Early Options: Administrative and Regulatory Issues

Early Options - A Provider's Guide to Medical Abortion

This page contains the following sections:

Supplies, Including Acquisition of Medications
Laboratory and Other Services
Quality Assurance and Quality Improvement
OSHA Requirements
The Cost of Providing Medical Abortion
Malpractice Insurance
Billing and Reimbursement
Reporting Medical Abortion
Public Awareness
Security

Supplies, Including Acquisition of Medications
Offices that currently offer reproductive health services will likely have on hand many of the supplies necessary to deliver medical abortion care. Figure 2 details a list of suggested supplies for medical abortion providers. Click here to view Figure 2.

Depending on the regimen used, the initial medication for medical abortion may be either mifepristone administered orally or methotrexate administered intramuscularly or orally.

Mifepristone can be obtained only through specific distributors. It is distributed directly to physicians who have submitted required documentation, including the FDA-required Mifeprex® Prescriber's Agreement, available from the Danco Laboratories, LLC website (www.earlyoptionpill.com). The Prescriber's Agreement outlines the qualifications and guidelines for use of mifepristone.

Methotrexate and misoprostol can be obtained through a variety of suppliers and through pharmacies. Because some women and providers have encountered difficulty with pharmacists refusing to dispense misoprostol as prescribed for medical abortion, some providers, depending on regulations, have chosen to dispense misoprostol directly to women for home administration so that women do not need to fill a prescription at a pharmacy. National Abortion Federation (NAF) members can order all of these medications through NAF's Group Purchasing Program.

Laboratory and Other Services
Laboratory and/or ultrasound diagnostic services do not need to be available in the office in order to provide medical abortion. However, facilities that do not have an on-site laboratory or ultrasound equipment can, if necessary, work out a collaborative relationship to ensure access to these services. At a minimum, the laboratory should provide Rh typing, hematocrit or hemoglobin levels to check for anemia or significant blood loss, urine human chorionic gonadotropin (hCG) assays to confirm the diagnosis of pregnancy, and serum ß-hCG levels when clinically indicated.

With regard to ultrasound, even in those settings where ultrasound use is not routine, this imaging study should be available as a diagnostic aid whenever gestational age or the outcome of the abortion is uncertain or ectopic pregnancy is suspected.

As mentioned earlier, about 2% to 5% of medical abortion patients will require surgical evacuation of the uterus to complete the abortion or, rarely, to control excessive bleeding.^3,4 Practices that do not perform vacuum aspiration will need to establish a referral agreement to ensure the availability of surgical backup.

With any collaborative agreements, it is important for the collaborating practice to be sensitive to the confidentiality and privacy needs of patients, and to use appropriate terminology (for instance, when discussing ultrasound findings with patients).

After reading this section, you should be able to answer the following question:
What do quality assurance and quality improvement standards establish?

Quality Assurance and Quality Improvement
The basic principles of quality assurance and improvement for medical abortion are similar to those for vacuum aspiration and other medical procedures. Facilities must adopt clear systems to ensure a high degree of medical accountability. Guidelines and standards should be established regarding individual responsibilities and scope of practice. This measure is particularly important where nonclinical staff will play a role. These documents should be readily accessible in the clinical setting, periodically reviewed with the staff, and updated to reflect evolving needs.

Secure storage of medication is essential. Medications should be logged, kept in a locked cabinet (or double-locked in the case of controlled substances), and inventoried monthly.

Designated staff should maintain records of complications, and these data should be analyzed periodically to discern trends. This process will help identify unusual practice patterns that require attention and may indicate the need for additional training or other changes.¹¹ An "action plan" for improvement can thus be developed and implemented.

Quality control checks must be performed on all laboratory equipment. Practices with on-site laboratories will need to comply with the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Each organization (e.g., hospital or Planned Parenthood clinic) may have additional specific guidelines for checking equipment. Every state designates an agency that is responsible for administering CLIA regulations within that state. These state agencies are the first resource for questions regarding CLIA.

Click here to check your understanding.

After reading this section, you should be able to answer the following question:
What do OSHA regulations require?

