Biden Administration Rescinds Trump Administration Insulin …
Oct 26, 2021 · One of the final healthcare actions made by the Trump Administration has been rescinded by the Biden Administration. On December 23, 2020, the Trump Administration finalized a rule that directed the Department of Health and Human Services (HHS) to take action to require that federally qualified health centers (FQHCs) make insulin and injectable epinephrine available to certain patients at 340B ...
DaVita Reaches $34 Million False Claims Act Settlement
Sep 12, 2024 · DaVita has agreed to pay more than $34 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce referrals to DaVita Rx, a former subsidiary that provided pharmacy services for dialysis patients, and by paying kickbacks to nephrologists and vascular access physicians to induce …
PhRMA Announces Updated Code on Interactions with Health …
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released its updated Code on Interactions with Health Care Professionals, a voluntary code of ethics that applies to pharmaceutical company interactions with United States health care professionals. As a member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the PhRMA ...
Summary of Section 1557 of the Affordable Care Act ... - Policy
Jun 13, 2024 · The United States Department of Health and Human Services (HHS) has issued a final rule under Section 1557 of the Affordable Care Act (ACA) to strengthen nondiscrimination protections and advance civil rights in healthcare. The new rule is effective July 5, 2024 and applies to all healthcare providers who bill Medicare, Medicaid or see patients who are insured through a ACA exchange plan.
Physician Payments Sunshine Act Final Rule: Quick Reference Guide
Feb 13, 2013 · We posted several stories analyzing the various aspects of the Final Rule to implement the Physician Payments Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA). In light of the significant complexity the rule presen
FDA Releases Draft Guidance on Randomized Controlled Drug …
Nov 1, 2024 · Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry.The guidance is intended to support the conduct of randomized controlled drug trials (RCTs) with streamlined protocols and procedures, with an emphasis on essential data collection ...
CMS Updates Guidance on Sunshine Act Reporting Thresholds for …
Jan 25, 2021 · At the end of 2020, the Centers for Medicare and Medicaid Services (CMS) issued updated guidance on the thresholds that require an Applicable Manufacturer or Group Purchasing Organization to report under the Sunshine Act. Under the new guidance, if an Applicable Manufacturer or Group Purchasing Organization spends $11.05 or more on a “Reportable Activity” for any Covered Recipient from ...
How Are Insurers Treating the $2M Drug, Zolgensma?
Oct 9, 2019 · For example, one of the nation’s largest private insurers, Anthem, sets out six months as the maximum age at treatment and stipulates covered infants must either show symptoms before then or have at most two copies of a related gene called SMN2, which produces a less effective, “back-up” form of SMN protein. Neither of those additional criteria are included in the FDA’s label.
ACA Section 1557: A Comprehensive Overview for Healthcare …
Jul 10, 2024 · On a recent evening, the Medical Society of New Jersey and Policymed.com hosted a pivotal webinar to discuss the 2024 final rule for ACA Section 1557.This regulation, which came into effect on July 5, 2024, addresses non-discrimination in healthcare and poses significant implications for healthcare providers.
New York is the Latest State to Allow Full Practice Authority for …
May 25, 2022 · On April 11, 2022, New York Governor Kathy Hochul signed the state budget into law, which includes reforms surrounding services that health care workers are allowed to provide and will allow nurse practitioners full practice authority.New York joined with 24 other states, the District of Columbia, and two United States territories in adopting full practice authority legislation.