CMS Invites Public Comments on Cesarean Birth (PC-02) eCQM

Public comments are invited on potential future inclusion of the Cesarean Birth (PC-02) eCQM (NQF #0471e) in the Hospital IQR Program. CMS is seeking public comment on any unintended consequences that might result from future adoption of this measure, as well as ways to address those potential unintended consequences. They note that they are also considering this measure for potential future inclusion in the Promoting Interoperability Program.

 

Document title: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals - A Proposed Rule by the Centers for Medicare & Medicaid Services on 05/03/2019

Cesarean Birth PC-02 ECQM proposed rule description is found on pp. 19492-4.

C. CESAREAN BIRTH (PC-02) ECQM (NQF #0471E)

(1) BACKGROUND

A Cesarean section (C-section) is the use of surgery to deliver a baby (or babies) in lieu of vaginal delivery. The procedure therefore entails surgical and anesthesia risks and requires mothers to undergo several days of inpatient, postoperative recovery. A C-section may occur on an emergency basis or elective basis.[528] Elective C-sections may be necessary due to preexisting medical conditions, such as high blood pressure (preeclampsia), other medical indications, or may be preferred for non-medical reasons. Non-medical reasons for elective C-section can relate to maternal preference, local practice patterns, fear of malpractice litigation, reimbursement anomalies, or other factors.[529 530 531]

The total rate of (emergency and elective) C-sections has risen since the 1990s in the United States.[532] C-sections Start Printed Page 19492accounted for about one-third of U.S. deliveries in 2016,[533] and there is a considerable amount of variation in the rates based on U.S. region, State, and healthcare institution.[534] U.S. practice guidelines have not indicated an optimal rate of C-section or an appropriate variance rate, but international studies suggest a preference for a lower range than current U.S. rates.[535 536 537] When medically justified, a C-section can effectively prevent maternal and perinatal mortality and morbidities. However, clinicians and consensus groups agree that increased C-section rates have not improved overall maternal-fetal outcomes and that C-sections are overused.[538 539] Below, we include literature outlining maternal and neonatal C-section outcomes.

For maternal outcomes, C-sections have significantly higher prenatal and postpartum morbidity and mortality (9.2 percent) than vaginal births (8.6 percent).[540] Existing literature largely does not distinguish whether inferior outcomes derive from cause (higher risk patients undergo C-section) or effect (surgery carries inherent risks due to anesthesia, bleeding, infection, postoperative recovery, etc.). However, taking an aggregate view of multiple studies over time, it appears that C-sections carry a higher risk of subsequent miscarriage, placental abnormalities, and repeat C-section.[541] Conversely, urinary incontinence and pelvic organ prolapse occur less frequently after C-section than after vaginal delivery.[542]

In terms of neonatal outcomes, C-sections have higher respiratory morbidity (1 to 4 percent) than vaginal births (<1 percent).[543] Children delivered by C-section also have a higher risk of asthma and obesity.[544] However, C-sections have better outcomes for shoulder dystocia (0 percent versus 1-2 percent).[545] Again, cause (high risk fetuses more likely to be delivered by C-section) versus effect (surgery increases risk to the fetus) remains epidemiologically obscure. The medical indications for C-section necessarily entail broad obstetrician discretion because of the need to: (1) Balance any conflicting medical conditions of mother versus fetus; and (2) balance C-section against any other competing clinical considerations or external constraints (for example, availability of operating room, personnel, and/or blood).

Furthermore, C-sections receive higher reimbursement than vaginal deliveries (typically about 50 percent more). Patient cost sharing may differ, depending upon insurance coverage. Insurance experiments suggest that higher cost sharing causes patients to consume less health care,[546] but that patients distinguish poorly between necessary and unnecessary services. The pervasive use of cesarean births carries economic impacts because C-sections are more expensive than vaginal deliveries and may be accompanied by adverse outcomes and complications which similarly have substantial cost implications.[547]

For these reasons, we are considering including the electronic version of PC-02 (NQF #0471e) in the eCQM measure set to enable hospitals to track C-sections and reduce unnecessary instances of C-sections.

