Highlight on California: Aid-in-dying law allows patients to be given deadly dose of drugs

On October 5, 2015, California Governor Jerry Brown (D) signed AB2-15, the End of Life Option Act. Effective January 1, 2016, the law will allow an adult who is terminally ill to request and obtain a prescription for an “aid-in-dying drug,” defined as “a drug determined and prescribed by a physician for a qualified individual, which the qualified individual may choose to self-administer to bring about his or her death.”  The law requires several procedural steps and other protections to assure that the patient understands the nature and consequences of the act and that the patient has maintained the intention for a period of time. Specifically, the law requires:

  • attestation by both the patient’s attending (treating) physician and a consulting physician that the patient’s condition is terminal, the patient has the capacity to make the decision, and has done so with informed consent
  • two oral requests for the aid-in-dying drug made by the patient to the physician at least 15 days apart, and a written request. The patient must  make the requests personally, not through a personal representative, attorney-in-fact, guardian, conservator, or health care agent. All three requests must be made to and received by the physician personally, and not through a designee.
  • the written request must be made in a form prescribed by statute and signed in the presence of two adult witnesses, who must attest to the individual’s identity and to their belief in the individual’s voluntary action, the lack of duress or undue influence.
  • before writing the prescription, the attending physician must evaluate the individual’s mental health and make a referral to a mental health professional if there is any indication of a mental disorder and await the determination of the mental health professional that the individual has the capacity to make medical decisions and is not suffering from impaired judgment due to a mental disorder..

The witnesses may not be the attending physician, consulting physician, or mental health specialist. Only one of the two witnesses may be either a member of the individual’s family or entitled to any portion of the estate at death or the owner, operator or an employee of the healath care facility where the individual resides or is receiving care.

The prescription

The attending physician must give the patient the opportunity to withdraw or rescind the request before he or she writes the prescription and must confirm that the individual has the capacity to make the medical decision and understands:

  • his or her diagnosis and prognosis;
  • the risks associated with taking the aid-in-dying drug,
  • the probable result of taking it;
  • the possibility that he or she may choose not to take the drug after receiving it, and
  • all of the other treatment options available, including hospice or palliative care.

In addition, the physician must counsel the patient:

  • to take the drug in the presence of another person;
  • not to do so in a public place;
  • to notify the next of kin of the request;
  • to keep the drug in a safe, secure location until he or she ingests it; and
  • to complete the final attestation form within 48 hours before ingesting the drug.

Interpreters’ services

If the individual makes the requests and has the discussions with a physician or mental health professional in a language other than English, he or she may sign the form in English, but the interpreter must execute a form declaring under penalty of perjury that the interpreter is fluent in both English and the patient’s language and that the individual understood the meaning and significance of the decision and the document he or she signed.  The interpreter may not be a related to the individual by blood, marriage, adoption, or registered domestic partnership and may not be entitled to any portion of the individual’s estate.


The attending physician must maintain records of the patient’s requests in the patient’s medical records. Thirty days after writing the prescription for an aid-in-dying drug, the physician must report the prescription to the state Department of Health. If the patient has used the drug, the attestation form also is to be turned in to the attending physician, who must submit it to the state.

Prohibitions in contracts, wills, and other documents

Under the statute, any provision in a contract, will, or other agreement executed on or after January 1, 2016, that would affect a person’s making, withdrawing, or rescinding a request for an aid-in-dying drug is not valid. No obligation under a contract may be conditioned upon an individual’s making, withdrawing, or rescinding a request for such a drug. The sale, procurement,  issuance, or price of a life or health insurance policy may not be conditioned upon an individual’s making or rescinding a request for an aid-in-dying drug.

An individual’s ingestion of an aid-in-dying drug in accordance with the statute is to be considered a natural death as a result of the underlying disease and not a suicide.

Administration of drug: a fine line?

The law provides that an individual must have both the physical and mental ability to self-administer the drug or to coerce or exercise undue influence to persuade an individual to request the drug. It is a felony to administer the drug to an individual without his or her knowledge and consent. Section 443.18 provides, “Nothing in this part may be construed to authorize a physician or any other person to end an individual’s life by lethal injection, mercy killing, or active euthanasia.”

At section 443.14, the law provides that a person shall not be subject to civil or criminal liability solely for being present when the individual self-administers the drug. Still, the statute also provides that the person who is present may assist the patient in preparing the drug so long as he or she does not assist the patient in ingesting the drug.  it appears the statute leaves open the possibility that assisting with the injection of a drug, even at the request of a patient, could subject the person to civil or criminal liability.

