CMS Enforcement With Respect to Issuers and Non-Federal Governmental Plans—Civil Money Penaltiesdoi:CFR 2021 TITLE45 VOL2 Subtitle A SUBCHAPTER B PART 150 Subpart C
total, barring exceptional circumstances. The failure to follow this roadmap promptly and in good faith may expose a provider or supplier to allegations of liability under the False Claims Act and Civil Monetary Penalties Statute. Depending on the complexity of the issue, ...
CMS further emphasized that restatements outside the 12-quarter window would not be permitted if due to a change of ownership. For manufacturers “concerned with liability associated with the prices or pricing metrics used by the selling manufacturer,” CMS advised...
The termination date is the earlier of the first day that the Selected Drug is no longer a Selected Drug or the date that the Agreement is terminated by either party. Participating manufacturers may be subject to civil monetary penalties and an excise “tax,...
are fully informed and in control,TPMOs must keep a record of all prior express written consents obtained. These records must be maintained and made available for CMS review upon request. Failure to maintain these records can result in significant civil monetary penalties and other enf...
If the carrier fails to report ORM and/or TPOC/Settlements timely, the carrier may be fined for Civil Monetary Penalties starting in April of 2025 as described ina previous blog. If attestations are not timely delivered to CMS for WCMSA’s, Medicare may deny injury-related treatment until ...
At the end of 2018, the Health Resources and Services Administration announced[11]it would move the effective date of its final rule to implement civil monetary penalties for manufacturers who knowingly and intentionally overcharge a 340B-covered entity beyond the ceiling price for covered drugs to...
EMTALA violations can result in civil monetary penalties, civil enforcement, a hospital's termination from Medicare or a physician's exclusion from Medicare and Medicaid. In addition to providing new educational resources to the public, HHS and CMS plan to provide hospitals and provider associa...
vaccine mandate could result in termination from the Medicare and Medicaid programs, according to the latest guidance. Nursing homes, which are required to implement a vaccine mandate policy under a separate rule, are also subject to civil monetary penalties and claim denials if they d...
("Stark Law"), the federal anti-kickback statute ("Anti-Kickback Statute"), and certain provisions of the civil monetary penalties law ("CMP Law"), to arrangements pursued by accountable care organizations ("ACOs") participating in the Medicare Shared Sav...