Consumer Power Report #510
Every person, regardless of race, creed, or country, is born into the world with certain natural rights, including the right to live, the Second Continental Congress declared 240 years ago this July 4.
From that right to life, surely one can infer a right to try to extend one’s own life and improve its quality.
For this reason, all 13 states that declared independence from Great Britain in 1776, and simultaneously declared unalienable each person’s rights to life and liberty, either have passed or are considering passing legislation expanding the freedom of terminally ill patients to try to survive.
Five of the original states – Georgia, New Hampshire, North Carolina, South Carolina, and Virginia – have already approved versions of a Right to Try Act. These laws allow manufacturers of experimental drugs and medical devices to offer terminally ill patients potentially life-saving products that have not received full approval from the U.S. Food and Drug Administration (FDA).
The remaining eight original states – Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, and Rhode Island – have introduced their own right-to-try legislation at least once since 2015.
As a group, these 13 states are behind the national curve; 60 percent of all states already have right-to-try laws on the books. Unfortunately, even in the country’s 30 right-to-try states, the federal bureaucracy is blocking some terminally ill patients from accessing experimental treatments. Living in one of the 20 states without a right-to-try law could set them even back further.
Under current federal regulations, before manufacturers of drugs and medical devices may make their products available to patients, they must obtain FDA approval. This approval process can take up to 15 years – obviously too long for terminally ill patients, and equally prohibitive for healthy people who will be diagnosed with a terminal illness in the near future.
Some investigational drugs make it through Phase 1 of FDA testing in a timelier manner. Enter state right-to-try laws, which help create a legal path for eligible patients willing to take their chances with these treatments.
Right-to-try legislation typically defines eligible patients as consenting individuals whose physicians have recommended an experimental treatment after issuing a terminal diagnosis. Patients must have already considered all treatment options fully approved by FDA. Unless the manufacturer foots the patient’s bill, patients must pay for the experimental treatment themselves, not through insurance. Manufacturers are protected from recrimination for failed treatments.
Some object to right-to-try legislation on the grounds FDA’s expanded access, or compassionate use program, already provides patients an avenue for accessing investigational treatments. Only 14 of 1,430 applicants, less than 1 percent, were declared “not allowed to proceed” in 2015, FDA reported. This percentage is probably deceptive, however, considering a 2016 report by the Goldwater Institute found “the number of ongoing clinical trials open to compassionate use is a tiny fraction, far less than 1 percent.” In other words, FDA may be accepting most applicants, but relatively few terminally ill patients (and doctors on their patients’ behalf) apply.
FDA Commissioner Robert Califf has acknowledged the burden of FDA’s expanded access application process. “One way we hope to make things simpler for physicians is to reduce the amount of time they spend filling out a request for access to an investigational drug,” Califf said in a June 2 statement announcing the release of a simplified compassionate use application form.
Simplified or not, the form will lose significance if state and federal lawmakers answer the plea of terminally ill patients for a legal path around FDA. Herein lies a second objection to right-to-try laws.
While dodging FDA, right-to-try states must not dodge the U.S. Constitution. The supremacy clause in Article VI subdues state right-to-try laws as long as FDA forbids drug and device manufacturers from offering patients partially approved products.
Congress, however, is contemplating a pair of federal right-to-try bills that would effectively end FDA’s obstruction of experimental treatments for the terminally ill in right-to-try states. Sen. Ron Johnson (R-WI) introduced the Trickett Wendler Right to Try Act of 2016 on May 10. The bill, whose counterpart in the House turns 1 year old this July, would let manufacturers and patients attempt investigational treatments in states that have passed their own version of a Right to Try Act.
A federal right-to-try law would vindicate the 30 right-to-try states that have set up their patients to cut through FDA’s approval process. Not so the 20 states plus Washington, DC that have not passed right-to-try legislation.
The right to try to extend and improve one’s life precedes our 240-year-old country. State lawmakers in 40 percent of states have yet to protect this right from federal overreach. They should do so now, ahead of federal lawmakers, whose legislation will activate existing state laws. Surely “a decent respect to the opinions of mankind” requires it.
— Michael T. Hamilton
IN THIS ISSUE
Though they have never met my son David and have no information about his specific diagnosis or care, bureaucrats at the Food and Drug Administration are endangering his life by proposing to stop the one treatment that has allowed him to lead a happy life that includes learning, socializing and having loving relationships with his family.
David is one of a small percentage of individuals with autism and mental disabilities who engages in life-threatening self-injurious behaviors, including shoving his hands down his throat and banging his head with such force as to permanently damage his ear. For the past 10 years he has been dissuaded from such activity by means of an abundance of rewards if he controls his self-harming behavior and an unpleasant, but harmless, two-second skin shock via an electronic stimulus device, or ESD, if he attempts self-injury.
While the device has been used effectively for many years with individuals like David at the Judge Rotenberg Educational Center, a residential special-needs school in Canton, Mass., the FDA is trying to ban it at the behest of ideologically driven advocacy groups such as the Disability Law Center in Massachusetts, whose executive director calls the therapy “horrible torture.”