OSHA Requirements
The U.S. Occupational Safety and Health Act (OSHA) requires that workplaces be free from recognized hazards that may cause death or serious physical harm to employees. During the course of providing medical abortion services, employees may be exposed to blood and other biological fluids that are potential sources of infection from infectious pathogens, particularly hepatitis B, hepatitis C, and human immunodeficiency virus. Appropriate precautions are required to minimize or prevent transfer of infectious pathogens resulting from the splashing, spraying, or splattering of body fluids.

Providers should review and have on file the Materials Safety Data Sheet (MSDS), available from a chemical's manufacturer, for any potentially hazardous chemicals used in the provision of medical abortion, and should comply with the safety protocols included in the MSDS. For instance, the MSDS for methotrexate specifies among other things that two pairs of latex exam gloves or rubber gloves should be worn to prevent contact with the skin.

Additionally, providers of medical abortion should review biomedical waste protocols and OSHA standards to ensure compliance in this area. Employers must institute infection control plans that include employee and job classifications, staff training and education, appropriate engineering controls, identification and proper disposal of medical waste, vaccination programs, and record-keeping. A biomedical waste protocol will also be necessary if there will be exposure to potentially infectious bodily fluids (e.g., blood, products of conception) in a facility. Facilities affiliated with larger institutions (e.g., hospitals and Planned Parenthood Federation of America) should follow institutional policies.

The local health department or the regional OSHA office can supply information about local requirements for compliance. The National Abortion Federation has published a resource, available to members, outlining CLIA regulations and requirements as well those of the Occupational Safety and Health Administration.

On a related note, some states have specific regulations in place regarding the examination of fetal tissue after an abortion or regarding the disposal of fetal tissue. The applicability of these regulations to medical abortion is largely a matter of interpretation, and may vary depending on the precise wording of the regulations. Certainly, in many cases (for instance if a woman is using misoprostol and passing pregnancy tissue at home), tissue examination laws as applied to medical abortion are vulnerable to legal challenge. Providers should consult with counsel regarding this issue.

Click here to check your understanding.

The Cost of Providing Medical Abortion
The total cost of providing medical abortion comprises several components, including staff compensation. There are many models for providing medical abortion services, with some practices utilizing a range of personnel (e.g. counselors, nurse-midwives, nurse practitioners, physician assistants, physicians) for different components of the medical abortion process, and others utilizing a clinician for the entire service. Personnel costs include not only staff who will see the patient during her routine office visits, but also staff who will provide on-call coverage and back-up vacuum aspiration in the few cases when that is necessary.

To quantitatively assess the costs of professional services required to provide this procedure, Picardo and colleagues¹¹ compared the personnel costs of providing medical abortion with mifepristone/misoprostol with the personnel costs of manual vacuum aspiration. The mifepristone/misoprostol regimen employed in this study included home rather than office administration of misoprostol. They considered three different staffing models with varying associated personnel fees and concluded that medical abortion costs less to provide than manual vacuum aspiration in terms of personnel costs. A more recent survey similarly found lower indexed staff costs for medical abortion compared to surgical abortion ($122 vs. $127).⁹ Staff costs, however, are not the only factor involved in costing out medical abortion services.

Other expenses involved in medical abortion include the cost of medications and other supplies and laboratory tests. Some practices may also incur costs associated with purchasing ultrasound equipment or equipment for providing surgical backup services if they do not already have this equipment and will be offering these services rather than referring out for them. Finally, a practice should research any possible adjustments in their malpractice insurance costs (see "Malpractice Insurance" below) and other insurance costs, and, possibly, the costs of making modest modifications to the physical facility. Security needs may introduce additional costs.

In the case of mifepristone, since data support the safety and efficacy of regimens involving 200 mg rather than 600 mg of mifepristone, utilizing these regimens can reduce costs associated with the purchase of mifepristone without affecting safety or effectiveness.

Malpractice Insurance
Most malpractice insurers require notification of any "material change" in the insured's practice. For those already providing vacuum aspiration and other abortion services, the addition of medical abortion services would probably not require notification. However, for clinicians offering abortion services for the first time, this change in clinical services could be construed as a material change in practice. The most prudent course of action is to notify the insurance carrier if there is any doubt about malpractice coverage.

Billing and Reimbursement
The American Medical Association has not designated a universal Current Procedural Terminology (CPT) code specific to medical abortion. As a result, the clinic staff will need to contact insurers to determine if coverage will be approved and which codes to use.

