Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that abortion is a covered benefit under Medi-Cal. Existing regulation authorizes reimbursement for specified medications used to terminate a pregnancy through the 70th day from the first day of the recipients last menstrual period.

This bill would require the department, by March 1, 2024, to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines. After the initial review, the bill would require the department to update its Medi-Cal coverage policies for medication abortion as needed to align with evidence-based clinical guidelines.

The bill would require the department to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that abortion is a covered benefit under Medi-Cal. Existing regulation authorizes reimbursement for specified medications used to terminate a pregnancy through the 70th day from the first day of the recipients last menstrual period.

Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law provides that abortion is a covered benefit under Medi-Cal. Existing regulation authorizes reimbursement for specified medications used to terminate a pregnancy through the 70th day from the first day of the recipients last menstrual period.

This bill would require the department to fully reimburse providers for the provision of medication to terminate a pregnancy that aligns with clinical guidelines, evidence-based research, and the discretion of the provider.

GOVERNOR'S VETO

GV Bill Id:AB 576

Author:(Weber)

As Enrolled Ver:September 12, 2023

2/3 vote

SUMMARY

Requires the Department of Health Care Services (DHCS) to update coverage policies for medication abortion.

Governor’s Veto Message

This bill would require the Department of Health Care Services (DHCS) to update Medi-Cal coverage for medication abortion to align with evidence-based clinical guidelines by March 1, 2024.

This bill is well intentioned, but unnecessary. In July 2023, DHCS updated its medication abortion policies for Medi-Cal to reflect current evidence-based clinical guidelines to reimburse providers for care through 77 gestational days. This aligns with the goal of AB 576 and the priority of this Administration to ensure that abortion care is safe, legal, and accessible.

COMMENTS

1. Medi-Cal Coverage of Abortion Services. Abortion services are covered by the Medi-Cal program as a physician service. Abortion is a covered benefit regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. Surgical abortion is covered, as well as medical abortion (also called medication abortion). Medi-Cal also covers medical services incidental or preliminary to an elective abortion.
2. Medication Abortion. Medication abortion is the use of pills to end a pregnancy. Since the United States (U.S.) Food and Drug Administration (FDA) first approved a drug called mifepristone in 2000, medication abortion has increased over time as a share of abortions nationally. According to the U.S. Centers for Disease Control and Prevention, in 2020, over 50% of all abortions were medication abortions.

The most common medication regimen, a protocol combining mifepristone and a second drug called misoprostol, works by stopping the growth of the pregnancy and then causing the lining of the uterus to shed. The FDA approved mifepristone when used in combination with misoprostol to end an intrauterine pregnancy (a pregnancy inside the uterus) through 10 weeks gestation (70 days or less since the first day of a patient's last menstrual period). This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence over time demonstrating its safety and efficacy.

1. Use of Mifepristone Outside the FDA's Approved Parameters. As noted, the FDA has approved the use of mifepristone under certain parameters, including through 70 days gestation. FDA approval of a drug means the FDA has reviewed an application submitted by a manufacturer for approval, including information and data from trials testing the drug's use under certain conditions. If the FDA's review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. According to the FDA, once the FDA approves a drug, health care providers may prescribe the drug for a use they judge is medically appropriate for their patient, including prescribing a drug in ways and for uses different than what the FDA approved. So-called "off-label" use of drugs is legal and common. According to the U.S. Agency for Healthcare Research and Quality, about 20% of all prescriptions written currently are for off-label use. There may even be clinical trials and other evidence demonstrating that a drug works well for an off-label use. However, even if off-label use becomes common or becomes the standard of care to treat a condition, this does not trigger the FDA to proactively update their approval or change the labeled use of a drug to include this new data or clinically relevant information.
2. Legal Challenges to Abortion Access.
   1. 2022 Supreme Court Decision. On Friday, June 24, 2022, the US Supreme Court issued its decision in Dobbs v. Jackson Women's Health Organization, thereby overturning Roe v. Wade, the 1973 Supreme Court decision that affirmed the constitutional right to abortion. This ruling had the effect of deferring issues of abortion rights and access to the state level, allowing states to impose restrictions on abortion rights. Consequently, abortion access in the United States now diverges starkly at the state level, with some states protecting the right to abortion, some having passed laws to ban abortion outright, and other states imposing gestational time limits or other restrictions. Although a landmark decision nationally, the ruling did not directly affect status of abortion as legal in California.
   2. Texas Lawsuit Challenging FDA Approval of Mifepristone. The Alliance for Hippocratic Medicine, a coalition of medical groups and doctors that oppose abortion, filed suit against the FDA in November 2022, alleging the abortion pill mifepristone was improperly approved, in 2000, as part of the two-drug protocol for medication abortion. Plaintiffs have filed a motion seeking a preliminary injunction to remove mifepristone from the U.S. market or limit its availability. As of March 15, 2022, the judge in the case said he would decide soon whether to issue a preliminary injunction ordering the FDA to withdraw its approval of the drug or wait for the full trial. According to legal analysts quoted in news reports, a ruling is expected soon.
3. Medication Abortion Clinical Guidelines and Limitations on Medi-Cal Coverage. A number of evidence-based clinical guidelines have been issued on medication abortion. Although the combination mifepristone-misoprostol regimen appears universally recognized as safe and effective through 70 days gestation, guidelines differ on medication abortion beyond 70 days. However, guidelines generally recognize conditions under which medication abortion can be done safely beyond 70 days. A sample of evidence-based guidelines is shown below:
   1. American College of Obstetricians and Gynecologists (ACOG). ACOG's medication abortion guidance applies to abortions up to 70 days of gestation. However, ACOG indicates in Practice Bulletin No. 135, published June 2013, second-trimester (beyond 12 weeks, or 84 days gestation) abortion can be safely accomplish through medication abortion, and provides dosing recommendations for second-trimester medication abortion.
   2. American Academy of Family Physicians. According to "Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion," Medication regimens using mifepristone and misoprostol are safe and effective for medication abortion up to 77 days' gestation.
   3. National Abortion Federation. According to the 2022 "Clinical Policy Guidelines For Abortion Care," medication abortion is a safe and effective method for termination of pregnancies beyond the first trimester (12 weeks, or 84 days gestation) when performed by trained clinicians in specified medical settings. The guidelines state, for medication abortion beyond the first trimester, that gestational age must be verified by ultrasound, prior to the termination of a pregnancy clinically estimated to be more than 14 weeks (98 days) gestation.
   4. World Health Organization (WHO). The WHO's 2022 update to "Abortion Care Guidelines" recognizes and makes recommendations related to dosage and medical management for medication abortion both before and beyond the first trimester (12 weeks, or 84 days gestation).

Per Medi-Cal billing guidelines, a combination regimen of mifepristone and misoprostol for medication abortion is covered only for pregnancies of 70 days gestation or less. This bill would require DHCS to update its medication abortion coverage policies on a one-time basis in 2024 and regularly thereafter. It would also require DHCS, for purposes of coverage determinations, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

1. California Future of Abortion (CA FAB) Council. In September 2021, more than 40 organizations joined together to form the CA FAB Council. Sexual and reproductive health care providers, reproductive rights and reproductive justice advocacy organizations, legal and policy experts, researchers, and advocates, as well as representatives from the Office of Governor Newsom and legislative leaders, convened to identify barriers to abortion services and recommend policy proposals supporting equitable and affordable access to abortion care for Californians and all who seek care in the state. The Council cited several institutional and administrative barriers that stand in the way of reproductive freedom, including limitations on the ability to provide medication abortion in the Medi-Cal program. The Council recommended DHCS should update its Medi-Cal billing policies around medication abortion.
2. Medi-Cal Post-Public Health Emergency (PHE) Medication Abortion Policy. As part of the 2022-23 Governor's Budget, DHCS proposed changes to policies for medication abortion for the period after the end of the federal COVID-19 PHE, which is scheduled to end on May 11, 2023. Some policy changes aligned with recommendations of the CA FAB Council. The post-PHE policy included adjustment to payments based on the scope of services rendered, allowing for ongoing use of telehealth and remote assessment, and specifying ultrasounds are not a required part of medication abortion services when not clinically indicated. As part of the post-PHE policy, DHCS indicates no change to the coverage of medication abortion through 70 days gestational age.

