July 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 the 2020 Virtual Annual Urology Advocacy Summit and our virtual meetings with National Institutes of Health agencies that focused on growth opportunities for urology grants.
We would like to offer our congratulations to Stephanie Storck on her recent announcement to retire on July 24. Stephanie started with the organization in May of 1998 as the Payment Systems Associate in the Health Policy Department. Since that time, Stephanie has taken on additional roles and responsibilities in the areas of Practice Management, Reimbursement and Regulation, was responsible for starting our Coding Hotline and manages the Coding and Reimbursement Committee and Urology Telehealth Task Force. We would like to thank Stephanie for her 20+ years of service and commitment to our organization.
Annual Urology Advocacy Summit: Registration for Virtual Event Launched
Make plans now to join the AUA in August when we bring Washington, DC, to you with the Virtual Annual Urology Advocacy Summit! The evening programming will begin on August 31. Featured speakers during the week include CBS’ Face the Nation Host Margaret Brennan and AUA member/U.S. Representative Greg Murphy, MD (R-NC-03). A special session for AUAPAC members will be held with Charlie Cook, the editor and publisher of the Cook Political Report. The Summit also will feature a virtual Hill Day of meetings with lawmakers and Congressional staff that will take place on September 1. Register today!
National Institutes of Health Agency Visits Strengthen Research Advocacy Efforts
On June 15 and 29, the AUA met virtually with the National Cancer Institute, National Institute on Aging, National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke. Meetings engaged National Institutes of Health (NIH) agency leadership in conversations about the relevance of urologic conditions to their specific agencies and highlighted how advocates for urologic research funding have contributed to recent gains in NIH funding (i.e., $2.6B increase for FY20). Conversations addressed the appreciation for supporting urologic research and highlighted current opportunities and challenges in urologic research that offer possibilities for collaboration in promoting aligning research agendas.
The meetings were attended by President Scott Swanson, MD; Immediate Past President John Lynch, MD; Secretary, John Denstedt, MD; Research Council Chair Aria Olumi, MD; Research Advocacy Committee (RAC) Chair Toby Chai, MD; RAC Chair-elect Michael Hsieh, MD, PhD; RAC member Gail Prins, PhD; RAC member Hyung Kim, MD; Research Education, Conference and Communications Committee Former Chair Rosalyn Adam, PhD; and Patient Advocacy Liaison to the Public Policy Council, John Fortin.
Patient Advocacy: AUA Virtually Convenes 25 Advocacy Organizations to Launch Friends of the Prostate Cancer Care Community
On June 23, the AUA-led Friends of the Prostate Cancer Care Community (FoPCCC) convened for its first coalition meeting. The meeting agenda included multiple activities, including a policy panel that examined the current political landscape amidst COVID-19 and considerations as we approach November elections. Panelists discussed federal and state legislative activities that affect the prostate cancer community, including access to prostate cancer screening, the Veterans Prostate Cancer Treatment and Research Act (H.R. 6092), and funding for prostate cancer research.
The half-day virtual meeting brought together 52 participants representing 25 advocacy organizations. Many thanks to AUA Legislative Affairs Committee Chair Mark Fallick, MD; AUA State Advocacy Committee Chair Arthur Tarantino, MD; and Research Advocacy Committee member Gail Prins, PhD, for their contributions to the program discussion.
COVID-19 Update: HHS to Extend Public Health Emergency 90 Days; Congress Votes to Extend Paycheck Protection Program
HHS to Extend COVID-19 Public Health Emergency (PHE)
The AUA, along with many other partners in the medical community, has been actively engaged in advocacy to extend the PHE and the policies have allowed providers to continue providing patients with uninterrupted access to health care services. Specifically, on June 26, the AUA submitted its letter to the Department of Health and Human Services (HHS) requesting that the PHE be extended. Three days later, HHS shared via social media its intention to extend the PHE by an additional 90 days. The PHE was previously set to expire on July 25.
There are a number of policies attached to the PHE, including the following:
- the Medicare inpatient 20 percent add-on payment for COVID-19 patients;
- increased federal Medicaid matching rates;
- requirements that insurers cover COVID-19 testing without cost-sharing; and
- waivers of telehealth restrictions.
