May 2021 - 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 AUA’s Telemedicine in Urology White Paper update and continued advocacy efforts to promote research funding and post-public health emergency telemedicine flexibilities.
AUA Board Approves the Current State of Advanced Practice Providers in Urologic Practice Paper
The AUA Board of Directors approved the Current State of Advanced Practice Providers in Urologic Practice paper, a resource on how to incorporate advanced practice providers as part of the physician-led multidisciplinary team in various urologic settings. The paper updates the 2014 Consensus Statement on Advanced Practice Provider with the addition of two new sections on compensation and inpatient utilization, as well as procedural data incorporated throughout the document from AUA’s Annual Census on advanced practice providers. The document also recognizes the American Academy of Physician Assistant’s House of Delegates’ decision to allow state chapters to advocate for independent practice. The AUA will share the paper next week through emails and a social media campaign.
The AUA thanks our work group members who volunteered their time to update this paper: Tim Brand, MD, Work Group Chair; Ken Mitchell, MPAS, PA-C; Susanne Quallich, APRN, BC, NP-C, CUNP; Jonathan Rubenstein, MD, FACS; Gwen Hooper, PhD; Jay Motola, MD; Brooke Zilinskas, MMS, PA-C; Jennifer Robles, MD; Brad Erickson, MD; Eugene Rhee, MD, MBA, Public Policy Council Chair and Aaron Spitz, MD.
Telemedicine in Urology White Paper Update
The AUA Telehealth Task Force has updated its Telemedicine in Urology White Paper. Originally published in 2016, the current circumstances allowed the workgroup to update the white paper and better reflect our new state of telehealth in this era of rapid adoption. Telemedicine adoption has accelerated greatly within all specialties due to the COVID-19 pandemic. More than 70% of urologists adopted some form of telemedicine usage during the ongoing public health emergency. With this unprecedented pandemic situation and increase in adoption also comes an influx of data and understanding. Telemedicine experiences in urology span the spectrum of the practice; from new consultations and surgery to virtual house calls and staff supervision. The white paper has been updated with current data on usage rates as well as updates on legislative efforts around telehealth.
The AUA thanks our task force members who volunteered their time to update this paper: Eugene Rhee, MD, MBA, Public Policy Council Chair; Aaron Spitz, MD, Urology Telehealth Task Force Chair; Matthew Gettman, MD, Urology Telehealth Task Force Member and Eric Kirshenbaum, MD, Urology Telehealth Task Force Member.
The updated Telemedicine in Urology White Paper is available to view here.
AUA Physicians Participate in Virtual Meeting with Physician House E&C Health Subcommittee Member
On April 21, Legislative Affairs Committee Chair Dr. Robert Bass and Urology Telehealth Task Force Chair Aaron Spitz participated in a virtual meeting with House Energy & Commerce Committee’s Subcommittee on Health member Representative Kim Schrier, MD (D-WA-08). During the Alliance of Specialty Medicine-hosted meeting, the AUA discussed the expanded use of telemedicine and the need for payment parity for audio-only visits. Dr. Schrier, who was a practicing pediatrician before coming to Congress, acknowledged the wide range of services physicians provide through audio-only visits as well as the lack of access to broadband services for many elderly and rural patients.
The AUA also brought up the need for H.R. 944, legislation that would create a student loan forgiveness bill for specialty physicians that practice in a rural area. Currently leading an effort on a congressional sign-on letter supporting increased access to specialty physicians in rural America, Dr. Schrier was unaware of this legislation but greatly interested in its tenets.
The AUA will continue working with domestic members in an effort to connect them to influential policymakers on telehealth and other key advocacy initiatives that are important to urologists and their patients.
ICYMI: Updates from the AUA Policy & Advocacy Brief blog
AUAPAC Participates in Fundraisers for Sen. Schatz and Reps. Bucshon and DelBene
On May 6, AUAPAC participated in a fundraiser for Sen. Brian Schatz (D-HI). Sen. Schatz sits on the Senate Appropriations Defense and Labor, Health & Human Services, & Education Subcommittees, which oversee critical medical research funding programs at the Department of Defense and the National Institutes of Health. He also co-chairs the Congressional Telehealth Caucus and is an ardent supporter of expanding telehealth services following the expiration of the public health emergency (PHE) due to the COVID-19 pandemic.
During the event, the AUA expressed appreciation and support for the senator’s efforts and leadership around telehealth, and in particular with sponsoring S. 1512, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act. Sen. Schatz has a personal knowledge of the need for retaining the telehealth waivers obtained during the public health emergency and stated that the role of physicians will be vital in promoting the CONNECT Act moving forward.
