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Health Care

PATIENT PROTECTIONS & WOMEN'S HEALTH:

THE PATIENTS' BILL OF RIGHTS ACT (S. 6/ H.R. 358)

Issues of Particular Concern to Women

WOMEN-SPECIFIC CRITERIA PATIENTS’ BILL OF RIGHTS ACT

Are plans required to provide a full range of health care services to meet women’s needs? 1

No

Are plans required to allow women to choose a provider trained to meet women’s particular health care needs (such as ob-gyns or geriatricians) as their primary care providers?

Plans that require or allow enrollees to designate a participating primary care provider must permit a female enrollee to designate a participating physician who specializes in obstetrics and gynecology.

Otherwise, plans are only required to permit each enrollee to receive primary care "from any participating primary care provider who is available to accept" such enrollee. The bill also contains provisions concerning the use of specialists as primary care providers under certain circumstances.

Are plans required to allow women direct access to ob-gyn services, without referral, regardless of whom they choose as their primary care provider?

Direct access to health care professionals specializing in obstetrics and gynecology must be allowed for "routine gynecological care (such as preventive women’s health examinations) and pregnancy-related services."

Are plans required to include in their network community-based providers that traditionally serve women, such as family planning clinics, particularly if the plan serves low-income women?

Plans are required to include in their network federally qualified health centers, rural health clinics, migrant health centers, and "other essential community providers" that are located in the service area "if necessary to meet" the adequacy of network provision set out in the bill.

Are plans required to have mechanisms in place to ensure continuity of care for members (including pregnant women) who are undergoing a course of treatment when the provider or the member leaves the plan?

Plans are required to ensure continuity with the same provider for enrollees "undergoing a course of treatment" when the provider leaves the plan or the enrollee’s employer changes plans. Care is to be continued for at least 90 days. The transitional period for institutional or inpatient care extends until discharge. Pregnant women who have begun the second trimester must be permitted to receive care from the same provider through the post-partum period. People with terminal illnesses must be permitted to receive care directly related to the terminal illness from the same provider for the remainder of their life.

Are plans prohibited from putting arbitrary limits on the manner in which services are provided if the treatment is a covered benefit? 2

Plans may not "arbitrarily interfere with or alter the decision of the treating physician regarding the manner or setting in which particular services are delivered if the services are medically necessary or appropriate for treatment or diagnosis to the extent that such treatment or diagnosis is otherwise a covered benefit." The bill defines "manner or setting" as "the location of treatment, such as whether treatment is provided on an inpatient or outpatient basis, and the duration of treatment such as the number of days in a hospital."

Are plans prohibited from discriminating against members or providers (or potential ones) on the basis of sex, race, color, national origin, language, religion, age, sexual orientation, socio-economic status, genetic make-up, source of payment, health status, perceived health status, anticipated need for health services?

Plans are prohibited from discriminating against enrollees in the delivery of health care services on the basis of race, color, ethnicity, national origin, religion, sex, age, mental or physical disability, sexual orientation, genetic information, or source of payment.

Plans are prohibited from discriminating against providers based on race, color, religion, sex, national origin, age, sexual orientation, disability (consistent with the Americans with Disabilities Act of 1990), or the provider’s license or certification.

Plans are also prohibited from using a high-risk patient base or location of a provider in an area with residents in poorer health as a basis for excluding providers from the network.

Are plans required to adopt mechanisms to ensure confidentiality -- which can be particularly important to women seeking sensitive services, including reproductive health services and mental health services?

The bill requires plans to establish procedures to safeguard the privacy of individually identifiable information and to assure timely access of individuals to their medical records. (No details are provided; this topic is expected to be addressed thoroughly in separate legislation.)

Are plans required to provide exceptions to any prescription drug formulary when the treating professional concludes that a particular drug (or combination of drugs) is medically necessary or appropriate for the patient in question, such as cases where formulary drugs have been ineffective or are contra-indicated for a particular patient? 3

"Consistent with the standards for a utilization review program," plans must "provide for exceptions from the formulary limitation when a non-formulary alternative is medically indicated."

Are plans prohibited from denying access to clinical trials or discriminating against members because of their participation in clinical trials?4

Plans are prohibited from denying a member participation in a clinical trial; denying, limiting, or imposing additional conditions on the coverage of routine patient costs furnished in connection with participation in a trial; and discriminating against members because of their participation in a clinical trial.

