The Daily Scan

October 9, 2018

Last Updated: 1:00 PM EST

Medicare & Medicaid

  • CMS has proposed new regulation related to quality assurance in long-term care facilities. The first proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. A second proposed rule would fully enforce Section 1150B requirements for reporting crimes to nursing home residents, we are proposing a regulation that will allow Civil Money Penalties (CMPs) to be imposed of up to $200,000 against covered individuals (staff, volunteers, etc.) who fail to report reasonable suspicion of crimes. This proposed regulation would also facilitate a 2-year exclusion for retaliating against individuals who report. Although CMS has the authority to impose CMPs against nursing homes, rule-making is required to facilitate CMPs and exclusions imposed against covered individuals. (CMS.gov)

Litigation

  • The Office of Inspector General of the Department of Health and Human Services has confirmed that the state of Wisconsin made 1,654 capitation payments totaling $589,478 on behalf of deceased beneficiaries. Caseworkers in Wisconsin did not always receive notification that beneficiaries had died or did not correctly input the dates of death (DODs) in the system resulting in these payments of $374,822 of Federal share dollars. OIG recommends that the State agency (1) recover unallowable payments totaling $589,478 from MCOs and refund $347,822 to the Federal Government; (2) identify and recover capitation payments made on behalf of deceased beneficiaries before and after our audit period, and repay the Federal share of amounts recovered; and (3) strengthen its policies and procedures for identifying deceased beneficiaries and correctly entering DODs in the Client Assistance for Reemployment and Economic Support system to ensure that DODs are recorded in a timely manner to prevent unallowable payments. (OIG.HHS.gov)

Research

  • A national poll of 1,200 randomly selected adults conducted in July by the Kaiser Family Foundation for an in-depth story published today in Kaiser Health News found that 26 percent of millennials (born between 1981 and 1996) said they did not have a primary care provider. Additionally, there was a pronounced difference in responses among millennial age groups: 45 percent of 18- to 29-year-olds had no primary care provider, compared with 28 percent of those 30 to 49. Dr. Ateev Mehrotra, an internist and associate professor in the Department of Health Care Policy at Harvard Medical School commented: "There is a generational shift. These trends are more evident among millennials, but not unique to them. I think people’s expectations have changed. Convenience [is prized] in almost every aspect of our lives," from shopping to online banking. (KHN.org)

Regulation

  • Today, FDA Commissioner Scott Gottlieb, M.D. announced a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS). Gottlieb commented: "The increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions. TDS products are applied to a patient’s skin and deliver the drug into and through the skin. Because of the inherent complexity of delivering a drug through a TDS, making generic copies of these complex drugs can be especially hard. As a result, many branded TDS products like drug patches have not faced timely generic competition. The new guidances we’re releasing include the revised draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, which provides updated advice for the design and conduct of studies evaluating the adhesive performance of a proposed generic TDS. A second draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed generic TDS. In addition to these documents, the FDA is also issuing 25 product-specific guidance documents. These include two new and 23 revised guidances." (FDA.gov)

 

 

 

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