Advocacy Update

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September 15, 2020

In this Issue:

CAP Convinces HHS to Make Substantial Changes to its COVID-19 Lab Reporting Rules

The Department of Health and Human Services (HHS) responded to the CAP’s advocacy by giving laboratories additional relief and more flexibility to meet new COVID-19 data reporting requirements during the current pandemic. Top agency officials stated during a presentation on September 9 that the government would only penalize laboratories for failing to report positive or negative test results and laboratories would further receive a three-week grace period to meet new rules.

Prior to the CAP’s engagement on this issue, laboratories had faced burdensome data requirements—some of which were impossible for laboratories to meet—and stiff penalties for failure to comply to the new rules. The CAP had called the original reporting rules unworkable and strongly opposed penalties the HHS sought to impose on those that do not meet the COVID-19 data reporting requirements.

Read an FAQ document developed by the CAP to answer additional questions about what’s required for laboratories.

The HHS responded to the CAP’s requests for clarification and stated that its policy “provides extensive guidance regarding other information, such as data transmission and reporting language via Logical Observation Identifiers Names and Codes and Systemized Nomenclature of Medicine that, at this time, is not regulatory.” Laboratories are still strongly encouraged to implement those elements. However, the HHS will only enforce whether laboratories are reporting COVID-19 positive or negative results to their respective public health departments.

The beginning of the three-week grace period is retroactive to September 2. The CAP remains engaged with HHS on implementation of the reporting requirements.

CAP Advocacy Win: CMS Increased Payment to Hospitals for CAR T-Cell Therapies

Because of CAP advocacy, the CMS increased Medicare payments to hospitals that administer chimeric antigen receptor (CAR) T-cell treatments. On September 2, the Centers for Medicare & Medicaid Services (CMS) announced the increase as part of its release of the final 2021 Inpatient Prospective Payment System (IPPS).

The CMS increased CAR T-cell payments by creating a Medicare Severity-Diagnosis Related Group (MS-DRG) pay rate that excludes clinical trial cases and unusually low hospital charges from the pay rate calculation. The CAP supported the proposal to exclude clinical trial data. Additionally, the CAP urged the CMS to reconsider its payment methodology and increase the hospital reimbursement for CAR-T cell therapies for inpatient services.

In the final 2021 regulation, the CMS finalized a market-based MS-DRG relative weight methodology that will begin in 2024 and will utilize market-based data collected on hospital cost reports beginning with reports ending on or after January 1, 2021. The CAP urged the CMS to not move forward with its proposed market-based MS-DRG relative weight proposed data collection and potential change in the calculation methodology. Initially, the CMS had proposed to tie all third-party payer rates to what Medicare’s fee-for-service inpatient payments, but was persuaded by the CAP to “take a more measured approach when adopting a market-based MS-DRG relative weight methodology.” For now, the CMS will only use Medicare Advantage plans’ negotiated payment rate data. The CMS will not use all private payer rate information as proposed, to calculate Medicare’s fee-for-service inpatient payment rates starting in fiscal year 2024.

Attention CLIA-Certified Labs: HHS Requests Information on COVID-19 Testing, Surge Capacity

To increase COVID-19 diagnostic testing capacity nationwide, the HHS wants to know about CLIA-certified laboratory testing capabilities. On September 10, the HHS asked CLIA-certified laboratories if they can provide additional COVID-19 testing if other testing instruments and equipment were available. Laboratories must respond and provide input by 5 PM ET on September 21.

To expand diagnostic testing capacity and prepare for a surge in COVID-19 testing, the HHS requested information from laboratories on their current ability to feasibly provide additional testing capabilities if supplementary testing instruments and reagents from Thermo Fisher Scientific were made available. Because the HHS has sought to expand testing significantly, responses from CLIA-certified laboratories that propose substantial increases in capability and should provide adequate justification.

Recent survey data collected by the CAP has shown laboratories have increased their testing capacity. Still the laboratories could do more if testing supply shortages were fixed and they had all the necessary supplies. For instance, 64% of laboratory directors responding to the survey reported difficulty acquiring reagents for platforms/test kits to conduct COVID-19 testing.

Pennsylvania Pathologists, CAP Seek Changes to Balance Billing Legislation

The Pennsylvania Association of Pathologists (PAP) and the CAP joined a state provider coalition to oppose State House Bill 1862, the Surprise Balance Billing Protection Act. Pennsylvania is an example of a state where its pathology society and the CAP have partnered to advocate on the issue of out-of-network billing to further protect patients from surprise medical bills while ensuring access to physician services.

While the provider coalition supports efforts to take consumers out of these billing disputes, the legislation would diminish access to care and compound the financial challenges currently facing all providers, wrote coalition chair Erik Kochert, MD, in a letter to the PA State House leadership. However, if the measure is amended, it could serve as an appropriate vehicle for ending surprise medical billing in the state, he says.

According to models developed by the Congressional Budget Office, HB 1862 in its current form would result in an overall 20% payment reduction to both in-network and out-of-network providers. The measure would unilaterally mandate the median of the insurer’s in-network rate as the payment for all out-of-network providers with no realistic recourse, such as an arbitration process or other type of independent dispute resolution.

The Pennsylvania provider coalition has consistently opposed state-mandated rate setting, instead supporting key elements that have been enacted in balance billing laws passed in Maine, New York, Texas, New Jersey, and Florida. Those elements include providing consumer protection from surprise medical bills; offering a range of payment options or a market-based system that is transparent and adjusted for inflation; ensuring an independent dispute resolution process and respecting free-market principles and limiting the government’s role in setting rules and rates for the market.

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