April 2020 - AUA Public Policy Council Update for MAS
From the Chair
I want to use the opportunity of my last section report to express what an honor and a privilege it has been to work with and serve fellow AUA members these past four years. It is said that during adverse situations character is revealed and not created. I have seen this repeatedly from AUA staff and members alike, especially in the last four weeks. I want to recognize Dr. Kathy Shanley for her outstanding work and innovation on behalf of our organization, and welcome Dr. Eugene Rhee as the incoming chair. The AUA Public Policy team is in great hands. I wish all health and comfort as we navigate these trying times.
The COVID-19 pandemic is rapidly shifting how urologists live and practice. The AUA is working to help our members navigate the ever-evolving landscape of this pandemic, and has set up a COVID-19 Information Center on AUAnet.org. This center contains helpful links and information, including details on telehealth, clinical insights and more. Here are a few updates and a request for your help in gathering stories to better focus our future legislative actions concerning COVID-19.
We Need your Help!
Due to the unprecedented COVID-19 pandemic, there are many issues impacting physicians, patients, and the nation’s healthcare delivery system in general. To help us better direct future legislative actions, we are asking that you complete a short, 12-question survey that is located here: www.auacovid19survey.com.
As Congress continues to move quickly to address the COVID-19 pandemic, in particular now looking to pass a fourth relief package in the coming weeks, your stories will help to put focus on the various obstacles facing urologists and urologic professionals around the country.
State Advocacy Update: AUA Urges Maryland Governor to Sign Prostate Cancer Legislation
On April 13, the AUA sent a letter urging Maryland Governor Larry Hogan, to sign HB 852/SB 661. HB 852, was introduced by House Delegate Erek Barron (D-24) and specifically requires 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. For a copy of the letter, please contact Andrea Oh at [email protected].
As a reminder, the AUA collaborated with ZERO – The End of Prostate Cancer , Chesapeake Urology and MedChi: The Maryland State Medical Society in moving this bill forward. We will keep you updated on the Governors actions on this bill.
Telehealth Webinar: AUA Urology Telehealth Task Force Provides Practical Telehealth Tips
The COVID-19 pandemic has led to unprecedented times and changes the way urologists practice today while promoting good public health through social distancing. Drs. Jonathan Rubenstein, AUA Coding and Reimbursement Chair, and Chad Ellimoottil, both members of the AUA Urology Telehealth Task Force, focus on how to implement telehealth services in your practice. Visit the COVID-19 Information Center and choose the Telemedicine tab and click on the Telehealth in Urology Practice from A to Z icon to view this important information.
COVID-19: The Coronavirus Aid, Relief, and Economic Security (CARES) Act Enacted; AUA Advocates on a Wide-Range of Issues
The House and Senate recently passed H.R. 748, the CARES Act, which is the federal government’s third legislative package aimed at addressing the many public health and economic challenges posed by the COVID-19 outbreak. Among many other things in the $2.2 trillion package, the legislation made important modifications to the Small Business Administration (SBA) 7(a) program, which historically offers “loan” amounts to eligible small businesses in the United States. Previously, only for-profit entities were eligible for these loans. However, under the CARES Act, medical facilities such as hospitals, clinics, emergency outpatient facilities, and medical and dental laboratories are eligible. Convalescent and nursing homes are also eligible, provided they are licensed by the appropriate government agency and services rendered go beyond those of room and board.
While the loans offered under the original program were focused on traditional business development, the CARES Act modifies the program in several key ways, including:
- Clarifying that businesses with up to 500 employees are eligible (for those with multiple locations, the 500-employee limit applies to each location;
- Increasing the maximum 7(a) loan amount to $10 million;
- Expanding allowable uses of 7(a) loans to include payroll support, such as paid sick or medial leave, employee salaries, mortgage payments, and any other debt obligations, and;
- Providing a process for loan forgiveness for certain payroll costs as well as mortgage, rent, and utility obligations.
The CARES Act also establishes a $100 billion fund to support health care providers for costs associated with responding to the pandemic as well as lost revenues because of COVID-19. Providers are defined broadly in the legislation, to be further defined and qualified by the Secretary of Health and Human Services. The bill also includes more than $1 billion to support community health centers responding to the pandemic, and allows for accelerated payments to hospitals during the public health emergency. Recipients would have four months before they have to start paying down the loan and would have a calendar year to make payments without any interest.
