February 2020 - AUA Public Policy Council Update for MAS
From the Chair
I am pleased to share updates from the AUA Public Policy Council that may benefit your Section members. Our updates include information on state advocacy in Maryland to support prostate cancer screening legislation as well as our joint congressional meetings with appropriations staff on appropriations funding for bladder cancer.
Annual Urology Advocacy Summit: Registration is Closing
Registration for next month’s Annual Urology Advocacy Summit is almost full! Thank you to the following Mid-Atlantic Section board members who are registered to attend next month:
- Dr. Arthur Burnett,
- Dr. B. Mayer Grobb,
- Dr. Tracey Krupski,
- Dr. Kurt McCammon, and
- Dr. Roger Schultz.
With more than 270 urologists and urologic health professionals from dozens of states planning on gathering in Washington, DC – don’t miss out on a unique opportunity to engage lawmakers and regulators in meaningful discussion about the top issues facing urology.
With the 2020 elections on the horizon, there’s no better time to connect with your elected officials and their staff, network with colleagues, and learn about how we can advance urology through advocacy.
Register today!
State Advocacy Update: Maryland Prostate Cancer Screening Bill Heard in Committee, Urologist Testifies
Last week, Maryland House Delegate Erek Barron (D-24) introduced HB 852 to specifically require the state of Maryland to cover a digital rectal exam and a PSA test for men between 40 and 75 years old and men who are at high risk of developing the disease. Following the introduction, on February 13, the legislation was heard by the Health and Governance Operations Committee where AUA Mid-Atlantic Section President Dr. Benjamin Lowentritt testified in support of the bill. To listen to the hearing, click here (hearing begins at the 1:45:45 mark; Dr. Lowentritt’s testimony begins at the 1:54:44 mark)
The AUA collaborated with ZERO – The End of Prostate Cancer , Chesapeake Urology and MedChi: The Maryland State Medical Society in formally endorsing the bill. The AUA sent a support letter (attached) to all Health and Governance Operations Committee members. The AUA also sent out a grassroots alert to more than 430 Maryland urologists – urging them to phone, tweet and write their state legislators to support HB 852. The legislation now awaits further consideration by members of the Governance Committee. We will continue to keep you updated as this bill moves through the legislative process.
As a reminder, promoting prostate cancer screening coverage with no cost-sharing is a top priority for the AUA’s State Advocacy Committee. The AUA will continue to partner with stakeholders such as ZERO to urge other legislatures to introduce similar measures around the country.
Patient Advocacy: AUA Attends Meetings with House Appropriations Staff to Secure Designated Funding for Bladder Cancer
On February 7, the AUA and Bladder Cancer Advocacy Network (BCAN) met with appropriations staff from Congressman Dutch Ruppersberger’s (MD-02) office to discuss Fiscal Year (FY) 2021 appropriations funding for bladder cancer under the Department of Defense’s Congressionally Directed Medical Research Program (CDMRP). The collaborative meeting discussed the need for bladder cancer to have its own $10 million line within the CDMRP. Since 2016, bladder cancer has resided within the Peer Reviewed Cancer Research Program (PRCRP) that entails sharing a pot of funding with multiple disease areas. In FY 2019, bladder cancer received $8.7 million of the total $90 million allocated to the PRCRP.
An additional meeting was held on February 11 with Congressman Matt Cartwright’s (PA-08) office to reinforce the relevance and benefits of bladder cancer being removed from the PRCRP and into the CDMRP. The AUA and BCAN will continue work with the House Appropriations committee and other members of Congress to dedicate a $10 million funding line item for bladder cancer in FY 2021. The AUA will keep you apprised of advocacy opportunities to promote this initiative.
Below are insurance updates from national insurance carriers.
Aetna
Aetna has updated its selected treatments for neurogenic bladder commercial medical policy. The following has been added to the list of interventions considered experimental and investigational:
- Intravesical instillation of gentamicin or neomycin-polymyxin.
- Aetna also added the following codes to its list of not covered procedures:
- 51700 – Bladder irrigation, simple, lavage and/or instillation.
- 97813 – Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient.
- +97814 – Each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s).
- J1580 – Injection, garamycin, gentamicin, up to 80 mg.
