LUGPA Government Affairs Update
Political advocacy is an essential component for LUGPA to fulfill our mission to preserve and advance the independent practice of urology. LUGPA has been evaluating and preparing comment on current and potential future healthcare policy that is positioned to affect patient and physician access to care. This year, LUGPA health policy and advocacy efforts have actively engaged on the following issues:
- USPSTF Recommendation on Prostate Cancer Screening
- Developing Urology-Specific Alternative Payment Models (APMs)
- Radiation Therapy Alternative Payment Model
LUGPA continues our ongoing review of the recently-released USPSTF recommendation on prostate cancer screening updated from its earlier 2012 recommendations — those which our Association strongly opposed. In summary, the updated recommendation changes the grade for PSA-based screening from “D” to “C” for men aged 55-69 years. As a result, the USPSTF now recommends that clinicians may consider discussing with men aged 55-69 what the potential benefits and harms of prostate (PSA) screening entail. For men aged 70 years and older, the USPSTF maintained its “D” recommendation that men 70 and older should not be screened for prostate cancer. Furthermore, the new recommendation did not adequately address men younger than 50 years old which could include higher-risk populations, inclusive of African American men and men with increased hereditary familial risk. Additionally, for men age 70 and older, who enjoy good health and are desire shared decision discussion with their physician, the USPSTF recommendations were lacking.
While the change in recommendation from “D” to “C” softens the impact regarding PSA screening with respect to men aged 55-69, LUGPA is still concerned regarding the USPSTF’s continued use of arbitrary age cutoffs in issuing its recommendations, both for younger and older men. In fact, LUGPA believes that the recent increase in newly diagnosed advanced prostate cancer with more aggressive biology is in part due to those earlier, misguided recommendations. Regrettably patients diagnosed with these higher-grade and higher-stage cancers have less likelihood for cure.
LUGPA has always recommended that patient-physician shared decision making requires thoughtful and clear communication with men of all ages that might be at risk for prostate cancer diagnosis. For those patients newly diagnosed with prostate cancer, LUGPA believes a full discussion of all treatment options (including active surveillance and approved interventions) is required.
LUGPA continues its review of the USPSTF draft recommendations and will work collectively with all experts in the field and will issue comments reflecting LUGPA’s commitment to the rights of individual men to access appropriate screening services. LUGPA will share with its members our subsequent official comments on the USPSTF draft guidelines and will continue to appraise member practices of any new developments.
Recently, the Physician-Focused Payment Model Technical Advisory Committee (PTAC) accepted LUGPA’s Letter of Intent (LOI) outlining our inaugural APM proposal for newly diagnosed, localized prostate cancer. To date, there have only been 17 LOI submitted nationally, and none of them are GU specific; LUGPA’s proposal is the first Urology disease specific APM. In conjunction with the leadership contributed by LUGPA’s APM and Health Policy Committees as well as our strategic partners, we have continued ongoing dialogue with Center for Medicare and Medicaid Innovation (CMMI). LUGPA will be formally submitting this inaugural APM very soon. This LUGPA APM model proposes episode-based payments for newly diagnosed, localized prostate cancer patients. Evidence-based literature confirms that a subgroup of this population can safely defer or avoid active intervention therapies, thus avoiding or reducing potential morbidities and healthcare costs. LUGPA has proposed an episode-based payment model which aligns incentives for physicians to recommend active surveillance in clinically appropriate patients.,. The LUGPA-developed APM will incentivize patient-physician shared decision making, compensating physicians for the management time required to responsibly evaluate and manage these patients on active surveillance. Benchmarks would be defined based upon a hybrid of an individual practice’s historical clinical decision making and regional decision-making patterns, considering prior use of active surveillance and interventional therapies. If total episode spending is less than the designated benchmark, and the practices continue to provide measurable, quality care, then groups would be eligible for a performance-based payment.
Although LUGPA designed the APM with our members in mind, the proposal is designed to allow participation for all urologists, regardless of practice size, affiliation or ownership of ancillary services. This proposal aligns the financial incentives of urologists with patient/physician shared decision making to appropriately care for very low and low risk prostate cancer patients. The LOI can be accessed here.
