CMS proposes rule cutting Medicare and Medicaid administrative requirements
Proposed changes would affect hospitals, critical access hospitals, nursing facilities and intermediate care facilities. The rule defines birth tissue and seeks comment on hospital collection assumptions.
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The Centers for Medicare & Medicaid Services published a proposed rule in the Federal Register on Nov. 10. The notice is titled "Medicare and Medicaid Programs; Cutting Administrative Requirements for Excellence in Patient Care." The title indicates that the proposed changes are intended to cut administrative requirements for patient care.
According to the notice, the proposed rule would revise the conditions of participation that hospitals and critical access hospitals must meet. A definition of the term "birth tissue" appears in the text. CMS wrote that it chose that term because tissue establishments and the hospitals they contract with already know it. The agency explained that its definition includes amniotic fluid. At the same time, CMS acknowledged that the Food and Drug Administration generally does not consider amniotic fluid to be a human cell or tissue product. The agency's definition encompasses amniotic fluid, a point on which it differs from the FDA's general approach.
For the proposed condition of participation, CMS said it would regulate how facilities interact with patients. It would also cover policies, documentation, and processes for informed decision-making and the safe release of birth tissues. The proposed condition of participation would govern these aspects of facility operations. The agency stated that it assumes all hospitals and critical access hospitals with obstetric services will offer tissue collection. CMS is seeking comment on that assumption, according to the notice.
In the section on nursing facility and intermediate care facility services, CMS said the proposals are specific to those institutional services. The agency may refer to them collectively as "institutional services." CMS wrote that it will not call them "long-term care facilities" because that term is not commonly used for intermediate care facilities serving people with intellectual disabilities. The proposed rule references studies on nursing home staff turnover, infection control citations, and COVID-19 prevention practices. It also states that only 2 percent of nursing facilities were Medicaid-certified only in 2020, according to the Congressional Research Service.
Sources: Federal Register
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