Highlight on Colorado: Residents to vote on adoption of single-payer system

Colorado is considering a giant leap in health care reform. Enough proponents of a single-payer health system submitted signatures to the Colorado Secretary of State’s office to see Initiative 20 placed on the 2016 ballot. This system, named ColoradoCare, would cover everyone who lives and earns income within the state.

Ivan Miller, the executive director of ColoradoCare Yes, believes that the initiative would allow the state’s residents to receive premium health coverage at a $5 billion discount from the current system. Administrative costs associated with private coverage would be reduced, and bulk rates for drugs would be available.

Opinions on the matter are loud and varied. Some opponents are hesitant for Colorado to be the first state to actually operate this type of health care coverage, especially on the heels of Vermont’s failure to implement a single-payer system. Others, such as the president of the board of the Colorado State Association of Health Underwriters, believe that such a system “would destroy our industry.” He notes that almost one-fifth of the state’s jobs are in health care, and he believes that the state would have difficulty recruiting physicians. Hospitals in the Colorado Hospital Association have not yet taken a position.

If the new system passes, ColoradoCare would pay instead of insurance coverage. Employers and employees would be responsible for a total payroll tax of 10 percent, while the self-employed would be required to pay 10 percent of net income. The state would apply for a waiver excusing it from the requirements of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).

What is single-payer?

Physicians for a National Health Program (PNHP) emphasizes that national health insurance is not socialized medicine. Single-payer insurance pays physicians on a fee-for-service basis, similar to the Medicare program. In contrast, in a socialized medicine system, doctors work for and receive salaries from the government. PNHP believes that a single-payer system allows physicians to maintain autonomy over patient care. The organization argues that many of the fears surrounding such a system, like care rationing, physician overuse, reduction in physician incomes, and bureaucracy, are unfounded or are already present in the current system.

Those that oppose ColoradoCare and single-payer systems believe that the higher taxes required to finance such a system would cause individuals and business owners to suffer. The decision to shut down the system in Vermont was based on economics, as Governor Pete Shumlin (D), who had promised a new health care system during his campaign, stated that the risk of ‘economic shock’ was too great.

Single-payer internationally

While the single-payer system has yet to gain a foothold in the U.S., it has been implemented in several countries. According to PNHP, Canada, Denmark, Norway, and Sweden have publicly administered health insurance. Canada’s national health insurance covers about 72 percent of the country’s health expenditures, and most citizens maintain supplemental insurance that covers the rest of their needs such as prescriptions and dental care. Most Canadian hospitals are publicly owned. In Denmark, all medical and nursing education is free. Patients are not subject to co-pays for doctor or hospital care, but must share some drug costs and some hold private insurance for medications. Norway provides free medical education as well, and imposes some co-pays for drug costs and doctor visits. Patients must register with a local general practitioner. Sweden also offers free medical education and co-pays for services and drugs are capped at a very low amount.

House subcommittee advances mental health overhaul, other reforms

Bipartisan legislation addressing issues with the country’s mental health system was approved in an 18-12 vote by subcommittee and will be before the full House Energy and Commerce Committee as a next step. The legislation, H.R. 2646, the Helping Families in Mental Health Crisis Act (the Act), is centered on “refocusing programs, reforming grants, and removing barriers to care,” according to the subcommittee. In the same markup session, the subcommittee also advanced six other health-related pieces of legislation to full committee, including those focused on reforming certain aspects of the Patient Protection and Affordable Care Act’s (ACA) (P.L. 111-148) food labeling requirements, Medicaid, and controlled substances.

Mental health reform

This comprehensive reform of the mental health system proposes to:

  • establish an Assistant Secretary for Mental Health and Substance Use Treatment within HHS to replace the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA);
  • establish a committee to assist the new Assistant Secretary;
  • establish a National Mental Health Policy Laboratory;
  • reform the Health Insurance Portability and Accountability Act (HIPAA) (L. 104-191) and allow licensed medical professionals to share certain diagnoses and instructions related to mental health patients with the patients’ caregivers;
  • increase brain research funding at the National Institute of Mental Health;
  • provide for eligibility of electronic health records among behavioral health specialists under the Health Information Technology for Economic and Clinical Health (HITECH) Act (L. 111-5);
  • reform SAMHSA “with restrictions on lobbying by systems that accept federal funds to protect and advocate the rights of individuals with mental illness;” and
  • require the Government Accountability Office to conduct research on discriminatory actions against those with mental illness and substance abuse issues.

The legislation also would require that the new Assistant Secretary be a licensed psychiatrist or clinical psychologist. A number of reforms to the Medicare and Medicaid systems are also included in the Act, according to the subcommittee’s summary.