 

(2) OVERVIEW OF MEASURE

The Joint Commission is the steward of the PC-02 measure, which assesses the rate of nulliparous women with a normal-term, singleton fetus in the vertex position (NTSV) undergoing C-section.[548] Nulliparous women are those who have never given birth. They have a lower risk during vaginal birth than do women who have undergone a previous C-section.[549 550] Full-term births have better outcomes than preterm births. Vertex presentations carry less risk than breach or transverse presentations.[551] However, this population still includes some patients with medical indications for elective C-section (for example, dystocia, chorioamnionitis, pelvic deformity, preeclampsia, fetal distress, prolapsed cord, placenta previa, abnormal lie, uterine rupture, macrosomia).[552] While the chart-abstracted and eCQM versions of PC-02 do not exclude those medical indications, extensive testing of the chart-abstracted version of the measure has shown that excluding them does not significantly increase a hospital's adjusted C-section rate, partially because the majority of these indications are rare in the NTSV population.[553]

Determining the NTSV C-section rate permits a hospital to compare its outcomes to other hospitals while focusing only on a lower-risk population. NQF has endorsed the chart-based form of this measure as a voluntary consensus standard since 2008.[554] NQF stated that decreasing the rate of unnecessary C-sections “will result in increased patient safety, a substantial decrease in maternal and neonatal morbidity and substantial savings in health care costs.” [555] Reducing the number of NSTV deliveries by C-section would also reduce the rate of repeat cesarean births.[556] We acknowledge that there are instances where C-sections are medically indicated, and we emphasize that this measure is not intended to discourage practitioners from performing C-sections when they are medically indicated. We believe that assessing the rate of NTSV C-sections may ultimately reduce the occurrence of non-medically indicated C-sections. We have encouraged hospitals whose measure rates are higher than rates at other hospitals to explore and evaluate differences in the medical and nursing management of women in labor.[557] Further, including this measure could help ensure that the Hospital IQR Program includes measures which are applicable to rural hospitals. The Rural Health Workgroup of the NQF's Measure Applications Partnership also identified the chart-abstracted version of PC-02 as a measure that holds particular relevance for rural hospitals, noting how important it is to focus on best practices in obstetric care in rural areas.[558]

The PC-02 eCQM was included in a publicly available document entitled “List of Measures Under Consideration for December 1, 2018.” [559] The MAP Coordinating Committee voted to conditionally support the PC-02 eCQM, citing the failure of the eCQM version of the measure to attain endorsement by the NQF as an area of concern.[560] The Coordinating Committee encouraged The Joint Commission to resubmit the eCQM version of PC-02 to the NQF for endorsement with additional clarifying data that has been collected since the previous attempt to attain endorsement. The MAP's Final Report of February 15, 2019, conditionally supports the PC-02 eCQM for rulemaking pending NQF evaluation and endorsement.[561] The MAP suggested feasibility testing, consultation with multiple stakeholders, and examination of unintended consequences.

 

(3) DATA SOURCES

Hospitals would provide data for this measure from their EHRs. Incorporating this eCQM would align with our goal to encourage greater use of EHR data for quality measurement.

 

(4) MEASURE CALCULATION

This measure assesses the rate of nulliparous women with a term, singleton baby in a vertex position delivered by cesarean birth. As the measure steward for both the chart-abstracted version of PC-02 (NQF #0471) and the eCQM version (NQF #0471e), The Joint Commission publishes a detailed methodology for its calculation.[562]

The measure's denominator consists of the number of nulliparous women with a singleton, vertex fetus at ≥37 weeks of gestation who deliver a liveborn infant. Its numerator consists of the subset delivering by C-section. The numerator includes women delivering by planned C-section due to obstetric indications and for other reasons.[563] This measure excludes patients with abnormal presentations or single stillbirth during the encounter, or patients with multiple gestations recorded less than or equal to 42 weeks prior to the end of the encounter.

