October 6, 2023

In this issue we feature:

September Fly-In Recap

In September, the Political Affairs Committee and members of LUGPA returned to Washington, DC, to advocate for their 2023 Legislative and Regulatory Agenda. The focus was on four key issues:

  1. Supporting Physician Payment against a planned 3.3% cut to the Medicare Physician Fee Schedule in 2024.
  2. Expanding regulations to allow in-office dispensing of cancer drugs to patients.
  3. Preserving physician reimbursement at ASP+6% despite new drug price controls under the Inflation Reduction Act.
  4. Promoting site neutrality for Medicare payments to level the playing field for independent providers.

This advocacy effort coincided with challenges in Congress related to funding the government, potentially leading to a shutdown. LUGPA members engaged in productive discussions with lawmakers, covering topics like Medicare funding, healthcare workforce concerns, rising drug costs, and value-based care.

Specifically, LUGPA addressed concerns about the proposed 3.3% cut to the physician fee schedule and advocated for long-term reforms to MACRA and the fee schedule. They also urged lawmakers to co-sponsor the "Strengthening Medicare for Patients and Providers Act" (HR 2474), which links payments to the Medicare Economic Index.

The second primary focus was the government's efforts to reduce drug prices, which could impact independent providers. LUGPA discussed the Protecting Patient Access to Complex Therapies Act (S.2764) (H.R. 5391), aiming to preserve physician reimbursement at ASP+6% and ensure patient access to essential therapies while achieving cost savings.

The third issue involved advocating for legislative reform to support in-office drug dispensing, with LUGPA endorsing the Seniors’ Access to Critical Medications Act (HR 5526). This bipartisan bill clarifies Stark law and addresses restrictions on medicine delivery, receiving strong support from LUGPA in meetings with lawmakers.


LUPGA Comments on MPFS Proposed Rule

In September, LUGPA submitted comments on the Calendar Year 2024 Medicare Physician Fee Schedule (MPFS) Proposed Rule to Administrator Brooks LaSure. The comments highlighted medical practices' ongoing challenges, including staffing shortages, increased labor costs, supply chain issues, and rising medical malpractice claims. These challenges are impacting patient care and causing healthcare providers to leave the profession.

In the comment, LUGPA called for several actions in their comments, including:

  • CMS should withdraw its medical malpractice GPCI update and revert to the prior malpractice component.
  • CMS should finalize its proposal to separately pay for HCPCS code G2211 but modify it to allow its use with the -25 modifier in certain circumstances.
  • CMS should finalize its proposal to continue delaying split or shared billing requirements.
  • CMS should reinstate telehealth services that were in effect during the COVID-19 Public Health Emergency, including audio-only communications, virtual supervision, and payment at the non-facility rate for non-facility physicians/practitioners.
  • CMS should pause its data collection process related to post-operative visits and certain procedure visits during global periods to focus on more urgent priorities.
  • CMS should create opportunities for urology-related specialties in the MVP and other value-based frameworks.

Additionally, LUGPA responded to CMS's Request for Information (RFI) regarding Histopathology, Cytology, and Clinical Cytogenetics Regulations under the Clinical Laboratory Improvement Amendments of 1988.


LUPGA Comments on OPPS Proposed Rule

In addition to our comments on MPFS, LUGPA also submitted comments in September on the Calendar Year (CY) 2024 Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems Proposed Rule to Administrator Brooks LaSure.

The comments can be summarized as follows:

  1. LUGPA supports CMS's use of the hospital market basket index to update the ASC payment system, seeing it as a logical policy that encourages safe, convenient, and cost-effective care.
  2. LUGPA supports CMS's efforts to enhance the enforcement of hospital transparency requirements related to standard charges.
  3. LUGPA advocates for policies promoting site-neutral payment under the OPPS, including eliminating the IPO list and expanding the ASC CPL.
  4. LUGPA expresses concerns about CMS's reduced reimbursement and access for extracorporeal shockwave lithotripsy in the ASC setting, which could hinder access to cost-efficient, non-invasive kidney stone treatment.
  5. LUGPA commends CMS's decision to map implantable tibial generator codes to the same APC as sacral neuromodulation (SNM) generator implant and revision/renewal.
  6. LUGPA supports separate hospital outpatient payments for diagnostic radiopharmaceuticals to improve patient access.

These comments reflect LUGPA's perspective on various aspects of the Proposed Rule related to outpatient and ambulatory surgical center payments.