According to the Author

Current Medi-Cal coverage policies for medication abortion only cover services through 70 days gestation. The author asserts this coverage policy is overly restrictive and does not align with the most current evidence-based guidelines as to when medication abortion can be done safely. The author concludes this bill is intended to ensure abortion services are covered when a clinical provider is following evidence-based clinical guidelines and determines the service is the best interest of the patient.

Arguments in Support

This bill is supported by reproductive health, consumer and faith-based organizations. According to NARAL Pro-Choice California, this bill will allow families to make the family planning decision that is most appropriate for their life. According to ACOG, District IX, taking medications to terminate a pregnancy, rather than a procedure, is approved by the FDA through 70 days of gestation, and while ACOG may also have guidance suggesting medication abortion up to the 70th day, evidence also exists to support safe and effective use of medication abortion with more advanced gestations. ACOG states in support that if a provider's professional clinical judgement suggests it appropriate for their patient to receive a safe and effective regimen for medication abortion beyond 70 days, equal treatment should apply to the reimbursement policies and coverage by Medi-Cal should be assured.

Arguments in Opposition

The California Catholic Conference (CCC) opposes this bill based on opposition to abortion generally and their belief that it takes the life of an innocent human being. CCC also opposes loosening standards for medication abortion pills, citing risk of side effects. Right to Life League opposes on similar ethical grounds.

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

1. Cost pressures of $6 million (General Fund), as evidenced by the author's request for an allocation of $6 million over three years in the state budget to implement this bill. However, this bill will likely result in a smaller change in the costs for Medi-Cal coverage of abortions, even if DHCS changes its coverage policies in response to this bill, as the author and sponsors expect. The bill is not likely to change the overall number of abortions provided, although it could alter the proportion of abortions that are medication (vs. clinic) abortions of pregnancies between 71 and 77 days gestation. Costs for Medi-Cal to cover more medication abortions are unknown, but likely less than $1 million per year (General Fund).
2. Additional one-time costs of an unknown amount, likely less than $150,000, to DHCS to review and update coverage policies to align with current guidelines, and inform health care providers of changes (General Fund).

VOTES

ASM HEALTH: 10-4-1

YES: Wood, Aguiar-Curry, Arambula, Boerner Horvath, Wendy Carrillo, Maienschein, McCarty, Rodriguez, Santiago, Weber

NO: Waldron, Flora, Vince Fong, Joe Patterson

ABS, ABST OR NV: Villapudua

ASM APPROPRIATIONS: 11-4-1

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Ortega

NO: Megan Dahle, Dixon, Mathis, Sanchez

ABS, ABST OR NV: Robert Rivas

ASSEMBLY FLOOR: 62-16-2

YES: Addis, Aguiar-Curry, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO: Alanis, Chen, Megan Dahle, Davies, Essayli, Flora, Vince Fong, Gallagher, Hoover, Lackey, Mathis, Jim Patterson, Joe Patterson, Sanchez, Ta, Waldron

ABS, ABST OR NV: Dixon, Grayson

SENATE FLOOR: 30-8-2

YES: Allen, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Cortese, Dodd, Durazo, Eggman, Glazer, Gonzalez, Hurtado, Laird, Limón, McGuire, Menjivar, Min, Newman, Padilla, Portantino, Roth, Rubio, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener

NO: Dahle, Grove, Jones, Nguyen, Niello, Ochoa Bogh, Seyarto, Wilk

ABS, ABST OR NV: Alvarado-Gil, Caballero

UPDATED

VERSION: September 12, 2023

CONSULTANT: Lisa Murawski / HEALTH / (916) 319-2097 FN: 0002538

 THIRD READING  

Bill No: AB 576

Author: Weber (D), et al.

Amended: 3/30/23 in Assembly

Vote: 21

SENATE HEALTH COMMITTEE: 10-0, 6/28/23

AYES: Eggman, Glazer, Gonzalez, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

NO VOTE RECORDED: Nguyen, Grove

SENATE APPROPRIATIONS COMMITTEE: 5-2, 9/1/23

AYES: Portantino, Ashby, Bradford, Wahab, Wiener

NOES: Jones, Seyarto

ASSEMBLY FLOOR: 62-16, 5/31/23 - See last page for vote

SUBJECT: Medi-Cal: reimbursement for abortion

SOURCE: Essential Access Health

NARAL Pro-Choice California

National Health Law Program

Planned Parenthood Affiliates of California

DIGEST:

This bill requires the Department of Health Care Services (DHCS) to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines. Requires DHCS to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with evidence-based clinical guidelines.

ANALYSIS:

Existing law:

1. Establishes the Medi-Cal program, administered by DHCS, to provide medical coverage for low-income individuals. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes federally required and optional Medicaid benefits, as well as benefits covered solely by the state, including prescription drugs, physician services, family planning services, and outpatient services. [WIC §14132]

This bill:

1. Requires DHCS to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines by March 1, 2024.
2. Requires DHCS to update its Medi-Cal coverage policies for medication abortion as needed to align with evidence-based clinical guidelines after the initial review.
3. Requires DHCS, in updating Medi-Cal coverage policies, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

