Proposed HHS regulations seek to protect provider conscience -- at the expense of patient access to care. Testimony submitted to the President's Council on Bioethics examines the harmful ramifications these regulations could have.

Editor’s Note: The following is excerpted from written testimony submitted by Lois Uttley, director of the MergerWatch Project, to the President’s Council on Bioethics, which is meeting Thursday and Friday of this week. Lois’s testimony concerns the harmful implications of proposed Dept. of Health and Human Services regulations regarding provider conscience, and puts forward alternative regulations that would protect patients’ conscience and access to care.

Recently, a great deal of public attention and public policy

has been focused on protecting the religious and ethical beliefs of health

providers. As your council discusses this issue, I urge you to consider another

imperative – protecting the rights of patients to receive accurate medical information

and needed treatment in a timely manner. In a pluralistic society such as we

have in the United States,

public policy must carefully balance the needs and rights of all affected parties.

Let’s use an example to make this discussion very concrete:

A 19-year-old rape victim – let’s call her Sally

— is brought to a hospital emergency department by the police. The physician

who treats her numerous injuries – Let’s call him Dr. Brown — omits any

mention of the potential to prevent pregnancy from the rape by using emergency

contraception, because he does not approve of it for religious reasons. Many

hours later, Sally leaves the hospital without being informed about emergency

contraception, or offered the medication. A friend takes her back to the

college dorm where they live and Sally, exhausted, falls asleep for 24 hours. Because emergency contraception is the most effective

when taken shortly after unprotected intercourse, Sally’s opportunity to

prevent pregnancy has now been greatly diminished. Sex. Abortion. Parenthood. Power. The latest news, delivered straight to your inbox. SUBSCRIBE

What has just happened? Is this proper medical care? What

are Sally’s rights? What are Dr. Brown’s? And, how should they be properly

balanced?

The patient’s rights

Let’s start with Sally. After all, the patient is supposed to be the focus of what the health professions now refer to as "patient-centered care." According to the Institute of Medicine, "patient-centered care is defined as health care that establishes a partnership among practitioners, patients and their families (when appropriate) to ensure that decisions respect patients’ wants, needs and preferences and solicit patients’ input on the education and support they need to make decisions and participate in their own care."

One of the central tenets of patients’ rights and

"patient-centered care" is the right to informed consent. For a patient to make

an informed decision about medical treatment, he or she must have knowledge of all

potential treatment options, and their risks and benefits. In this case, the

rape victim has not been informed about an important potential treatment option

– use of emergency contraception to prevent pregnancy. As it happens, Sally is

one of the millions of American women of reproductive age who are not aware of

EC. So, Sally has had no opportunity

to consider this option or use her own moral, ethical or religious perspectives

to decide whether she wishes to risk the chance of bearing the child of a

rapist. Further, she has had no chance to discuss with her physician the

potential medical complications of an unplanned pregnancy, in view of her existing

medical conditions, which include diabetes.

How could this violation of patients’ rights be corrected? The

simplest method would be to require all hospital emergency department

personnel, including Dr. Brown, to always offer EC to rape victims who are of

reproductive age.

Physicians’ rights

and responsibilities

But now, let’s focus on Dr. Brown. A fundamentalist Christian,

he believes that emergency contraception is the same thing as abortion, even

though medical and scientific experts say that is untrue and the FDA has stated

unequivocally that emergency contraception prevents pregnancy and does not

cause an abortion.

Dr. Brown argues that requiring him to give emergency

contraception to Sally would violate his religious beliefs. "I shouldn’t have

to give up my religious freedom in order to be a doctor," he says.

Let’s pause for a moment to consider whether personal

beliefs that are unsupported by or unrelated to medical science should be

considered valid reasons why a licensed medical professional should be

permitted to refuse to provide needed medical care, especially in an emergency

situation in a facility that serves the general public. How far should we allow

Dr. Brown or one of his colleagues to go with such claims? If Dr. Brown also

believes that AIDS is a just punishment from God for perverted behavior, should

he be allowed to refuse to treat any

patients with AIDS? What if one of his colleagues believes that under Islamic

law, anyone who committed murder

should be sentenced to death? Should he be permitted to refuse to treat

suspected murderers who are brought to the emergency room for treatment of

wounds suffered in the attack? Where would we draw the line between acceptable

and unacceptable moral reasons for refusing to provide care?

In the interests of moving our analysis along, however,

let’s set that issue aside and see if there is a compromise we could arrive at

that would permit Dr. Brown to refuse to give EC to Sally, while still ensuring

that she gets the medication in a timely manner. What if we just require Dr. Brown to refer

Sally to another physician or a nurse in the emergency department who could inform

her about EC and provide her the medication if she wishes to use it?

That, too, is unacceptable, Dr. Brown says, because it

requires him to cooperate in helping the patient receive treatment he finds

morally objectionable. "I cannot be implicated in any way in helping her commit

an immoral act," he states.