While LUGPA and its strategic partners are in the midst of submitting the LUGPA localized prostate cancer APM to government bodies for approval as outlined above, additional work in APM development is ongoing in conjunction with more than 40 LUGPA groups.
About 33 of these groups are in the midst of a best practice pathway process that includes retrospective analysis of each groups’ active surveillance pattern, development of a LUGPA prospective active surveillance protocol, and prospective measurement of protocol adherence once adopted by the groups. This process with be critical in understanding the ability of a wide range of LUGPA practices to actually implement an active surveillance protocol and participate in the LUGPA APM once approved.
In addition, another 11 LUGPA groups are assessing their ability to adopt and adhere to a common infection prophylaxis regimen for prostate biopsy. Data suggests that adherence to a common prophylaxis protocol, tailored to the particular pattern of microbial antibiotic resistance in local regions, is the single best way to reduce infectious complications after prostate biopsy. Depending upon the results of this study, as well as financial analysis of the cost of infectious complications after prostate biopsy in the Medicare population, LUGPA is hoping to develop another APM surrounding prostate biopsy.
LUGPA is very proud of the immense and widespread commitment of its rank-and-file members in the APM development process.
Stark Modernization — With the evolving transition to value based care, there is a need to develop novel payment paradigms that align physician compensation with these new practice models. Provisions in existing Stark law, which was written to curb potential abuses in fee-for-service payment, has been recognized by both regulatory bodies and legislators as a potential impediment in both the development and adoption of value-based care models. LUGPA’s Health Policy and Advocacy teams are actively working in a bipartisan, bicameral fashion to modernize Stark law — our goal is to afford independent practices the ability to develop and test alternative payment models by lessening the administrative burden on practices. These changes will make Stark law consistent with the goals espoused in MACRA, allowing for fair and balanced access to care which will assist all healthcare providers and patient clinical outcomes. LUGPA is a key member in a coalition involving nearly two dozen medical societies that are aligned in these efforts.
MACRA — LUGPA’s comments on the final MACRA regulations (released October 2016) set forth several suggestions that CMS could consider ensuring that specialty providers and integrated urology practices can participate meaningfully in the MIPS, APM incentive, and other programs under the rule. LUGPA is continuing to monitor the implementation of MACRA and will be communicating information on how best to meet the challenges of the new payment system.
LUGPA was part of a coalition that successfully lobbied for a statutory freeze on reimbursement for radiation oncology services — this freeze prevented potentially devastating payment cuts to services for patients with prostate cancer. These provisions of this bill, known as the Patient Access and Medicare Protection Act (PL 114-115), expire at the end of 2018; it was conceived as a pathway to the development of an APM in radiation therapy. Consequently, a part of this statute required reports to Congress on the development of such an APM; this report is due to be delivered in June 2017. In May, the Center for Medicare and Medicaid Innovation (CMMI) held a Radiation Therapy Public Forum held at CMS headquarters in Baltimore, MD; the purpose of the forum was to allow stakeholders to provide input on the design of a radiation therapy APM. LUGPA attended the forum to represent its member practices that perform radiation therapy services and which could be affected by the components of radiation therapy APMs. LUGPA CEO Celeste Kirschner provided input at the CMS meeting — of note is that LUGPA was the only non-radiation oncology organization presenting to CMS at the forum. Ms. Kirschner presented data supporting the significant role independent urology plays in overall prostate cancer radiotherapy services and reviewed the essential components that would allow independent urology groups to participate in a radiation therapy APM.
This has proven to be an exemplary year for LUGPA’s advocacy efforts. Our Association has been fortunate to enjoy a record level of support and interest in LUGPA’s advocacy activities. At the 2016 Annual Meeting, more than 70 groups pledged their support for political events in 2017. Since early spring, we have been working on the distribution of the pledged funds, and LUGPA will complete a record number of political events with policymakers by the November 2017 Annual Meeting in Chicago.
The purpose of LUGPA’s Advocacy activities is to support LUGPA’s 2017 Legislative Agenda, summarized below:
- Maintaining the In-Office Ancillary Service Exemption (IOASE).