Comments

1. Author’s statement. According to the author, California has long been a leader in protecting an individual’s right to access abortion. And while these efforts have helped to maintain this right for decades, there are still remaining barriers to accessing care – including cost and timeliness of coverage. To address these barriers, reproductive health providers in California offer care to patients who are unable to afford the cost of services, or have coverage through the state’s Medi-Cal program. Currently, Medi-Cal covers abortion medication up to 70 days gestation. However, studies have shown that medication abortion for pregnancies between 71 and 77 days was equally effective as the same regimen from 64 to 70 days. By extending the time, by 7 days, that a pregnant individual can receive abortion medication under Medi-Cal, we are allowing families to make the family planning decision that is most appropriate for their life. Every single day matters when making such a major decision, and the decision should not be dependent on whether the individual has the funds or coverage to cover the medication. There are over eight million women eligible for Medi-Cal in the State. Individuals who are receiving the state’s health insurance benefits should be receiving the same level of access and care as those in the private insurance market.
2. Abortion. According to the Center for Disease Control and Prevention (CDC), a legal induced abortion is defined as an intervention performed by a licensed clinician that is intended to terminate an ongoing pregnancy. Ending a pregnancy with medications is an option for women who are less than ten weeks pregnant and would like to have an abortion at home with a less invasive procedure. The CDC reports that 620,327 abortions were reported nationally from 49 reporting areas in 2020. From 2019 to 2020, the total number of abortions decreased 2%, and from 2011 to 2020, the total number of reported abortions decreased 15%. In 2020, women in their 20s accounted for more than half of abortions (57%). By contrast, adolescents under 15 years (0.2%) and women over 40 (3.7%) years accounted for the lowest percentages of abortions. In 2020, nearly all abortions (93%) were performed at or less than 13 weeks gestation. In 2020, the highest proportion of abortions were performed by early medication abortion at or less than nine weeks gestation (51%), followed by surgical abortion at or less than 13 weeks gestation (40%), followed by, surgical abortion at more than 13 weeks gestation (6.7%), and medication abortion at more than nine weeks gestation (2.4%). In 2019, the most recent year for which data were reviewed for pregnancy-related deaths, four women died as a result of complications from legal induced abortion.
3. California data. According to the Guttmacher Institute, in 2020, 154,060 abortions were provided in California, though not all abortions that occurred in California were provided to state residents. There was a 17% increase in the abortion rate in California between 2017 and 2020, from 16.4 to 19.2 abortions per 1,000 women of reproductive age. Abortions in California represent 16.6% of all abortions in the U.S. There were 173 clinics providing abortion in California in 2020. This number represent a 3% increase in clinics from 2017, when there were 161 clinics. In 2020, 38% of California counties had no clinics that provided abortions, and 3% of California women lived in those counties.
4. Medication abortion. Medication abortion, which now amounts to the majority of the abortions performed nationally, is the use of pills to end a pregnancy. The most common medication regimen, a protocol combining the drugs mifepristone and misoprostol, works by stopping the growth of the pregnancy and then causing the lining of the uterus to shed. The U.S. Food and Drug Administration (FDA) has approved mifepristone when used in combination with misoprostol to end an intrauterine pregnancy within 70 days or since the first day of the individual’s last menstrual period. This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence over time demonstrating its safety and efficacy. Providers can legally prescribe the regimen after the 70th day through off-label use, or use not specifically approved by the FDA. While currently not the case for medication abortion, according to the U.S. Department of Health & Human Services’ Agency for Healthcare Research and Quality, about one in five of prescriptions written are written for off-label use. Although the FDA has updated the gestational age once since the approval of mifepristone in 2000, it does not typically update approval guidelines to accommodate later off-label use, even when that use becomes more commonplace and supported by evidence.

A number of organizations have clinical guidelines permitting the mifepristone-misoprostol regimen beyond the 70th day: the World Health Organization’s 2022 guidelines recommend using it within 84 days (12 weeks), the American College of Obstetricians and Gynecologists and the National Abortion Federation both have guidelines on second trimester usage (after the 12th week), and the American Academy of Family Physicians guidelines include up to 77 days of gestation. While studies have shown a lower success rate for medication abortions performed after the 70th day, other studies have shown this gap can be narrowed by including two doses of misoprostol after the initial mifepristone dose. Clinical guidelines on later medication abortions reflect this modification.

1. Medi-Cal coverage of medication abortion. The Medi-Cal program is one of 16 state Medicaid programs that use their own funds to cover abortion services and follow-up services for beneficiaries. Abortion is a covered benefit without cost sharing regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. The Medi-Cal program covers surgical abortions as a physician service. Medication abortions and the associated services and supplies (e.g. patient counseling, ultrasound to confirm pregnancy, etc.) are covered according to the FDA’s currently approved regimen for mifepristone and misoprostol, which requires mifepristone to be dispense in a clinic, medical office, or hospital, requires the regimen to occur before the 70th day from the first day of the recipient’s last menstrual period, and requires a follow-up appointment with the healthcare provider.
2. California Future of Abortion Council (CA FAB Council). According to the CA FAB Council website, in September 2021 it convened to identify the most pressing barriers to care for patients seeking abortion services in California. More than 40 organizations representing sexual and reproductive health care providers, reproductive rights and reproductive justice advocacy organizations, legal and policy experts, researchers, and advocates, with the support of California policymakers, joined together to recommend policy proposals supporting equitable and affordable access to abortion care for Californians and all who seek care here. The CA FAB Council initially provided 45 policy recommendations, and published an addendum in December of 2022 updating on the progress of those recommendations and adding an additional 16 recommendations. This bill seeks to implement one of those updated recommendations. According to the December 2022 addendum, research and clinical practice demonstrate that medication abortion can, and is, safely and effectively provided after 70 days gestation. The addendum states that DHCS should align its billing policies to support full reimbursement for the provision of medication abortion to align with up-to-date clinical guidelines, subject to the provider’s professional judgment and scientific evidence.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee, this bill has unknown General Fund costs, likely hundreds of thousands, for DHCS to conduct the coverage policy reviews and updates. It also has unknown overall General Fund fiscal impact to Medi-Cal abortion services, partly depending on impact to utilization of medication abortions rather than non-medication abortion services.

SUPPORT: (Verified 8/23/23)

Essential Access Health (co-source)

NARAL Pro-Choice California (co-source)

National Health Law Program (co-source)

Planned Parenthood Affiliates of California (co-source)

Attorney General Rob Bonta

Office of Lieutenant Governor Eleni Kounalakis

American College of Obstetricians and Gynecologists, District IX

American Nurses Association, California

California Academy of Family Physicians

California Health+ Advocates

California Legislative Women’s Caucus

California Nurse Midwives Association

California State Council of Service Employees International Union

California Women’s Law Center

City and County of San Francisco

City and County of San Francisco Department on the Status of Women

If/When/How: Lawyering for Reproductive Justice

National Association of Social Workers, California Chapter

National Council of Jewish Women California

San Francisco Black and Jewish Unity Coalition

San Francisco City Attorney’s Office

Santa Barbara Women’s Political Committee

OPPOSITION: (Verified 8/23/23)

California Catholic Conference

California Right to Life Educational Fund

Right to Life League

ARGUMENTS IN SUPPORT: Co-sponsor Essential Health Access writes that while people with commercial health coverage who are more than 70 days pregnant have been able to get medication abortion coverage, Medi-Cal will only cover medication abortion services rendered up to the 70th day of gestation. As a result, Medi-Cal beneficiaries seeking medication abortions that fall within this gestational “coverage gap” might not be able to access the abortion method they prefer because of an administrative policy rather than clinical guidelines. This creates a troubling inequity between patients with low incomes enrolled in Medi-Cal compared to patients accessing abortion care within the private insurance market. Co-sponsor Planned Parenthood state that more than 70% of their patients seeking an abortion ultimately receive a medication abortion. By extending the window in which medication abortion is covered by Medi-Cal, this bill would give an additional 10% of Medi-Cal recipients the ability to choose a medication abortion, rather than being restricted to an in-clinic procedural abortion. Supporters American College of Obstetricians and Gynecologists, District IX write that if a provider’s professional clinical judgement suggests it is appropriate for their patient to receive a safe and effective regimen for medication abortion beyond 70 days, equal treatment should apply to the reimbursement policies and coverage by Medi-Cal should be assured.

ARGUMENTS IN OPPOSITION: The California Catholic Conference writes that this bill encourages loosening standards for administration of mifepristone and misoprostol, which could be severely detrimental to women’s health and safety. They cite one study that finds complications to be more likely with medication abortion than surgical abortion and another that found emergency room visits were more likely after medication abortion than after surgical abortion. They also state there is no lack of access to abortion in California and that legislation should focus on the other needs of pregnant and parenting women. Opponents the Right to Life League write that because this bill does not also provide funding for childbirth it violates the California Constitution and cites as evidence the California Supreme Court Case that required the Medi-Cal program to fund abortions. California Right to Life Educational Fund says this bill encourages and facilitates the improper and illegal dumping of human remains.