One could argue that Dr. Brown’s professional responsibilities

to his patient should obligate him to provide Sally with at least a referral in

such a situation. But, under a proposed "Provider Conscience Regulation" issued

by the U.S. Department of Health and Human Services (HHS) on August 26, 2008,

no entity receiving federal funding (such as the hospital where Dr. Brown works)

could require him to give Sally the medical information or referral she needs

if he claims a religious objection. To attempt do so would be to "discriminate"

against him, and could result in the loss of federal funding, according to the

rule. Not a single other physician or

nurse in the hospital could be required to step in and give Sally what she

needs, if that health professional held the same views as Dr. Brown.

Moreover, HHS has proposed a very expansive definition of the

term "assist in the performance of" to permit refusals for "participation in any activity with a reasonable connection to the

objectionable procedure, including referrals, training and other arrangements

for offending procedures." Arguably, this definition would permit a pharmacy

technician to refuse to stock emergency contraception in the hospital pharmacy,

or a hospital purchasing agent to refuse to order it. Again, we face the

question of where we should draw the line between acceptable and unacceptable

refusals. The proposed HHS rule would seem to draw no line at all, instead

allowing medical professionals and hospital personnel to use personal moral or

religious beliefs to exempt themselves from any

medical obligations to their patients.

Let’s consider another alternative – requiring the hospital

to be responsible for ensuring that Sally’s rights as a patient are protected.

Hospital responsibilities

Arguably, the hospital should

already be responsible for ensuring that Sally’s medical needs are met. In

order to participate in the federal Medicare program, and to be reimbursed

under the Medicaid program, hospitals must adhere to "Conditions of

Participation." These conditions are meant to ensure that patients’ rights are

respected and they received medically appropriate care. For example, hospitals

are required to:

"Honor a patient’s right to make informed

decisions regarding his or her medical care."

decisions regarding his or her medical care." "Meet the emergency needs of patients in

accordance with acceptable standards of practice."

accordance with acceptable standards of practice." "Have pharmaceutical services that meet the

needs of patients."

But since the Medicaid/Medicare Conditions of Participation has

not yet been enforced to require the provision of EC to rape victims, a

number of states have enacted so-called EC in the ER or Compassionate

Care for Rape Victims laws. These statutes specifically require

hospitals to offer emergency contraception to rape victims, or, at

minimum, inform rape victims about the potential to use the medication

to prevent pregnancy.

How should the hospital go about fulfilling these

responsibilities for patients like Sally? Should administrators fire Dr. Brown

and replace him with someone who will dispense EC to rape victims? No, that

would not be the preferable way of dealing with this situation, because there

are far less drastic options available.

Instead, the hospital could offer Dr. Brown a transfer out

of the ER into another unit of the hospital where he would not be expected to

dispense EC, and replace him in the ER with someone who has no objections to

EC. Such an arrangement would be an example of a "reasonable accommodation"

under Title VII of the Civil Rights Act of 1964, which requires employers to

reasonably accommodate an employee’s religious beliefs or practices, unless doing

so places an "undue hardship" on the employer’s business. This type of careful balancing

of competing rights is a hallmark of American public policy.

But, Dr. Brown might argue that he is being discriminated

against even by such a reasonable accommodation, because it removes him from

the practice of emergency medicine, which he sees as his mission in life. The

proposed HHS rule might give him ammunition to do so, because it lacks any attempt to balance his rights with the patients’

rights and the obligation of the hospital to serve its patients.

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HHS Secretary Michael Leavitt, in a press conference to

release the department’s proposed rule, went so far as to frame the issue this

way: ""Freedom of conscience is not to be surrendered upon issuance of a

medical degree." He told reporters, "This is about protecting the right of

a physician to practice medicine according to his or her moral compass."

Is there another solution? How about requiring the hospital

to have a routine protocol of offering EC to all rape victims, and designating

someone on each shift who does not object to EC to step in, inform the patient

about EC and offer it? This surely would be somewhat cumbersome, and would

require careful management of hospital staffing schedules. It also would

require that Dr. Brown and any other hospital emergency department personnel

who have objections to dispensing EC disclose those objections up front, so

that hospital administrators can make appropriate scheduling decisions.

Religious hospital

claims to "conscience" rights

But what if the hospital as an institution operates under a religious

doctrine that expresses grave reservations about the use of emergency

contraception? Let’s put Dr. Brown and Sally in the emergency department of St.