Caterpillar Employer Plan
Caterpillar Employer Plan has created a new form that applies to prior authorization requests for Erleada. Questions include, but are not limited to, the following:
- Does the member have distant metastatic disease identified on bone scan and computed tomography?
- Is the member’s tumor classified as N0 or N1 on the tumor-node-metastatic staging system?
- Has the member had an orchiectomy?
CGS Administrators
CGS Administrators has added a new article addressing billing and coding procedures that complement the LCD for Botulinum Toxins. The policy describes new requirements for patient medical record documentation. The patient’s medical record should include but is not limited to:
- The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit,
- Relevant medical history
- Results of pertinent tests/procedures
- Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.)
For coverage of botulinum toxin treatment by Medicare, the medical record should include:
- Documentation of the medical necessity for this treatment. For spastic conditions other than upper limb spasticity, blepharospasm, hemifacial spasm, cervical dystonia or other focal dystonias, documentation should include a statement that the spastic condition has been unresponsive to conventional treatment;
- A covered diagnosis;
- Dosage, site(s) and frequency of injection;
- Documentation of the medical necessity for associated electromyography when used; and
- Description of the effectiveness of this treatment.
Due to the short life span of the drug once it is reconstituted, Medicare will reimburse the unused portions of Botulinum toxins. However, the documentation in the medical records must show the precise amount of the drug administered and the amount discarded. Documentation must be available upon request of the contractor. Peer-reviewed medical literature may be requested for case-by-case determinations.
Utilization Guidelines: It is generally not considered medically necessary to give Botulinum toxin injections for spastic or excess muscular contraction conditions more frequently than every 90 days.
ConnectiCare
ConnectiCare has created a new prior authorization for the prostate cancer drug Erleada. Erleada, a prescription medicine used to treat prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone, may be considered medically necessary when the following criteria are met:
- Member is 18 years of age or older;
- Member has a diagnosis of non-metastatic, castration-resistant prostate cancer (NM-CRPC);
- Member has a diagnosis of metastatic castration-sensitive prostate cancer.
EmblemHealth
EmblemHealth has updated its medical policy related to cryosurgical ablation for prostate cancer. Relevant updates include the following:
- Removed medically necessary requirement from criteria for cryosurgery as salvage therapy for prostate cancer recurrence when the disease is localized stating that the test result indicates Gleason score < 9.
- Updated the references access dates.
Read the complete update.
Excellus, Univera Healthcare
Excellus, Univera Healthcare has updated its clinical review prior authorization list with the following additions:
- The service category Erectile Dysfunction with associated coding and requirements; applicable codes include:
- 37788 – Penile revascularization, artery, with or without vein graft
- 54408 – Repair of component(s) of a multi-component, inflatable penile prosthesis
- 93980 – Duplex scan of arterial inflow and venous outflow of penile vessels; complete study
- C1813 – Prosthesis, penile, inflatable
- J2760 – Injection, phentolamine mesylate, up to 5 mg
Also, the service category Gas Permeable Scleral Contact Lenses was removed from this policy.
Express Scripts
Express Scripts recently reviewed its prior authorization requirements for Xtandi, adding the following changes to criteria:
- Covered uses: All FDA-approved indications not otherwise excluded from Part D. Plus non-metastatic, castration-resistant prostate cancer, and patients already started on Xtandi for a Covered Use.
- Required Medical Information: Diagnosis for which Xtandi is being used. For metastatic castration-resistant prostate cancer, prior therapies tried.
- Coverage Duration: Authorization will be for 3 years.
First Coast Service Options
First Coast Service Options has added a new article addressing billing and coding procedures that complement the LCD for Biofeedback. Highlights from the article are listed below:
- All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
- The documentation for the use of biofeedback training for persons with urinary incontinence would include:
- A baseline evaluation
- History–a focused medical, neurologic and genitourinary history. Areas to assess would include duration and characteristics of urinary incontinence (UI); the most bothersome symptom(s) to the patient; frequency, timing and amount of continent voids and incontinent episodes; precipitants of incontinence (cough, laugh, sneeze, new medications, surgery, etc.); other urinary tract symptoms; daily fluid intake; bowel habits; alteration in sexual function due to UI; amount and type of perineal pads or protective devices; previous treatments for UI and effects on UI; and expectations of treatment.