- Promoting Stark law reform to allow independent practices to thrive under MACRA.
- Reform of the USPSTF, to allow for greater transparency and stakeholder engagement.
- Monitoring regulatory implementation of MACRA.
- Promote neutrality of physician reimbursement regardless of site of service.
- Promote the continuation of legislatively mandated radiation therapy reimbursement freeze as radiation therapy bundles are developed.
- Advocate for physicians’ ability to continue to provide in-office dispensing of pharmaceuticals (where allowed by state law).
LUGPA has hosted several “mini fly-ins” associated with our political events in Washington, D.C., this year. In this way, rank-and —file LUGPA members have an opportunity to join LUGPA leadership in D.C.to attend LUGPA political events, interact with members of Congress or their staff on Capitol Hill, and generally learn the process of political advocacy. LUGPA wishes to recognize not only members of the LUGPA Health Policy Committee and the LUGPA Political Affairs Committee, but the rank-and-file individuals listed below who have taken time from their practices to attend LUGPA political events and “fly-ins” this year:
- Dr. Matt Soroush, Academic Urology
- Dr. David King, Urological Surgeons of Northern California.
- Dr. Robert Bruce, Urologic Specialists of Oklahoma
- Dr. Donald Moylan, Michigan Institute of Urology
- Dr. Peter Knapp, Urology of Indiana
- Dr. Bradley Orris, Urology of Indiana
- Dr. William Swanson, Pioneer Valley Urology
- Dr. David Kelley, Pioneer Valley Urology
LUGPA’s advocacy activities will continue throughout 2017. If your group is contributing to LUGPA political action and is interested in joining us in D.C. to witness the work of LUGPA advocacy firsthand, do not hesitate to contact Celeste Kirschner, LUGPA CEO, at email@example.com.
LUGPA Comments on OPPS
LUGPA recently commented to Centers for Medicare and Medicaid Services (CMS) regarding its recent Outpatient Prospective Payment System (OPPS) Final Rule for 2017.
LUGPA’s comments focus on CMS’s implementation of Section 603 of the Bipartisan Budget Act of 2015 (“BBA”). This law mandates that an off-campus provider-based department (“PBD”) will no longer be reimbursed under the OPPS, but instead under another “applicable payment system,” unless the PBD was in operation prior to November 2, 2015. As CMS recognized in the OPPS Proposed Rule issued in July, Section 603 “is intended to curb the practice of hospital acquisition of physician practices that then result in receiving additional Medicare payment for similar services.”
LUGPA commends CMS for finalizing many provisions of the Proposed Rule in a manner that reflects Congress’s important site-neutrality goals. Unfortunately, in certain important respects, the Final Rule creates interim policy that appears to contradict the language and purpose of Section 603 of the BBA. Without certain revisions, we believe that “the exceptions will swallow the rule” and CMS will have failed to implement a site-neutral payment structure as Congress directed. We are particularly concerned with the following:
- The Final Rule appears to remove all limitations on the services for which an “excepted PBD” may bill under the OPPS-even if these services are entirely different from the types of services the PBD provided prior to November 2, 2015; and
- The Final Rule creates a new payment system for “non-excepted PBDs” that will perpetuate the dramatic payment disparity Congress sought to remedy in Section 603 of the BBA. The data we present in this comment letter shows that, if left unchecked, this payment disparity could approach half a billion dollars annually with respect to commonly performed urologic services alone.
LUGPA believes that the creation of a truly site neutral reimbursement for each CPT Code is the only way to achieve Congress’s goal of curbing the practice of hospital acquisition of physician practices; a practice that results in additional out-of-pocket costs for Medicare beneficiaries and greater expenses for the healthcare system as a whole.
LUGPA ‘s formal request for action provides CMS specifics regarding how the interim rule could be modified so that the Medicare Physician Fee Schedule (which governs non-facility reimbursement) can be effectively implemented in non-excepted PBDs.
Thank you to all LUGPA members for your continued support of our health policy advocacy efforts. LUGPA will maintain its dedication to be the voice of independent urology practices.
