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November 10, 2023
In this issue we feature:
LUGPA Submits Comments to USPSTF on PSA-Based Screening
On November 8, LUGPA sent a comment letter to the U.S. Preventive Services Task Force strongly supporting PSA-based screening for prostate cancer and providing a comprehensive response to the USPSTF Draft Research Plan on this topic. The letter emphasizes the benefits of PSA-based screening, particularly its potential to reduce prostate cancer mortality without significant additional risks. LUGPA advocates for personalized screening, focusing on high-risk groups like African-American men and those with a family history of prostate cancer. It also addresses the benefits, harms, and diagnostic accuracy of PSA screening, highlighting the critical importance of early detection. LUGPA suggests that the USPSTF should distinguish between diagnosis and treatment, considering the risks of screening and overtreatment.
Furthermore, the comments highlight the importance of tailoring PSA screening to different age, race, and family history groups, particularly benefiting Black men and others at higher risk. LUGPA discusses the issue of overdiagnosis and overtreatment and how contemporary protocols, such as active surveillance, are mitigating these concerns. Finally, the letter counseled the USPTF against conflating screening and cancer diagnosis with treatment, as active surveillance protocols have advanced whereby men with indolent cancers are monitored and treatment is delayed, often times indefinitely. The overarching message is the significance of screening and early detection in saving lives and preventing advanced prostate cancer cases. LUGPA recommends that the USPSTF focus on identifying aggressive tumors without restricting screening protocols, advocating for a personalized screening approach.
You can read the full comment here.
CMS Releases Medicare Physician Fee Schedule with Payment Cuts
The Centers for Medicare and Medicaid Services (CMS) have recently confirmed significant payment cuts for physicians and hospitals starting January 1, 2024. Following the initial proposal, these cuts include a 3.34 percent decrease in the fee schedule's conversion factor, resulting in lower reimbursements for Medicare services. Additionally, Medicare plans to implement payment cuts for certain procedures performed in facilities from 2026 to balance the budget after a payback related to 340B hospitals. Despite these cuts, Medicare will extend telehealth provisions, supported by various stakeholders, to continue virtual care services due to the ongoing COVID-19 pandemic.
CMS also introduced an add-on payment (HCPCS Code G2211) to recognize resource costs for evaluation and management visits related to complex patient care. This code aims to address the insufficiency of existing reimbursement for such care and will enhance patient care coordination. However, it cannot be billed alongside a visit with modifier 25 for a separate service simultaneously. Independent practices, already facing challenges due to the COVID rebound, workforce shortages, and rising costs, are closely monitoring these developments and collaborating with policymakers to ensure fair reimbursement and the sustainability of their practices and patient access to care.
LUGPA is working hard with Congress to try and prevent these payment cuts from taking effect. The Senate Finance Committee recently marked up legislation that would mitigate physician payment cuts by 1.25%, lowering the overall cuts to 2.15% this year. The House is also expected to act and we are working hard to mitigate these payment cuts by as much as possible. Longer term, we are urging Congress to support bipartisan efforts to pass comprehensive payment reform that will provide a permanent inflation-based update based on the Medicare Economic Index. This will provide independent physician practices with more stability and predictability to the physician payment system moving forward.
New No Surprises Act Amendments Aim to Address Concerns with Existing Rules
The No Surprises Act (NSA), enacted in January 2022, protects consumers from unexpected healthcare costs by prohibiting balance billing in cases of out-of-network emergency care. It covers emergency care scenarios and establishes an independent dispute resolution process. A new Proposed Rule introduced in November focuses on enhancing communication and dispute resolution.
Key proposed amendments include using Claim Adjustment Reason Codes (CARCs) and additional disclosures about payment determinations. Furthermore, it amends open negotiation and IDR initiation content, batching rules, and various aspects of the Federal IDR process. These changes aim to improve transparency, predictability, and consumer protection. LUGPA supports these amendments for more efficient dispute resolution and consumer safeguards. LUGPA has been working with the Ways and Means Committee to provide greater oversight of CMS flawed implementation, which has resulted in a hearing, roundtable with administration officials and a strong letter to the Administration from Republican Members on the Committee offering concrete solutions.
October DC Fly-In and Advocacy Efforts
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In this video, shown at the LUGPA Annual Meeting in Orlando, Fly-In participants talk
about their experiences and the importance of talking to legislators face-to-face. |
In October, LUGPA held its final DC Fly-In, centering discussions on essential healthcare reforms outlined in the 2023 Legislative and Regulatory Agenda. These reforms encompassed preserving physician payment, expanding in-office dispensing, protecting physician reimbursement for administration of Part B drugs subject to price controls, and reforming the 340B Program.
During this two-day event, LUGPA members actively engaged with lawmakers on these issues and explored additional topics, including telehealth reimbursement, site of service reimbursement disparities, telehealth waivers, healthcare consolidation, and healthcare price increases. This dedicated advocacy occurred simultaneously with a historic Speaker vote, underscoring LUGPA's steadfast commitment to advancing policies that benefit independent medical practices and enhance patient care.
The full recap is available here.
LUGPA Submits Comment on Rural Patient Access and Healthcare Policy
In October, LUGPA submitted a comprehensive comment to Chairman Jason Smith of the Ways and Means Committee, emphasizing key recommendations and challenges in the healthcare sector, with a primary focus on rural patient access and healthcare policy.