As a reminder, the CONNECT Act, which the AUA offered input on and has officially endorsed once again in the 117th Congress, would:
- Permanently remove all geographic restrictions on telehealth services and expand originating sites to include the home and other sites;
- Allow health centers and rural health clinics to provide telehealth services, a provision currently in place due to the pandemic but on a temporary basis;
- Provide the Secretary of Health and Human Services with the permanent authority to waive telehealth restrictions, a provision currently in place due to the pandemic but on a temporary basis;
- Allow for the waiver of telehealth restrictions during public health emergencies; and
- Require a study to learn more about how telehealth has been used during the current COVID-19 pandemic.
On May 12, AUAPAC participated in a fundraiser for Representative Larry Bucshon, MD (R-IN-08). A cardiothoracic surgeon before coming to Congress, Dr. Bucshon serves on the House Energy & Commerce Subcommittee on Health. He also is the Republican lead on the AUA-supported Prostate-Specific Antigen Screening for High-risk Insured Men Act (PSA Screening for HIM Act – H.R. 1176), which would allow for PSA testing for African-American men and those with a family history without cost-sharing. During the meeting, Dr. Bucshon talked about the need to protect physician reimbursements during the public health emergency. He also discussed the effects COVID-19 is having on the physician workload and burnout, with the greatest concern being an exacerbation of the physician workforce shortage.
On May 14, AUAPAC participated in a fundraiser for Representative Suzan DelBene (D-WA-01). Rep. DelBene is vice-chair of the House Ways & Means Committee, which is one of two committees in the House with jurisdiction on healthcare. She also is co-chair of the Kidney Caucus and chair of the New Democrat coalition, comprised of moderate members of the House of Representatives who represent purple districts around the country. During the fundraiser, the AUA expressed appreciation for her being the lead on H.R. 3173, the Improving Seniors’ Timely Access to Care Act. This bipartisan bill, which was reintroduced May 13 and had a broad list of more than 300 supporters last Congress, would improve care delivery by streamlining and standardizing prior authorization in Medicare Advantage while also providing much-needed oversight and transparency of health insurance for America’s seniors. As a reminder, reducing regulatory burdens (e.g., MACRA implementation, prior authorizations, step-therapy) and promoting practice sustainability during the COVID-19 public health emergency remains a top legislative priority for the AUA. The congresswoman also addressed the importance of drug pricing, telehealth, and medical research, all issues she is seeking to lead and co-sponsor legislation this congress.
Defense Health Research Consortium Circulates Dear Colleague Letter
The AUA joined the Defense Health Research Consortium (DHRC) in circulating a Dear Colleague letter asking lawmakers to continue their support of the Congressionally Directed Medical Research Programs (CDMRP). The DHRC addressed the letter to Representative Betty McCollum (D-MN-04), Chairwoman of the House Appropriations Defense Subcommittee, and Representative Ken Calvert (R-CA-42), Ranking Member of the same subcommittee. The DHRC is a coalition of patient advocacy organizations, medical provider groups including the AUA, veterans’ organizations, research advocacy groups, and private sector interests. The letter was signed by more than fifty members of Congress. The CDMRP, which includes millions in funding for kidney, prostate and bladder cancer, plays a unique role in the medical research community, investing in high-risk, high reward research through a peer review system that also incorporates feedback from patient advocates, and the AUA is a strong supporter of this research funding mechanism.
AUA Continues Series of Virtual Meetings with Freshman Lawmakers
The AUA continued its series of meetings with first-year lawmakers in the U.S. House of Representatives and Senate. The goal is to introduce urology and the AUA’s top advocacy initiatives, such as addressing physician workforce shortages, enhancing access to prostate cancer screening, expanding access to telehealth services and increasing federal research funding. Over the past few weeks, the AUA specifically met with staff in the offices of Senator Cynthia Lummis (R-WY) and Representatives Jerry Carl (R-AL-01), Mondaire Jones (D-NY-17), Tracey Mann (R-KS-01), Ronny Jackson, MD (R-TX-13), Scott Franklin (R-FL-15), Deborah Ross (D-NC-02), Sara Jacobs (D-CA-53), Kweisi Mfume (D-MD-07), and Carol Miller (R-WV-03).
Below are insurance updates from national insurance carriers. If you have questions about insurer issues, contact Ray Wezik at email@example.com.
Aetna reviewed its Cryoablation Policy revising its list of indications experimental and investigational for treatment with cryoablation from bony metastases from renal cell carcinoma to bony metastases from prostate cancer or renal cell carcinoma.