Are plans required to ensure that premiums, deductibles, and co-payments are affordable? 5

The bill contains three provisions dealing with the financial burden on enrollees:

(1) enrollees who seek emergency care from a nonparticipating provider cannot be required to pay more out-of-pocket than if such services had been provided by a participating health care provider; (2) providers who provide transitional coverage to enrollees after the provider leaves the plan cannot require the enrollee to pay more out-of-pocket than would have been required if the provider had not left the plan; and (3) if a plan refers a member to a nonparticipating specialist, services must be provided at no additional cost to the individual beyond what the individual would have paid for services provided by a participating specialist.

Are plans required to have a system for reviewing plan treatment and coverage decisions that provides for independent outside review?

The bill provides for external review of decisions when: (1) the amount in dispute exceeds a significant threshold; or (2) the patient’s life or health is jeopardized (including, in the case of a child, development) as a consequence of the decision.

Entities that conduct external reviews must be certified by the state or the Secretary of Labor, and are subject to conflict of interest requirements to promote unbiased decisions.

Review entities must use "clinical peers" to conduct reviews. Clinical peers are defined as a physician or other health care professional who is appropriately credentialed in the same or similar specialty as typically manages the condition, treatment, or procedure under review; only physicians may be a clinical peer with respect to review of a decision by a physician.

The bill also includes explicit due process guarantees (e.g., written notice and opportunity to be heard) and time frames for making decisions.

Are plans required to have a system for reviewing plan treatment and coverage decisions that provides for independent outside review?

The bill provides for external review of decisions when: (1) the amount in dispute exceeds a significant threshold; or (2) the patient’s life or health is jeopardized (including, in the case of a child, development) as a consequence of the decision.

Entities that conduct external reviews must be certified by the state or the Secretary of Labor, and are subject to conflict of interest requirements to promote unbiased decisions.

Review entities must use "clinical peers" to conduct reviews. Clinical peers are defined as a physician or other health care professional who is appropriately credentialed in the same or similar specialty as typically manages the condition, treatment, or procedure under review; only physicians may be a clinical peer with respect to review of a decision by a physician.

The bill also includes explicit due process guarantees (e.g., written notice and opportunity to be heard) and time frames for making decisions.

Does the bill give consumers the legal right to hold health plans accountable for the decisions the plans make?

Yes, by pursuing claims for damages by personal injury of wrongful death under state law. The bill defines "personal injury" as "a physical injury and includes and injury arising out of the treatment (or failure to treat) a mental illness or disease."

Are plans required to use evidence-based clinical guidelines that address gender differences in presentation, diagnosis, and treatment? 7

Utilization review programs must meet certain standards, including the use of written clinical review criteria that take into account gender-specific criteria.

Are plans required to have a structured quality improvement system in place that monitors, measures, and reports on clinical issues relevant to women?

The quality assurance program must include gender-specific quality criteria "where available and appropriate."

Are plans required to have a structured quality improvement system in place that monitors, measures, and reports on underutilization and overutilization of services? 8

The bill does not explicitly address under- and overutilization.

Are plans required to collect (and report) data by gender and collect (and report) data about clinical issues that are important to women?

The Secretary is to specify a minimum uniform data set (to be collected by plans) that must include "data on quality indicators and health outcomes ... on a gender-specific basis."

Are plans required to have family-friendly policies (such as evening and weekend hours, locations near public transportation, and child care) that would make it easier for women to obtain care for themselves and their families?

No

Additional Issues That Need To Be Addressed

GENERAL CRITERIA

PATIENTS' BILL OF RIGHTS ACT

Are plans required to provide (without preauthorization) access to emergency services under the prudent layperson standard?

Yes, if the plan provides coverage for emergency services.

Are plans required to allow members access to a second opinion?

No

Are plans required to allow members access to out-of-network providers (at no additional cost) when the plan is unable to provide timely or appropriate services through in-network providers?

Yes

Are plans generally required to have a quality improvement system in place?

Yes

Are plans required to have a quality improvement system that undergoes a periodic review by an independent, external reviewer?

No

Are plans prohibited from compensating providers in a manner that may lead to the denial or withholding of medically necessary or appropriate care (including referrals)?

The bill extends provisions already applicable to Medicare and Medicaid plans to the private sector plans covered under this bill. The efficacy of the provisions in current law are a matter of some debate.

Are plans prohibited from interfering with medical communications between providers and patients?

Yes

Are plans prohibited from compensating reviewers in a manner that may lead to the denial or withholding of medically necessary or appropriate care (including referrals)?

Yes

Are plans required to provide full, complete, and readable disclosure of benefits, exclusions, cost-sharing arrangements, and plan structures/processes?