ASSEMBLY FLOOR: 62-16, 5/31/23

AYES: Addis, Aguiar-Curry, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Connolly, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Santiago, Schiavo, Soria, Ting, Valencia, Villapudua, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NOES: Alanis, Chen, Megan Dahle, Davies, Essayli, Flora, Vince Fong, Gallagher, Hoover, Lackey, Mathis, Jim Patterson, Joe Patterson, Sanchez, Ta, Waldron

NO VOTE RECORDED: Dixon, Grayson

Prepared by: Jen Flory / HEALTH / (916) 651-4111

9/2/23 9:57:19

**** END ****

SENATE COMMITTEE ON

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 576 (Weber) - Medi-Cal: reimbursement for abortion

Bill Summary:

AB 576 would require the Department of Health Care Services (DHCS) to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines.

Fiscal Impact:

• Unknown General Fund costs, likely hundreds of thousands, for DHCS to conduct the coverage policy reviews and updates.
• Unknown overall General Fund fiscal impact to Medi-Cal abortion services, partly depending on impact to utilization of medication abortions rather than non-medication abortion services.

Background:

The Medi-Cal program is one of 16 state Medicaid programs that uses their own funds to cover abortion services and follow-up services for beneficiaries. Abortion is a covered benefit without cost sharing regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. The Medi-Cal program covers surgical abortions as a physician service. Medication abortions and the associated services and supplies (e.g. patient counseling, ultrasound to confirm pregnancy, etc.) are covered according to the U.S. Food and Drug Administration’s currently approved regimen for mifepristone and misoprostol, which: requires mifepristone to be dispense in a clinic, medical office, or hospital; requires the regimen to occur before the 70th day from the first day of the recipient’s last menstrual period; and requires a follow-up appointment with the healthcare provider.

Proposed Law:

Specific provisions of the bill would:

• Require DHCS to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines by March 1, 2024.
• Require DHCS to update its Medi-Cal coverage policies for medication abortion as needed to align with evidence-based clinical guidelines after the initial review.
• Require DHCS, in updating Medi-Cal coverage policies, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: AB 576

SUBJECT: Medi-Cal: reimbursement for abortion

SUMMARY:

Requires the Department of Health Care Services (DHCS) to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines. Requires DHCS to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with evidence-based clinical guidelines.

Existing law:

1. Establishes the Medi-Cal program, administered by DHCS, to provide medical coverage for low-income individuals. [WIC §14000, et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes federally required and optional Medicaid benefits, as well as benefits covered solely by the state, including prescription drugs, physician services, family planning services, and outpatient services. [WIC §14132]

This bill:

1. Requires DHCS to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines by March 1, 2024.
2. Requires DHCS to update its Medi-Cal coverage policies for medication abortion as needed to align with evidence-based clinical guidelines after the initial review.
3. Requires DHCS, in updating Medi-Cal coverage policies, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, this bill will incur cost pressures of $6 million (General Fund), as evidenced by the author’s request for an allocation of $6 million over three years in the state budget to implement this bill. However, this bill will likely result in a smaller change in the costs for Medi-Cal coverage of abortions, even if DHCS changes its coverage policies in response to this bill, as the author and sponsors expect. The bill is not likely to change the overall number of abortions provided, although it could alter the proportion of abortions that are medication (vs. clinic) abortions of pregnancies between 71 and 77 days gestation. Costs for Medi-Cal to cover more medication abortions are unknown, but likely less than $1 million per year (General Fund). Additional one-time costs of an unknown amount, likely less than $150,000, to DHCS to review and update coverage policies to align with current guidelines, and inform health care providers of changes (General Fund).

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, California has long been a leader in protecting an individual’s right to access abortion. And while these efforts have helped to maintain this right for decades, there are still remaining barriers to accessing care – including cost and timeliness of coverage. To address these barriers, reproductive health providers in California offer care to patients who are unable to afford the cost of services, or have coverage through the state’s Medi-Cal program. Currently, Medi-Cal covers abortion medication up to 70 days gestation. However, studies have shown that medication abortion for pregnancies between 71 and 77 days was equally effective as the same regimen from 64 to 70 days. By extending the time, by 7 days, that a pregnant individual can receive abortion medication under Medi-Cal, we are allowing families to make the family planning decision that is most appropriate for their life. Every single day matters when making such a major decision, and the decision should not be dependent on whether the individual has the funds or coverage to cover the medication. There are over eight million women eligible for Medi-Cal in the State. Individuals who are receiving the state’s health insurance benefits should be receiving the same level of access and care as those in the private insurance market.
2. Abortion. According to the Center for Disease Control and Prevention (CDC), a legal induced abortion is defined as an intervention performed by a licensed clinician that is intended to terminate an ongoing pregnancy. Ending a pregnancy with medications is an option for women who are less than ten weeks pregnant and would like to have an abortion at home with a less invasive procedure. The CDC reports that 620,327 abortions were reported nationally from 49 reporting areas in 2020. From 2019 to 2020, the total number of abortions decreased 2%, and from 2011 to 2020, the total number of reported abortions decreased 15%. In 2020, women in their 20s accounted for more than half of abortions (57%). By contrast, adolescents under 15 years (0.2%) and women over 40 (3.7%) years accounted for the lowest percentages of abortions. In 2020, nearly all abortions (93%) were performed at or less than 13 weeks gestation. In 2020, the highest proportion of abortions were performed by early medication abortion at or less than nine weeks gestation (51%), followed by surgical abortion at or less than 13 weeks gestation (40%), followed by, surgical abortion at more than 13 weeks gestation (6.7%), and medication abortion at more than nine weeks gestation (2.4%). In 2019, the most recent year for which data were reviewed for pregnancy-related deaths, four women died as a result of complications from legal induced abortion.
3. California data. According to the Guttmacher Institute, in 2020, 154,060 abortions were provided in California, though not all abortions that occurred in California were provided to state residents. There was a 17% increase in the abortion rate in California between 2017 and 2020, from 16.4 to 19.2 abortions per 1,000 women of reproductive age. Abortions in California represent 16.6% of all abortions in the U.S. There were 173 clinics providing abortion in California in 2020. This number represent a 3% increase in clinics from 2017, when there were 161 clinics. In 2020, 38% of California counties had no clinics that provided abortions, and 3% of California women lived in those counties.
4. Medication abortion. Medication abortion, which now amounts to the majority of the abortions performed nationally, is the use of pills to end a pregnancy. The most common medication regimen, a protocol combining the drugs mifepristone and misoprostol, works by stopping the growth of the pregnancy and then causing the lining of the uterus to shed. The U.S. Food and Drug Administration (FDA) has approved mifepristone when used in combination with misoprostol to end an intrauterine pregnancy within 70 days or since the first day of the individual’s last menstrual period. This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence over time demonstrating its safety and efficacy. Providers can legally prescribe the regimen after the 70th day through off-label use, or use not specifically approved by the FDA. While currently not the case for medication abortion, according to the U.S. Department of Health & Human Services’ Agency for Healthcare Research and Quality, about one in five of prescriptions written are written for off-label use. Although the FDA has updated the gestational age once since the approval of mifepristone in 2000, it does not typically update approval guidelines to accommodate later off-label use, even when that use becomes more commonplace and supported by evidence.

A number of organizations have clinical guidelines permitting the mifepristone-misoprostol regimen beyond the 70th day: the World Health Organization’s 2022 guidelines recommend using it within 84 days (12 weeks), the American College of Obstetricians and Gynecologists and the National Abortion Federation both have guidelines on second trimester usage (after the 12th week), and the American Academy of Family Physicians guidelines include up to 77 days of gestation. While studies have shown a lower success rate for medication abortions performed after the 70th day, other studies have shown this gap can be narrowed by including two doses of misoprostol after the initial mifepristone dose. Clinical guidelines on later medication abortions reflect this modification.