- Mental status evaluation–the assessment would include both the cognitive ability and the motivation to self-toilet.
- Functional Assessment–areas to assess include manual dexterity, mobility, ability to toilet unaided, uses of physical or chemical restraints.
- Evaluation of the individual’s living environment –areas to assess include access and distance to toilets or toilet substitutes as well as ease when rising from beds or chairs.
- Social factors – areas to assess include living arrangements, the presence of care givers and to what degree care-givers are involved, influence of UI on their socialization.
- Bladder records – most commonly a seven day voiding diary which details the frequency, timing and amount of voids; amount of incontinence episodes; activities associated with UI and type/amount of fluid intake.
- Physical examination – guided by the medical history. Areas examined usually include:
- General exam for assessment of edema and neurologic abnormalities.
- Abdominal exam.
- Rectal exam to assess perineal sensation, resting and active sphincter tone, fecal impaction, presence of masses and in men, the consistency and contour of the prostate.
- Genital exam in men.
- Pelvic exam in women to assess skin condition, genital atrophy, pelvic organ prolapse, pelvic masses, paravaginal muscle tone and any other abnormalities.
- And if needed: Direct observation of urine loss by using cough stress test with full bladder; an estimation of post void residual volume; or urinalysis.
- The treatment plan will contain the goals of therapy, the exercise prescription, and measurable objectives.
- Individual progress notes will reflect the individualized activity, any instructions given, the patient’s response to the service and their progress toward stated goals of therapy.
- The following CPT code was deleted and replaced:
- 90911 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry
- 90911 was replaced with the following CPT codes:
- 90912 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient
- 90913 Each additional 15 minutes of one-on-one physician or other qualified health care professional contact with the patient (List separately in addition to code for primary procedure)
- A baseline evaluation
The effective date of this revision is based on date of service.
First Coast Service Options has added a new article addressing billing and coding procedures that complement the LCD for Botulinum Toxins.
- Documentation Requirements:
- All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
- The following CPT codes have been updated:
- J0585 Injection, Onabotulinumtoxina, 1 unit
- J0586 Injection, Abobotulinumtoxina, 5 units
- J0587 Injection, Rimabotulinumtoxinb, 100 units
- J0588 Injection, Incobotulinumtoxin a, 1 unit
First Coast Service Options has added a new article addressing billing and coding procedures that complement the LCD for Posterior Tibial Nerve Stimulation.
- All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
- The medical record must substantiate the medical need for PTNS with documentation of duration of symptoms and unsuccessful treatments for OAB as outlined in the LCD.
- The following code should be used for PTNS:
- 64566 Posterior Tibial Neurostimulation, percutaneous needle electrode, single treatment, includes programming
First Coast Service Options has added a new article addressing billing and coding procedures that complement the LCD for Prostatic Urethral Lift.
- All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
- The medical record should clearly document:
- Trial(s) of medical therapy attempted and reason for discontinuation or reason patient is not a suitable candidate for the usual BPH medication(s);
- Prostatic volume as measured by ultrasound;
- Absence of obstructive median lobe;
- BPH symptoms and AUASI;
- Rationale for choosing PUL (e.g., can be a simple chart notation indicating patient preferred PUL over TURP because of concerns about erectile function).
- The following codes should be used for PUL:
- 52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant
- 52442 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (list separately in addition to code for primary procedure)
- C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants
- C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants
Independent Health
Independent Health has updated prior authorization criteria for the prostate cancer drug Nubeqa. Coverage for the drug will be provided in the following conditions:
- Patient is at least 18 years old; AND
- Patient will receive a GnRH-analog or has had a bilateral orchiectomy; AND
- Will not be used in combination with other androgen receptor inhibitors (e.g., enzalutamide, apalutamide, etc.); AND
- Patient will avoid concomitant use with the following drugs:
- Combined P-gp and Strong or Moderate CYP3A4 Inducer (e.g., rifampin, carbamazepine, St. John’s Wort, etc.); OR
- Breast Cancer Resistance Protein (BCRP) Substrates (e.g., glyburide, statins, prazosin, etc); AND
- Patient has NON-metastatic castration-resistant disease (nmCRPC); AND
- Patient has a prostate-specific antigen (PSA) doubling time of ≤ 10 months: AND
- Patient has a baseline PSA > 2 ng/mL.