LUGPA Comments on Concerns Over Genetic Testing for Oncology Local Coverage Determination

In June, Novitas and First Coast introduced a new policy, the Genetic Testing for Oncology Local Coverage Determination (LCD), raising concerns about potential reimbursement challenges. This policy could lead to suspending payments for specific markers, especially bladder markers, and excluding FISH testing from coverage. This may result in Medicare beneficiaries with cancer losing access to critical genetic tests, even those historically covered by these contractors.

In response, LUGPA, in partnership with AUA and AACU, is actively engaging with the Medical Administrative Contractors (MACs). Our primary objective is to provide a clear understanding of these tests' practical application in real clinical scenarios and their vital role in patient care.

In late August, LUGPA submitted comments expressing significant concerns about the LCD's recommended non-coverage of specific genetic tests crucial to urology practice, particularly in bladder cancer detection, characterization, management, and treatment.


CMS Announces New Model to Giving States Incentives to Redesign Health Care Delivery

On September 5, the Centers for Medicare & Medicaid Services (CMS) introduced a new model called "States Advancing All-Payer Health Equity Approaches and Development" (States Advancing AHEAD or AHEAD Model). This model aims to improve healthcare management in states, particularly in addressing chronic diseases, behavioral health issues, and other medical conditions. CMS plans to provide awards to up to eight states for this initiative.

The Notice of Funding Opportunity (NOFO) with application requirements will be released in late fall 2023, with states having 90 days to apply in the first application period. A second application period is expected to open in Spring 2024, lasting 60 days. The pre-implementation phase is set to begin for the first cohort in summer 2024. The model's performance period for states will commence in January 2026 or January 2027, depending on the cohort, and will run until December 2034.

More information about the AHEAD Model can be found on the CMS website at https://innovation.cms.gov/innovation-models/ahead, and a related press release is available at https://www.cms.gov/newsroom/press-releases/cms-announces-transformative-model-give-states-incentives-and-flexibilities-redesign-health-care.

divider CMS Issues Medicare Savings Program Eligibility Determination and Enrollment Final Rule

On September 18, CMS issued a final rule called "Streamlining Medicaid; Medicare Savings Program Eligibility Determination and Enrollment," aimed at simplifying enrollment in the Medicare Savings Programs (MSPs). This rule is expected to make healthcare coverage more affordable for around 860,000 individuals. CMS anticipates that these changes will save older adults and people with disabilities nearly 19 million hours in paperwork annually and reduce state administrative burdens by over 2 million hours each year.

Key highlights of the final rule include the automatic enrollment of many Supplemental Security Income recipients into the most comprehensive form of MSP coverage, known as the Qualified Medicare Beneficiary eligibility group, which covers Medicare premiums and cost-sharing. The rule also encourages better utilization of Medicare Part D Low Income Subsidy program data.

CMS plans to address remaining provisions and public comments from the proposed rule in a subsequent final rule expected in 2024, under the title "Streamlining the Medicaid, Children's Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes."

For more information, you can refer to the press release at https://www.cms.gov/newsroom/press-releases/hhs-takes-most-significant-action-decade-make-care-older-adults-people-disabilities-more-affordable and the fact sheet at https://www.cms.gov/newsroom/fact-sheets/streamlining-medicaid-and-chip-final-rule-fact-sheet. The final rule is available in the Federal Register at https://public-inspection.federalregister.gov/2023-20382.pdf.

divider Congress Continues Focus on PBM Reform

Bringing reform to pharmacy benefit managers (PBMs) continues to be one of the top healthcare issues in Congress this session. On September 19, the House Oversight Committee held a hearing titled "The Role of Pharmacy Benefit Managers (PBMs) in Prescription Drug Markets Part II: Not What the Doctor Ordered." Various topics related to PBMs and their impact on the healthcare system were discussed during the hearing. LUGPA’s DC team attended the event and reported the following key points from the hearing:

  • The discussion centered on the monopolistic and anticompetitive practices of PBMs, which contribute to high out-of-pocket drug costs. Bipartisan support was evident for increased transparency in the PBM industry to address opaque fees and promote generic drugs and biosimilars.
  • Concerns were raised about PBMs prioritizing profits, their influence on drug prices, and their impact on patients and taxpayers.
  • Key witnesses included representatives from various healthcare organizations and associations.
  • Topics ranged from the need for transparency in PBM pricing to the impact of PBMs on independent pharmacies, drug prices, and their role in the healthcare system.
  • Questions were raised about PBM consolidation's potential effects on drug prices, their role in negotiating drug costs for patients, and the impact of copay accumulators on patient access to medications.
  • Several legislative solutions and bills were mentioned as potential ways to address PBM and drug pricing issues, including the PBM Sunshine and Accountability Act and the HELP Copays Act.