1. Medi-Cal coverage of medication abortion. The Medi-Cal program is one of 16 state Medicaid programs that use their own funds to cover abortion services and follow-up services for beneficiaries. Abortion is a covered benefit without cost sharing regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. The Medi-Cal program covers surgical abortions as a physician service. Medication abortions and the associated services and supplies (e.g. patient counseling, ultrasound to confirm pregnancy, etc.) are covered according to the FDA’s currently approved regimen for mifepristone and misoprostol, which requires mifepristone to be dispense in a clinic, medical office, or hospital, requires the regimen to occur before the 70th day from the first day of the recipient’s last menstrual period, and requires a follow-up appointment with the healthcare provider.
2. California Future of Abortion Council (CA FAB Council). According to the CA FAB Council website, in September 2021 it convened to identify the most pressing barriers to care for patients seeking abortion services in California. More than 40 organizations representing sexual and reproductive health care providers, reproductive rights and reproductive justice advocacy organizations, legal and policy experts, researchers, and advocates, with the support of California policymakers, joined together to recommend policy proposals supporting equitable and affordable access to abortion care for Californians and all who seek care here. The CA FAB Council initially provided 45 policy recommendations, and published an addendum in December of 2022 updating on the progress of those recommendations and adding an additional 16 recommendations. This bill seeks to implement one of those updated recommendations. According to the December 2022 addendum, research and clinical practice demonstrate that medication abortion can, and is, safety and effectively provided after 70 days gestation. The addendum states that DHCS should align its billing policies to support full reimbursement for the provision of medication abortion to align with up-to-date clinical guidelines, subject to the provider’s professional judgment and scientific evidence.
3. Related legislation. SB 385 (Atkins) allows qualified physician assistants to perform abortions by aspiration techniques without the personal presence of a supervising physician, as specified. SB 385 is set for hearing on June 27, 2023 in the Assembly Judiciary Committee.
4. Support. Co-sponsor Essential Health Access writes that while people with commercial health coverage who are more than 70 days pregnant have been able to get medication abortion coverage, Medi-Cal will only cover medication abortion services rendered up to the 70th day of gestation. As a result, Medi-Cal beneficiaries seeking medication abortions that fall within this gestational “coverage gap” might not be able to access the abortion method they prefer because of an administrative policy rather than clinical guidelines. This creates a troubling inequity between patients with low incomes enrolled in Medi-Cal compared to patients accessing abortion care within the private insurance market. Co-sponsor Planned Parenthood state that more than 70% of their patients seeking an abortion ultimately receive a medication abortion. By extending the window in which medication abortion is covered by Medi-Cal, this bill would give an additional 10% of Medi-Cal recipients the ability to choose a medication abortion, rather than being restricted to an in-clinic procedural abortion. Supporters American College of Obstetricians and Gynecologists, District IX write that if a provider’s professional clinical judgement suggests it is appropriate for their patient to receive a safe and effective regimen for medication abortion beyond 70 days, equal treatment should apply to the reimbursement policies and coverage by Medi-Cal should be assured.
5. Opposition. Opponents, the California Catholic Conference writes that this bill encourages loosening standards for administration of mifepristone and misoprostol, which could be severely detrimental to women’s health and safety. They cite one study that finds complications to be more likely with medication abortion than surgical abortion and another that found emergency room visits were more likely after medication abortion than after surgical abortion. They also state there is no lack of access to abortion in California and that legislation should focus on the other needs of pregnant and parenting women. Opponents the Right to Life League write that because this bill does not also provide funding for childbirth it violates the California Constitution and cites as evidence the California Supreme Court Case that required the Medi-Cal program to fund abortions.

SUPPORT AND OPPOSITION:

Support: Essential Access Health (cosponsor)

NARAL Pro-Choice California (cosponsor)

Planned Parenthood Affiliates of California (cosponsor)

American College of Obstetricians and Gynecologists, District IX

American Nurses Association, California

Attorney General Rob Bonta

California Academy of Family Physicians

California Health+ Advocates

California Nurse Midwives Association

California State Council of Service Employees International Union

California Women’s Law Center

City and County of San Francisco

City and County of San Francisco Department on the Status of Women

If/When/How: Lawyering for Reproductive Justice

National Association of Social Workers, California Chapter

National Council of Jewish Women CA

National Health Law Program

Office of Lieutenant Governor Eleni Kounalakis

San Francisco Black and Jewish Unity Coalition

San Francisco City Attorney’s Office

Santa Barbara Women’s Political Committee

Oppose: California Catholic Conference

Right to Life League

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 576

Author:(Weber)

As Amended Ver:March 30, 2023

Majority vote

SUMMARY

Requires the Department of Health Care Services (DHCS) to update coverage policies for medication abortion.

Major Provisions

COMMENTS

1. Medi-Cal Coverage of Abortion Services. Abortion services are covered by the Medi-Cal program as a physician service. Abortion is a covered benefit regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. Surgical abortion is covered, as well as medical abortion (also called medication abortion). Medi-Cal also covers medical services incidental or preliminary to an elective abortion.
2. Medication Abortion. Medication abortion is the use of pills to end a pregnancy. Since the United States (U.S.) Food and Drug Administration (FDA) first approved a drug called mifepristone in 2000, medication abortion has increased over time as a share of abortions nationally. According to the U.S. Centers for Disease Control and Prevention, in 2020, over 50% of all abortions were medication abortions.

The most common medication regimen, a protocol combining mifepristone and a second drug called misoprostol, works by stopping the growth of the pregnancy and then causing the lining of the uterus to shed. The FDA approved mifepristone when used in combination with misoprostol to end an intrauterine pregnancy (a pregnancy inside the uterus) through 10 weeks gestation (70 days or less since the first day of a patient's last menstrual period). This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence over time demonstrating its safety and efficacy.