Aetna reviewed its Pharmacogenetic and Pharmacodynamic Testing Policy with the following changes:
- Added medically necessary statements for:
- BRCA testing (e.g., FoundationOne CDx) for men with metastatic castrate-resistant prostate cancer who have been treated with androgen receptor-directed therapy and are considering initiation of olaparib
- Added not medically necessary statements for:
- FoundationOne Liquid CDx for assessing candidacy of persons with ovarian cancer or prostate cancer being considered for treatment with rucaparib
Aetna reviewed its Urinary Incontinence (Commercial) Policy adding the following criteria for urinary incontinence interventions:
- Added medically necessary continuation criterion for percutaneous tibial nerve stimulation if member’s symptoms has remained improved;
- Moxibustion as an experimental and investigational for the treatment of post-stroke urinary incontinence
BCBS Federal Employee Plan
BCBS Federal Employee Plan reviewed its Urinary Biomarkers for Cancer Diagnosis and Surveillance Policy adding the following investigational indications for urinary tumor markers:
- Screening for bladder cancer;
- Screening for precancerous colonic polyps
CGS Administrators reviewed its Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) (MolDX) (J15) (L37836) Local Coverage Determination (LCD) with the following changes:
- Revised policy statement indicating that limited coverage for an androgen receptor splice variant 7 messenger RNA protein test (AR-V7) to help determine which members with metastatic castrate resistant prostate cancer or other androgen receptor containing tumors may benefit from androgen receptor signaling inhibitor therapy and which may benefit from chemotherapy is provided; added indication of other androgen receptor containing tumors; changed oncotype DX AR-V7 nucleus detect to androgen receptor splice variant 7 messenger RNA protein test.
- Added coverage criteria for AR-V7 including but not limited to the following: members must have progressive mCRPC as defined by the ‘Prostate Cancer Working Group 2’ guidelines levels 1 or more weeks apart, new lesions by bone scintigraphy, and/or new or enlarging soft tissue lesions by computed tomography or MRI; circulating tumor cells with nuclear expression of AR-V7 protein must be assessed prior to initiation of therapy.
- Updated the summary of evidence, analysis of evidence, and bibliography sections.
- Changed title from ‘Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer’ to ‘Androgen Receptor Variant Protein Test’.
CGS Administrators published its Response to Comments: Androgen Receptor Variant (AR-V7) Protein Test (MoIDX) (A58478) Local Coverage Article (LCA).
Centers for Medicare and Medicaid Services (CMS)
CMS reviewed its Cryosurgery of Prostate (230.9) National Coverage Determination (NCD) with the following changes:
- Added Change Request 12124 (TN 10624)
- Contractors shall add CPT 55880 effective January 1.
- CWF edits for multiple lines not billed within 11 full months, read beneficiary record to verify sex code, and edit against 5 active rejects.
Cigna has released new prior authorization criteria for the usage of Orgovyx to treat prostate cancer. In addition, Cigna provided clarification for the definition of “advanced disease.” Orgovyx may be approved for three years when the following criteria are met:
- Individual is ≥ 18 years of age; AND
- Individual has advanced disease.
Note: Advanced disease is defined as disease that has spread to other parts of the body, beyond the prostate. It can also include individuals with persistent prostate specific antigen (PSA) levels or rising PSA levels after radiotherapy or surgery. Metastatic disease also is considered as advanced disease.
In conjunction with prior authorization criteria, Cigna released new Quality Limit criteria for Orgovyx. Cigna reports: “A quantity of 30 of the 120 mg tablets per Rx will be covered without prior authorization. This is enough drug for a 30-day supply. For coverage of additional quantities for individuals taking Orgovyx with a P-gp and strong CYP3A inducers, a coverage review is required. The objective of this program is to prevent stockpiling, misuse and/or overuse while providing a sufficient quantity for indications covered.”
“For individuals taking a combined P-gp inducer AND a strong CYP3A inducer (i.e., apalutamide, carbamazepine, fosphenytoin, phenobarbital, phenytoin, rifampin), approve 60 tablets/Rx for 12 months.”
Cigna reviewed its Prostate-Specific Antigen (PSA) Screening for Prostate Cancer Policy revising the following criterion for annual PSA testing for prostate cancer screening:
- Regarding asymptomatic men, changed from “age 50 and over with a life expectancy of at least 10 years” to “beginning at age 45”
Humana reviewed its Botox (Commercial, Medicare, Medicaid) Pharmaceutical Policy revising medically necessary criteria for urinary incontinence revised language from “with two formulary muscarinic receptor antagonists” to “with two muscarinic receptor antagonists”.