In addition to our advocacy around the PHE, the AUA has – and will continue to – identify key programs and flexibilities that should remain even after the PHE expires. On June 29, the AUA sent a letter to HHS and the Centers for Medicare & Medicaid Services (CMS) requesting that CMS continue offering telehealth flexibilities after the PHE has been cancelled. The request specifically called for leaders to:
- maintain the expanded Telehealth Services List Medicare implemented during the PHE;
- continue coverage and enhance payment for telephone visits (CPT codes 99441-99443);
- continue telehealth and virtual services for new and established patients; and
- continue relaxation of telehealth originating site requirements to allow patients to receive telehealth services in their homes.
The letter also recommends the following changes to the Quality Program:
- delay the implementation of the MIPS Values Pathway (MVP) Program until at least the 2022 performance year to reduce the burden on physicians whose practices are focused on COVID-19 and do not have the resources to implement the workflow and reporting changes that will be required;
- delay the implementation of qualified clinical data registry (QCDR) measure testing and data collection until September of the year following the completion of the COVID-19 PHE; and
- delay the implementation of appropriate use criteria (AUC) from January 1, 2021 to at least January 1, 2022
For more information about these efforts, or to obtain copies of the letters, please contact PaymentPolicy@AUAnet.org.
House and Senate Vote to Extend Paycheck Protection Program
On June 30, the Senate passed legislation that would extend the deadline for businesses to apply for the Paycheck Protection Program (PPP) to August 8. On July 1, the House of Representatives unanimously passed the application deadline legislation, and President Trump signed it into law shortly thereafter. The application deadline was June 30, 2020, but the program still has roughly $130 billion of unused funds remaining.
The additional five weeks should give small businesses more opportunity to participate in the program without disruptions while the House and Senate negotiate the next COVID relief package – which is expected to come out of the Senate before it breaks for the August recess. The House passed its version, the HEROES Act, back in May.
The PPP initially was funded at $349 billion, with an additional round of funding of $310 billion being added later. While the original funds where quickly claimed by U.S. businesses, the second round has been less successful due to the confusion over program eligibility and loan forgiveness. Recent data from the American Medical Association has echoed this issue, as many physicians have applied for the PPP and other relief funds, but the shifting regulatory requirements around those programs have created an increase in administrative burden for many practices.
Below are insurance updates from national insurance carriers.
Aetna reviewed its Implantable Hormone Pellets Policy with the following changes to criteria and supporting information:
- Revised approval criteria for implantable testosterone pellets.
- Added medically necessary indication of gender dysphoria in a member who is able to make an informed decision to engage in hormone therapy.
- Added pain management in women to the list of indications considered experimental and investigational for the use of implantable testosterone pellets.
- Added CPT +20700 – Manual preparation and insertion of drug-delivery device(s), deep (e.g., subfascial) (List separately in addition to code for primary procedure)
Aetna reviewed its Benign Prostatic Hyperplasia Policy with the following changes to criteria, coding, and supporting information:
- Added experimental and investigational policy statement for CYP17 rs743572 polymorphism testing for estimating BPH susceptibility.
- Revised the list of experimental and investigational treatment for BPH; clarified that temporary prostatic urethral stent includes implantable nitinol devices.
- Revised the list of medically necessary treatment for BPH as alternatives to transurethral resection of the prostate; added language to state that usually 4 to 6 UroLift implants are placed into the prostate.
- Added the following not covered HCPCS code:
o C2625 – Stent, non-coronary, temporary, with delivery system [urethral stent]
Aetna reviewed its Tumor Markers Policy with the following changes to criteria, coding, and supporting information:
- Revised criteria to indicate that the following may be considered medically necessary:
o Androgen receptor splice variant 7 (AR-V7) in circulating tumor cells to select therapy in metastatic castrate-resistant prostate cancer after progression on abiraterone or enzalutamide.
o Decipher, Oncotype DX Prostate, Prolaris, and ProMark for men with very low, low risk or intermediate risk prostate cancer when criteria are met.
o Decipher for men with an undetectable PSA after prostatectomy for prostate cancer when criteria are met.
- Revised criteria to indicate that the following are considered experimental and investigational:
o Insight TNBCtype, liquid biopsy for prostate cancer.
o NantHealth GPS Cancer Panels.
o Specified that repeat testing or use of more than one type of test to assess risk of prostate cancer progression (Oncotype Dx Prostate, Decipher, Prolaris, or ProMark) is considered experimental and investigational.
AllWays Health Partners
AllWays Health Partners reviewed its Evaluation and Management (E/M) Payment Policy with the following changes to non-reimbursable services and coding language:
- Removed reference to telehealth consultation.