1. Use of Mifepristone Outside the FDA's Approved Parameters. As noted, the FDA has approved the use of mifepristone under certain parameters, including through 70 days gestation. FDA approval of a drug means the FDA has reviewed an application submitted by a manufacturer for approval, including information and data from trials testing the drug's use under certain conditions. If the FDA's review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. According to the FDA, once the FDA approves a drug, health care providers may prescribe the drug for a use they judge is medically appropriate for their patient, including prescribing a drug in ways and for uses different than what the FDA approved. So-called "off-label" use of drugs is legal and common. According to the U.S. Agency for Healthcare Research and Quality, about 20% of all prescriptions written currently are for off-label use. There may even be clinical trials and other evidence demonstrating that a drug works well for an off-label use. However, even if off-label use becomes common or becomes the standard of care to treat a condition, this does not trigger the FDA to proactively update their approval or change the labeled use of a drug to include this new data or clinically relevant information.
2. Legal Challenges to Abortion Access.
   1. 2022 Supreme Court Decision. On Friday, June 24, 2022, the US Supreme Court issued its decision in Dobbs v. Jackson Women's Health Organization, thereby overturning Roe v. Wade, the 1973 Supreme Court decision that affirmed the constitutional right to abortion. This ruling had the effect of deferring issues of abortion rights and access to the state level, allowing states to impose restrictions on abortion rights. Consequently, abortion access in the United States now diverges starkly at the state level, with some states protecting the right to abortion, some having passed laws to ban abortion outright, and other states imposing gestational time limits or other restrictions. Although a landmark decision nationally, the ruling did not directly affect status of abortion as legal in California.
   2. Texas Lawsuit Challenging FDA Approval of Mifepristone. The Alliance for Hippocratic Medicine, a coalition of medical groups and doctors that oppose abortion, filed suit against the FDA in November 2022, alleging the abortion pill mifepristone was improperly approved, in 2000, as part of the two-drug protocol for medication abortion. Plaintiffs have filed a motion seeking a preliminary injunction to remove mifepristone from the U.S. market or limit its availability. As of March 15, 2022, the judge in the case said he would decide soon whether to issue a preliminary injunction ordering the FDA to withdraw its approval of the drug or wait for the full trial. According to legal analysts quoted in news reports, a ruling is expected soon.
3. Medication Abortion Clinical Guidelines and Limitations on Medi-Cal Coverage. A number of evidence-based clinical guidelines have been issued on medication abortion. Although the combination mifepristone-misoprostol regimen appears universally recognized as safe and effective through 70 days gestation, guidelines differ on medication abortion beyond 70 days. However, guidelines generally recognize conditions under which medication abortion can be done safely beyond 70 days. A sample of evidence-based guidelines is shown below:
   1. American College of Obstetricians and Gynecologists (ACOG). ACOG's medication abortion guidance applies to abortions up to 70 days of gestation. However, ACOG indicates in Practice Bulletin No. 135, published June 2013, second-trimester (beyond 12 weeks, or 84 days gestation) abortion can be safely accomplish through medication abortion, and provides dosing recommendations for second-trimester medication abortion.
   2. American Academy of Family Physicians. According to "Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion," Medication regimens using mifepristone and misoprostol are safe and effective for medication abortion up to 77 days' gestation.
   3. National Abortion Federation. According to the 2022 "Clinical Policy Guidelines For Abortion Care," medication abortion is a safe and effective method for termination of pregnancies beyond the first trimester (12 weeks, or 84 days gestation) when performed by trained clinicians in specified medical settings. The guidelines state, for medication abortion beyond the first trimester, that gestational age must be verified by ultrasound, prior to the termination of a pregnancy clinically estimated to be more than 14 weeks (98 days) gestation.
   4. World Health Organization (WHO). The WHO's 2022 update to "Abortion Care Guidelines" recognizes and makes recommendations related to dosage and medical management for medication abortion both before and beyond the first trimester (12 weeks, or 84 days gestation).

Per Medi-Cal billing guidelines, a combination regimen of mifepristone and misoprostol for medication abortion is covered only for pregnancies of 70 days gestation or less. This bill would require DHCS to update its medication abortion coverage policies on a one-time basis in 2024 and regularly thereafter. It would also require DHCS, for purposes of coverage determinations, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

1. California Future of Abortion (CA FAB) Council. In September 2021, more than 40 organizations joined together to form the CA FAB Council. Sexual and reproductive health care providers, reproductive rights and reproductive justice advocacy organizations, legal and policy experts, researchers, and advocates, as well as representatives from the Office of Governor Newsom and legislative leaders, convened to identify barriers to abortion services and recommend policy proposals supporting equitable and affordable access to abortion care for Californians and all who seek care in the state. The Council cited several institutional and administrative barriers that stand in the way of reproductive freedom, including limitations on the ability to provide medication abortion in the Medi-Cal program. The Council recommended DHCS should update its Medi-Cal billing policies around medication abortion.
2. Medi-Cal Post-Public Health Emergency (PHE) Medication Abortion Policy. As part of the 2022-23 Governor's Budget, DHCS proposed changes to policies for medication abortion for the period after the end of the federal COVID-19 PHE, which is scheduled to end on May 11, 2023. Some policy changes aligned with recommendations of the CA FAB Council. The post-PHE policy included adjustment to payments based on the scope of services rendered, allowing for ongoing use of telehealth and remote assessment, and specifying ultrasounds are not a required part of medication abortion services when not clinically indicated. As part of the post-PHE policy, DHCS indicates no change to the coverage of medication abortion through 70 days gestational age.

According to the Author

Current Medi-Cal coverage policies for medication abortion only cover services through 70 days gestation. The author asserts this coverage policy is overly restrictive and does not align with the most current evidence-based guidelines as to when medication abortion can be done safely. The author concludes this bill is intended to ensure abortion services are covered when a clinical provider is following evidence-based clinical guidelines and determines the service is the best interest of the patient.

Arguments in Support

This bill is supported by reproductive health, consumer and faith-based organizations. According to NARAL Pro-Choice California, this bill will allow families to make the family planning decision that is most appropriate for their life. According to ACOG, District IX, taking medications to terminate a pregnancy, rather than a procedure, is approved by the FDA through 70 days of gestation, and while ACOG may also have guidance suggesting medication abortion up to the 70th day, evidence also exists to support safe and effective use of medication abortion with more advanced gestations. ACOG states in support that if a provider's professional clinical judgement suggests it appropriate for their patient to receive a safe and effective regimen for medication abortion beyond 70 days, equal treatment should apply to the reimbursement policies and coverage by Medi-Cal should be assured.

Arguments in Opposition

The California Catholic Conference (CCC) opposes this bill based on opposition to abortion generally and their belief that it takes the life of an innocent human being. CCC also opposes loosening standards for medication abortion pills, citing risk of side effects. Right to Life League opposes on similar ethical grounds.

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

1. Cost pressures of $6 million (General Fund), as evidenced by the author's request for an allocation of $6 million over three years in the state budget to implement this bill. However, this bill will likely result in a smaller change in the costs for Medi-Cal coverage of abortions, even if DHCS changes its coverage policies in response to this bill, as the author and sponsors expect. The bill is not likely to change the overall number of abortions provided, although it could alter the proportion of abortions that are medication (vs. clinic) abortions of pregnancies between 71 and 77 days gestation. Costs for Medi-Cal to cover more medication abortions are unknown, but likely less than $1 million per year (General Fund).
2. Additional one-time costs of an unknown amount, likely less than $150,000, to DHCS to review and update coverage policies to align with current guidelines, and inform health care providers of changes (General Fund).

VOTES

ASM HEALTH: 10-4-1

YES: Wood, Aguiar-Curry, Arambula, Boerner Horvath, Wendy Carrillo, Maienschein, McCarty, Rodriguez, Santiago, Weber

NO: Waldron, Flora, Vince Fong, Joe Patterson

ABS, ABST OR NV: Villapudua

ASM APPROPRIATIONS: 11-4-1

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Ortega

NO: Megan Dahle, Dixon, Mathis, Sanchez

ABS, ABST OR NV: Robert Rivas

UPDATED

VERSION: March 30, 2023

CONSULTANT: Lisa Murawski / HEALTH / (916) 319-2097 FN: 0000711

Date of Hearing: May 3, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 576

Author:(Weber) – As Amended Ver:March 30, 2023

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill requires the Department of Health Care Services (DHCS), by March 1, 2024, to review and, if needed, update, Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines. The bill requires DHCS to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with evidence-based clinical guidelines.

FISCAL EFFECT:

Cost pressures of $6 million (General Fund), as evidenced by the author’s request for an allocation of $6 million over three years in the state budget to implement this bill. However, this bill will likely result in a smaller change in the costs for Medi-Cal coverage of abortions, even if DHCS changes its coverage policies in response to this bill, as the author and sponsors expect. The bill is not likely to change the overall number of abortions provided, although it could alter the proportion of abortions that are medication (vs. clinic) abortions of pregnancies between 71 and 77 days gestation. Costs for Medi-Cal to cover more medication abortions are unknown, but likely less than $1 million per year (General Fund).

