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July 7, 2023
In this issue we feature:
House Committee Discussed Medicare Physician Payments and Need for MACRA Reform
On June 22, theHouse Energy & Commerce – Oversight & Investigations Subcommittee held a hearing titled “MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors” to review Medicare physician payments for the first time since 2019. The hearing focused on an issue that has long been a top legislative priority for LUGPA, reform to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Members of the committee discussed the status of MACRA. They shared LUPGAs concern that MACRA has not developed Advanced Alternative Payment Models (APMs), which were the main goal of the Act, and have not done enough to mitigate the administrative burdens of the Merit-based Incentive Payment System (MIPS), which members and experts noted, in a bipartisan manner, is not improving patient care or value.
The LUPGA Washington team attended the hearing and noted other important discussion points, including the need for improved data collection systems, the effects of the rapid growth of Medicare Advantage (MA), and cost-sharing for chronic care management services.
CMS MAC Contractors End Medicare Coverage for Several Bladder Cancer Genetic Tests
In late May, Medicare Administrative Contractors Novitas Solutions and First Coast released a local coverage determination update placing limits on several cancer genetic tests. These changes included bladder cancer tests from Pacific Edge Diagnostics and Abbott.
In the LCD, Novitas and First Coast reviewed the published literature for the tests. They decided to rescind coverage for Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Detect, Monitor, Enhanced Triage, and Resolve assays—the new coverage limitations take effect July 17.
According to comments in the LCD in evaluating the Cxbladder portfolio of tests, Pacific Edge’s lab tests all suffered "from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract.
The review concluded, “Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given these findings, the Cxbladder line of tests is considered not medically reasonable and necessary for Medicare patients.”
A similar literature review for Abbott’s UroVysion FISH tests was conducted. The LCD concluded, “In summary, the body of peer-reviewed literature concerning UroVysion FISH is insufficient to establish the analytic validity, clinical validity, and clinical utility of this test in the Medicare population. As such, this test does not currently meet medically reasonable and necessary criteria for Medicare patients and will not currently be covered.”
LUPGA has been following this issue and is concerned about CMS’s evaluation of tests like Cxbladder and UroVysion FISH. This new LCD was an abrupt policy shift with no prior announcement or opportunity to comment in the draft comment period. LUGPA is currently communicating with key stakeholders to determine how best to advocate for our members and patients, and we will engage with regulatory agencies, including CMS and legislators, to convey those positions.
SEE UPDATE TO THIS ARTICLE HERE.
LUGPA’s Efforts on Pharmacy Benefit Manager Reform Featured in Urology Times
On May 30, an article featuring LUGPA’s efforts to promote pharmacy benefit manager reforms was featured in Urology Times. The report, an interview with Dr. Mara R. Holton, highlighted policy efforts that LUGPA supports to help lower patient costs, including legislation aimed at pharmacy benefit manager (PBM) reforms. “Fundamentally, all of these statutory initiatives are designed to promote transparency, limit profits and ensure that rebates are passed along to the consumer rather than increasing the profit margin for the PBM,” Dr. Holton explained. “From a LUGPA vantage point, we are extremely excited to see the significant congressional attention to PBMs… we are very hopeful that patients will get some meaningful reform and some relief to the escalating burden of health care costs.”
Congress Holds Multiple Hearings on Consolidation and Corporate Ownership in Health Care and PBM Transparency
On June 8, the Senate Finance Committee held a hearing discussing the impact of consolidation and corporate ownership in the healthcare system, focusing on private equity investment and its effects. LUGPA’s Washington DC team attended the hearing and reported on the discussions, which touched on the need for site neutrality to combat consolidation, updating the fee-for-service payment system to a more value-based system incentivizing providers when their patients are healthy rather than treating once sick, prior authorization, updating hospital price transparency data, and shining a light on the PBM industry practices.
On June 21, the Subcommittee on Health, Employment, Labor, and Pensions held its own hearing on rising healthcare costs, particularly related to vertical integration, hospital consolidation, and PBM transparency. LUGPA’s Washington DC team attended this hearing as well, and one major discussion point involved a suggestion to grant the Federal Trade Commission (FTC) the authority to oversee and investigate non-profit hospital acquisitions and mergers.
These discussions are consistent with what LUGPA has heard at other committee meetings this session, including the Energy & Commerce, Ways & Means, Senate HELP, and other committees of jurisdiction.
In response to these hearings, LUGPA has produced a new Policy Brief discussing hospital consolidation, mergers, and acquisitions and their implications in the healthcare industry. The brief outlines how Healthcare consolidation is rapidly increasing because the mergers and acquisitions conducted in the healthcare sector have mainly gone unchecked by federal and state antitrust enforcers.
The brief examines how consolidation has profoundly affected the healthcare market, resulting in higher prices, diminished quality of care, fewer employment options, limited wage growth, longer hours, staff shortages, reduced innovation, and reduced patient care access.
Senators Introduce Two Bills to Lower Drug Costs and Hold PBMs Accountable
In June, two bills were introduced in the Senate which are designed to reform how PBMs operate to lower drug costs and ensure accountability of PBMs by addressing retroactive assessment fees on pharmacies and limiting the ability of PBMs to manipulate drug prices for Medicare Part D beneficiaries by delinking PBM compensation from list prices and utilization levels.
The first bill, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, seeks to increase transparency and hold PBMs accountable for retroactively assessing fees on pharmacies. According to a press release on the proposed bill, the Act would:
- Redefine “negotiated price” under the statute to include all pharmacy price concessions at the point of sale so that a senior’s cost-sharing will reflect all possible discounts.