Menu labeling

The Common Sense Nutrition Disclosure Act, H.R. 2017, which was also advanced by the subcommittee, proposes to amend the provisions of the ACA that require calorie and nutrition information to be provided to customers in certain food retail establishments. Specifically, the bill would help alleviate the burden of this requirement on businesses and account for diverse business models when implementing these requirements.

Controlled substances

Another piece of legislation passed on to the full committee by the subcommittee was the Synthetic Drug Control Act of 2015, H.R. 3537. This bill was proposed to help stop the sale of synthetic drugs by identifying them as Schedule I under the Controlled Substances Act (CSA) (21 U.S.C. § 812). The American Hospital Association has voiced its support of this proposal, noting that many new synthetic substances “have entered the market, leading to devastating health consequences and increased mortality, particularly among the nation’s youth.”

The subcommittee also considered and advanced the Medical Controlled Substances Transportation Act, H.R. 3014, which would provide for a means of agreement and approval by the Drug Enforcement Administration (DEA) for physicians to transport and administer controlled substances outside of their practice areas and in disaster areas.

Medicaid reform

Three Medicaid-related pieces of legislation were considered and moved forward by the subcommittee. The Medicaid Directory of Caregivers Act, H.R. 3821, would establish a directory of physicians that have treated Medicaid beneficiaries in the last 12 months in states that operate Medicaid programs with fee-for-service and primary care case management programs. The Ensuring Medicaid Providers Are Removed from Medicaid and CHIP Act, H.R. 3716, would attempt to reduce the prevalence of providers that are registered in states’ Medicaid or Children’s Health Insurance Programs (CHIP) who have been excluded or removed from other states’ programs. H.R. 2446, would amend the Social Security Act to require use of electronic visit verifications for personal care services provided to Medicaid beneficiaries.

New hearing aid uses lasers, direct eardrum stimulation

Hearing aids have been around since the very end of the 1800s, but surely none of the first users imaged that the devices would eventually use lasers. On September 29, 2015, the FDA approved a new type of hearing aid for marketing that combines laser pulses and direct eardrum stimulation to amplify sound. The EarLens Contact Hearing Device™ (CHD) has received an indication for use in adults with mild to severe hearing impairment.

How does it work?

This device depends on two different parts working in unison. A tympanic membrane transducer (TMT) is placed on the eardrum (non-surgically) while an audio processor sits on the outer ear. The audio processor is connected to an ear tip containing a laser diode, which is placed into the ear canal. When the behind-the-ear (BTE) processor receives external sound waves, it converts them to low electronic signals that are sent to the ear tip. The signals are converted to pulses of light, which shine onto the TMT’s photodetector. The photodetector converts the light back into electronic signals and then transmits the sound vibrations onto the ear drum.

How is it different?

There are already multiple types of hearing aids. Some sit in the ear (ITE), some in the canal (ITC) and some behind the ear.  Older analog hearing aids simply amplified sounds, and some users struggled with them because all sounds were equally amplified by the device’s microphone. Some of these aids are programmable to hold separate settings for various environments, but they are not as sensitive to sounds as digital aids. Digital aids contain a chip that analyzes sounds based on the environment and user’s degree of hearing loss. The microphone amplifies sounds with an adjustment for volume and pitch, as well as feedback.

The EarLens, by contrast, is custom molded to the eardrum. The sounds are amplified by direct stimulation of the eardrum. The FDA believes that this is a new option for amplifying sounds over many frequencies.

Safety and effectiveness

The EarLens was studied over a four-month period for safety and effectiveness. The trials assessed residual hearing stability, amplification gain, and improved word recognition. Users’ ability to hear sentences in background noise with the device was compared to listening without any amplification. After a month of using the device, the 48 subjects experienced word recognition improvement by about a third. They also experienced a significant functional gain in the high frequency range. A maximum of 68 decibels was gained in the 9000-10,000 Hz range, which the FDA notes is not usually achieved with conventional hearing aids. There were some ear canal abrasions experienced, mainly due to the ear tip or forming the impressions. However, no serious adverse events were reported.

Who pays?

Medicare does not cover routine hearing exams or hearing aids. Part B will cover some diagnostic hearing exams if a doctor order these tests (20 percent of the Medicare-approved amount, along with the Part B deductible). Some Medicare Advantage plans may have some sort of hearing coverage. Only a few private insurance companies cover hearing aids, although three states (Arkansas, New Hampshire, and Rhode Island) require coverage for adults. This can be a problem for patients who suffer hearing loss, as prices can range up to thousands of dollars for one aid.

A House bill was introduced in March 2015 (H.R. 1653) proposing to repeal the Medicare hearing aid exclusion. After it was introduced, the Government Accountability Office (GAO) was instructed to study financial aid programs for hearing aids, as well as related examinations for patients suffering hearing loss.