Additional one-time costs of an unknown amount, likely less than $150,000, to DHCS to review and update coverage policies to align with current guidelines, and inform health care providers of changes (General Fund).

COMMENTS:

1. Purpose. This bill is cosponsored by Planned Parenthood Affiliates of California, NARAL Pro-Choice California, and Essential Access Health. According to the author:

Currently Medi-Cal covers abortion medication up to 70 days gestation. However, studies have shown that medication abortion for pregnancies between 71 and 77 days was equally effective as the same regimen from 64 to 70 days. By extending the time, by 7 days, that a pregnant individual can receive abortion medication under Medi-Cal, we are allowing families to make the family planning decision that is most appropriate for their life. Every single day matters when making such a major decision, and the decision should not be dependent on whether the individual has the funds or coverage to cover the medication.

There are over 8 million women eligible for Medi-Cal in the State. Individuals who are receiving the state’s health insurance benefits should be receiving the same level of access and care as those in the private insurance market.

1. Background.
   
   Medi-Cal Coverage of Abortion Services. According to the Guttmacher Institute, the 1977 Hyde Amendment prohibits the use of federal Medicaid funds for abortion, except in cases of rape, incest, or life endangerment. All state Medicaid programs must cover abortions under these circumstances, and states have the option to cover other abortions using their own funds. Abortion services are covered by the Medi-Cal program as a physician service, without regard to the gestational age of the fetus, and without medical justification or authorization. Surgical abortion is covered, as well as medical (medication) abortion. Medi-Cal also covers medical services incidental or preliminary to an elective abortion.
   
   Medication Abortion. Medication abortion is the use of pills to end a pregnancy. The U.S. Food and Drug Administration (FDA) first approved the drug mifepristone in 2000, and according to the U.S. Centers for Disease Control and Prevention, in 2020, over 50% of all U.S. abortions were medication abortions. The most common medication regimen, a protocol combining mifepristone and a second drug called misoprostol, stops the growth of the pregnancy and then causes the lining of the uterus to shed the pregnancy. The FDA approved mifepristone used in combination with misoprostol to end a pregnancy through 10 weeks gestation. This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence demonstrating its safety and efficacy.
   
   According to the FDA, once the FDA approves a drug, health care providers may prescribe the drug for a use they judge is medically appropriate for their patient, including prescribing a drug in ways and for uses different than what the FDA approved. So-called “off-label” use of drugs is legal and common. Approximately 20% of all prescriptions are written for off-label use. However, even if off-label use becomes common or becomes the standard of care to treat a condition, the FDA does not proactively update its approval or change the labeled use of a drug.
   
   Medication Abortion Clinical Guidelines and Limitations on Medi-Cal Coverage. The combination mifepristone-misoprostol regimen appears universally recognized as safe and effective through 70 days gestation. Although clinical guidelines differ on medication abortion beyond 70 days, guidelines generally recognize conditions under which medication abortion can be done safely beyond 70 days. The American College of Obstetricians and Gynecologists, American Academy of Family Physicians, National Abortion Federation, and World Health Organization have all issued guidelines recognizing the safety of medication abortion through 77 days gestation or longer.
2. Related Legislation. AB 1432 (Wendy Carrillo) applies provisions of current law requiring coverage of abortion, abortion-related services, and gender-affirming care to every group health care service plan contract marketed, issued, or delivered to a resident of this state, regardless of the site of the contract or the subscriber. AB 1432 is pending in this committee.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 11, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 576

Author:(Weber) – As Amended Ver:March 30, 2023

SUBJECT: Medi-Cal: reimbursement for abortion.

SUMMARY: Requires the Department of Health Care Services (DHCS) to update coverage policies for medication abortion. Specifically, this bill:

1. Requires DHCS, by March 1, 2024, to review and update Medi-Cal coverage policies for medication abortion to align with current evidence-based clinical guidelines.
2. Requires DHCS, after the initial review, to update its Medi-Cal coverage policies for medication abortion as needed to align with evidence-based clinical guidelines.
3. Requires, for purposes of updated coverage policies as described in 1) and 2), above, DHCS to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

EXISTING LAW:

1. Establishes the Medi-Cal Program, administered by DHCS, to provide comprehensive health benefits to low-income individuals who meet specified eligibility criteria. [Welfare and Institutions Code (WIC) § 14000 et seq.]
2. Establishes a schedule of benefits under the Medi-Cal program, which includes federally required and optional Medicaid benefits, including prescription drugs and outpatient services. [WIC §14132]

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. This bill is cosponsored by Planned Parenthood Affiliates of California, NARAL Pro-Choice California, and Essential Access Health, to ensure Medi-Cal enrollees have access to evidence-based coverage for medication abortion. According to the author, current Medi-Cal coverage policies for medication abortion only cover services through 70 days gestation. The author asserts this coverage policy is overly restrictive and does not align with the most current evidence-based guidelines as to when medication abortion can be done safely. The author concludes this bill is intended to ensure abortion services are covered when a clinical provider is following evidence-based clinical guidelines and determines the service is the best interest of the patient.
2. BACKGROUND.
   1. Medi-Cal Coverage of Abortion Services. Abortion services are covered by the Medi-Cal program as a physician service. Abortion is a covered benefit regardless of the gestational age of the fetus, and medical justification and authorization for abortion are prohibited. Surgical abortion is covered, as well as medical abortion (also called medication abortion). Medi-Cal also covers medical services incidental or preliminary to an elective abortion.
   2. Medication Abortion. Medication abortion is the use of pills to end a pregnancy. Since the U.S. Food and Drug Administration (FDA) first approved a drug called mifepristone in 2000, medication abortion has increased over time as a share of abortions nationally. According to the U.S. Centers for Disease Control and Prevention, in 2020, over 50% of all abortions were medication abortions.

The most common medication regimen, a protocol combining mifepristone and a second drug called misoprostol, works by stopping the growth of the pregnancy and then causing the lining of the uterus to shed. The FDA approved mifepristone when used in combination with misoprostol to end an intrauterine pregnancy (a pregnancy inside the uterus) through 10 weeks gestation (70 days or less since the first day of a patient’s last menstrual period). This combination regimen is generally recognized as the standard of care for medication abortion, with a large body of evidence over time demonstrating its safety and efficacy.