The newly enacted law includes also contains several health policy provisions, most of which are tied to the COVID-19 response. These include provisions that:
- Further expand telehealth access by:
- removing a requirement that Medicare beneficiaries need to have had a face-to-face encounter with a provider during the past three years to be eligible for telehealth;
- allowing high-deductible health plans to cover telehealth services pre-deductible;
- allowing Federally Qualified Health Centers and Rural Health Centers to be originating sites; and
- allowing for the use of telehealth to meet some hospice benefit requirements;
- Reduce face-to-face monitoring requirements of the in-home dialysis benefit;
- Temporarily eliminate the Medicare payment reduction (sequester) from May until the end of 2020 while adding an additional year to sequestration on the out-years;
- Establish a 20 percent Medicare add-on payment for treating COVID-19 patients during the emergency;
- Eliminate any Medicare Part B beneficiary cost-sharing for eventual COVID-19 vaccinations, and;
- Require Medicare Prescription Drug (Part D) plans to furnish beneficiaries with 90-day refills if requested during the emergency.
AUA Advocacy on the CARES Act
The AUA joined numerous other groups – including the American Medical Association, Alliance of Specialty Medicine, and the American College of Surgeons’ Surgical Coalition – in sending multiple letters to congressional leadership requesting various provisions be included in the stimulus to help stave off the extreme challenges created by the coronavirus pandemic.
The letters covered a wide-range of issues, including protecting front-line physicians by ensuring they have the equipment they need, ensuring that Good Samaritans are protected when crossing state lines, preventing frivolous lawsuits as they relate to new perceived violations of HIPAA during expanded telehealth treatment, to promoting efficient access to necessary care through relieving prior authorization requirements, protecting physician practices through small business relief programs, and suspending the 2 percent annual Medicare budget sequester.
Visit the AUA’s COVID-19 Info Center for ongoing updates on how new legislation and policies affect you, your patients, and your practice.
National Insurance Updates
The following are national Medicare Administrative Contractor (MAC) and commercial insurance updates.
Aetna
Aetna has reviewed and updated its Pituitary Suppressive Agents medical policy with the addition of the following drugs to the list of drugs requiring prior authorization:
- Lupaneta Pack
- Lupron Oncology
- Orilissa
- Supprelin
- Synarel
- Triptodur
- Zoladex
Aetna has reviewed and updated its Tumor Markers medical policy with the following changes:
- Aetna considers the Mi-Prostate Score (MiPS) for detection of prostate cancer (Mi-Prostate Score (MiPS), an assay of TMPRSS2:ERG (T2:ERG) gene fusion, post-DRE urine expression of PCA3, and serum PSA (KLK3)) test to be experimental and investigational. The peer reviewed medical literature does not support these tests as having sufficient sensitivity or specificity necessary to define their clinical role.
Aetna reviewed and updated its Urinary Incontinence Policy with the following changes to criteria, coding, and supporting information:
- Added that FemiLift (CO2 laser) for the treatment of urinary incontinence is considered experimental and investigational because its effectiveness has not been established.
- Removed cancer as an exclusion for the use of InterStim Continence Control Therapy/Sacral Nerve Stimulation.
Aetna made the following changes to its Prostate Saturation Biopsy policy:
- Added policy statement indicating that spectral analysis of prostate tissue by fluorescence spectroscopy is considered investigational.
- Added the following CPT code:
- 0443T – Real-time spectral analysis of prostate tissue by fluorescence spectroscopy, including imaging guidance
Aetna made the following changes to its Urological Supplies policy:
- Added medically necessary indications for ureteral stents, including the following: before surgery (e.g., gynecologic surgery, rectosigmoid surgery, aortoiliac surgery) to assist with intraoperative identification of the ureter; following ureteroscopy for ureteral stone disease, ureteral stricture, or treatment of transitional cell carcinoma of the ureter or kidney; management of ureteral obstruction due to nephrolithiasis, tumor, or retroperitoneal fibrosis; following the creation of a ureteral anastomosis (i.e., ureteroureterostomy) for repair of ureteral injury (e.g., trauma, iatrogenic), kidney surgery (e.g., pyeloplasty), or renal transplant (i.e., neo-ureterostomy); or protection of a ureteral anastomosis prophylactically before extracorporeal shock wave lithotripsy.
- Added investigational policy statement for ureteral stents for all other indications.