- Added the coding range G0425-G0427 to the consultation code list.
- Revised the comment for procedure code 99050 to include language that it is not reimbursable when billed with telemedicine visits.
- Revised comments for procedure codes relating to telephone services and online medical evaluation to state that they are reimbursable only during the COVID-19 state of emergency.
- Revised codes for online medical evaluation, changing it from 99444 to 99421-99423.
- Revised the coding descriptors for the coding range G0425-G0427, changing it to “telehealth consultation, emergency department or initial inpatient, communicating with the patient via Telehealth.”
AmeriHealth, Independence Blue Cross
AmeriHealth, Independence Blue Cross reviewed its eviCore Lab Management Program with the following changes to applicable guidelines and criteria:
- Indicated that lab management guidelines have been revised; changes include but are not limited to the following.
- Added the following new guidelines:
o Date of Service and Authorization Period Effective Date
o CHARGE Syndrome Genetic Testing
o GeneSight Psychotropic Test
o myChoice CDx
- Retired the following guidelines:
o AssureMDx Testing for Bladder Cancer
- Revised the following guidelines with substantive changes to criteria:
o UroVysion FISH for Bladder Cancer
Anthem reviewed its Jevtana Policy updating medically necessary diagnosis to “metastatic castration-resistant prostate cancer”.
Anthem reviewed its Provenge Policy adding that Provenge may not be approved for use in those with small cell/neurodendocrine prostate cancer.
Centers for Medicare & Medicaid Services (CMS)
CMS released a newsletter for May 15 including the following topics:
- Hospitals: Physician Time Studies During the COVID-19 Public Health Emergency (PHE)
- Telephone E/M Visits
Effective June 8, CGS Administrators retired its Aldesleukin, Proleukin, and Interleukin II (IL 2) – (LCA) (J15) (A56831).
Effective June 7, CGS Administrators retired its Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer – LCA (J15) (A52422).
Effective June 7, CGS Administrators retired its Denosumab (Prolia, Xgeva) – LCA (J15) (A56534).
Effective June 8, CGS Administrators retired its Jevtana – LCA (J15) (A56893).
Effective June 7, CGS Administrators retired its Taxotere (Docetaxel) – LCA (J15) (A56577).
Effective June 8, CGS Administrators retired its Zoledronic Acid – LCA (J15) (A57362).
CGS Administrators released its draft Prognostic and Predictive Molecular Classifiers for Bladder Cancer (MoIDX) LCD (J15) (DL38586), on May 28th. A synopsis of the draft is as follows:
- CGS Administrators will cover molecular diagnostic tests for use in a member with bladder cancer when all criteria are met. Criteria include, but are not limited to, the following:
o The member is being actively managed for bladder cancer.
o The member is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.
o The member has not had a cystectomy.
CGS Administrators released its draft Guardant 360 Plasma-Based Comprehensive Genomic Profiling in Solid Tumors (MoIDX) LCD (J15) (L38065) policy into future effective policy.
The associated response to comments article can be found here.
Changed title from “Guardant 360 Plasma Based Comprehensive Genomic Profiling in Solid Tumors” to “Plasma Based Genomic Profiling in Solid Tumors.”
CGS Administrators reviewed its Urological Supplies Article (A52521) with the following changes:
- Added section regarding requirements for specific DMEPOS items pursuant to final rule 1713 (84 Fed. Reg. Vol. 217) to article text.
- Added statement that when the prescribing practitioner is also the supplier, and is permitted to furnish specific items of DMEPOS, a separate order is not required and that the medical record must still contain all of the required order elements, within the policy specific documentation requirements section.
- Added the continued medical need subsection within the policy specific documentation requirements stating that there is no requirement for further documentation of continued medical need as long as the member continues to meet the prosthetic devices benefit.
- Added inFlow device to KX modifier directions.
- Revised the billing direction for inFlow and urological supplies when inserted or used in practitioner’s office within the general section.
- Revised inFlow device statement to replace “battery and/or wand” with “activator” within the coding guidelines section.
CGS Administrators, Noridian
CGS Administrators, Noridian released its Urological Supplies draft policy into future effective policy. The associated response to comments article can be found here.
CGS Administrators and Noridian reviewed their Ostomy Supplies Article (JB, JC) (A52487) adding a section for continued medical need, stating that there is no requirement for further documentation of continued medical need after the initial justification is established at the time of order.