Humana reviewed its Urinary Bladder Dysfunction Policy with the following changes:
- Added coverage criteria including:
- For members following treatments for UUI/OAB, absence of contraindications listed in the Coverage Limitations section;
- For members following treatments for UUI/OAB, failure of or contraindication to a minimum of two conservative management therapies, including pharmacotherapy, over a consecutive 60 day period;
- For initial evaluation for urinary retention after initial diagnostic evaluation above has been performed, cystoscopy, cystourethroscopy, electromyography (EMG) or urodynamic testing for CUR may be performed for the following indications;
- For conservative management for urinary retention, catheterization, indwelling or intermittent;
- For coverage limitations, neurogenic bladder (e.g., diabetic neuropathy, multiple sclerosis, spinal cord injury).
- Removed the following coverage limitations criterion:
- Presence of progressive, systemic neurologic diseases.
- Revised coverage criteria including:
- To revise criteria language from “urinary incontinence” to “urinary bladder dysfunction” and “diagnostic testing” to “diagnostic evaluation”;
- For coverage criteria statement language from “PTNS for urinary incontinence” to “PTNS and SNS for urinary bladder dysfunction”;
- For treatments for SUI to indicate member has a failure of or contraindication to a minimum of two conservative management therapies, removal of intolerance language;
- For treatments for UUI/OAB to indicate member has had at least 12 consecutive months of symptoms;
- For sacral nerve stimulation to replace language “diagnosis of UUI/OAB” with “diagnosis of non-obstructive CUR”.
- Updated supporting and administrative information.
- Revised policy title from “Urinary Incontinence Evaluation and Treatments” to “Urinary Bladder Dysfunction”.
Noridian reviewed its Molecular Diagnostic Tests (MDT) (MolDX) (JF) (A57527) Local Coverage Article (LCA) with the following changes to coding due to the MoIDX program and Q1 2021 CPT/HCPCS code update.
- Added CPT codes including, but not limited to, the following:
- 0133U – Hereditary prostate cancer–related disorders, targeted mRNA sequence analysis panel (11 genes) (List separately in addition to code for primary procedure)
- 0168U – Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma without fetal fraction cutoff, algorithm reported as a risk score for each trisomy
Noridian reviewed the following Local Coverage Determinations and Local Coverage Articles removing the following CPT code due to typographical error:
- 0228U – Oncology (prostate), multianalyte molecular profile by photometric detection of macromolecules adsorbed on nanosponge array slides with machine learning, utilizing first morning voided urine, algorithm reported as likelihood of prostate cancer
Prolaris Prostate Cancer Genomic Assay (MolDX) (JE) (A57509) LCA
Prolaris Prostate Cancer Genomic Assay (MolDX) (JF) (A57511) LCA
Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease (MolDX) (JE) (A57514) LCA
Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease (MolDX) (JF) (A57691) LCA
Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (JF) (A57236) LCA
Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MoIDX) (JE) (A57372) LCA
United Healthcare reviewed its Molecular Pathology/Molecular Diagnostics/Genetic Testing (Medicare Advantage) Policy adding the following medically necessary bladder tumor marker:
United Healthcare reviewed its Prostate Surgery (Value & Balance Exchange) Policy with the following changes:
- Added InterQual criteria and link for radical proctectomy to policy.
- Removed the following coverage criteria that are not present for prostatic urethral lift:
- An obstructive or protruding median lobe of the prostate;
- A known allergy to nickel.
- Revised the following prostatic urethral lift coverage criteria:
- For treating symptoms due to urinary outflow obstruction to include lateral and medial lobe hyperplasia;
- For conditions not present to increase prostate volume from greater than 80 to greater than 100.
- Removed the following unproven and not medically necessary criterion:
- PUL for treating symptoms due to urinary outflow obstruction secondary to BPH for all other indications is unproven and not medically necessary due to insufficient evidence of efficacy.
WPS Government Health Administrators
WPS Government Health Administrators retired its Oncotype DX Genomic Prostate Score (MolDX) Local Coverage Article (LCA) effective March 22. The contractor states that the information in this article has been incorporated within the new LCA “Billing and Coding: MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease”.
Read the update. (A56334/A57106)
Read the update. (L37667/L38433)
Read the update. (L36789/L38433)
WPS Government Health Administrators reviewed its Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (MolDX) (J5, J8) (A57106) Local Coverage Article (LCA) adding the following CPT code to group 1 CPT/HCPCS code:
- 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
Local and Regional Updates
The following are updates in your section. The AUA routinely monitors state legislative, regulatory, and insurance policy trends. Please contact AUA State Advocacy Manager Catherine Hendricks at chendricks@AUAnet.org for more information on any of these issues. In addition, check out our interactive map on the AUA State Advocacy Webpage for the most updated information on bill status.