LifeWise Health Plans, Premera
LifeWise Health Plans, Premera has reviewed and updated its pharmacy policy related to prostate cancer targeted therapies with the following changes:
- Nubeqa was added, which may be considered medically necessary for the indication of non-metastatic castration-resistant prostate cancer.
- The criteria for Erleada was revised by adding the indication of metastatic castration-sensitive prostate cancer.
- Reauthorization criteria was added for all drugs for up to 12 months when criteria are met and the patient has a clinical response to therapy.
- The template was revised, adding a documentation requirement section requiring office visit notes with the diagnosis, relevant history, physical evaluation, and medication history.
Medical Mutual
Medical Mutual reviewed and updated its pharmacy policy for hormone replacement therapy patches to include the following step therapy exception criteria:
- The patient has an atypical diagnosis and/or unique patient characteristics which prevent use of all preferred agents. If so, please list specific diagnosis and/or specific patient characteristics.
- The patient has a contraindication to all preferred agents. If so, please list the specific contraindications to each preferred agent.
- The patient is continuing therapy with the requested non-preferred agent after being stable for at least 90 days or, if not available, verification by prescribing physician is required, and meets one of the following:
- The patient has at least 130 days of prescription claims history on file and claims history supports that the patient has received the requested non-preferred agent for 90 days within a 130-day look-back period.
- When 130 days of the patient’s prescription claims history file is unavailable for verification, the prescriber must verify that the patient has been receiving the requested non-preferred agent for 90 days and that the patient has been receiving the requested non-preferred agent via paid claims (i.e. the patient has not been receiving samples or coupons or other types of waivers in order to obtain access to the requested non-preferred agent).
- There are no generic alternatives to the requested non-preferred agent.
This form is for use when requesting authorization for the drug Yonsa. Questions include, but are not limited to, the following:
- Does the member have high-risk newly diagnosed locally advanced disease?
- Was metastatic disease first diagnosed within the past 3 months?
- Are there any other comments, diagnoses, symptoms, medications tried or failed, and/or any other information the physician feels is important to this review?
Mercy Care Plan
Mercy Care Plan has added and/or revised the following prior authorization criteria for botulinum toxins:
- Added alternative medically necessary indication for Dysport for blepharospasm stating member must be at least 18 years of age and previously treated with Botox and Xeomin.
- Added criterion for Botox for migraine prophylaxis stating medication will not be used concurrently with calcitonin gene-related peptide receptor antagonists.
- Added criteria for Botox and Dysport (added applicability) for severe primary axillary hyperhidrosis including, but not limited to, at least one episode per week; and there is local, visible, excessive sweating for at least 6 months without apparent cause with two of the following (see policy for list; added the existing indication interferes with daily activities)
- Added criterion for Botox for chronic anal fissures stating the requirement of a completed endoscopy to rule out Crohn’s disease.
- Removed criterion for Botox for esophageal achalasia stating member presents with atypical achalasia symptoms and Botox is needed to help guide therapy and/or confirm diagnosis.
- Revised criterion for Botox for migraine prophylaxis regarding inadequate response to/ intolerable side effects with at least 3 medications from 2 classes of migraine headache prophylaxis medication to, from at least two months, increased to at least three months.
- Revised age criterion for Botox, Xeomin, and Dysport for chronic upper limb spasticity, from at least 18 years, to at least 2 years of age.
- Revised criteria for Botox for neurogenic bladder and overactive bladder regarding trial and failure of formulary urinary anticholinergics, from try/fail of two, to requiring try/fail of all formulary urinary anticholinergics.
- Revised criterion for Botox for chronic anal fissures regarding trial and failure of nitroglycerin ointment, etc. to increase the duration from 1 month to 2 months.
- Revised criterion for Botox and Dysport for focal spasticity or equinus gait due to Cerebral Palsy regarding occupational therapy care to include physical care.
- Added renewal criterion for Botox stating for pediatric members, the dosage should not exceed the lower of 8 units every 90 days.
Noridian
Noridian has added a new article addressing billing and coding procedures that complement the LCD for Circulating Tumor Cell Marker Assays.