The AUA was made aware of an issue regarding Noridian’s denial of coverage of gemcitabine for intravesical use. In response the AUA contacted the Medical Directors at Noridian to discuss the matter. Noridian has notified the AUA that they have entered an updated instruction covering gemcitabine for intravesical use. Practitioners with denied claims for this appropriate use should contact Noridian’s Provider Contact Center for directions on the resubmission of claims. Noridian will reprocess claims back until October 1, 2019, where they have a record of discussing the developing BCG shortage.
HCSC reviewed its Implanted Adjustable Continence Therapy Policy adding the following HCPCS codes:
- 0549T – Transperineal periurethral balloon continence device; bilateral placement, unilateral placement, including cystoscopy and fluoroscopy
- 0550T – Transperineal periurethral balloon continence device; removal, each balloon
- 0551T – Transperineal periurethral balloon continence device; adjustment of balloon(s) fluid volume
Humana reviewed its Urinary Incontinence Evaluation and Treatments Policy with the following changes effective July 1:
- Added the following not covered CPT codes:
o 0596T – Temporary female intraurethral valve-pump (i.e., voiding prosthesis); initial insertion, including urethral measurement
o 0597T – Temporary female intraurethral valve-pump (i.e., voiding prosthesis); replacement
Humana reviewed its COVID 19 Telehealth and Other Virtual Services policy with following changes to criteria, recommendations, waivers, coding, and supporting information:
- Revised PHE telehealth and other virtual services coverage criteria regarding audio-only services, stating that services that must ordinarily be furnished face-to-face can be provided using only if those services can be provided without video and only if it is impossible to use video to provide that specific service.
- Revised recommendations for reporting PHE telehealth services, stating that a procedure code for a medical discussion should not be used to report a service if no medical discussion occurred, and time spent discussing administrative or other non-medical matters should not be included in calculating medical discussion time.
- Revised PHE waivers statement, stating that waivers are subject to change at any time, and apply to services covered under individual and group MA, fully-insured commercial and Medicare supplement plans, and not necessarily self-insured commercial plans.
- Clarified telehealth and COVID-19 related waivers statement language, changing “full amount” to “100% of the contracted rate or base maximum amount payable under the member’s plan.”
Humana reviewed its Benign Prostatic Hyperplasia (BPH) Treatments Policy with the following changes to criteria, coding, and supporting information.
Updated coverage limitations section, adding:
- Optilume Basic as an example of transurethral balloon dilatation.
- A note to state that Optilume drug-coated balloon (0619T) has not been FDA approved for BPH treatment.
Added the following not covered CPT code (effective July 1):
- 0619T – Cystourethroscopy with transurethral anterior prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed
Kaiser Permanente published its provider bulletin announcing updates to its Telemedicine Services Policy.
Magellan published a provider bulletin announcing information specific for COVID-19 related drugs.
National Government Services (NGS)
NGS released its draft Water Vapor Thermal Therapy for LUTS/BPH (DL37808) policy. A synopsis of draft is as follows:
- Removed urinary retention (e.g., PVR >250-300mL, catheterization requirement, history of being unable to void) from the “Coverage Indications, Limitations and/or Medical Necessity” section of the LCD.
- Revised the “Summary of Evidence” section to add a statement that an analysis of 38 catheter-dependent men with complete urinary retention treated with water vapor thermal therapy found that 70.3% voided spontaneously and were catheter free a median of 26 days post procedure, with minimal adverse effects. Authors concluded that as a minimally invasive surgical procedure it represents an alternative for treatment of catheter-dependent urinary retention in elderly and frail patients who are at anesthesia risk for invasive surgical approaches to relieve retention.
Please note that the urinary retention requirement is the only change open for official comment.
Comment period began June 4 and ends July 18.
Noridian released its draft Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia LCD (JE) (DL38707).
- CMS requires that members be no greater than 80 years of age, with a prostate volume of 30-80 cc by TRUS, and have persistent moderate to severe symptoms despite maximal medical management including: international Prostate Symptom Score (IPSS) ≥12; maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc); failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride).
- Members with known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines) or a prostate specific antigen (PSA) >10 ng/mL, pivotal study exclusion criteria, or any other contraindications will not be provided coverage.