• 1. Use of Mifepristone Outside the FDA’s Approved Parameters. As noted, the FDA has approved the use of mifepristone under certain parameters, including through 70 days gestation. FDA approval of a drug means the FDA has reviewed an application submitted by a manufacturer for approval, including information and data from trials testing the drug’s use under certain conditions. If the FDA’s review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. According to the FDA, once the FDA approves a drug, health care providers may prescribe the drug for a use they judge is medically appropriate for their patient, including prescribing a drug in ways and for uses different than what the FDA approved. So-called “off-label” use of drugs is legal and common. According to the U.S. Agency for Healthcare Research and Quality, about 20% of all prescriptions written currently are for off-label use. There may even be clinical trials and other evidence demonstrating that a drug works well for an off-label use. However, even if off-label use becomes common or becomes the standard of care to treat a condition, this does not trigger the FDA to proactively update their approval or change the labeled use of a drug to include this new data or clinically relevant information.
  2. Legal Challenges to Abortion Access.
     1. 2022 Supreme Court Decision. On Friday, June 24, 2022, the US Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, thereby overturning Roe v. Wade, the 1973 Supreme Court decision that affirmed the constitutional right to abortion. This ruling had the effect of deferring issues of abortion rights and access to the state level, allowing states to impose restrictions on abortion rights. Consequently, abortion access in the United States now diverges starkly at the state level, with some states protecting the right to abortion, some having passed laws to ban abortion outright, and other states imposing gestational time limits or other restrictions. Although a landmark decision nationally, the ruling did not directly affect status of abortion as legal in California.
     2. Texas Lawsuit Challenging FDA Approval of Mifepristone. The Alliance for Hippocratic Medicine, a coalition of medical groups and doctors that oppose abortion, filed suit against the FDA in November 2022, alleging the abortion pill mifepristone was improperly approved, in 2000, as part of the two-drug protocol for medication abortion. Plaintiffs have filed a motion seeking a preliminary injunction to remove mifepristone from the U.S. market or limit its availability. As of March 15, 2022, the judge in the case said he would decide soon whether to issue a preliminary injunction ordering the FDA to withdraw its approval of the drug or wait for the full trial. According to legal analysts quoted in news reports, a ruling is expected soon.
  3. Medication Abortion Clinical Guidelines and Limitations on Medi-Cal Coverage. A number of evidence-based clinical guidelines have been issued on medication abortion. Although the combination mifepristone-misoprostol regimen appears universally recognized as safe and effective through 70 days gestation, guidelines differ on medication abortion beyond 70 days. However, guidelines generally recognize conditions under which medication abortion can be done safely beyond 70 days. A sample of evidence-based guidelines is shown below:
     1. American College of Obstetricians and Gynecologists (ACOG). ACOG’s medication abortion guidance applies to abortions up to 70 days of gestation. However, ACOG indicates in Practice Bulletin No. 135, published June 2013, second-trimester (beyond 12 weeks, or 84 days gestation) abortion can be safely accomplish through medication abortion, and provides dosing recommendations for second-trimester medication abortion.
     2. American Academy of Family Physicians. According to “Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion,” Medication regimens using mifepristone and misoprostol are safe and effective for medication abortion up to 77 days' gestation.
     3. National Abortion Federation. According to the 2022 “Clinical Policy Guidelines For Abortion Care,” medication abortion is a safe and effective method for termination of pregnancies beyond the first trimester (12 weeks, or 84 days gestation) when performed by trained clinicians in specified medical settings. The guidelines state, for medication abortion beyond the first trimester, that gestational age must be verified by ultrasound, prior to the termination of a pregnancy clinically estimated to be more than 14 weeks (98 days) gestation.
     4. World Health Organization (WHO). The WHO’s 2022 update to “Abortion Care Guidelines” recognizes and makes recommendations related to dosage and medical management for medication abortion both before and beyond the first trimester (12 weeks, or 84 days gestation).

Per Medi-Cal billing guidelines, a combination regimen of mifepristone and misoprostol for medication abortion is covered only for pregnancies of 70 days gestation or less. This bill would require DHCS to update its medication abortion coverage policies on a one-time basis in 2024 and regularly thereafter. It would also require DHCS, for purposes of coverage determinations, to allow flexibility for providers to exercise their clinical judgment when services are performed in a manner that aligns with one or more evidence-based clinical guidelines.

• 1. California Future of Abortion (CA FAB) Council. In September 2021, more than 40 organizations joined together to form the CA FAB Council. Sexual and reproductive health care providers, reproductive rights and reproductive justice advocacy organizations, legal and policy experts, researchers, and advocates, as well as representatives from the Office of Governor Newsom and legislative leaders, convened to identify barriers to abortion services and recommend policy proposals supporting equitable and affordable access to abortion care for Californians and all who seek care in the state. The Council cited several institutional and administrative barriers that stand in the way of reproductive freedom, including limitations on the ability to provide medication abortion in the Medi-Cal program. The Council recommended DHCS should update its Medi-Cal billing policies around medication abortion to facilitate equitable access for Medi-Cal beneficiaries using telehealth consistent with current clinical guidelines. According to the December 2021 Council report, this includes allowing abortion providers to bill for medication abortion without mandating the provision of any unnecessary ultrasounds, specified testing, or follow-up visit, and without a rate reduction that falls below the costs of providing the care.
  2. Medi-Cal Post-Public Health Emergency (PHE) Medication Abortion Policy. As part of the 2022-23 Governor’s Budget, DHCS proposed changes to policies for medication abortion for the period after the end of the federal COVID-19 PHE, which is scheduled to end on May 11, 2023. Some policy changes aligned with recommendations of the CA FAB Council. The post-PHE policy included adjustment to payments based on the scope of services rendered, allowing for ongoing use of telehealth and remote assessment, and specifying ultrasounds are not a required part of medication abortion services when not clinically indicated. As part of the post-PHE policy, DHCS indicates no change to the coverage of medication abortion through 70 days gestational age.
     

1. SUPPORT. This bill is supported by reproductive health, consumer and faith-based organizations. According to NARAL Pro-Choice California, this bill will allow families to make the family planning decision that is most appropriate for their life. According to ACOG, District IX, taking medications to terminate a pregnancy, rather than a procedure, is approved by the FDA through 70 days of gestation, and while ACOG may also have guidance suggesting medication abortion up to the 70th day, evidence also exists to support safe and effective use of medication abortion with more advanced gestations. ACOG states in support that if a provider’s professional clinical judgement suggests it appropriate for their patient to receive a safe and effective regimen for medication abortion beyond 70 days, equal treatment should apply to the reimbursement policies and coverage by Medi-Cal should be assured.
2. OPPOSITION. The California Catholic Conference (CCC) opposes this bill based on opposition to abortion generally and their belief that it takes the life of an innocent human being. CCC also opposes loosening standards for medication abortion pills, citing risk of side effects. Right to Life League opposes on similar ethical grounds.
3. RELATED LEGISLATION.
   1. AB 1194 (Wendy Carrillo) implements privacy protections for information related to accessing, procuring, or searching for services regarding contraception, pregnancy care, and perinatal care, including, but not limited to, abortion services. AB 1194 is pending in the Assembly Committee on Business and Professions.
   2. AB 1432 (Wendy Carrillo) applies provisions of current law requiring coverage of abortion, abortion-related services, and gender-affirming care to every group health care service plan contract marketed, issued, or delivered to a resident of this state, regardless of the situs of the contract or the subscriber. AB 1432 is pending in the Assembly Health Committee.
   3. SB 36 (Skinner) contains a number of provisions to protect individuals whose alleged offense or conviction is for the violation of a law of another state that authorizes a criminal penalty to an individual performing, receiving, supporting, or aiding in the performance or receipt of an abortion, contraception, reproductive care, or gender-affirming care, as specified. SB 36 is pending in the Senate Judiciary Committee.
   4. SB 385 (Atkins) allows qualified physician assistants to perform abortions by aspiration techniques without the personal presence of a supervising physician, as specified. SB 385 is pending in the Senate Committee on Business, Professions, and Economic Development.

REGISTERED SUPPORT / OPPOSITION:

Support

Essential Access Health (cosponsor)

NARAL Pro-Choice California (cosponsor)

Planned Parenthood Affiliates of California (cosponsor)

ACOG, District IX

American Nurses Association/California

California Health+Advocates

California Nurse Midwives Association

If/When/How: Lawyering for Reproductive Justice

National Association of Social Workers, California Chapter

National Council of Jewish Women CA

National Health Law Program

San Francisco Black and Jewish Unity Coalition

Opposition

California Catholic Conference

Right to Life League

Analysis Prepared by: Lisa Murawski / HEALTH / (916) 319-2097