As proposed in 428.302(c)(4), CMS would grant a reduction in the rebate amount owed if a manufacturer of an eligible drug submits to CMS a request in writing demonstrating that (1) a severe supply chain disruption has occurred during the applicable period, (2) the severe supply chain disruption directly affects the manufacturer itself, a supplier of an ingredient or packaging, a contract manufacturer, [596] or a method of shipping or distribution that the manufacturer uses in a significant capacity to make or distribute the generic Part D rebatable drug or biosimilar, and (3) the severe supply chain disruption was caused by a natural disaster or other unique or unexpected event

This includes areas that may increase the risk of a patient leaving care prematurely, such as unmet mental health or other disability, medical and oral health needs, the need for culturally supportive care that addresses race, ethnicity, sexual orientation, religion or gender identity, and social determinants of health, such as housing and transportation, that may pose barriers to treatment engagement, or harm reduction and recovery support service needs. New changes to the ( definition of initial assessments now include patient-centered language regarding the need for care plans to include the patient's goals and mutually agreed-upon actions for the patient to meet those goals, and new references are added for harm reduction interventions and recovery support services to be included as components of care plans if a patient needs and wishes to pursue these services
Men who smoke have a higher risk of erectile dysfunction
Li KJ, Chen ZL, Huang Y, Zhang R, Luan XQ, Lei TT, et al
This one is a little different from that one, however