- This policy was presented at the open meeting for Alaska, American Samoa, Arizona, California, Guam, Hawaii, Idaho, Montana, Nevada, North Dakota, Northern Mariana Islands, Oregon, South Dakota, Utah, Washington, and Wyoming on July 15.
- The comment period began June 25, and ends August 8.
Effective August 1, Noridian will release its new Intensity Modulated Radiation Therapy (IMRT) – LCA (JE) (A58236).
Effective August 1, Noridian will release its new Intensity Modulated Radiation Therapy (IMRT) – LCA (JF) (A58245).
On May 15, Noridian Healthcare Solutions retired its Guardant360 and Prospera LCA (JE) (A58190), as all coverage and coding content is published in separate articles.
On May 15, Noridian Healthcare Solutions retired its Guardant360 and Prospera LCA (JF) (A58191), as all coverage and coding content is published in separate articles.
Noridian reviewed its Molecular Diagnostics Tests (MDT) (MoIDX) LCA (JE) (A57526) with the following changes to coding:
Added the following codes and code ranges to group 1 CPT/HCPCS codes, due to coding associated with the MolDx program:
- 0053U-0060U – Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade – Twin zygosity, genomic-targeted sequence analysis of chromosome 2, using circulating cell-free fetal DNA in maternal blood
- 0113U – Oncology (prostate), measurement of PCA3 and TMPRSS2-ERG in urine and PSA in serum following prostatic massage, by RNA amplification and fluorescence based detection, algorithm reported as risk score
Revised the coding group range 81161-81400 under group 1 CPT/HCPCS codes to now read as 81161-81364; the following codes were added due to the annual CPT/HCPCS update:
- 81542 – Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as metastasis risk score
Novitas reviewed its Biomarkers for Oncology LCS (JH, JL) (A52986) removing the following HCPCS Code effective July 1:
- 0005U – Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score
Novitas released its Draft Transurethral Waterjet Ablation of the Prostate LCD (JH, JL) (DL38712) on June 25. A synopsis of the draft is as follows:
- Treatment for LUTS/BPH treatment will be considered medically reasonable and necessary when performed once in members with the following: indications including all of the following:
o Age ≤80, prostate volume of 30-80 cc by transrectal ultrasound (TRUS), persistent moderate to severe symptoms despite maximal medical management including all of the following: international Prostate symptom score (IPSS) ≥124, maximum urinary flow rate (Qmax) of ≤15 mL/s4 (voided volume greater than 125 cc), failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride), only treatment using an FDA approved/cleared device will be considered medically reasonable and necessary.
Optima Health published its provider bulletin announcing coverage changes due to COVID-19, including expanded telehealth services, covered FDA-approved vaccinations for COVID-19 when they become available, expanded billing code list, and waiving certain requirements.
Palmetto reviewed its Fluid Jet System in the Treatment of Benign Prostatic Hypertrophy (BPH) (MoIDX) Draft LCD (JJ, JM) (DL38549) extending the comment period end date through July 7 in order to allow stakeholders additional time to prepare and submit comments.
Palmetto reviewed its Prognostic and Predictive Molecular Classifiers for Bladder Cancer (MoIDX) Draft LCD (JJ, JM) (DL38576) extending the comment period end date through July 7 in order to allow stakeholders additional time to prepare and submit comments.
Paramount published its provider bulletin announcing updates to the following Medicare and Commercial policies due to COVID-19:
- Telehealth Services: COVID-19 Emergency
- COVID-19 Reimbursement
- COVID-19 Diagnostic Laboratory Screening/Testing
Announced refill-too-soon edits have been relaxed through the extended duration of the emergency period.
Paramount reviewed its Telehealth Services COVID-19 Policy with the following changes to coverage, reimbursement and coding:
- Removed a statement which indicated that physical, occupational, and speech-language therapists are not qualified to furnish Medicare telehealth services.
- Extended effective end date to June 30.
- Revised coding section, adding that licensed clinical social workers, clinical psychologists, physical therapist, occupational therapists, and speech language pathologists can provide e-visits.
- Added billing information for audio-only evaluation and management services.
- Added codes including, but not limited to, the following:
o S9685 – Physician service or other qualified health care professional for the evaluation and management of a beneficiary’s acute change in condition in a nursing facility. This service is for a demonstration project.
o 99324 – Domiciliary or rest home visit for the evaluation and management of a new patient, which requires these 3 key components: a problem focused history; a problem focused examination; and straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient’s and/or family’s needs. Usually, the presenting problem(s) are of low severity. Typically, 20 minutes are spent with the patient and/or family or caregiver.
o 99443 – Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion
- Updated coding section to indicate which codes are temporary additions for the Public Health Emergency (PHE) for the COVID-19 pandemic.