The cohort consists of all patients in the denominator: Nulliparous women with a singleton, vertex fetus at ≥37 weeks of gestation who deliver a liveborn infant. The cohort includes all pertinent patients regardless of payer (for example, Medicare, Medicaid, other public programs, private insurance, self-pay, charity care) or admission source (for example, home, emergency department, nursing home, hospice, another hospital, law enforcement).[564] The cohort for a region, hospital, and practitioner may differ from the national rate because of higher medical indications for C-section.

 

(5) OUTCOME

The outcome of interest is the number of C-sections to nulliparous women with a term, singleton baby in a vertex position divided by all deliveries to nulliparous women with a term, singleton baby in a vertex position.[565]

This measure is not risk adjusted. The Joint Commission decided to exclude risk-adjustment from this measure based on careful consideration of a Technical Advisory Panel's recommendations and data that indicated the results adjusted by age were sensitive to low sample sizes and applying age as a risk factor only marginally impacted the outcome.[566] The Joint Commission removed all risk adjustments from this measure, effective with discharges beginning July 1, 2016.[567]

We are inviting public comment on potential future inclusion of the Cesarean Birth (PC-02) eCQM (NQF #0471e) in the Hospital IQR Program. We are specifically seeking public comment on any unintended consequences that might result from future adoption of this measure, as well as ways to address those potential unintended consequences. We note that we are also considering this measure for potential future inclusion in the Promoting Interoperability Program.

COMMENT HERE: https://www.regulations.gov/comment?D=CMS-2019-0073-0003

 

 

 

Citations:

528.  National Quality Forum, Quality Measure PC-02 (Cesarean Birth). Available at: https://www.qualityforum.org/QPS/MeasureDetails.aspx?standardID=291&print=1&entityTypeID=1.

529.  Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.

530.  Schifrin BS, Cohen WR. The effect of malpractice claims on the use of caesarean section. Best Pract Res Clin Obstet Gynaecol. 2013 Apr;27(2):269-83. doi: 10.1016/j.bpobgyn.2012.10.004. Epub 2012 Dec 1. Review.

531.  Chen CS, Liu TC, Chen B, Lin CL. The failure of financial incentive? The seemingly inexorable rise of cesarean section. Soc Sci Med. 2014 Jan;101:47-51. doi: 10.1016/j.socscimed.2013.11.010. Epub 2013 Nov 15.

532.  Osterman, M.J.K., Martin, J.A. (2014). Trends in Low-risk Cesarean Delivery in the United States, 1990-2013. National Vital Statistics Reports,63(6): 1-16.

533.  Martin, J.A., Hamilton, B.E., Osterman, M.J.K., Driscoll, A.K., Drake, P. (2018). Births: Final Data for 2016. National Vital Statistics Reports, 67(1): 1-55.

534.  Kozhimannil, K.B., Law, M.R. & Virnig, B.A. (2013). Cesarean delivery rates vary tenfold among US hospitals; reducing variation may address quality and cost issues. Health Affairs, 32(3): 527-35.

535.  National Collaborating Centre for Women's and Children's Health. (2011). Caesarean Section: NICE Clinical Guideline (commissioned by the United Kingdom National Institute for Health and Clinical Excellence).

536.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

537.  Keag, O.E., Norman, J.E. & Stock, S.J. (2018). Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. Plos Med, 15(1): e1002494.

538.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

539.  National Collaborating Centre for Women's and Children's Health. (2011). Caesarean Section: NICE Clinical Guideline (commissioned by the United Kingdom National Institute for Health and Clinical Excellence).

540.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

541.  Keag, O.E., Norman, J.E. & Stock, S.J. (2018). Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. Plos Med, 15(1): e1002494.

542.  Keag, O.E., Norman, J.E. & Stock, S.J. (2018). Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. Plos Med, 15(1): e1002494.

543.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

544.  Keag, O.E., Norman, J.E. & Stock, S.J. (2018). Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. Plos Med, 15(1): e1002494.

545.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

546.  Aron-Dine, A., Einav, L. & Finkelstein, A. (2013). The RAND Health Insurance Experiment, Three Decades Later. The Journal of Economic Perspectives, 27(1): 197-222.

547.  Kozhimannil, K.B., Law, M.R. & Virnig, B.A. (2013). Cesarean delivery rates vary tenfold among US hospitals; reducing variation may address quality and cost issues. Health Affairs, 32(3): 527-35.