- Added the following covered HCPCS codes:
- T4545 – Incontinence product, disposable, penile wrap, each
- C1875 – Stent, coated/covered, without delivery system
- C2617 – Stent, non-coronary, temporary, without delivery system
AmeriHealth, Independence Blue Cross
AmeriHealth, Independence Blue Cross has reviewed and updated its Experimental/Investigational Services CPT/HCPCS Codes Policy to remove 53854 – Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy
The change became effective January 27.
AmeriHealth, Independence Blue Cross has reviewed and updated its Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia with the following changes to coding:
- The HCPCS code C2596 – Probe, image-guided, robotic, waterjet ablation was added.
- The HCPCS code C9747 – Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance was changed from experimental to experimental/investigational.
AmeriHealth, Independence Blue Cross has reviewed and updated its Telehealth Services Policy with the following changes to criteria, coding, and supporting information:
- Added that telehealth services for the purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke are not subject to the location criteria.
- Revised policy statement to specify that the policy does not describe telehealth services that are provided by a telemedicine vendor.
- The following eligible originating sites have been added:
- Home of beneficiaries with end-stage renal disease receiving home dialysis
- Home of individuals receiving treatment for a substance use disorder or a co-occurring mental health disorder
- Mobile Stroke Units
- Removed coverage statement for asynchronous, store and forward telemedicine.
- The following codes have been added (note: this is not a complete list of codes added to this policy):
- 99201 – Office or other outpatient visit for the evaluation and management of a new patient
- 99307 – Subsequent nursing facility care, per day, for the evaluation and management of a patient
- G0459 – Inpatient telehealth pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy
- G0506 – Comprehensive assessment of and care planning for patients requiring chronic care management services (list separately in addition to primary monthly care management service)
- The following codes have been removed (note: this is not a complete list of codes added to this policy):
- 99446 – Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient’s treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review
- 99452 – Interprofessional telephone/Internet/electronic health record referral service(s) provided by a treating/requesting physician or other qualified health care professional, 30 minutes
- G0459 – Inpatient telehealth pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy
AmeriHealth, Independence Blue Cross reviewed its Services Paid Above Capitation for Health Maintenance Organization (HMO) and Health Maintenance Organization Point of Service (HMO-POS) Primary Care Providers Policy with the following changes to supporting information:
- Added a reference to the following news article:
- “Telemedicine Services for Independence Commercial Members (Updated March 30, 2020).”
Highmark Inc.
Highmark Inc. has combined its pharmacy policies for Erleada, Nubeqa and Xtandi into a single document on androgen receptor inhibitors.
Highmark Inc. has reviewed its Zytiga and Yonsa pharmacy policies and updated them with the following changes to criteria and supporting information:
Zytiga
When a benefit, coverage of Zytiga may be approved when one of the following criteria are met:
- Zytiga is used in combination with prednisone and the following:
- The member has a diagnosis of castration-resistant prostate cancer.
- The member has a diagnosis of metastatic high-risk castration-sensitive prostate cancer.
- Documentation that generic abiraterone acetate is ineffective or not tolerated.
Yonsa
When a benefit, coverage of Yonsa may be approved when all of the following criteria are met:
- Yonsa is to be used in combination with methylprednisolone.
- The member has been diagnosed with metastatic castration-resistant prostate cancer.
- Documentation that generic abiraterone acetate is ineffective or not tolerated.
Humana
Humana has reviewed its Urinary Incontinence Treatments medical policy and updated it with the following changes to criteria, coverage limitations, coding, and supporting information:
Revised criteria for the following indications:
- Stress urinary incontinence (SUI)
- Urge urinary incontinence (UUI)
Updated coverage limitations:
Humana members may NOT be eligible under the Plan for urinary incontinence treatments for any indications other than those listed above including, but may not be limited to:
- Extracorporeal magnetic innervation (ExMI) (e.g., NeoControl Pelvic Floor Therapy System); OR
- Implanted percutaneous tibial nerve stimulation (PTNS) (e.g., CAN-Stim System, RENOVA, StimRouter); OR
- Laser procedures (e.g., IncontiLase, FemTouch); OR
- Nonimplanted percutaneous tibial nerve stimulation (PTNS) (e.g., NURO System, Urgent PC) for any indication not listed above OR if used longer than 12 months; OR
- Sacral nerve stimulation (e.g., Axonics Sacral Neuromodulation System, InterStim, InterStim II) for any indication not listed above OR if contraindications are present; OR
- Stem cell transplantation; OR
- Transperineal implantation of permanent adjustable balloon continence device (e.g., ProACT system, ACT system); OR
- Transurethral radiofrequency ablation (e.g., Renessa procedure); OR
Urinary prosthesis (e.g., inFlow Intraurethral Valve Pump)
Humana has been reviewed and updated its BPH Treatments medical policy with the following changes to coding:
Added the following not covered HCPCS code:
- C2596 Probe, image-guided, robotic, waterjet ablation
Removed the following deleted HCPCS code:
- C9748 Transurethral destruction of prostate tissue; by radiofrequency water vapor (steam) thermal therapy
Humana has reviewed and updated its Gene Expression Profiling Policy with the following addition to CPT coding: 81542 – Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score.