United Healthcare (UHC)
UHC reviewed its Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions Policy with the following changes to coding:
Removed the following from CPT codes with associated documentation requirements:
- 0011M – Oncology, prostate cancer, mRNA expression assay of 12 genes (10 content and 2 housekeeping), RT-PCR test utilizing blood plasma and/or urine, algorithms to predict high-grade prostate cancer risk
- 0012M – Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma
- 0013M – Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma
- 0047U – Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score
- 0113U – Oncology (prostate), measurement of PCA3 and TMPRSS2-ERG in urine and PSA in serum following prostatic massage, by RNA amplification and fluorescence-based detection, algorithm reported as risk score
- 81542 – Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as metastasis risk score
UHC reviewed its Prostate Services and Procedures Medicare Coverage Summary with the following changes to criteria and supporting information:
Removed the following coverage criteria guidelines:
- Prostatic Urethral Lift (CPT/HCPCS codes 52441, 52442, C9739, C9740 and L8699).
Medicare does not have National Coverage Determination (NCD) for prostatic urethral stent. Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these policies is required where applicable.
UHC reviewed Urological Supplies Policy with the following changes to coding, language, and supporting information:
- Removed the following Modifier code:
o EY – No physician or other licensed health care provider order for this item or service.
- Replaced “beneficiary” with “member” in criteria language.
UHC reviewed its Xtandi Step Therapy Policy with the following changes:
- Added Prostate Cancer criteria including, but not limited to, the following:
- Diagnosis of metastatic, castration-sensitive prostate cancer.
- History of failure, contraindication, or intolerance to both of the following: Zytiga (abiraterone) or Erleada (apalutamide).
- As continuation therapy.
- Patient has not received a manufacturer supplied sample at no cost from a prescriber’s office, or any form of assistance from the Astellas sponsored Xtandi Support Solutions program or a 30 day free trial from a pharmacy as a means to establish as a current user of Xtandi.
- Revised Other Indications criterion from “Diagnosis other than castration-resistant or recurrent prostate cancer” to “Diagnosis other than prostate cancer.”
WPS Government Health Administrators (WPS)
WPS released its Fluid Jet System Treatment for LUTS/BPH draft LCD (J5, J8) (DL38682) policy. A synopsis of draft is as follows:
- Fluid jet system for treatment of LUTS/BPH may be covered when the following requirements are met:
o Age is equal or less than 80 years
o Prostate volume of 30-80 cc by TRUS
o Persistent moderate to severe symptoms despite maximal medical management including IPSS equal to or greater than 12, maximum urinary flower rate of equal to or less than 15mL/s, and failure, contraindication, or intolerance to at least three months of conventional medical therapy for LUTS/BPH.
WPS released its Prognostic and Predictive Molecular Classifiers for Bladder Cancer (MoIDX) draft LCD (J5, J8) (DL38684) policy. A synopsis of the draft is as follows:
- Molecular diagnostic tests for use in a beneficiary with bladder cancer will be covered when criteria are met. Criteria include, but are not limited to, the following:
o The beneficiary is being actively managed for bladder cancer.
o The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.
o The patient has not had a cystectomy.
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.
Horizon BCBS New Jersey reviewed its Solesta Policy with the following changes:
- Added Medicare coverage information stating that there is no National Coverage Determination (NCD), that in the absence of an NCD, coverage decisions are left to the discretion of Local Medicare carriers, that Novitas Solutions, Inc., the local Medicare carrier for jurisdiction JL, has not issued a determination for this service, and therefore, Medicare Advantage products will follow the Horizon BCBSNJ medical policy.
- Removed the following HCPCS code:
o L8604 – Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies
- Added note stating that for Medicare Advantage, the Medicare coverage section can be referred to for coverage guidance.
Horizon BCBS New Jersey reviewed its Intravesical Transurethral Electrical Bladder Stimulation (ITEBS Policy adding a note within the Medicare coverage section stating that biofeedback rendered by a practitioner in an office or other facility setting is covered for the treatment of stress and/or urge incontinence in cognitively intact members who have failed a documented trial of pelvic muscle exercise (PME) training.