To report a CTC service, please submit the following claim information:
- Select the appropriate CPT® code
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837
- Item 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
The following codes should be used for Circulating Tumor Cell Marker Assays (MolDX):
- 86152 Cell enumeration using immunologic selection and identification in fluid specimen (e.g. circulating tumor cells in blood)
- 86153 Cell enumeration using immunologic selection and identification in fluid specimen (e.g. circulating tumor cells in blood); physician interpretation and report, when required
SelectHealth
SelectHealth has created a new prior authorization form for the prostate cancer drug Nubeqa. Questions include, but are not limited to, the following:
- What is the member’s diagnosis?
- Is the prescribing physician an oncologist or urologist?
- Will Nubeqa be given in combination with GnRH analog?
Tufts Health Plan
Tufts Health Plan has modified its pharmacy policy for oral cancer medications with the following coverage criteria additions and/or revisions:
- Added Inrebic to the policy. Inrebic may be approved for the documented diagnosis of intermediate-2 or high-risk, primary or secondary myelofibrosis and the prescriber is an oncologist or hematologist.
- Added Rozlytrek to the policy. Rozlytrek may be approved when indication-specific criteria are met. See policy for criteria.
- Added that the plan does not cover the following medications on all Commercial and Medicaid formularies: Erleada, Nubeqa, Yonsa, and Zytiga 500 mg.
Union Pacific Employer Plan
Union Pacific Employer Plan reviewed its prior authorization criteria for the drug Xtandi and updated it with following revisions to the criteria and specifications:
- Required medical information – Castration-resistant or castration-recurrent prostate cancer (CRPC): diagnosis of castration-resistant (chemical or surgical) or recurrent prostate cancer. One of the following:
- Use in combination with a gonadotropin-releasing hormone (GnRH) analog [e.g. Lupron (leuprolide), Zoladex (goserelin), Trelstar (triptorelin), Vantas (histrelin), Firmagon (degarelix)] OR
- Patient has had bilateral orchiectomy.
UnitedHealthcare
Nubeqa, a prescription medicine used to treat men with prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone, may be approved when the following criteria are met:
- Diagnosis of prostate cancer;
- Disease is castration-resistant or recurrent;
- Disease is non-metastatic.
WPS Government Health Administrators
WPS has added a new article addressing billing and coding procedures that complement the LCD for MolDx: Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease. To report a Prolaris prostate cancer assay service, please submit the following claim information:
- Select CPT code 81541
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select ICD-10-CM code C61
The following code should be used for MolDx: Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease:
- 81541 – Oncology (prostate), MRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score
WPS has added a new article addressing billing and coding procedures that complement the LCD for ConfirmMDx Epigenetic Molecular Assay. To report a ConfirmMDx epigenetic assay service, please submit the following claim information:
- Select CPT® code 81551
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier, adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier, adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select the appropriate ICD-10-CM code
The following code should be used for ConfirmMDx Epigenetic Molecular Assay (MolDX):
- 81551 – Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy
WPS has added a new article addressing billing and coding procedures that complement the LCD for Decipher Prostate Cancer Classifier Assay. To report a Decipher® Prostate Cancer Classifier Assay service, please submit the following claim information:
- Select CPT® code 81542.
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select ICD-10-CM code C61.
The following code was deleted and replaced:
- 81479 – Unlisted molecular pathology procedure
- 81479 was replaced with the following code:
- 81542 – Oncology (prostate), MRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score
WPS has added a new article addressing billing and coding procedures that complement the LCD for Decipher Biopsy Prostate Cancer Classifier Assay for Men with Intermediate Risk Disease. To report a Decipher® Prostate Cancer Classifier Assay service, please submit the following claim information:
- Select CPT® code 81542
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select tICD-10-CM code C61
The following code was deleted and replaced:
- 81479 – Unlisted molecular pathology procedure
81479 was replaced with the following code:
- 81542 – Oncology (prostate), MRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score
WPS has added a new article addressing billing and coding procedures that complement the LCD for MolDx: Prolaris Prostate Cancer Genomic Assay.