The comment addressed critical points, including the Urological Rural Access Problem, unsustainable physician payment, and support for The Strengthening Medicare for Patients and Providers Act (H.R. 2474) to safeguard against payment cuts and establish a robust payment solution for physician practices.
It also highlighted the need to reduce payment gaps for high-volume medical procedures and raise the Geographic Price Cost Indices (GPCI) floor in rural and shortage areas. Additionally, LUGPA’s comment advocated for In-Office Ancillary Services (IOAS) modification to enable medication delivery to patients.
You can read the full comment here.
White House Announces Manufacturers Participating in Drug Price Negotiation Program
In October, the White House revealed the participation of all ten manufacturers of selected drugs in the Inflation Reduction Act's Medicare Drug Price Negotiation Program. This development aims to lower drug prices for Medicare beneficiaries and includes drugs used to treat various conditions, such as heart failure, diabetes, arthritis, cancers, blood clots, and more.
The negotiated prices for these drugs will take effect in 2026, with negotiations for up to 60 drugs covered under Medicare Part D and Part B over the next four years and additional drugs each year thereafter.
For additional information, you can view the White House’s release here.
Groundbreaking New Publication on PCR in UTI Evaluation
In response to MolDx's sudden announcement of new guidelines impacting PCR reimbursement, LUGPA has been actively involved in efforts to define, explain, and support the role of PCRs in clinical GU practice. The new guidelines, which limited patient access to this diagnostic tool, were implemented without notification or input from critical stakeholders, potentially impacting urological practices nationwide.
LUGPA has conducted several studies to establish and highlight the real-life practical application of PCR urine testing. In collaboration with P4Diagnostics, the health policy and research team are delighted 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.
LUGPA Policy Brief: Preserving Patient Access and Physician Reimbursement in Medicare Drug Pricing Reform
LUGPA has long recognized the need for comprehensive healthcare reform, including efforts to reduce drug prices in Medicare. However, the proposed reductions in reimbursement for Part B and Part D drugs under the Inflation Reduction Act raise serious concerns for independent healthcare providers. The Protecting Patient Access to Cancer and Complex Therapies Act (S. 2764, H.R. 5391) is a critical piece of legislation designed to ensure patients' continued access to essential medications while protecting healthcare providers from the adverse impacts of drug pricing negotiations between Medicare and pharmaceutical manufacturers.
This legislation offers a balanced solution by preserving physician reimbursement, safeguarding independent providers, achieving cost savings for Medicare, and streamlining drug pricing negotiations. LUGPA remains committed to educating policymakers on these proposed reforms, prioritizing the protection of patient access and the sustainability of independent healthcare practices in the context of Medicare drug pricing reform.
Learn more about the Protecting Patient Access to Cancer and Complex Therapies Act here.
LUGPA Policy Brief: Seniors' Access to Critical Medications Act
Efficient, high-quality, outcomes-driven healthcare relies on patient compliance with prescribed care plans. To maximize the benefits of life-extending and lifesaving medications, several key factors must be addressed, including patient education, removing barriers, and compliance monitoring.
LUGPA actively advocates for physicians' ability to continue providing in-office pharmaceutical dispensing where allowed by state statute, the retraction of CMS's 2021 FAQ on in-office dispensing, maintaining the current In-Office Ancillary Services Exception (IOASE) within the Stark Laws to allow in-office dispensing, and educating policymakers on the distinction between delivery and dispensing and the benefits of in-office dispensing. LUGPA remains dedicated to advocating for patient access to integrated urology care and will continue its efforts to protect the autonomy of patients and physicians in making treatment decisions. We have been building bipartisan support for the legislation and it was recently featured in an Energy & Commerce hearing, the first step to moving the bill.
Read the full Policy Brief here.
CMS Publishes Final Rule for Medicare Secondary Payer and Civil Money Penalties (CMS-6061-F)
On October 11, CMS released the final rule on "Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties," specifying how and when CMS calculates and imposes civil money penalties (CMPs) when reporting entities fail to meet their Medicare Secondary Payer reporting obligations. The rule establishes CMP amounts and the circumstances for imposing CMPs.
The final rule is available on The Federal Register here.
CMS Releases 2024 Medicare Parts A and B Premiums and Deductibles
On October 12, CMS unveiled the 2024 premiums, deductibles, and coinsurance amounts for Medicare Part A and Part B programs, along with the 2024 Medicare Part D income-related monthly adjustment amounts. Notable changes include an increase in the standard monthly premium for Medicare Part B enrollees to $174.70 in 2024, and the Medicare Part A inpatient hospital deductible will be $1,632 in 2024.
A Fact Sheet on CMS’s changes is available here.
Calendar Year 2024 End-Stage Renal Disease Prospective Payment System Final Rule
On October 27, CMS issued a final rule updating payment rates and policies for renal dialysis services furnished to Medicare beneficiaries under the end-stage renal disease (ESRD) prospective payment system (PPS) for 2024. The rule includes changes related to ESRD PPS payment policies, increasing the ESRD PPS base rate, and introducing new requirements for reporting "time on machine" data and reporting of certain renal dialysis drugs.
A fact sheet on the CY 2024 ESRD PPS final rule is available here.
New White House AI Executive Order
On October 30, President Biden issued an Executive Order to ensure the responsible and safe development and deployment of artificial intelligence (AI) in healthcare and other sectors. The order sets new standards for AI safety, privacy protection, equity and civil rights, responsible AI use in healthcare, and more. It emphasizes international collaboration to ensure safe and trustworthy AI deployment.
For more details on the Executive Order, click here.
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