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11 September 2023

New Final DEA And CMS FY 2024 Payment Rules

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The United States Drug Enforcement Agency ("DEA") recently published a final rule amending its regulations regarding the transfer of electronic prescriptions for schedules II–V controlled substances between...
United States Food, Drugs, Healthcare, Life Sciences
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DEA Finalizes Rules on Electronic CDS Prescriptions and Seeks Public Input on Telemedicine

The United States Drug Enforcement Agency ("DEA") recently published a final rule amending its regulations regarding the transfer of electronic prescriptions for schedules II–V controlled substances between registered retail pharmacies. Additionally, the DEA has announced a listening session for public input on controlled dangerous substance ("CDS") prescribing in telemedicine encounters.

The final rule (88 FR 48365) supplements the DEA's March 31, 2010 interim final rule ("IFR") regarding electronic prescribing of CDS. Specifically, this final rule amends DEA regulations to explicitly state that an electronic prescription for schedule II–V CDS may be transferred between retail pharmacies upon request from the patient. However, the transfer may only be made for the initial filling, on a one-time basis, and any authorized refills transfer with the original prescription. In addition, the final rule (i) establishes the information required for documenting such electronic CDS prescription transfers between pharmacies, (ii) clarifies the extent a pharmacy may use prescription processing software to capture information from an electronic prescription in lieu of manual data entry, and (iii) requires pharmacies to maintain records of the transfer for at least two years. The existing requirements for all prescriptions, as outlined in 21 CFR Part 1306, and for prescribing and pharmacy applications, as outlined in 21 CFR Part 1311, remain unchanged in this final rule.

The DEA also recently announced it will hold public listening sessions to receive public input concerning the prescribing of CDS via telemedicine. The focus of such sessions will be to discuss telemedicine safeguards for detecting and preventing diversion of CDS prescribed via telemedicine. The listening sessions will be held on September 12-13, 2023, from 9 a.m. to 5:30 p.m. at DEA Headquarters, 700 Army Navy Drive, Arlington, VA 22202.

Additional information regarding this final rule can be found here. Information regarding virtual attendance of the DEA's public listening sessions can be found here.

CMS Updates FY 2024 Prospective Payment System Changes

The United States Centers for Medicare & Medicaid Services ("CMS") recently published final rules updating its Fiscal Year ("FY") 2024 Prospective Payment System ("PPS") for certain inpatient facilities and services. Specifically, CMS has updated the FY 2024 PPS for skilled nursing facilities, inpatient rehabilitation facilities, inpatient psychiatric facilities, and hospice services.

Skilled Nursing Facilities

CMS's final rule (88 FR 53200) updating its FY 2024 Skilled Nursing Facility Prospective Payment System ("SNF-PPS") (i) updates various reimbursement rates for FY 2024, (ii) implements new ICD-10 code mapping for the Patient Driven Payment Model, (iii) updates the SNF Quality Reporting Program and SNF Value-Based Purchasing Program, and (iv) finalizes a constructive waiver process related to the handling of civil monetary penalty appeals. CMS estimates that the aggregate impact of the payment policies in this final rule will result in a net increase of 4.0% in Medicare Part A payments to SNFs in FY 2024. Additionally, pursuant to Section 4121(a)(4) of the Consolidated Appropriations Act, 2023, this final rule clarifies that Medicare will exclude marriage and family therapist ("MFT") services and mental health counselor services from SNF consolidated billing and instead allow these services to be billed separately by the performing clinician rather than being included in the Medicare Part A SNF payment.

The final rule becomes effective on October 1, 2023. A fact sheet summarizing this final rule can be found here.

Inpatient Rehabilitation Facilities

CMS's final rule (88 FR 50956) updating its FY 2024 Inpatient Rehabilitation Facility Prospective Payment System ("IRF-PPS") (i) updates the IRF-PPS payment rates, (ii) finalizes modifications to the IRF Quality Reporting Program "(IRF-QRP"), and (iii) modifies its IRF Excluded Unit Regulation. CMS estimates an overall 4.0% increase in FY 2024 IRF payments. Regarding the IRF-QRP, this rule readjusts the program's quality reporting measures for FY 2024 in anticipation of enforcing the new quality metrics beginning in FY 2025. Moreover, under this rule, CMS is modifying regulations governing the exclusion of hospital units to allow hospitals to open a new IRF unit and begin being paid under the IRF-PPS at any time during the cost reporting period.

The final rule becomes effective on October 1, 2023. A fact sheet summarizing this final rule can be found here.

Inpatient Psychiatric Facilities

CMS's final rule (88 FR 51054) updating its FY 2024 Inpatient Psychiatric Facility Prospective Payment System ("IPF-PPS") (i) updates the IPF-PPS payment rates, (ii) finalizes modifications to the IPF Quality Reporting Program "(IPF-QRP"), and (iii) modifies its IPF Excluded Unit Regulation. CMS estimates an overall 2.3% increase in FY 2024 IPF payments. Regarding the IPF-QRP, this rule readjusts the program's quality reporting measures for FY 2024 in anticipation of enforcing the new quality metrics beginning in FY 2025. Similar to the above rule on rehabilitation facilities, under this rule, CMS is modifying regulations governing the exclusion of hospital units to allow hospitals to open a new IPF unit and begin being paid under the IPF-PPS at any time during the cost reporting period.

The final rule becomes effective on October 1, 2023. A fact sheet summarizing this final rule can be found here.

Hospice Services

CMS recently published a final rule (88 FR 51164) updating its FY 2024 Medicare payments related to hospice services. Specifically, this rule (i) updates the FY 2024 Medicare payment rate for hospice services, (ii) updates various aspects of the hospice quality reporting program (HQRP), and (iii) updates regulations regarding enrollment for hospice-certifying physicians. CMS estimates an overall 3.1% increase in FY 2024 Medicare payments for hospice services. Regarding the HQRP, CMS has codified several updates regarding quality measures, including the HQRP data completion threshold policy, at 42 C.F.R. §418.312. Under this rule, CMS also implemented several updates aimed at developing future HQRP health equity measures.

Importantly, under this rule, CMS is updating its payment requirements for hospice-certifying physicians. In order for a patient to receive hospice services, Medicare requires a patient's terminal condition to be certified by either (i) the hospice medical director or the physician member of the hospice interdisciplinary group or (ii) the patient's attending physician. Under this rule, hospice-certifying physicians must either enroll in Medicare, or affirmatively opt out of Medicare, in order for hospice services to be paid by CMS.

The final rule becomes effective on October 1, 2023. A fact sheet summarizing this final rule can be found here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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