To report a Prolaris™ assay service, please submit the following claim information:
- Select CPT® code 81541
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select ICD-10-CM code C61
The following code should be used for MolDx: Prolaris Prostate Cancer Genomic Assay:
- 81541 – Oncology (prostate), MRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score
WPS has added a new article addressing billing and coding procedures that complement the LCD for ProMark Risk Score. To report a ProMark assay service, please submit the following claim information:
- Select CPT® code 81479
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select ICD-10-CM code C61
The following code should be used for ProMark Risk Score (MolDX):
- 81479 – Unlisted molecular pathology procedure
Local and Regional Updates
The following are updates in your Section. Please contact AUA Executive Vice President Kathleen Shanley at KShanley@AUAnet.org for more information on any of these issues.
Maryland
As mentioned in our lead story, on February 3, Delegate Erek Barron (D) introduced HB 852 to prohibit cost sharing for prostate cancer screenings in the state of Maryland. This bill specifically requires coverage for conducting a digital rectal exam and a PSA test:
- for men who are between 40 and 75 years of age;
- when used for the purpose of guiding patient management in monitoring the response to prostate cancer treatment;
- when used for staging in determining the need for a bone scan in patients with prostate cancer; or
- when used for male patients who are at high risk for prostate cancer.
HB 852 was heard on February 13 in the House Health and Governance Operations Committee. The bill is awaiting further action by the committee. Read the bill.
MD Wise
MD Wise has updated its managed Medicaid prior authorization guidelines to reflect the following changes to the applicable drugs and criteria:
The drug Nubeqa was added to the prior authorization list. The guideline for Nubeqa requires a diagnosis of non-metastatic castration resistant prostate cancer (nmCRPC).
- Rationale: Promote appropriate utilization and dosing of Nubeqa for its FDA approved indication.
- FDA Approved Indications: Nubeqa is an androgen receptor inhibitor indicated for treatment of patients with non-metastatic castration-resistant prostate cancer.
- Dosage and Administration: 600 mg of Nubeqa is administered orally twice daily.
- Available Strengths: 300 mg tablets
Criteria was revised for the following drugs:
Botox requires one of the following non-cosmetic conditions:
- treatment of overactive bladder (OAB) in adults,
- treatment of urinary incontinence in adults,
- prophylaxis of chronic migraine headaches in adults,
- treatment of upper or lower limb spasticity in adults,
- treatment of upper limb or lower spasticity in pediatric patients 2 to 17 years of age,
- treatment of cervical dystonia (spasmodic torticollis or involuntary contracting of the neck muscles) in adults,
- treatment of severe axillary hyperhidrosis (excessive underarm sweating) in adults,
- treatment of blepharospasm in patients age 12 years or greater, or
- treatment of strabismus (crossed-eye) in patients age 12 years or greater.
This medication will not be approved for the improvement of appearance of glabellar lines in the face (e.g., wrinkles). Additional guideline requirements apply. For the treatment of overactive bladder (OAB), approval requires:
- Age 18 years or greater.
- Documentation that the patient has had a previous trial of or contraindication to THREE of the following anticholinergic medications (chart notes required in the absence of electronic prescription claims history): Ditropan/Ditropan XL, Detrol/Detrol LA, Enablex, Gelnique, Myrbetriq, Oxytrol, Toviaz, VESIcare, or Sanctura.
For the treatment of urinary incontinence, approval requires:
- Age 18 years or greater.
- Detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)].
- Documentation that the patient has had a previous trial of or contraindication to THREE of the following anticholinergic medications (chart notes required in the absence of electronic prescription claims history): Ditropan/Ditropan XL, Detrol/Detrol LA, Enablex, Gelnique, Myrbetriq, Oxytrol, Toviaz, VESIcare, or Sanctura.
Pennsylvania
Aetna
Aetna has reviewed and updated its BPH policy with the following changes:
- Added experimental and investigational policy statement for Prosta-Seq for diagnosis of benign prostatic hyperplasia (BPH).
- Added experimental and investigational policy statement for measurement of blood-based microRNAs and seminal cell free DNA concentration for differential diagnosis of prostate cancer and BPH.
- Added acupuncture and MRI-guided laser focal ablation to the list of experimental and investigational treatments of BPH.