548.  National Quality Forum, Quality Measure PC-02 (Cesarean Birth). Available at: https://www.qualityforum.org/QPS/MeasureDetails.aspx?standardID=291&print=1&entityTypeID=1.

549.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

550.  National Quality Forum, Perinatal and Reproductive Health 2015-2016 Final Report. Available at: http://www.qualityforum.org/Publications/2016/12/Perinatal_and_Reproductive_Health_2015-2016_Final_Report.aspx.

551.  American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. (2014). Safe prevention of the primary cesarean delivery. American Journal of Obstetrics and Gynecology, 210(3): 179-93.

552.  Mylonas, I. & Friese, K. (2015). Indications for and Risks of Elective Cesarean Section. Deutsches Arzteblatt International, 112(29-30): 489-95.

553.  Centers for Medicare & Medicaid Services. (2015). Cesarean Birth (PC-02) Measure Public Comment Summary. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/PC-02-Public-Comment-Summary-Memo.pdf.The PC-02 eCQM cannot capture all possible medical indications. Thus, PC-02 does not equate to elective C-section for non-medical reasons.

554.  National Quality Forum, Quality Measure PC-02 (Cesarean Birth). Available at: https://www.qualityforum.org/QPS/MeasureDetails.aspx?standardID=291&print=1&entityTypeID=1.

555.  National Quality Forum (NQF), Perinatal and Reproductive Health Project. NQF #0471 PC-02 Cesarean Section: Measure Submission and Evaluation Worksheet 5.0. October 24, 2008. Available at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=69252.

556.  Curtin, S.C., Gregory, K.D., Korst, L.M., & Uddin, S.F. (2015). Maternal Morbidity for Vaginal and Cesarean Deliveries, According to Previous Cesarean History: New Data From the Birth Certificate, 2013. National Vital Statistics Reports, 64(4): 1-13.

557.  Centers for Medicare & Medicaid Services. (2015). Cesarean Birth (PC-02) Measure Public Comment Summary. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/PC-02-Public-Comment-Summary-Memo.pdf.

558.  National Quality Forum, Measure Applications Partnership. (2018). A Core Set of Rural-Relevant Measures and Measuring and Improving Access to Care: 2018 Recommendations from the MAP Rural Health Workgroup.Available at: http://www.qualityforum.org/Publications/2018/08/MAP_Rural_Health_Final_Report_-_2018.aspx.

559.  List of Measures Under Consideration for December 1, 2018. Available at: http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75369.

560.  Measure Applications Partnership, December 2018 NQF MAP Hospital Workgroup Meeting Transcript. Available at: http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75369.

561.  National Quality Forum, Measure Applications Partnership, MAP 2019 Considerations for Implementing Measures in Federal Programs: Hospitals.Available at: http://www.qualityforum.org/Publications/2019/02/MAP_2019_Considerations_for_Implementing_Measures_Final_Report_-_Hospitals.aspx.

562.  See, for example, The Joint Commission. Specifications Manual for Joint Commission National Quality Measures, Measure Information Form PC-02. Available at: https://manual.jointcommission.org/releases/TJC2018A1/MIF0167.html.

563.  List of Measures Under Consideration for December 1, 2018. Available at: http://www.qualityforum.org/ProjectMaterials.aspx?projectID=75369.

564.  Ibid.

565.  The Joint Commission, Specifications Manual for Joint Commission National Quality Measures, Measure Information Form PC-02. Available at: https://manual.jointcommission.org/releases/TJC2018A1/MIF0167.html.

566.  National Quality Forum, (2016) Perinatal and Reproductive Health 2015-2016 Final Report. Available at: http://www.qualityforum.org/Publications/2016/12/Perinatal_and_Reproductive_Health_2015-2016_Final_Report.aspx.

567.  National Quality Forum, Perinatal and Reproductive Health 2015-2016 Final Report. Available at: http://www.qualityforum.org/Publications/2016/12/Perinatal_and_Reproductive_Health_2015-2016_Final_Report.aspx.

Jill Arnold