Blog/ Healthcare regulations
RN 465: what changed
Understand the updates to the rule that governs the list of covered procedures, including coverage of outpatient injectable therapies and expanded newborn screening tests, ensuring payers’ regulatory compliance
- By
- Rivio, Editorial team
- Published
- Reading time
- 2 minutes
Brazil’s National Supplementary Health Agency (ANS) has published Normative Resolution (RN) No. 575, which amends parts of RN No. 465/2021, the rule that governs the List of Health Procedures and Events in Private Healthcare. The update adds a new medication and expands a utilization guideline (DUT) related to newborn screening.
Here is what changed:
1. Inclusion of epoetin alfa as an outpatient injectable drug therapy (with a DUT)
RN 575 makes coverage of the drug epoetin alfa mandatory for adult patients with Low-Risk Myelodysplastic Syndrome, with symptomatic anemia (Hb ≤ 10 g/L) and before the onset of transfusion dependence.
The indication is now included in Utilization Guideline (DUT) No. 158 in Annex II of RN 465/2021.
2. Expanded DUT for the acylcarnitine test (tandem mass spectrometry)
The rule amends DUT No. 2, establishing mandatory coverage of the acylcarnitine test (qualitative and/or quantitative) for:
-
Suspected clinical cases (hypoketotic hypoglycemia, neurological deterioration, Reye’s syndrome, cardiomyopathy of undetermined cause, myopathies and neuromuscular).
-
Asymptomatic patients with risk factors (family history, unexplained sudden death, previous pregnancy with HELLP or acute fatty liver).
-
Newborn screening for early detection of MCADD (medium-chain acyl-CoA dehydrogenase deficiency).
Effective date and availability
The ANS sets out the changes above in Normative Resolution No. 575, which took effect on March 10, 2023.
It is important for the auditor and the team to always stay up to date in order to provide mandatory coverage and remain in compliance with the legislation in force.