- Added the following CPT code, covered if selection criteria are met:
- 53854 – Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy
- Removed the following CPT code, covered if selection criteria are met:
- 53852 – Transurethral destruction of the prostate tissue; by radiofrequency thermotherapy [TUNA]
- Added the following not covered CPT code:
- 37243 – Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction [PAE]
- Added the following not covered HCPCS code:
- C9747 – Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance
- Added the following not covered ICD-10 code:
- C61 – Malignant neoplasm of prostate [not covered for Prosta-Seq test and measurement of seminal cell free DNA concentration]
Aetna recently reviewed and updated its medical policy regarding prior authorization requirements for nocturnal enuresis treatments, adding the following not-covered codes:
- E0720 Transcutaneous electrical nerve stimulation (TENS) device, 2 lead, localized stimulation
- E0730 Transcutaneous electrical nerve stimulation (TENS) device, 4 or more leads, for multiple nerve stimulation
Provider Partners Health Plan
The drug Erleada was reviewed and the following changes were made to the applicable drugs, criteria, and specifications:
- Covered Uses – All medically accepted indications not otherwise excluded from Part D.
- Exclusion Criteria – Pregnancy.
- Required Medical Information – Diagnosis of one of the following:
- Non-metastatic castration-resistant prostate cancer, or
- Metastatic, castration-sensitive prostate cancer.
- Age restrictions – 18 years of age and older.
- Prescriber restrictions – Prescribed by or in consultation with an oncologist.
- Coverage duration – 12 months.
- Other criteria – none.
New Jersey
AB 1112 – Medical Licensure
On January 14, Assemblymember Carol Murphy introduced AB 1112. This bill enters New Jersey into the Interstate Medical Licensure Compact (Compact), which is an interstate agreement that provides a streamlined process for physicians who are in good standing in their own states to quickly and easily become licensed in other member states without the need to complete the full standard licensing process in the other state.
AB 1112 was referred to the Assembly Health Committee and awaits consideration. Read the bill.
Horizon BCBS New Jersey
Horizon BCBS NJ has updated its genetic and protein biomarkers for the diagnosis and cancer risk assessment of prostate cancer medical policy with the following revised Medicare coverage criteria:
The 4Kscore test is covered for testing of men 45 years of age and older, prior to an initial biopsy or following a negative biopsy, when a confirmed moderately elevated PSA (greater than 3 and less than 10 ng/mL; greater than or equal to 4 and less than 10 ng/mL in men greater than 75 years of age) is present.
Virginia
SB 279 – Certificate Of Need
On January 1, Senator George Barker (D) introduced SB 279. This bill makes clear that the impact of the proposed project on all people to whom services may be provided, not only residents of the service area, must be considered in determining whether or not to grant a certificate of need.
On January 27, SB 279 was assigned to the Certificate of Public Need Subcommittee of the Senate Committee on Education and Health. This bill awaits subcommittee consideration. Read the bill.
SB 330 – Certificate Of Need
On January 6, Senator Creigh Deeds (D) introduced SB 330. This bill clarifies that only hospitals licensed by the Department of Health are subject to certificate of need requirements.
On January 27, SB 330 was assigned to the Certificate of Public Need Subcommittee of the Senate Committee on Education and Health. This bill awaits subcommittee consideration. Read the bill.
HB 1094 – Certificate of Need
On January 7, Delegate Jason Miyares (R) prefiled HB 1094. This bill exempts physician-owned ambulatory surgery centers, as that term is defined in the bill, from the requirement of obtaining a certificate of public need before undertaking a project.
On January 17, HB 1094 was assigned to the Health Subcommittee of the House Committee on Health, Welfare and Institutions. This bill awaits a hearing. Read the bill.
HB 1230 – Certificate of Need
On January 7, Delegate Stephen Heretick (D) prefiled HB 1230. This bill makes it easier for a project to obtain a certificate of need when that project will be located in an area in which one provider or group of providers controls a majority of the market for similar medical service.
On January 17, HB 1230 was assigned to the Health Subcommittee of the House Committee on Health, Welfare and Institutions. This bill awaits subcommittee consideration. Read the bill.
ICYMI: Updates from the AUA Policy & Advocacy Brief blog
AUAPAC: AUA Attends Event for Pennsylvania Congressman
On February 10, AUAPAC attended a fundraiser for Rep. Mike Kelly (R-PA-16). Congressman Kelly is a member of the House Ways & Means Committee, one of the two committees in the House that has jurisdiction on healthcare policy. He also is one of the leading cosponsors of the Improving Seniors’ Timely Access to Care Act (H.R. 3107), a bill that would improve delivery of care by streamlining and standardizing prior authorization in Medicare Advantage, while also providing much needed oversight and transparency of health insurance for America’s seniors.