In states that provide Medicaid coverage for abortions, an administrator or other clinic personnel should ascertain which codes to use for the service. Most state Medicaid programs have developed their policies for medical abortion reimbursement.

Private insurance companies that provide coverage for surgical abortions are nearly universally covering medical abortion as well, and in some cases they have designated billing codes for this procedure. Most private insurance companies that cover abortion have reimbursement policies for medical abortion. As with other services, it may be wise for the provider to verify coverage before initiation of the service.

Providers who have entered into successful contracts with health maintenance organizations (HMOs) to provide surgical abortion services to their members can explore similar arrangements for medical abortion as well. The website for Danco Laboratories, LLC (www.earlyoptionpill.com) has updated state-by-state information about reimbursement for abortions with mifepristone.

In many instances, current providers of medical abortion charge a fee similar to that charged for early surgical abortion. As is the case with other clinical services, charges for medical abortion will be based on the staff time required, the components of the service (e.g., laboratory testing and ultrasonography), the cost of the medications, and administrative costs.

Reporting Medical Abortion
The only way to determine the incidence of medical abortion, or if it has an impact on the morbidity and mortality associated with abortion procedures, is by accurate monitoring of all legally induced abortions. Forty-six states require reporting of abortions to the state.¹³ Providers use the same form that is used for surgical procedures; reporting forms of 29 states include a category for medical (nonsurgical) abortion procedures. Most states then submit their data to the Centers for Disease Control and Prevention, which generates an annual report on abortions performed in the United States.

Additionally, the Prescriber's Agreement for Mifeprex® also requires providers to report adverse events, such as a continuing pregnancy not subsequently terminated surgically, hospitalization, and transfusion, to Danco Laboratories, LLC using the tracking code on the package. As such, all offices must have a system in place for such reporting.

Public Awareness
In the years since mifepristone's approval, the majority of practices that previously offered surgical abortion have integrated medical abortion into their practice, and some practices without prior experience in abortion care have also initiated this service.

In terms of the percentage of women who choose this option, data from experiences in countries in Europe where mifepristone has been available since the late 1980s and early 1990s indicate that more than half of the abortions within the gestational age limits during which mifepristone is offered are provided using mifepristone in Sweden (51%), France (56%), and Scotland (61%), while in England and Wales only 18% of eligible patients use mifepristone.¹⁴ Generally, the proportion of mifepristone abortions has increased slowly over time. Of note, there is substantial regional variation within these countries in terms of the use of mifepristone, with a high proportion of mifepristone abortions in some areas, and quite low usage in others. In the U.S. the percentage of women choosing medical abortion vs. vacuum aspiration also varies significantly from practice to practice.¹⁵

Clinicians and administrators considering whether to provide medical abortion may want to assess the extent of existing reproductive health care services in their area and gauge the demand for medical abortion. Facilities already providing surgical abortion can contact referral sources to develop a sense of public awareness of medical abortion and the potential reception of this service.

Efforts to inform the public about the availability of medical abortion services in the community can be ambitiously prominent or subdued and low-key. A practice may choose to publicize the availability of this service only to its existing patients through word of mouth or displays of educational materials within the office or clinic. More prominent marketing can include advertising in the Yellow Pages, in newspapers and magazines, and on the radio. Press releases, referral letters, and the creation of a website (or additions to an existing website) are other options for letting the public know about this service.

Providers offering medical abortion services should expect to receive calls from a number of interested women as soon as they initiate efforts to inform the public. Therefore, all clinical and administrative preparations for service delivery should be finalized before informing the public about the availability of medical abortion.

Security
As in the case of surgical abortion, providers of medical abortion should address issues of security for their facilities, staff, and patients. First-time providers and staff should consider the impact this new role and the attendant security issues will have on both their practices and their day-to-day lives.

The security needs of medical abortion providers will depend on many factors, including the size and resources of the facility as well as the degree of anti-abortion activity in that particular community. Figure 3 provides an overview of security equipment and protocols to consider. Click here to view Figure 3.

The National Abortion Federation (NAF) provides a range of valuable resources for administrators who are dealing with security issues. These resources include printed materials, individual consultation services, and site evaluations.

Proceed to Resources for Medical Abortion Providers.

References for this module