LUGPA Mid-Year Government Affairs Update
- 2017 Physician Fee Schedule Proposed Rule
- Medicare Fee Schedule Comparison Tool
- Stark Modernization
- MACRA – MIPS and APMs
- Proposed Part B Drug Payment Model
2017 Physician Fee Schedule Proposed Rule
Currently, LUGPA is considering commentary to CMS in response to the July 7, 2016 Medicare Physician Fee Schedule Proposed Rule. Upon initial review, it appears that while urology as a specialty has approximately a 1% overall reduction in global RVUs, the decrease in reimbursement is greater than that when the decrease in conversion factor (CF) is included; in addition, there may be changes based on member practice Geographical Practice Cost Index (GPCI) variations – in some cases these changes are significant. Thanks to legislative changes instituted from advocacy efforts championed by the Radiation Therapy Alliance (RTA – of which LUGPA is a member), radiation oncology codes are flat overall, and any reimbursement decrease can be attributed to changes in the CF and GPCI. The most significant change in pathology payments is a decrease in reimbursement for prostate biopsies of 9.1%; an increase of 17% in professional revenue is more than offset by a 19% decrease in technical revenue. Regarding diagnostic imaging, CPT codes for in-office sonograms are essentially flat, as are those for common urological CT scanning procedures.
Specifically, within urology, cystoscopy, EMG and greenlight laser (CPT codes 52000, 51784 and 52648, respectively) have very substantive decreases in professional fees. CPT codes 52000 and 51784 were singled out as misvalued in the fee schedule rule. The table below illustrates the fees for these procedures:
Also cited by CMS was prostate biopsy (55700); however, a near 25% decrease in work RVUs was compensated by an increase in practice expense RVUs; overall, this code increased by 3.6% – unfortunately, this nominal increase in reimbursement was the largest fee increase for GU codes.
CMS also devoted attention in the proposed rule to the robotic prostatectomy code (55866); they acknowledged that the refinement panel (which was a cooperative effort between LUGPA and the AUA) recommended an increase in RVUs; however, they declined to accept the recommendation. CMS has indicated that additional commentary may be submitted, suggesting that they may be open to revisiting this issue as part of the final rule.
LUGPA will continue its review of the proposed rule and will advise the membership of any further areas of concern. Full LUGPA comments on the proposed rule will be provided at a later date.
Medicare Fee Schedule Comparison Tool
The RVU analysis mentioned in the previous section was prepared using a Medicare fee schedule comparison tool that is available for your use. This tool will compare RVUs and reimbursement for any geographic area in the United States, and will incorporate not only the CF but all relevant GPCI codes as well. The worksheet is prepared as a Microsoft Excel freeware application. In order to use the tool, you must be using a current version of Microsoft Excel with macros enabled, and must accept the end user license agreement (EULA) to proceed. There is no charge to use or distribute the comparison tool, but it may not be used for any commercial purpose.
LUGPA continues to advocate for reformation of the Stark Law and has been working closely with other stakeholders, including the AUA, to ensure that our goals for Stark reform are aligned.
In its comment letter, LUGPA asked Congress to explore responsible ways to modernize the Stark Law for the benefit of millions of Medicare beneficiaries and taxpayers in the program. In enacting the Stark Law, Congress intended to limit potential incentives for overutilization and unnecessary care present in a fee-for-service payment system. However, in more than 25 years since its passage, the law has become one of the most significant sources of regulatory burden on physicians and, ultimately, for Medicare beneficiaries. Given that the system is rapidly transitioning away from fee-for-service payment, the law is outdated.
The Stark Law’s system of strict liability coupled with extremely narrow and technical exceptions means that every healthcare transaction, partnership, and initiative carries significant legal and operational risk. These restrictions make it more difficult for independent physician practices to coordinate care, creating a competitive advantage for large hospital systems.
In brief, in its comment letter, LUGPA proposed the following reforms to the Stark Law:
- Congress should extend language consistent with the waivers of the Stark Law for Accountable Care Organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) to cover relationships necessary to participate in an Alternative Payment Model (“APM”) or private equivalent under MACRA.
