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The proposed rule from the Department of Health and Human Services aims to amend regulations related to the exclusion of individuals and entities from Federal health care programs to prevent fraud and abuse. It reflects changes made by the Medicaid Services Investment and Accountability Act of 2019, involving exclusion authorities for misclassification and false information about outpatient drugs. The rule also proposes updates to the Office of Inspector General's procedures and clarifications on factors influencing the length of exclusions and conditions for reinstatement. Public comments are open until January 31, 2025, and can be submitted electronically or by mail.

The Health and Human Services Department has issued a final rule updating the standards for electronic transactions in retail pharmacies under HIPAA. The rule adopts modifications to improve data exchange, enhance patient safety, and streamline processes, like replacing several free text fields with specific data fields. These changes include implementing the NCPDP Telecommunication Standard Implementation Guide, Version F6, and the NCPDP Batch Standard Subrogation Implementation Guide, Version 10, specifically for Medicaid agencies. The new standards are set to take effect beginning February 11, 2028, with compliance required 36 months after the final rule's publication, including an 8-month transition period to ease the changes.

The Internal Revenue Service (IRS) has proposed new rules to manage an excise tax on the sale of certain designated drugs by manufacturers, producers, and importers. These regulations detail how the tax will be applied and calculated, particularly focusing on sales during specific periods defined by law. The proposed rules include definitions of terms like "manufacturer" and "sale," guidelines for identifying sales subject to the tax, and methods for calculating the tax amount. The rules aim to ensure that the tax is assessed fairly and are seeking public comments and possible requests for a hearing by March 3, 2025.

The Treasury Department and Internal Revenue Service (IRS) have issued new regulations to clarify the definition of a "coverage month" for calculating the Premium Tax Credit (PTC). Starting in 2025, these rules ensure a month is considered a coverage month even if the full premium isn't paid, provided certain conditions are met. This applies in cases such as grace periods, state emergency orders, or meeting a premium payment threshold. The regulations aim to enhance reporting consistency across exchanges, impacting taxpayers who receive health insurance via the Health Insurance Exchange.

The Railroad Retirement Board (RRB) is seeking public comments on their proposed changes to several forms related to the collection of information on annuities for employees, survivors, and individuals with disabilities under the Railroad Retirement Act. These changes include updates to the instructions and questions on the forms, aimed at improving clarity and ensuring the information accurately reflects the applicants' current situations, such as daily activities and work history. The RRB encourages feedback on the practical use of these forms and ways to reduce the paperwork burden on respondents. Comments should be sent to the Board or the Office of Management and Budget (OMB) within 30 days of the notice's publication.

The U.S. Department of the Treasury is submitting various information collection requests to the Office of Management and Budget for review, inviting public comments before April 28, 2025. These collections cover topics such as third-party documentation for tax credits, reporting distributions from medical savings accounts, and reporting requirements under the Foreign Account Tax Compliance Act (FATCA). Some forms, like Form 1099-SA and Forms 1099-LS and 1099-SB, are used to report financial transactions related to health accounts and life insurance contracts. The aim is to ensure compliance with tax regulations and accurately assess tax benefits and obligations.

The Department of Health and Human Services (HHS) is updating an existing system of records, named Federal Advisory Committee/Subgroup Member, Subscriber/Registrant, and Guest Speaker Records. This update includes adding records about guest speakers at advisory committee meetings and changing the system's name. New routine uses for the records have been established, such as sharing limited information about guest speakers’ qualifications and financial interests. The update aims to enhance transparency and ensure compliance with federal advisory committee regulations. Comments on the new and revised policies are invited until January 27, 2025.

In the Federal Register notice titled "Ibrahim Al-Qawaqneh, D.D.S.; Decision and Order," the DEA sought to revoke Dr. Ibrahim Al-Qawaqneh's registration due to his exclusion from federal health care programs after pleading nolo contendere to a charge of offering unlawful Medi-Cal remuneration. Despite being given a chance to defend himself, the DEA found that Dr. Al-Qawaqneh failed to take full responsibility for his actions, which led to doubts about his trustworthiness. Consequently, his DEA Certificate of Registration was revoked to ensure compliance with laws regulating controlled substances.

The final rule from the Department of Justice and the Department of Health and Human Services allows Veterans Affairs (VA) practitioners to prescribe controlled substances to VA patients via telemedicine without needing an in-person medical evaluation by the prescribing practitioner. This is permissible if another VA practitioner has conducted an in-person evaluation. This change provides greater access to care for veterans, especially those in rural or underserved areas, while still implementing safeguards against the misuse of controlled substances. The rule includes requirements for reviewing the patient's electronic health record and state prescription drug monitoring program data before prescribing.

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have finalized a rule expanding the ability for practitioners to prescribe certain controlled substances for opioid use disorder (OUD) treatment through telemedicine, including audio-only calls. Under these new rules, practitioners can prescribe a six-month supply of these medications after reviewing the patient's prescription drug monitoring program data, with the possibility of extending prescriptions through telemedicine or after a face-to-face evaluation. Additional safeguards include identity verification by pharmacists before filling prescriptions to prevent misuse. The rule aims to continue the telemedicine flexibilities introduced during the COVID-19 pandemic while addressing the opioid crisis and concerns about substance misuse.