluation will not make any statements on
  causation.

    The outcome measures listed in Table 1 will be used to determine 
the success of the demonstration. To estimate the impact of the 
demonstration on the outcome measures, the evaluation of this 
demonstration will use a pretest-posttest non-equivalent control group 
methodology. For each outcome measure, the eligible population in the 
demonstration states (i.e., the treatment group) will be compared to 
the eligible population in the non-demonstration states (i.e., the 
control group) before the demonstration, annually, and at the 
conclusion of the demonstration. This methodology will allow DHA to 
estimate the impact of the demonstration (i.e., the treatment effect) 
by subtracting the difference between the treatment and control groups 
at baseline from the difference between the groups at the 
demonstration's conclusion for each outcome measure. Baseline data will 
consist of one calendar year of data.
    In addition to the above outcome measures, this demonstration will 
include a patient survey to measure reasons a patient begins and ceases 
PT visits, as well as access to care, quality of care, and overall 
health status. This information will supplement the outcome measures 
and will provide important context for the data analysis. For example, 
if patients cease PT visits because the LBP is resolved, there is 
evidence that incentivizing PT visits improved patient outcomes. On the 
other hand, if PT visits cease due to non-compliance or because PT 
services are not improving patients' symptoms, the demonstration was 
not successful in improving patient outcomes. The survey will be 
administered electronically to TRICARE beneficiaries with a primary 
diagnosis of LBP who receive PT services in demonstration states. The 
survey questions and collection methodology will go through the 
Department of Defense licensure process for approval and will require 
an additional Federal Register notice. The contractor shall provide 
contact information for participants to DHA, who will administer the 
survey, collect survey results, and evaluate survey data. The 
qualitative and quantitative analyses of survey results may also be 
used to determine the success of the demonstration. If the survey is 
not approved, it will not be included in the demonstration or its 
evaluation.

    Dated: June 25, 2020.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2020-14042 Filed 6-29-20; 8:45 am]
BILLING CODE 5001-06-P