CLE Regulatory Submissions & Approvals 2 — Questions and Answers
Question 1: Under FDA regulations, electric breast pumps are classified as which type of medical device?
- Class I (general controls only)
- Class II (special controls and 510(k) clearance) (Correct answer)
- Class III (premarket approval)
- Unclassified consumer product
Correct answer: Class II (special controls and 510(k) clearance)
Electric breast pumps are Class II medical devices requiring 510(k) premarket notification demonstrating substantial equivalence to a predicate device.
Question 2: Which federal law requires employers with 50 or more employees to provide reasonable break time and a private space for nursing mothers to express milk?
- Family and Medical Leave Act (FMLA)
- Break Time for Nursing Mothers Act under the FLSA (Correct answer)
- Affordable Care Act Section 4207
- Pregnancy Discrimination Act
Correct answer: Break Time for Nursing Mothers Act under the FLSA
The Break Time for Nursing Mothers Act, an amendment to the Fair Labor Standards Act (FLSA), mandates break time and private space for up to one year after birth.
Question 3: A hospital seeking Baby-Friendly designation must submit evidence of compliance with all Ten Steps. Which agency administers this designation in the United States?
- The Joint Commission (TJC)
- Baby-Friendly USA (BFUSA) (Correct answer)
- American Academy of Pediatrics (AAP)
- Centers for Disease Control and Prevention (CDC)
Correct answer: Baby-Friendly USA (BFUSA)
Baby-Friendly USA is the accrediting body authorized by WHO/UNICEF to administer the Baby-Friendly Hospital Initiative in the United States.
Question 4: When submitting a new lactation support program proposal to a hospital's Institutional Review Board (IRB), which factor most determines whether full board review is required?
- Program cost exceeds $10,000
- More than 20 participants are enrolled
- Research involves greater than minimal risk to subjects (Correct answer)
- Program involves non-licensed educators
Correct answer: Research involves greater than minimal risk to subjects
IRB full board review is triggered when research involves greater than minimal risk to participants, regardless of cost or enrollment size.
Question 5: Under HIPAA, which of the following disclosures of a breastfeeding patient's health information does NOT require written authorization?
- Sharing records with a lactation product company for marketing
- Disclosing to treatment team members involved in her care (Correct answer)
- Providing information to her employer's wellness program
- Selling de-identified data to a research consortium
Correct answer: Disclosing to treatment team members involved in her care
HIPAA's Treatment, Payment, and Healthcare Operations (TPO) exception allows disclosure to treating providers without patient authorization.
Question 6: Which ICD-10-CM code category is primarily used to document lactation difficulties for billing and regulatory reporting purposes?
- O91 – Infections of breast associated with childbirth
- O92 – Other disorders of breast and lactation (Correct answer)
- Z39 – Encounter for maternal postpartum care
- P92 – Feeding problems of newborn
Correct answer: O92 – Other disorders of breast and lactation
ICD-10-CM category O92 covers disorders including cracked nipple, retracted nipple, agalactia, hypogalactia, and other lactation problems.
Question 7: A lactation educator submitting documentation to a third-party payer for reimbursement should use which CPT code for individual lactation counseling provided by a non-physician?
- 99401 – Preventive medicine counseling
- S9443 – Lactation classes, per session (Correct answer)
- 97802 – Medical nutrition therapy
- T1015 – Comprehensive multidisciplinary evaluation
Correct answer: S9443 – Lactation classes, per session
CPT code S9443 is the designated code for lactation classes per session and is commonly used by non-physician lactation providers billing third-party payers.
CLE Regulatory Submissions & Approvals 2
Under FDA regulations, electric breast pumps are classified as which type of medical device?