Yes

Are plans required to deliver health care in a manner that is geographically, culturally, and linguistically accessible?

The network adequacy provision requires that covered services be "accessible in a timely manner." The information disclosure provision requires a description of how the plan addresses the needs of non-English speakers and those who have other special communication needs.

Does the bill give consumers the legal right to hold health plans accountable for the decisions the plans make?

Yes, by pursuing claims for damages for personal injury or wrongful death under state law. The bill defines "personal injury" as "a physical injury and includes an injury arising out of the treatment (or failure to treat) a mental illness or disease."

Does the bill establish an adequately funded, independent consumer ombuds program to assist consumers in choosing a health plan and addressing problems with their plan?

The bill creates a grant program to allow states to establish an ombuds program through a contract with a non-profit organization that operates independent of health plans. The bill authorizes appropriations to provide grants to the states for this purpose. The federal government is authorized to establish and maintain an ombuds program (through contract with a non-profit organization) for states that do not establish such a program.

If the bill creates an official role for accreditation or certification by outside bodies, is HHS (or DOL) required to independently determine whether any such outside body’s accreditation standards meet or exceed federal standards?

Plans are deemed to meet certain quality assurance requirements if accredited by a national organization that the Secretary "certifies as applying, as a condition of certification, standards at least as stringent as those required" under the bill.


ENDNOTES

1.Women need access to a full range of health care services -- from preventive care such as osteoporosis screening and family planning services to treatment for acute, chronic, or disabling conditions such as heart disease, cancer, arthritis, and depression. Many plans do not cover prescription contraceptives, even though they cover other prescription drugs.

2. This type of requirement is intended to address practices like outpatient mastectomies, where plans put arbitrary limits on inpatient stays (or length of stays) that are not based on the particular needs of the patient.

3.Plans often limit the drugs health care providers can prescribe to those on a plan-approved list, called a formulary. What is and is not on the list can make a big difference for women, especially older women, because they use more prescription drugs than men. Historically, when a drug was tested on men and deemed safe, it was then automatically assumed to be equally safe and effective for women. We now know that men and women respond to some drugs quite differently. By not allowing a provider sufficient flexibility to order the drug that may best meet a woman's needs, health plans jeopardize her health and, in some cases, her life.

4.Until recently, women and minorities were routinely excluded from participation in clinical trials, and research into diseases that primarily affect women was almost non-existent. Clinical research on women-specific diseases, such as breast and ovarian cancer, is essential to finding more effective treatments. It is equally critical that clinical research explore the differences in the way common diseases appear in women and men, and the differences in how women and men respond to individual drugs or treatments. Health plans should not stand in the way of advancing research into women's health by prohibiting participation in clinical trials or otherwise discriminating against women who participate in them. Nor should they deny coverage for medical expenses incurred in connection with clinical trials that they would otherwise routinely cover.

5.Because women use more health services and generally have lower incomes than men, affordable care is especially important to them. Women also have higher out-of-pocket costs than men, in part because health plans often do not cover the services women need, such as prescription contraceptives. As employers pass on a greater share of health care costs to employees, an increasing number of the poorest workers are declining health care coverage due to cost.

6. Many providers still practice medicine based on the traditional male model of biology and disease. Yet, gender plays a leading role in many health issues -- from the types and prevalence of diseases women experience to their symptoms to the treatments that are most appropriate for them. One alarming example points to the need for training in women's health: a 1998 Gallup poll revealed that nearly 2/3 of primary care physicians wrongly believe there is no difference in men's and women's heart disease symptoms. Health plans can play a pivotal role in advancing the practice of gender-based medicine, and they should make sure women have access to both primary care and specialty providers who are trained to meet their particular health care needs.

7.Health plans use rules known as clinical practice guidelines to direct providers in selecting treatments and to help plans determine what treatments or services to cover. Given gender differences, plans should base decisions about treatment and coverage on gender-specific medical evidence rather than on cookie-cutter rules that best fit the average male's health profile. The plan's clinical practice guidelines should be developed by knowledgeable experts and specialty groups, not the plan's accountants.

8.In this era of cost-consciousness, women are particularly at risk of not being appropriately treated for conditions like heart disease for which women already tend to receive less aggressive treatment than men. As a result, women can benefit from efforts to measure underutilization of such services. By measuring overutilization, women will benefit from efforts to measure the excessive use of procedures like hysterectomies.


Take action today! Send a letter to encourage your Senators and Representative to support the Patients' Bill of Rights Act (S. 6/H.R. 358).

Click here for more information on the Patients' Bill of Rights Act (S. 6/H.R. 358).



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