Biofeedback is not a treatment, per se, but a tool to help members learn how to perform PME.
A failed trial of PME training is defined as no clinically significant improvement in urinary incontinence after completing 4 weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength.
AR 149 – Workforce Shortage (Urological Practices)
On March 3, Assemblymember William Moen (D) introduced AR 149. This bill urges the President and Congress of the United States to continue the federal Public Service Loan Forgiveness Program.
On July 9, AR 149 passed the Assembly Higher Education Committee. This bill awaits consideration on the Assembly floor. Read the bill.
SB 2467 – Telemedicine
On July 1, Assemblymember Nellie Pou (D) introduced SB 2467. This bill extends existing laws relating to coverage of telemedicine, telehealth, and testing costs during the COVID-19 public health emergency.
On July 1, Governor Phil Murphy (D) signed SB 2467, which became effective immediately. Read the bill.
HB 2350 – Medical Licensure
Representative Aaron Kaufer (R) introduced HB 2350. This bill requires any provider that seeks to operate in the Medicaid program to use either a National Provider Identification (NPI) or register for a State Provider Identifier (SPI). The Department of Human Services would be required to establish a standardized program for any company, which lacks an NPI and must register for provider identification with the state.
On July 7, HB 2350 passed the House and is eligible for Senate Consideration. Read the bill.
HB 2350 – Medical Licensure
Representative Thomas Murt (R) introduced HB 2350. This bill provides loan forgiveness awards to qualified applicants. The Pennsylvania Higher Education Assistance Agency will administer the program for active first responders on a statewide basis.
On June 29, HB 2644 was introduced and referred to the House Veterans Affairs and Emergency Preparedness Committee. HB 2350 is eligible for a hearing. Read the bill.
ICYMI: Updates from the AUA Policy & Advocacy Brief blog
Physician Workforce Shortage: AUA Signs Letter Supporting Increased GME Funding
On June 23, the AUA joined its colleagues in the Graduate Medical Education (GME) Advocacy Coalition in requesting that Congress increase funding for GME and lift the cap on residency positions that has been in place since 1997. The letter requests that Congress include the Resident Physician Shortage Reduction Act (H.R. 1763/S. 348) in the next COVID-19 legislative package. This legislation would create 3,000 new residency slots a year – covered by Medicare – for a period of five years after its passage. Half of the newly created slots would have to go to specialties that have been identified as being in a shortage, like urology. For a copy of the letter, please contact AUA Legislative & Political Affairs Manager Joshua Webster at JWebster@AUAnet.org.
The GME Advocacy Coalition is a group of medical organizations, led by the Association of American Medical Colleges, which routinely advocates on physician workforce and GME-related issues. Addressing physician workforce shortages through legislation such as H.R. 1763/S. 348 also has long been a top legislative priority for the AUA and its members.
Medical Liability Reform: AUA Signs Letter Supporting Main Principles for COVID-Relief
On June 26, the AUA joined its colleagues in the Alliance of Specialty Medicine on a letter to House and Senate leadership urging them to provide additional medical liability protections for physicians in the next legislative response to the COVID-19 pandemic. The letter stresses that physicians are facing the ominous threat of lawsuits due to circumstances such as suspending most elective and urgent in-person visits and procedures, providing care outside the physician’s general practice area, delaying care due to shortages of equipment such as ventilators, having inadequate testing capabilities that could lead to delayed or inaccurate diagnosis, and delaying overall treatment for patients with conditions other than COVID- 19.
For a copy of this particular letter, please contact AUA Legislative & Political Affairs Director Brad Stine at BStine@AUAnet.org.
The AUA and Alliance will continue to advocate on this important issue, particularly as the coronavirus continues to greatly challenge our health care delivery system around the country.
As a reminder, the AUA is actively monitoring the issue of telehealth and has developed a strategy to retain telemedicine waiver provisions after the coronavirus pandemic is over, which includes educating lawmakers on the importance of telemedicine access to patients around the country. In addition, the AUA’s Urology Telehealth Task Force is partnering with the Regulatory Workgroup to communicate with the Centers for Medicare & Medicaid Services to focus on issues such as maintaining expansion of services included on the telehealth services list; providing coverage and enhanced payment for the telephone E/M services (CPT codes 99441-99443); and preserving direct supervision revisions that allow physicians to supervise in-office clinical staff using communications technologies, when appropriate as well as retaining other waivers.
With my warmest wishes for your good health,