State and federal updates for pathology and laboratory clients: New York, California, PAMA
New York’s Patient Consent and Payment Laws
On October 20, 2024, several amendments to New York State law will take effect and, for pathology and laboratory providers who operate in the State of New York or are licensed by the State of New York, these amendments may require modifications to existing protocols.
New Section 18-c of New York Public Health Law requires all health care providers to obtain separate consents from patients for treatment and for payment. This section requires that the consent to pay for any health care services by a patient cannot be given until after discussing treatment costs with the patient and after the patient receives the services. Obviously this new amendment creates many complications for health care providers. Not only do many providers currently use a combined consent for both treatment and payment, other federal and state laws as well as payer requirements mandate that the patient consent to pay for non-covered health care services before the services are provided. For example, the Medicare program requires providers to obtain an Advance Beneficiary Notice from the Medicare beneficiary in advance of providing the services. If such an Advance Beneficiary Notices is not obtained in advance of providing the services, the providers are prohibited from billing the Medicare beneficiary from the non-covered services. The state Medicaid program has a similar requirement, as do most private payers. Section 18-c of the New York Public Health Law has generated considerable concern across the health care industry, and it is anticipated that intense lobbying efforts may result in modifications to the law or a delay in implementation.
Additionally, New York General Business Law Section 519-a will prohibit health care providers from requiring credit card preauthorization or keeping a credit card on file as a condition of delivering emergency or medically necessary services. Health care providers also must inform patients about the risks of using credit cards for medical payments. The New York State Department of Health has not yet provided a sample notice that can be utilized by health care providers, although it is anticipated that the Department of Health will prepare one in the future.
California Remote Interpretations
The Governor of California signed AB2107 at the end of September. This measure, sponsored by the California Society of Pathologists, is intended to authorize pathologists to provide interpretations of digital images at remote locations under the primary laboratory’s CLIA certificate. This new law will require the California Department of Public Health to consult with the Centers for Medicare and Medicaid Services (the agency that implements the CLIA program) by the end of June 2025 and then determine by December 2025 whether pathologists in California may perform such remote interpretations of digital images. California is the only state in the country that does not clearly recognize the current CLIA position that remote interpretations may be performed consistent with federal law. To date, the California Department of Public Health has taken the position that only a change in the federal law will authorize such remote review.
One Year PAMA Delay
Late last month, Congress passed another one-year delay in PAMA cuts, delaying the Medicare payment cuts of up to 15% for laboratory services that were scheduled to become effective in January 2025. This is a one-year reprieve until 2026. Data reporting has also been delayed until 2026. This is the sixth time that data reporting has been delayed by congressional action, and the fifth time that Congress has delayed Medicare payment cuts for services under PAMA.
For questions, contact one of the McDonald Hopkins healthcare attorneys listed below.
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Elizabeth Sullivan |
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Emily Johnson |
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Jane Pine Wood |
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Patrick Campbell Associate, Healthcare Practice Group pcampbell@mcdonaldhopkins.com 216.348.5405 |
