Esposito Writes on Pharmacists’ Duties

Not Just Bottle-Fillers: Pharmacists’ New Duty to Protect Patient’s Health Care Coverage

Progress does not come cheap, a fact no more evident than in the field of pharmacology.  The progress, of course, is undeniable.  Once blends of herbs, roots, oils, and powders—with a prayer thrown in for luck—today’s complex, scientifically-based compounds can cure conditions unknown in past centuries.  But they don’t come without years of research and testing supported by huge financial investments for which investors hope to be handsomely rewarded.

These days, medicines can be very expensive, sometimes even cost-prohibitive, for consumers.  Health insurance has becomes essential for consumers to obtain them.  Faced with high payouts, insurers look for ways to keep costs down.  One is through lower-cost generic drugs.  Some insurers will not pay for prescribed drugs if cheaper generic drugs are available.

Enter the pharmacist.  No longer just a person putting pills in a bottle, a pharmacist must be ready to interact with a physician, the physician’s patient, and the patient’s insurer as to a prescription.  It puts new business demands on the pharmacist.  And now, new legal demands.  In Correa v. Schoeck, 279 Mass. 686, 2018 Mass. LEXIS 353, a divided Massachusetts Supreme Judicial Court has recognized them.

Facts

In May 2009 Yarushka Rivera, age 18, suffered an epileptic seizure.  Her doctor prescribed Topamax to control them.  Yarushka filled the prescription at a Walgreens store.  MassHealth (a Medicaid program) covered the cost. When she and her family tried to refill the prescription, they were told that once Yarushka turned 19, MassHealth would require her physician to complete a “prior authorization” form for her to obtain coverage.  The form was designed to ensure that cost-effective generic drugs were used if available.  According to the family, a pharmacist said that Walgreens would contact the doctor.  Though not required, Walgreens routinely faxed notices to physicians about the need for the form.  Occasionally a pharmacist would place a follow-up call.  If an insurer denied coverage for lack of a signed form, a pharmacist would follow up with the physician by phone and/or fax.

Unfortunately, the players were not on the same page.  According to plaintiffs, they repeatedly called the pharmacy and doctor about the needed authorization.  Walgreens supposedly assured them that they would handle the paperwork.  Walgreens denied the conversations and assurances.  The doctor’s personnel claims that they never heard from the family or Walgreens about the need for the form.

Meanwhile Yarushka, then age 19, had a second seizure in August.  MassHealth refused to cover the prescription because no one had submitted the form.  The family could not afford the $400 needed for the medicine.  There were more disputes over contacts, or the lack of them, to the doctor to get the form.

Near the end of October 2009 Yarushka had a third seizure, this one fatal.  She had been off Topamax since August. Her estate’s administrator sued Walgreens and the doctor for wrongful death.  The trial court ruled that Walgreens had no legal duty to Yarushka.

Analysis

The Supreme Judicial Court disagreed.  It ruled that each time Yarushka tried to fill the prescription, Walgreens owed her a “limited duty to take reasonable steps” to advise her and her physician about the need for the form.  Pharmacists’ roles have expanded over the years, and pharmacists were well suited to provide important information to doctors.  State regulations require them to identify and prevent risks, consult with physicians, and offer to counsel patients.  Given what pharmacists must do, those seeking their services more their patients than their customers.

Pharmacists are also required to react when they know about a specific risks to a patient.  The learned-intermediary doctrine does not relieve a pharmacist who knows of a those risks from acting.  Rather than interfering with a doctor-patient relationship, imposing a duty on pharmacists supports it by helping to ensure that a patient receives prescribed medication.  Industry practices also support the duty to notify both patient and physician of the need for prior authorization.  Having the notice come from a pharmacist rather than a patient is more effective because of a pharmacists’ knowledge and objectivity.  Walgreens’ pharmacists were trained to notify both doctor and patient.  Absent notice, it is reasonably foreseeable to pharmacists that a patient unable to afford medicine will suffer harm.

The Court limited the new duty.  It only applies to insurance-related problems.  A pharmacist need only advise doctor and patient that for a patient to receive insurance coverage, the doctor must complete a form.  The Court rejected plaintiff’s argument that a pharmacist must follow up with doctors who do not provide the form.  Nor does a pharmacist need to impose enforcement mechanisms on doctors failing to act.  As long as a pharmacist provides the notices and records it, the duty is discharged.

The ruling was not unanimous.  The dissenting justice argued that a pharmacist should only be required to notify a patient, not a doctor, each time a patient presents a prescription.  Imposing a weak duty on pharmacists while simultaneously lessening the responsibility of insurers, doctors, and patients will compromise patient safety.  Patients may develop a false sense of security that prescriptions will be filled when, in fact, pharmacists have no control over the result.  Moreover, the extent of the new duty is uncertain.  Will voicemail be enough?  How many messages must be left?  Must a pharmacist confirm receipt?  What, if anything, must a pharmacist tell a health insurer about patient information and needs?  Will small businesses be able to comply with document retention issues?  Will physicians and insurers be allowed to delegate responsibilities to pharmacists?  These and other questions troubled the dissent.

Learning Points

Generally a court’s first foray into an issue does not resolve matters entirely, and that’s the case here.  Over time, the reviewing court will likely answer many of the dissenter’s questions.

The biggest question may be one that the justice failed to ask: will the duty to provide notice eventually extend to health insurers?  In the law, duties tend to expand, not contract.  As a government program, MassHealth might enjoy immunities, but that’s not usually true for private health plans.  They owe duties to their beneficiaries.  Where they know about a patient’s serious condition and/or inability to afford medicine, the law might someday impose a duty to take active steps to help with obtaining needed authorizations.

One more thing: the case offers an important lesson about record keeping.  Walgreens repeatedly claimed that it provided notice; Walgreen’s problem was that it did not keep a written record of doing so.  Especially where health issues are concerned, documenting efforts to protect patient health is vital.