Please note: this is a non-covered procedure.
Humana has reviewed and updated its Gene Expression Profiling Policy with the following addition to CPT coding: 81542 – Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score.
Please note: this is a non-covered procedure.
Humana made the following changes to its Benign Prostatic Hyperplasia (BPH) Treatments policy: Revised coverage decision for water jet tissue resection (i.e., AquaBeam) from not eligible for coverage to eligible for coverage for the treatment of benign prostatic hyperplasia (BPH) when nonsurgical management has failed.
Humana made the following changes to its Jevtana (cabazitaxel) policy to add the following HCPCs code: C9276 – Injection, cabazitaxel, 1 mg
Humana changed its Nubequa policy by revising criteria for prostate cancer (non-metastatic castration-resistant) by removing the criterion that the member has a prostate-specific antigen doubling time (PSADT) of less than or equal to 10 months.
UnitedHealthcare
UnitedHealthcare has reviewed and updated its Urinary and Fecal Incontinence Diagnosis and Treatment medical policy to remove the following: A56331– Posterior Tibial Nerve Stimulation Billing and Coding Guidelines.
UnitedHealthcare has updated its Specialty Pharmacy Prior Authorization Guidelines for several drugs. Relevant to urology, see the required criteria for the prostate cancer drug Nubeqa and the overactive bladder drug Botox listed below:
Drug Name: Botox
Approval Criteria – One of the following conditions: [1, 3, E, F]
- Urinary incontinence that is associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis)
- Overactive bladder with symptoms (e.g., urge urinary incontinence, urgency, and frequency) AND
- Prescribed by or in consultation with a urologist AND
- Trial and failure, contraindication, or intolerance to at least one oral anticholinergic (antispasmodic or antimuscarinic) agent [e.g., Bentyl (dicyclomine), Donnatal (atropine/scopolamine/hyoscyamine/phenobarbital), Levsin/Levsinex (hyoscyamine), Ditropan (oxybutynin), Enablex (darifenacin), or VESIcare (solifenacin)] AND
- Patient is routinely performing clean intermittent self-catheterization (CIC) or is willing/able to perform CIC if he/she has post-void residual (PVR) urine volume greater than 200 mL
Drug Name: Nubeqa
Approval Criteria
- Diagnosis of prostate cancer AND
- Disease is castration-resistant or recurrent AND
- Disease is non-metastatic
- One of the following:
- Used 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
United Healthcare published a Coverage Summary Updates Bulletin announcing significant revisions to the following coverages summaries:
- Complementary and Alternative Medicine
- Oxygen For Home Use
- Physician Services
Furthermore, UHC announced minor revisions to the following coverage summaries:
- Telemedicine/Telehealth Services
United Healthcare published a Coverage Summary Updates provider bulletin advising of revisions in coverage summaries:
Announced significant revisions to the following coverage summaries:
- Medications/Drugs (Outpatient/Part B)
- Solutions for Caregivers
- Telemedicine/Telehealth Services
Announced minor revisions to the following coverage summaries:
- Brachytherapy Procedures
- Radiologic Therapeutic Procedures
United Healthcare West
United Healthcare West published a Benefit Interpretation Policy updates provider bulletin announcing revisions to the following benefit interpretation policies:
- Announced major revisions to the following benefit interpretation policies:
- Genetic Testing (OR, OK, TX, WA)
- Telemedicine/Telehealth Services/Virtual Visits (CA)
- Announced minor revisions to the following benefit interpretation policies:
- Genetic Testing (CA)
Local and Regional Updates
The following are updates in your Section. Please contact AUA Executive Vice President Kathleen Shanley at [email protected] for more information on any of these issues.
