(May 8, 2020) – FDA Issues Policy for Manufacturers to Prevent Medical Device Shortages
The Food and Drug Administration issued guidance implementing section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers to notify FDA of a permanent discontinuance or significant interruption in the manufacture of certain medical devices to prevent or mitigate shortages during the COVID-19 emergency. FDA said the guidance aims to clarify and make recommendations regarding who must notify FDA, how, and what information to include in the notification.
CMS Announces Preview Period for July 2020 Publicly Reported Data
The preview period for hospitals to review July 2020 publicly reported data ends Wednesday, June 3. The preview period is applicable for hospitals and facilities participating in the following programs:
- Hospital Inpatient Quality Reporting
- Hospital Outpatient Quality Reporting
- Prospective Payment System Exempt Cancer Hospitals Quality Reporting
Additional details are available on QualityNet.
New AHA Resource Supports Patient and Provider Communication
A new resource from the American Hospital Association, Proactive Conversations that Support Providers and Patients, addresses the importance of identifying and documenting critical information about a patient’s language preference, emergency contacts, and advance directives to ensure patient communication and treatment preferences are understood and respected throughout the continuum of care. Additionally, the resource provides scripting for front-line staff to quickly and easily collect this critical information.
CMS Issues New Round of Changes to Support COVID-19 Response
Last week, the Centers for Medicare & Medicaid Services released a press release and background information regarding "another round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation's seniors and provide flexibility to the health care system as America reopens." The various changes fall under the categories of increasing hospital capacity, augmenting the health care workforce, reducing administrative burden and expanding Medicare telehealth services.
SAMHSA Updates TIP 63, Medications for Opioid Use Disorder
The updated treatment improvement protocol by the Substance Abuse and Mental Health Services Administration reviews the use of the three Food and Drug Administration-approved medications used to treat opioid use disorder: methadone, naltrexone and buprenorphine. It also discusses other strategies and services needed to support long-term recovery for community members who suffer with OUD.
This Week Is Maternal Mental Health Awareness Week
May 4-8 is Maternal Mental Health Awareness Week. Because of the COVID-19 pandemic, now more than ever mothers find themselves with competing full-time roles as childcare providers, educators and employees. According to the National Perinatal Association, maternal mental health disorders include anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorders, psychosis and postpartum depression.
The Centers for Disease Control and Prevention research reports one in eight women experience symptoms of postpartum depression. According to the American Academy of Pediatrics, postpartum depression and anxiety affect more than just the mother. It impairs parent-child interactions, affects infant growth and development, and can lead to overutilization of health care resources. The need for early identification of postpartum depression and anxiety is critical, and it begins with obstetrical care by physicians and providers, and continues throughout an infant's first six months of life. AAP recommends pediatricians include surveillance screenings in an infant's one-, two-, four- and six-month appointments, as they have the distinct opportunity to see the family unit continuously, and acts to enhance the dyad relationship.
The Office of Primary Care and Rural Health notes the following:
- Approximately one in four women develop depression during their lifetime. Depression is the leading cause of disease burden among women.
- Many women do not seek treatment due to cost, lack of awareness, not believing that treatment is necessary, lack of time, not knowing where to go for services and the stigma surrounding mental illness.
MLN Connects Provider eNews Available
The Centers for Medicare & Medicaid Services issued updates to MLN Connects Provider eNews. eNews includes information about national provider calls, meetings, events, announcements and other MLN educational product updates. The latest issue provides updates and summaries of the following:
- Inpatient Rehabilitation Facilitiy Prospective Payment System, FF
- CMS adds new COVID-19 clinical trials improvement activity to the Quality Payment Program
- Infection control guidance to home health agencies on COVID-19
- Medicare Diabetes Prevention Program: become a Medicare-enrolled supplier