- Congress should modify CMS’s authority to create new exceptions and other regulatory changes to the scope of the Stark Law to require CMS to proactively support Congressional payment reform.
- Congress should clarify that the definition of “fair market value” in section 42 U.S.C. § 1395nn(h)(3) of the Stark Law is not intended to prohibit healthcare practices regulated under the law from paying compensation to incentivize high-quality, cost-efficient care, even if such compensation takes into account “the volume or value of referrals.”
- Congress should revise the definition of “group practice” to clarify that members of group practices may be paid on the basis of furnishing high quality care without running afoul of the Stark Law.
MACRA – MIPS and APMs
Current implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) will fundamentally transform the delivery of healthcare. In our comments, we continued to stress to CMS that MACRA provides important opportunities to move toward value-based payment paradigms rather than the traditional fee-for-service model. A successful transition to innovative APMs will require more coordination of care within and across specialties to improve patient outcomes and reduce overall healthcare costs.
While LUGPA commended CMS for its efforts to develop a workable policy framework consistent with the goals of the Medicare Access and CHIP Reauthorization Act (“MACRA”), there are elements of CMS’s proposed policy that will make it difficult for independent urology and other specialty practices that have the capacity to create meaningful APMs, to participate fully in the payment system created by MACRA.
LUGPA’s comments set forth several suggestions that CMS can implement to ensure that specialty providers, generally, and integrated urology practices, in particular, are able to participate meaningfully in the MIPS, APM incentive, and other programs under MACRA. In short, LUGPA asks CMS to do the following:
- Improve the transparency of the model approval process used by the Center for Medicare and Medicaid Innovation (“CMMI”) and ensure that APMs proposed by the Physician-Focused Payment Model Technical Advisory Committee and stakeholders are reviewed and acted upon in timely fashion.
- Clarify that an APM may define a specialty-focused benchmark for purposes of becoming an Advanced APM, rather than using total Medicare costs as the benchmark, and provide certain other clarifications of the Advanced APM rules.
- Use the Center for Medicare and Medicaid Innovation (CMMI) waiver to ensure that participants in APMs that start after 2019 are not unduly discouraged from becoming Qualifying Participants.
- Provide Clinical Practice Improvement Activities that are more meaningful to urologists and other independent specialty practices, and do not allow the “topped out” rules to penalize specialty practices.
- Provide more information on how patients will be attributed to single specialty practices for purposes of measuring resource use, and how patient relationship codes will interact with the proposed primary care-focused, “two-step” attribution process.
- Withhold inclusion of Part D expenditures in CMS’ calculation of resource use.
- Exercise caution in the use of USPSTF recommendations in constructing quality measures for the MIPS.
- Remove CMS-created barriers to provider alignment and collaboration in the physician self-referral Stark law regulations, including ending CMS’ prohibition on “under arrangements” collaboration between hospitals and physician groups where tied to MIPS, CPIA or APM goals.
Proposed Part B Drug Payment Model
Member practices responded in force to the LUGPA request to contact their members of Congress to urge them to send letters to CMS to abandon plans to implement the proposed model to change the way that Part B drugs are paid. Both Republican and Democratic members of Congress submitted joint, as well as individual letters to CMS asking it to withdraw or substantially modify the proposal.
LUGPA firmly believes that this initiative, implemented without sufficient stakeholder input, will adversely affect the care and treatment of Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, Crohn’s disease and ulcerative colitis as well as primary immunodeficiency diseases.
In support of our position, LUGPA provided substantive comments to CMS concerning the Proposed Part B Drug Payment Model. Key LUGPA comments included:
- Opposition to a demonstration that could harm patient access to prostate cancer treatment
- Opposition to the major changes in the way that Medicare pays for costs associated with drug administration
- Objection to the model that creates clinically irrational financial incentives in drug ordering
- Identifying the failure to address essential operational considerations associated with the proposed model
- A request for the CMS withdraw the proposed rule until the Agency addresses with stakeholder input, the challenges with the proposal as currently framed
We thank LUGPA members who responded to the call to contact their members of Congress to ask them to stop implementation of the demonstration project. We continue to monitor the situation and are awaiting publication of further information about the proposed model.