State Session Information
Legislative sessions ended for Maryland (April 9) and West Virginia (April 10)
Highmark BCBS Delaware
Highmark BCBS Delaware reviewed its Experimental/Investigational Services (Commercial) Policy removing the following codes:
- K1010 – Indwelling intraurethral drainage device with valve, patient inserted, replacement only, each
- K1011 – Activation device for intraurethral drainage device with valve, replacement only, each
- K1012 – Charger and base station for intraurethral activation device, replacement only
- C1982 – Catheter, pressure-generating, one-way valve, intermittently occlusive
Highmark BCBS Delaware reviewed its Treatment of the Prostate (Commercial) Policy with the following changes:
- Reformatted medical necessity criteria; changes include but may not limited to the following (see policy for full changes):
- Removed the list of procedures that can be utilized from criteria and replaced with abbreviated examples;
- Revised criterion for BPH regarding diagnosis of lower urinary tract symptoms (LUTS) secondary to BPH to remove examples of symptoms;
- Added separate criteria section for prostatic urethral lift;
- Added medical necessity criteria for whole gland high-intensity focused ultrasound (HIFU) for treatment of recurrent prostate cancer following radiation therapy;
- Removed laser ablation, cryoablation, and high-intensity focused ultrasound (HIFU) from the list of experimental/investigational treatments for localized prostate cancer;
- Updated medically necessary policy statement for prostatectomy for localized prostate cancer to include simple prostatectomy;
- Removed the following HCPCS codes:
H.B. 160 – Telehealth
Introduced by Representative Dave Bentz (D), H.B. 160 seeks to amend state telehealth law to allow health care providers to provide telehealth services by telephone; establish the patient-physician relationship; provide informed consent; and would start the process for Delaware to join the Interstate Medical Licensure Compact. The bill was referred to the House Health and Human Development Committee. Read the bill.
S.B. 3 – Telehealth ENACTED
Introduced by Senator Melony Griffith (D), S.B. 3 seeks to expand telehealth for Medical Assistance; allow for audio-only conversations between a health care provider and patient; and to reimburse telehealth healthcare services at the same rate as an in-person visit. The bill was signed by Governor Larry Hogan (R) on April 13. Read the bill.
- 3610 – Telemedicine
Introduced by Senator Holly Schepisi (R), S. 3610 seeks to amend state telehealth law to require a health care provider to have an emergency referral plan should a patient present at a telehealth visit and need emergency care. The bill was referred to the Senate Health, Human Services and Senior Citizens Committee. Read the bill.
Independence Blue Cross
Independence Blue Cross reviewed its Genetic Testing Attachment C (Commercial) Supporting Coverage Document with the following changes:
- Added CPT codes including:
- 0228U – Oncology (prostate), multianalyte molecular profile by photometric detection of macromolecules adsorbed on nanosponge array slides with machine learning, utilizing first morning voided urine, algorithm reported as likelihood of prostate cancer
- Removed CPT codes including:
- 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
H.B. 225 – Step-Therapy
Introduced by Representative Steve Mentzer (R), H.B. 225 seeks to amend state insurance law to establish the specific sequence prescription drugs for a medical condition a patient has and provides an exception for immediate coverage of the health care providers selected prescription drug. The bill has been referred to the House Insurance Committee. Read the bill.
H.B. 681 – Restrictive Covenants
Introduced by Representative Torren Ecker (R), H.B. 681 seeks to prohibit enforcement of covenants not to compete in health care practitioner employment agreements. There is an exemption if the health care provider is located in certain counties; the geographic restriction is less than a 45-mile radius; and the length of time is no more than two years. An employer may recover expenses incurred to recruit a health care practitioner. The bill was referred to the House Judiciary Committee. Read the bill.
S.B. 425 – Medical Liability
Introduced by Senator John Gorder, S.B. 425 seeks to amend state liability law to determine who can provide informed consent to a patient. The bill was referred to the Senate Appropriations Committee. Read the bill.
Highmark WV Medicare Advantage
Highmark WV Medicare Advantage released new policy for Transurethral Waterjet Ablation of the Prostate. The procedure may be considered medically necessary for ICD 10 code N40.1.
H.B. 2024 – Telehealth ENACTED
Introduced by Representative Roger Hanshaw (R), H.B. 2024 seeks to allow all licensed medical personnel to use telehealth, allows for audio-only telehealth services, limit the ability of professional licensure boards to restrict telehealth, and to require reimbursement for telehealth to be the same as an in-person service. The bill was signed by Governor Jim Justice (R) on April 9. Read the bill.