(Medicare National Coverage Determinations Manual)

Inpatient hospital services are frequently not required in many cases when L-Dopa therapy is initiated.  Therefore, determine the medical need for inpatient hospital services on the basis of medical facts in the individual case.  It is not necessary to hospitalize the typical, well-functioning, ambulatory Parkinsonian patient who has no concurrent disease at the start of L -Dopa treatment.  It is  reasonable to provide inpatient hospital services for Parkinsonian patients with concurrent diseases, particularly of the cardiovascular, gastrointestinal, and neuropsychiatric systems.  Although many patients require hospitalization for a period of under two weeks, a 4-week period of inpatient care is not unreasonable.  Laboratory tests in connection with the administration of L-Dopa - The tests medically warranted in connection with the achievement of optimal dosage and the control of the side effects of L -Dopa include a complete blood count, liver function tests such as SGOT, SGPT, and/or alkaline phosphatase, BUN or creatinine and urinalysis, blood sugar, and electrocardiogram.   Whether or not the patient is hospitalized, laboratory tests in certain cases are reasonable at weekly intervals although some physicians prefer to perform the tests much less frequently.  Physical therapy furnished in connection with administration of L -Dopa -  Where, following administration of the drug, the patient experiences a reduction of rigidity which permits the reestablishment of a restorative goal for him/her, physical therapy services required to enable him/her to achieve this goal are payable provided they require the skills of a qualified physical therapis t and are furnished by or under the supervision of such a therapist.  However, once the individuals restoration potential has been achieved, the services required to maintain him/her at this level do not generally require the skills of a qualified physica l therapist.  In such situations, the role of the therapist is to evaluate the patients needs in consultation with his/her physician and design a program of exercise appropriate to the capacity and tolerance of the patient and treatment objectives of the physician, leaving to others the actual carrying out of the program.  While the evaluative services rendered by a qualified physical therapist are payable as physical therapy, services furnished by others in connection with the carrying out of the maintena nce program established by the therapist are not.  (See the Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 30.)   B.  Part A Reimbursement for L -Dopa Therapy in SNFs   Initiation of L -Dopa therapy can be appropriately carried out in the skilled nursing facility (SNF) setting, applying the same guidelines used for initiation of L -Dopa therapy in the hospital, including the types of patients who should be covered for inpat ient services, the role of physical therapy, and the use of laboratory tests.  (See subsection A.)   Where inpatient care is required and L -Dopa therapy is initiated in the SNF, limit the stay to a maximum of four weeks; but in many cases the need may be no longer than one or two weeks, depending upon the patients condition.  However, where L -Dopa therap y is begun in the hospital and the patient is transferred to a SNF for continuation of the therapy, a combined length of stay in hospital and SNF of no longer than four weeks is reasonable (i.e., 1- week hospital stay followed by three weeks SNF stay; or tw o weeks hospital stay followed by two weeks SNF stay; etc.).  Medical need must be demonstrated in cases where the combined length of stay in hospital and SNF is longer than four weeks.  The choice of hospital or SNF, and the decision regarding the relative length of time spent in each, should be left to the medical judgment of the treating physician.  See the Medicare Benefit Policy Manual, Chapter 8, Coverage of Extended Care (SNF) Services Under Hospital Insurance, 50.5.   C.  L -Dopa Coverage Under Part B   Part B reimbursement may not be made for the drug L -Dopa since it is a self -administrable drug.  (See the Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 20.4.1.)  However, physician services rendered in connection wit h its administration and control of its side effects are covered if determined to be reasonable and necessary.  Initiation of L -Dopa therapy on an outpatient basis is possible in most cases.  Visit frequency ranging from every week to every 2 or 3 months is acceptable.  However, after half a year of therapy, visits more frequent than every month would usually not be reasonable.   160.18 - Vagus Nerve Stimulation (VNS)   (Rev. 10199, Issued: 06-23-2020, Effective: -02-15- 2019, Implementation: 07-22-2020)  A. General   Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent fro m the battery -powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. The Food and Drug Administration (FDA) approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in 2005.  B. Nationally Covered Indications  Effective for services performed on or after July 1, 1999, VNS is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed.  Effective for services performed on or after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) will cover FDA -approved VNS devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in  a CMS -approved, double-blind, randomized, placebo- controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS-approved, double-blind, randomized placebo -contr olled trial has completed enrollment, and there are positive interim findings.   Each study must be approved by CMS and as a fully-described, written part of its protocol, must address whether VNS improves health outcomes for TRD patients compared to a control group, by answering all of the following research questions below.  The details of the prospective longitudinal study must be described in the original protocol for the double-blind, randomized, placebo- controlled trial.   Response is defined as a  50% improvement in depressive symptoms from baseline, as measured by a guideline recommended depression scale assessment tool.   Remission is defined as being below the threshold on a guideline recomm ended depression scale assessment tool.   The following research questions must be addressed in a separate analysis for patients with bipolar and unipolar disease.  Research Questions:    What is the rate of response (defined as person months of response/total months of study participation)?  What is the rate of remission (defined as person months of response/total months of study participation)?  What is the time from treatment until response scores are first achieved?   What is the time from treatment until remission scores are first achieved?   What are the population distributions of the maximum months of response, both consecutive and overall, separately?   What are the population distributions of the maximum months of remission, both consecutive and overall, separately?   What are the patient variables associated with successful treatment of TRD with VNS?   What are the observed harms?   What are the changes in disability, quality of life, general psychiatric status, and suicidality?  Patient Criteria:  The following criteria must be used to identify patients demonstrating TRD:   The patient must be in a major depressive disorder (MDD) episode for  two years or have had at least four episodes of MDD, including the current episode.  In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used.   The patients depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.  The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.  Patients must maintain a stable medication regimen for at least four weeks before device implantation.   If patients with bipolar disorder are included, the condition must be carefully characterized.  Patients must not have:   Current or lifetime history of psychotic features in any MDE;  Current or lifetime history of schizophrenia or schizoaffective disorder;  Current or lifetime history of any other psychotic disorder;   Current or lifetime history of rapid cycling bipolar disorder;   Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;   Current suicidal intent; or,   Treatment with another investigational device or investigational drugs.  Individuals who receive placebo VNS will be offered active VNS at the end of the trial. In addition, CMS will review studies to determine if they meet the 13 criteria listed below.  If CMS determines that they meet these criteria, the study will be posted on CMS CED website ( https://www.cms.gov/Medicare/Coverage/Coverage- w ith-Evidence-Development/index.html ).  a) The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.  b) The rationale for the study is well supported by available scientific and medical evidence.  c) The study results are not anticipated to unjustifiably duplicate existing knowledge.  d) The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.  e) The study is sponsored by an organization or individual capable of completing it successfully.  f) The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data. g) All aspects of the study are conducted according to appropriate standards of scientific integrity.  h) The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.  i) The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options. j) The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).  k) The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for prima ry and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on- line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).  l) The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.  m) The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.   Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the above- listed research questions.