In addition to the hearing, another development is emerging in the Senate. On September 28, Senate Finance Committee Chair Ron Wyden and Ranking Member Mike Crapo introduced the Modernizing and Ensuring PBM Accountability (MEPA) Act. This bipartisan bill aims to enhance transparency, accountability, and competition within PBMs. MEPA prohibits Medicare-linked PBM compensation tied to drug sticker prices, introduces independent audit and enforcement measures for greater transparency, and supports independent community pharmacies adversely affected by harmful PBM practices. The Act has garnered support from various healthcare organizations and patient groups.

Overall, these efforts in Congress seek to shed light on PBM practices, their impact on drug costs, and potential legislative actions to address these issues.


New Legislation Tackles Health Care Costs and Transparency

The Lower Costs, More Transparency Act (LCMTA) is a comprehensive legislative proposal aimed at enhancing healthcare price transparency, reducing prescription drug costs, and supporting various stakeholders in the healthcare system. It amalgamates elements from multiple bills considered by the U.S. House in 2023, resulting from negotiations involving several House Committees.

The provisions in this bill aim to boost healthcare transparency, empower patients, and alleviate costs. The LCMTA seeks to create a competitive and patient-centric healthcare environment. LUGPA has actively engaged in supporting these initiatives.

A full copy of the proposed bill is available here, and a summary is available here.

A LUGPA Policy Brief on the bill is available here.


CMS Announces Part B Rebatable Drug Coinsurance Reduction

On September 13, CMS announced that there will be a reduction in Part B beneficiary coinsurance for 34 prescription drugs between October 1 and December 31, 2023. This reduction is in accordance with the Inflation Reduction Act, which aims to lower coinsurance for certain Part B drugs if their prices increase faster than the inflation rate.

The beneficiary coinsurance for these drugs will be set at 20 percent of the inflation-adjusted payment amount, resulting in lower costs for beneficiaries compared to regular coinsurance rates. These adjustments started on April 1, 2023, and the list of Part B drugs affected by coinsurance changes may change quarterly.

CMS has provided detailed information about these 34 Part B drugs and biological products in the quarterly Average Sales Price (ASP) public files, which can be accessed here.

Additional resources, such as a press release and a fact sheet, are available to provide more information on the Part B rebatable drug coinsurance reduction:

These measures aim to reduce out-of-pocket prescription drug costs for Medicare beneficiaries, particularly drugs with rapidly increasing prices.


New Policy Brief: Enhancing Value-Based Care Adoption through Federal Legislation

On September 7, LUGPA released a new Policy Brief that underscores the importance of value-based care, federal legislation, and the role of independent healthcare providers in its implementation.

The new brief highlights several key points:

Medicare's Shift to Value-Based Care: Medicare has been transitioning to value-based care models since 2008 to improve quality, population health, and cost-efficiency, requiring providers to report specific metrics.

Value in Health Care Act: The Value in Health Care Act of 2023, supported by physicians, aims to modify Medicare's Alternative Payment Models (APMs). Changes include increased shared savings, community-specific risk consideration, eliminating arbitrary distinctions, metric adjustments, technical support, and extended participation incentives.

LUGPA's Focus on Specialty Value-Based Care: LUGPA endorses a specialty-focused value-based care model. They submitted an APM application in 2017 to encourage shared decision-making for prostate cancer patients, but CMS didn't recommend it.

Congressional Recommendations: LUGPA proposes five key recommendations to improve value-based care. These include preventing Medicare fee cuts, involving independent physicians in APM development, reforming the MIPS program, ensuring fair Medicare payments, and promoting innovative care models.

CMS's Episode-Based Payment Model: CMS is developing a prospective episode-based payment model for comprehensive patient care. Stakeholder input is sought to enhance care quality, transitions, and specialist engagement. The model is planned for a 2026 rollout.

The Policy Brief is available here.


LUGPA Research Team's Groundbreaking New Publication on PCR in UTI Evaluation

Since the sudden announcement by MolDx of new guidelines pertaining to PCR reimbursement, LUGPA has been intensively involved in the effort to define, explicate, and support the role of this modality in clinical GU practice. The new guidelines, which limited patient access to this diagnostic tool, were implemented without notification or input by critical stakeholders and could dramatically impact urological practices nationwide.

LUGPA has been involved in several studies to establish and highlight the real-life practical application of PCR urine testing, lending both support and research to these efforts. In collaboration with P4Diagnostics, the health policy and research team are pleased to announce the publication of “The Essential Role of PCR Panel Size in Comparison with Urine Culture in Identification of Polymicrobial and Fastidious Organisms in Patients with Complicated Urinary Tract Infections,” a recently published article in the International Journal of Molecular Science. Read more here.

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