Amazingly, the FDA says similar therapy is allowable if it is used to deter cigarette smoking. …
SOURCE: Paul E. Peterson, The Wall Street Journal
Providing Medicaid patients with a primary care “medical home” cut costs of their care by as much as $4,100 a year and lowered their number of doctors visits and hospitalizations, according to a Perelman School of Medicine-led study published today in the Journal of General Internal Medicine. The research analyzed claims from Pennsylvania Medicaid patients who had both a chronic illness and a substance abuse or psychiatric condition.
The findings come at a time when governmental and private health insurance providers alike are moving toward value-based – higher quality, lower cost – care. Increasingly, health care providers are incentivized to focus on quality outcomes and prevention efforts, such as reducing emergency department visits and hospitalization. The authors of the new research say their findings underscore the importance of medical homes in programs built to enhance health care value.
The team analyzed records from 2008 to 2011 from patients treated at regular primary care physician offices and primary care practices that participated in the state-wide Chronic Care Initiative (CCI). CCI primary care offices served as a “medical home” for patients – allowing them to receive team-based primary care that also included patient education, behavioral health support, and chronic care coordination all in one place.
“The take-away from the analysis of these claims is that if we focus intensive care coordination efforts on the highest risk patients, such as those with chronic medical conditions and mental health and/or substance abuse diagnoses, we can achieve significant cost savings, even in the first year of a program,” said lead author, Karin Rhodes, MD, a vice president in the Office of Population Health Management, Hofstra Northwell School of Medicine. …
SOURCE: University of Pennsylvania School of Medicine via EurekAlert!
Gov. Matt Bevin on Wednesday announced sweeping changes to the state’s $10 billion-a-year Medicaid program, saying he will seek permission from the federal government to reshape the federal-state health program that covers about 1.3 million Kentuckians.
Bevin, in a press conference at the Capitol Rotunda, hailed his proposal for a “waiver” from the federal government to revise Kentucky’s Medicaid plan as an opportunity “to come up with what is going to be truly a transformative and sustainable and fantastic program.”
The proposal called Kentucky HEALTH – for Helping to Engage and Achieve Long Term Health – would encourage Kentuckians to get healthier and transition to the commercial health insurance model to become independent of the government program, Bevin said.
“We are robbing people of the ability to do for themselves,” he said.
Bevin’s proposal would allow Medicaid to begin charging a small monthly premium for coverage that is now largely free. It also would allow the state to cut off Medicaid coverage for those who don’t pay, a “lockout” provision similar to Indiana’s Medicaid plan, which Bevin has cited as a possible model.
It limits coverage to that offered by the plan for state employees and does not include dental and vision coverage now included in Medicaid.
SOURCE: Deborah Yetter, Courier-Journal (Louisville)
Louisiana and Georgia have many political similarities. Both states face significant health challenges affecting their populations. And until recently, both states had identical approaches to Medicaid expansion.
Georgia Gov. Nathan Deal, a Republican, has rejected expansion since he took office in 2011, and GOP lawmakers have repeatedly backed him up. They point to concerns about the future cost of expansion, saying it would eventually put too much strain on the state budget.
But on Friday, Louisiana will become the 31st state – and only the third Southern state – to expand the government program, which is jointly financed by state and federal governments. Gov. John Bel Edwards, a Democrat elected last fall, on his second day in office reversed the course set by his predecessor, Republican Bobby Jindal, by signing an executive order that began the process. Already, more than 200,000 state residents have been signed up.
“This isn’t just about expanding health care coverage and saving money,” Edwards said earlier this month when addressing reporters at a seminar sponsored by the Kaiser Family Foundation. “We want healthier people in Louisiana.” (KHN is an editorially independent program of the foundation.)
And there are small signs of a crack in the opposition to expansion in Georgia.
Georgia state Sen. Renee Unterman (R-Buford), who chairs the Senate Health and Human Services Committee, recently made headlines calling for Georgia to “re-examine” the possibility of Medicaid expansion, perhaps looking at a “waiver” plan similar to the Arkansas expansion program. …
Yet Georgia state Rep. Sharon Cooper of Marietta, the Republican chairwoman of the Georgia House’s Health and Human Services Committee, told Modern Healthcare that she and her colleagues will entertain the proposals, but added that she doesn’t believe an expansion plan will solve the problem of access to care.
“The problem with expansion is, ‘Who is going to treat these people?'” Cooper said. “We don’t have the physicians, nurse practitioners or physician assistants to care for them in rural areas of the state.” …
SOURCE: Andy Miller, Georgia Health News with Kaiser Health News
Having a cold, allergies, rash, or urinary tract infection used to mean a visit to the doctor’s office. Now, Harvard Pilgrim Health Care members can video chat with a doctor instead.
Starting July 1, the state’s second largest commercial insurer will cover telehealth, offering the video chat service through California-based Doctor On Demand and from doctors in the Harvard Pilgrim network that offer telehealth.
The insurer is the second in the state to cover telehealth services, and shows a growing trend of allowing patients access to doctors through video chats, a far cry from the roadblocks regulations presented just two years ago.
“We believe this service will provide flexibility and value to augment the existing relationships our members have with their primary care physicians,” said Beth Roberts, Harvard Pilgrim’s senior vice president of enterprise sales & marketing, in a release.
SOURCE: Jessica Bartlett, Boston Business Journal