Quality Payment Program: AUA, AMA, Address Meaningful Measures Initiative
The AUA signed on to an American Medical Association-led letter to the Centers for Medicare & Medicaid Services (CMS) regarding ongoing concerns with CMS’ 2020 policies for accepting and removing quality measures from the Merit-based Incentive Payment System (MIPS) and new Qualified Clinical Data Registry (QCDR) measure testing requirements. The January 31 letter states opposition to the new testing requirements placed on the QCDR measures in light of meeting the testing deadlines and requirements. The American Medical Association also requests that CMS delay removal of measures in 2020 and install a gradual timeline for removing measures. Furthermore, the letter encourages CMS to broaden its bench of clinical and measurement experts and includes recommendations regarding the new testing requirements to allow for a feasible timeline for testing reliability and validity of measures. The letter is attached.
Preferred Specialty Pharmacy Network: AUA, Others Sign On to Letter to BlueCross BlueShield (BCBS) of Tennessee
The AUA joined seven other medical associations in a sign-on letter to BCBS of Tennessee regarding a new policy that requires providers to get pre-authorization for drugs on their specialty drug list. For urology, this prior authorization and purchase requirement would affect drugs such as Lupron, Trelsar, Eligard, Zoladex, Vantas, Firmagon, Provenge, Botox, Jevtana, Testopel, Xgeva, Xiaflex, and Zometa. In addition, the new policy requires drugs to be purchased through the BCBS of Tennessee Preferred Specialty Pharmacy Network, or the Providers will not receive payment. The letter urges BCBS to reconsider their decision is attached.
Merit-based Incentive Payment System: AUA recommends Additional Measure for IPSS or AUA-SI
On January 21, 2020, the AUA asked the Centers for Medicare Service (CMS) to add to the measure specialty sets used in the Merit-based Incentive Payment System (MIPS). The AUA recommended adding Quality Measure #476 [International Prostate Symptom Score (IPSS) or American Urological Association-Symptom Index (AUA-SI) Change 6 -12 Months after Diagnosis of Benign Prostatic Hyperplasia] to the urology measure set. Currently, there are only four urology-based measures in MIPS (and thus in the urology measure set), and two of those are likely to be topped out in the near future. The remaining measures in the urology measure set are general measures.
Thus, says the AUA, adding a urology specific measure increases meaningful participation in both a specialty measure set and MIPS in general for those who care for urologic patients. The letter is attached.
Top Takeaways: Listening Session on Medicare Administrative Contractor (MAC) Opportunities to Enhance Provider Experience – January 29, 2020
The top takeaway from the CMS January 29 Listening Session on MAC Opportunities to Enhance Provider Experience call focused on stakeholder input on ways CMS and MACs could improve the provider experience, and reduce burdens on the provider. Read more here.
Resident Advocacy: Fireside Chat Scheduled for March
On Sunday, March 1, the Policy & Advocacy Resident Workgroup will hold its quarterly Fireside Chat advocacy education call. This call will focus on the upcoming Annual Urology Advocacy Summit. The call will be moderated by Dr. Hans Arora, former AUA Holtgrewe Fellow and current AUA Delegate to the AMA. Dr. Tom Rechtschaffen will review the four issues Summit attendees will be talking about during their Hill meetings, and resident urologists/previous Summit participants Ruchika Talwar, Mei Tuong, and Vikas Bhatt will be discussing their past advocacy experiences.
The link to register for the call can be found here: https://attendee.gotowebinar.com/register/6905957072189614348. If you know any urologists attending the Summit for the first time, please share the link with them and encourage their participation. If you have any questions on the fireside chats or would like to suggest an advocacy topic, please reach out to Joshua Webster at JWebster@AUAnet.org or Dr. Kevin Koo at kkoo@jhmi.edu.
AUA Now Accepting 2020 Holtgrewe Fellowship Applications
The AUA is now accepting applications for the 2020 Holtgrewe Legislative Fellowship program. The program is open to residents, fellows and first-year post-graduates with an interest in public policy and legislation.