Highlight on Alaska: FTC, DOJ back Alaska Senate’s move to eliminate certificates of need

Citing “considerable competitive concerns” raised by certificate of need (CON) laws, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued a joint statement in support of Alaska Senate Bill 62 (SB 62), which would repeal Alaska’s CON program effective July 1, 2019. CON programs generally require firms to demonstrate an unmet need for services to the state before being permitted to enter the health care market, for example, by building a new hospital. Sen. David Wilson (R-Wasilla), who submitted the bill, applauded the statement, noting, “As government officials, we should not lose sight of a basic truth that competition improves the quality and lowers the costs of services; it’s what drives innovation and ultimately leads to the delivery of better healthcare.”

CON laws were enacted to reduce costs and improve access to care, based on the assumption that the existence of too many health care facilities in the same area could lead to inflated pricing for services. However, the FTC and DOJ opined that the laws create barriers to entry and expansion, allow entities to abuse the process to delay or halt competitors’ entry or expansion, and deny consumers effective remedies from anticompetitive mergers.

Alaska’s program requires parties wishing to spend at least $1.5 million on health care facility construction, alter an existing facility’s bed capacity, or add a category of health services provided to an existing facility to secure a CON after demonstrating that the quality, availability, or accessibility of existing health care resources is less than necessary “to maintain the good health of citizens of [the] state.” Specifically, it requires parties to submit an application with a fee ranging from $2,500 to $75,000.  The Department of Health and Social Services holds a public meeting and solicits comments and then submits a recommendation to the Commissioner of Health and Social Services, who makes the ultimate decision. Members of the public substantially impacted by the CON may initiate administrative proceedings and eventually seek judicial review.

The agencies stated that the existing state law raises both the monetary and time-based costs of entry and expansion, eliminates or reduces competitive pressure that normally incentivizes firms “to innovate, improve existing services, introduce new ones, or moderate prices,” and, in the event of denials, prohibits entry or expansion.  Furthermore, the law allows incumbent firms to drag out the CON application process by filing challenges or comments in order to delay competitors’ entry into the market. It also provides a platform that allows firms to form anticompetitive agreements–for example, two firms could agree to file CON applications for separate services to avoid a lengthy application process and potential challenges from one another. Finally, the existing law could impede antitrust remedies. As an example, the joint statement cited to the case of FTC v. Phoebe Putney.  Although the Supreme Court eventually ruled that an anticompetitive merger was subject to antitrust scrutiny, the entities involved had already merged and the applicable state’s CON laws made divestiture “virtually impossible.”

 

How will access to contraception coverage fare in light of the ACA repeal?

With the uncertainty about continued contraception coverage, a number of states have either enacted or introduced legislation to ensure that individuals continue to have access to contraception coverage and the number of women inquiring about birth control has increased. Since the November election and, in the wake of the imminent repeal of Obamacare, requests for intrauterine devices (IUDs) have been increasing significantly. Cecile Richards, President of Planned Parenthood, told CNN on January 9, 2017, that the demand for IUDs, a form of long-term birth control, has shot up 900 percent at Planned Parenthood branches because women “are desperately concerned that they will lose their access to health care,” SFGate news reported.

A December 7, 2016, Kaiser Family Foundation report that addressed private insurance coverage of contraception stated that many states have mandated minimum benefits for decades, including contraceptive coverage. Moreover, since the passage of the Affordable Care Act (ACA) (P.L. 111-148), states have strengthened and expanded the federal contraceptive coverage requirement. Among those states that have recently adopted contraceptive laws expanding ACA mandates for contraceptive coverage are New York, California, Oregon, Illinois, and Vermont.

New York

On January 11, 2017,  New York Attorney General Eric T. Schneiderman introduced “The Comprehensive Contraception Coverage Act of 2017” (CCCA), legislation that would provide access to cost-free contraception for women and expand coverage to men to ensure the continuation of contraception coverage under state law in light of Republicans’ goal of repealing the ACA.  The CCCA would (1) statutorily require state-governed health insurance policies to provide cost-free coverage for all FDA-approved methods of birth control, including emergency contraception, (2) prohibit insurance companies from “medical management” review restrictions that can limit or delay contraceptive coverage; (3) cover men’s contraceptive methods and bring their insurance coverage in line with the benefits enjoyed by women; and (4) allow for the provision of a year’s worth of a contraceptive at a time.

Crain’s New York Business addressed a number of items that are at stake in terms of women’s access to health care in New York under Donald Trump’s presidency. Although New York’s contraception legislation “has taken on new urgency for advocates since Trump’s victory,” the bill faces opposition from insurers because the provisions go beyond the ACA mandates, Crain’s predicted. In addition, Crain’s pointed out that Republicans in Congress will renew their efforts to defund Planned Parenthood, noting that access to services such as breast exams, Pap tests, STD screenings and family planning are most likely at risk of elimination for female Medicaid enrollees. Finally, abortion rights in New York might be curtailed if President-elect Trump’s Supreme Court judge appointee provides the Court with a majority of votes to overturn Roe v. Wade, the case that affirmed a woman’s constitutional right to an abortion under the 14th amendment. New York state law allows an abortion after 24 weeks only if it’s a matter of life and death for the woman, while constitutional law allows a woman to get a late-stage abortion if an anomaly poses a serious risk to her health or makes the fetus unviable, Crain’s explained.

Other States

In 2014, California passed the Contraceptive Coverage Equity Act of 2014 that requires plans to cover prescribed FDA-approved contraceptives for women without cost-sharing. In April of 2016, under the law, girls and women are able to drop by their neighborhood pharmacy and pick up birth control such as pills, patches, and injections without a doctor’s prescription but must speak with a pharmacist and fill out a questionnaire. Starting in January 2016, health plans were required to provide access to the full range of contraceptive methods approved by the FDA, including a variety of IUDs, for all insured individuals without cost-sharing, delays, or denial of coverage.

In 2015, Oregon passed two laws in 2015  expanding women’s access to birth control that became effective January 1, 2015.  HR2879 permits pharmacists to prescribe hormonal contraceptive patches and self-administered oral hormonal contraceptives, while HR3343 requires insurers to pay for a three-month supply of contraceptives when first prescribed, followed by a 12 month supply of contraceptives regardless of whether the woman was insured by the same plan at the time of the first dispensing. This law applies to oral contraceptive pills, the patch, and the vaginal ring.

The State Journal Register reported that Illinois adopted House Bill 5576, which will take effect January 1, 2017. Under the law, all ACA options must be covered without co-payments or deductibles, at least for women covered through health plans regulated by the state and plans that cover state employees, retirees, and their dependents. In addition, insurance companies must allow women to get a 12 month supply all at once.

The Burlington Free Press reported that Vermont legislation includes mandates from the ACA in the state law, but also expands upon the mandates to include additional birth-control methods, such as vasectomies. The bill specifies the 12 contraceptive products and services that must be included in health insurance plans as well as restrictions on cost-sharing for contraceptive services. It directs the Department of Vermont Health Access to establish 15 value-based payments for the insertion and removal of long-acting reversible contraceptives comparable to those for oral contraceptives.

Conclusion

Whether Congress repeals the ACA mandates requiring health insurance plans to provide contraceptive coverage and defunds Planned Parenthood is not certain. As of this writing, Congress has already taken initial steps to repeal the law. It remains to be seen if the actions the states have taken to ensure that both men and women have access to contraception under state law will hold up, and whether states that have introduced bills to ensure coverage will progress to enactment in the face of strong opposition.

 

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.

Recordkeeping

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.