- Eliminate the retroactive nature of DIR clawback fees.
- Improve transparency in price concessions and fees by requiring prescription drug plans and Medicare Advantage drug plans to report any pharmacy price concession or incentive payment they apply after the point-of-sale to a pharmacy.
The second bill, the Patients Before Middlemen (PBM) Act, would limit the ability of PBMs to manipulate drug prices for Medicare Part D beneficiaries by delinking PBM compensation from list prices and utilization levels. The Act aims to create better incentives for PBMs, drug manufacturers, and pharmacies to lower prescription drug costs for Medicare Part D beneficiaries.
In a media release on the bill, the bill’s sponsors argued that the delinking would address the flaws in the current system, where PBMs are paid based on the price of a drug and are encouraged to favor higher-priced drugs in their negotiations, which leads to increased costs for everyone, with seniors bearing the greatest burden.
LUPGA has actively supported recent legislation to limit the influence of PBMs on drug costs, and both bills are strong steps toward ending their disruptive practices and bringing drug costs down.
CMS Announces New List of Prescription Drugs with Reduced Coinsurance
On June 9, CMS announced a list of 43 prescription drugs for which Part B beneficiary coinsurances may be lower between July 1 and September 30, 2023. This reduction in out-of-pocket costs is in response to the Inflation Reduction Act, which requires lowering the coinsurance for certain Part B drugs and biologicals with prices that have increased faster than the inflation rate.
The beneficiary coinsurance for these drugs will be 20 percent of the inflation-adjusted payment amount, which is lower than the usual coinsurance. The information about these drugs is available in the quarterly Average Sales Price (ASP) public file.
For additional information on these reductions, you can view a CMS Fact Sheet here: https://www.cms.gov/files/document/fact-sheet-part-b-rebatable-drug-coinsurance-reduction.pdf.
Proposed AMA Modification to Stark Law and the In-Office Exemption
In June, the American Medical Association (AMA) House of Delegates (HOD) proposed a modification to the Stark Law related to the delivery of medicine to patients (Resolution 246). The AMA requests that the Center for Medicare & Medicaid Services (CMS) retract its determination that certain delivery methods violate the in-office exception of the Stark Law. The AMA advocates for legislation to clarify that surrogates can deliver medicine dispensed at a physician-owned pharmacy without violating the Stark Law. LUGPA is working with other urology and independent practice organizations to monitor the proposed modification.
CMS Releases Equity-Related Data Briefs for Medicaid and CHIP
In June, CMS released five data briefs focusing on equity-related factors in the Medicaid and Children's Health Insurance Program (CHIP) populations, addressing disparities in access to care. The briefs cover topics such as race and ethnicity, disability-related eligibility, primary language, and rural residency. The briefs are part of a larger CMS effort to measure disparities in access to care and improve health equity for Medicaid and CHIP beneficiaries. The briefs are listed below.
Making Care Primary (MCP) Model Announcement
In June, CMS announced the launch of the Making Care Primary (MCP) Model, a primary care model being tested in eight states, aiming to improve care for Medicare and Medicaid beneficiaries. The model aims to improve care for Medicare and Medicaid beneficiaries by equipping primary care clinicians with tools to form partnerships with specialists and address patients' health and social needs. The MCP model will support care transformation across payers and prioritize reducing disparities in care and improving patient outcomes. Participating states include Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina, and Washington.
For more information, review the detailed official press release.
To view the MCP webpage, visit https://innovation.cms.gov/making-care-primary.
To view a model key highlights video, visit https://youtu.be/8vy3PHHlCe4.
Policy Brief: Financial Toxicity
The rapid rise in healthcare costs and the increasing burden this imposes on American patients and their families is increasingly being recognized. Regulatory changes associated with the ACA have allowed a gradual cost-shifting from insurance to patients as the cost of care has increased; the rising burden of those related expenses on patients during and even after treatment is a pervasive problem with serious implications for patients across all types of conditions.
The consequences of healthcare debt are often felt by patients facing cancer treatment, a long process that already places a complex physical and emotional burden on patients and their families. A new term for the financial burden created by medical debt has gained increasing parlance in the academic literature and the press: financial toxicity.
LUGPA believes that providers must act to address this growing problem or risk having legislative changes to control expenditures and modifying physician behavior thrust upon them. This Policy Brief examines the issue of financial toxicity, and possible reforms lawmakers and providers can consider to address the issue.
Senators Taking a Closer Look at the 340B Program
In late June, a bipartisan group of Senators sent a letter to stakeholders seeking feedback on ways to improve the 340B program. In the letter, the senators request input on bipartisan policy solutions that would create improved stability and transparency in the 340B program, allowing it to achieve its original intent of supporting entities serving eligible patients. A copy of the letter is available here: https://www.capito.senate.gov/download/06-16-2023-340b-letter.
340B is one of LUGPA’s top legislative policy priorities. We will monitor this group’s efforts and respond when appropriate.
LUGPA Works with ZERO Prostate on California Screening Legislation
In June, LUGPA began a new collaboration with ZERO Prostate Cancer on advocacy and health care policy. We posted a news story on ZERO’s PSA Screening for HIM on the LUGPA website, and we are now working with ZERO to sign on to new Texas and California screening legislation. The California bill has unanimously advanced out of its initial committee, the Senate Health Committee.
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