Mary’s Roman Catholic Hospital. Like other Catholic hospitals, it is governed

by the Ethical and Religious Directives

for Catholic Health Care Services (ERDs), which offer guidance about EC that has been interpreted in a variety of ways. Some

Catholic hospitals provide EC to all rape victims. Some administer a pregnancy

test, even though such a test would only be able to detect a pregnancy that was

established prior to the rape (and if the woman is already pregnant, she does

not need EC). Some require the rape victim to undergo an ovulation test. If the

test comes back positive, EC is denied because of the hypothetical possibility

that there might be a fertilized egg in existence. Still other Catholic

hospitals refuse to offer EC at all.

St. Mary’s Hospital, as it

happens, is one of the Catholic hospitals that refuse to allow any dispensing

of EC. Moreover, the hospital does not permit staff to even discuss EC with

patients like Sally, citing another two of the ERDs.

Under a new state law taking effect in six months, St.

Mary’s and all other hospitals in this state (including Catholic ones) will be

required to offer EC to rape victims. Dr. Gray, a colleague of Dr. Brown’s in

the emergency department, is happy about the new law, because he believes it is

his professional and ethical obligation to serve the patient’s medical needs,

and he wants to be able to offer EC to patients like Sally. He is upset about

what he views as the hospital’s violation of his rights to use his own ethical

beliefs and his medical training in deciding how to treat patients. (The

proposed HHS regulation, it should be noted, does not seem to protect

physicians like Dr. Gray, who wish to provide

medical treatment, not refuse it, but

are stymied by institutional religious restrictions.)

St. Mary’s, which opposed the new law, hopes to argue that since

it considers emergency contraception to be an abortifacient, it cannot be

compelled to obey the law. Administrators of St.

Mary’s plan to cite the proposed HHS rule which, in seeking to enforce

compliance with a longstanding federal law allowing federally-funded hospitals

to refuse to perform abortions or sterilizations, seems to leave the definition

of abortion open to interpretation.

The regulation, as promulgated, dropped a definition of

abortion that had appeared in an earlier draft that had attempted to conflate

contraception with abortion by including anything

that could interfere with a fertilized egg. But, as the Washington Post

reported, supporters and critics alike agreed that the language remains broad

enough to apply to contraceptives. HHS

Secretary Leavitt, in response to reporters’ questions about the proposed rule,

acknowledged that there was no definition of abortion and that some medical

providers may want to "press the definition" and make the case that some forms

of contraception are tantamount to abortion, according to the Wall Street

Journal.

Does this mean that state health officials who try to

enforce the new state law at St. Mary’s – in order to ensuring that all rape

victims are offered emergency contraception — might risk being found guilty of

"discrimination" against St. Mary’s? Could the state lose all of its federal

health funding as a result? Is that really the outcome we should be seeking in

federal policy?

If St. Mary’s were to be successful in its claim, what would

happen to rape victims who need emergency contraception? Should they be

expected to go to drugstores to buy it, even though they have just suffered a

traumatic attack, may have had their clothes torn and may have been robbed of

their purses, their money and their car keys? What if the local pharmacy also

objects to emergency contraception? The proposed HHS rule, which purports to be

about protecting health providers from having to perform abortions and

sterilizations, extends provider conscience protections to pharmacies (and

also, it should be noted to a wide variety of other health care institutions,

including nursing homes and dentists offices).

Should rape victims be expected to leave St. Mary’s and go

to a different hospital, again in a traumatized state? What if St. Mary’s is the only local hospital?

Conclusions

To hear HHS Secretary Leavitt and his colleagues tell it, the

department’s regulatory might and funding power must be marshaled behind medical

professionals in this country who, they contend, are at serious risk of

retaliation, firing or being forced to surrender their medical licenses for

exercising their religious consciences. The department’s introduction to its

proposed rule on provider conscience states, "There appears to be an attitude

toward the health professions that health care professionals and institutions should

be required to provide to assist in the provision of medicine or procedures to

which they object, or else risk being subjected to discrimination." The

Department’s commentary, however, did not supply a single example of a health

professional who actually had been discriminated against.

Secretary Leavitt claimed at his press conference releasing

the proposed regulation that "there is nothing in this rule that would in

any way change a patient’s right to

a legal procedure" and that "this regulation does not limit patient

access to health care."

But, as the story of Sally, Dr. Brown and St. Mary’s

Hospital has demonstrated, that would not be the case. In fact, the proposed

HHS rule has the potential to seriously undermine the already fragile balance

between providers’ rights and patients’ rights in the American health care

system. It would tip the scales far over in the direction of objecting health

providers, and leave patients at risk of going without needed medical

information and care. It would allow

providers’ personal moral beliefs to come before patients’ rights and would take

American health care in the opposite direction from "patient-centered care."

Recommendations

Clearly, the proposed HHS rule should be withdrawn. It is

both unnecessary and overreaching in its broad interpretation of those existing

statutes.

But I also recommend that your council consider ways in

which public policy could more strongly protect patients’ rights and access to

care, without unduly burdening individual health practitioners who have moral

objections to providing certain medical services. What would be some ways of

doing this?