For COVID-19 state related resources, please see the following links below:
- For a list of your state executive orders and proclamations, please visit the main webpages for Stateside Associates or the National Governors Association
- AMA resources/policy options relating to COVID-19
- American College of Surgeon’s COVID-19 resources
For more information, please contact State Advocacy Manager Andrea Oh at [email protected].
New Jersey
AR 149 – Workforce Shortage (Urological Practices)
On March 23, Assemblymember William Moen (D) introduced AR 149. This bill urges the President and U.S. Congress to continue the federal Public Service Loan Forgiveness Program.
ACR 149 bill was referred to the Assembly Higher Education Committee and awaits a hearing. Read the bill.
SB 172 – Balance Billing
On April 9, Senator Thomas Kean (R) introduced SB 172. This bill provides civil and criminal immunity for certain malpractice claims made during the public health emergency and state of emergency declared by the Governor’s Executive Order 103 of 2020. The measure also authorizes temporary reinstatement and recertification of certain professional certifications.
SB172 was introduced and moved directly to the floor. This measure is eligible for immediate consideration in the Senate. Read the bill.
SB 2148 – Balance Billing
On March 16, Senator Joseph Vitale (D) introduced SB 2148. This bill, which supplements the “Health Care Quality Act,” requires health care facilities, health care professionals and health insurance carriers to make certain disclosures regarding health insurance network status. SB 2148 was referred to the Senate Commerce Committee and awaits a hearing. Read the bill.
Master (R) signed HB 313. This measure took effect upon enactment. Read the bill.
Washington
SB 6359 – Certificate Of Need
On February 14, Senator Shelly Short (R) introduced SB 6359. This bill creates regulation exemptions for rural health clinics providing services in a designated home health shortage area. On March 31, Governor Jay Inslee (D) signed SB 6359. This measure will take effect on June 11. Read the bill.
ICYMI: Updates from the AUA Policy & Advocacy Brief blog
Veteran’s Prostate Cancer Treatment and Research Act: AUA Meetings Continue
The AUA held teleconference meetings with the offices of Reps. Gilbert Cisneros (D-CA-39), Anthony Brindisi (D-NY-22), Chris Pappas (D-NH-01), and Steve Watkins (R-KS-02) in an effort to build support for the new VA Clinical Pathway legislation. All of these lawmakers are members of the House Veterans’ Affairs Committee, which has primary jurisdiction on H.R. 6092.
As a reminder, the AUA worked closely with Reps. Neal Dunn (R-FL-02) and Joe Cunningham (D-SC-01) to introduce this measure to establish a national clinical pathway for prostate cancer, a comprehensive standardized system of treatment for veterans and establishes a real-time registry to track patients’ progress. The bipartisan bill also creates a national prostate cancer care program with recommendations on the use of transformative innovations, research and uniform clinical data designed in collaboration with disciplines across the public and private sector to guide evidence-based care for veterans. Read the AUA press release.
COVID-19: CMS Interim Rule Changes for Medicare
On March 30, the Centers for Medicare & Medicaid Services (CMS) released an Interim Rule to allow hospitals, ambulatory surgical centers and physician offices the ability to rapidly expand treatment capacity that allows them to separate patients infected with COVID-19 from those who are not affected. These temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. There are major changes for telehealth services and other areas. The AUA’s analysis of important changes affecting the care of beneficiaries during the COVID-19 pandemic can be found here.
AUA Requests State Action for Physician Liability Protections During a Pandemic
On April 7, the AUA participated in the Health Coalition on Liability Association (HLCA) meeting hosted by the Medical Professional Liability Association. During the meeting, HCLA members (including the AUA) raised concerns regarding medical liability for when physicians are expanding their scope of practice to assist during a pandemic. While existing federal and state laws provide important protections to health care professionals, particularly volunteer physicians, more needs to be done to protect physicians across the country. HCLA and the American Medical Association created policy recommendations to encourage states to pursue liability protections through state actions. For a copy of these recommendations, please contact Andrea Oh at [email protected].
2020 AUA Summit: New Dates Confirmed
The AUA is pleased to announce the 2020 Annual Urology Advocacy Summit has been rescheduled and will now take place from August 31 to September 2, 2020 at the Hyatt Regency Capitol Hill in Washington, DC.
For those that were originally planning to attend, we have transferred your registration to the new dates. In the coming weeks, we will share additional information regarding hotel and travel, along with information to help you easily engage your lawmakers on the issues most important to you and your practice.
If you are able to attend, no further action is needed at this time. However, if you are unable to attend, please email [email protected] to cancel your registration.