Posted on December 9, 2016
In a day when approval of Congress barely exceeds 10 percent of poll respondents and few believe the body ever gets anything meaningful done, the 21st Century Cures Act is, if you will, a remedy of sorts.
The $6.3 billion bipartisan legislation, shepherded through the Senate by Tennessee Republican Sen. Lamar Alexander, chairman of the body's Health, Education, Labor and Pensions Committee, overwhelmingly passed both houses of Congress and was expected to be signed by President Barack Obama.
As with last year's Every Student Succeeds Act, the Tennessee senator worked with members of the Democratic Party to achieve a bill that, in his words, "will help virtually every American family."
Before Republicans gained the Senate in 2014, passing such legislation was practically impossible because then-Senate Majority Leader Harry Reid, D-Nev., would not allow such comprehensive bills that weren't strictly part of Obama's agenda to see the light of day.
This freshly minted package will, among other things, help bring safe drugs and medical devices into the market more quickly and at less cost than before; provide more funding for cancer research, genetic, lifestyle and environmental variations of disease, and brain diseases such as Alzheimer's; provide funding to states for the opioid crisis; provide funding for the Food and Drug Administration; improve the electronic heath records system; and address the country's mental health crisis.
The most controversial but perhaps the most immediately helpful portion of the bill is that which will speed approval of drugs and medical devices. Because of regulatory barriers, drugs currently may take 15 years to make it to market. For many individuals with Alzheimer's disease, cancers or cystic fibrosis, that will be too late.
The drugs or medical devices may be being used in other countries with success but cannot make it to the U.S. market for many more years. Now, patients will be allowed to exercise a certain amount of risk in using the drugs or devices if their situation is dire enough. And without as many regulatory barriers, costs naturally will be reduced.
"We're trying to reduce the cost and reduce the amount of time it takes and still makes it safe," Alexander said.
For Tennessee, the $1 billion in funding over two years for the opioid crisis across the nation — through state grants — also is critical. The state is second in the nation for opioid prescriptions with 1.18 scripts for every man, woman and child, according to IMS data. In 2014, the latest year for which statistics are available, 1,263 Volunteer State residents died from opioid overdose, a number which exceeds those who died annually from car accidents or firearms deaths.
Of course, opioid abuse always affects more people than just the abuser. Opioid addiction can be passed to infants when they are born to mothers who are drug addicts. And the longer such babies whose parents do not have private insurance are treated in neonatal intensive care, the bigger hit the TennCare budget suffers.
Money in Tennessee through the grants could be spent on treatment, on training doctors and other professionals on how to treat the addiction, and on learning how individuals might be predisposed to addiction, officials said.
The funding for cancer research and that for genetic, lifestyle and environmental variations of disease go hand in hand. The idea is that a person's DNA, the life a person leads and where a person lives can play both a part in what type of cancer or other disease a person may be diagnosed with and why one type of treatment would be helpful for one person but not for another.
Although unrelated on the surface, the push for improved electronic health records could be an additional boon to research on cancer and other diseases. If medical records are easily shareable by permission, a potentially larger database for research immediately becomes available. The larger the database, the more easy it is to extrapolate information about the cancers and other devastating diseases.
More simply, electronic health records afford an easy transfer of information from a primary care physician to a specialist and from a physician in one city to a physician in another who happens to be treating a patient.
One last but certainly not least aspect of the bill is funding for mental health. As House co-sponsor Rep. Eddie Bernice Johnson said, while funding the treatment of mental illness is expensive, "it's more expensive to ignore it."
The Cures Act, among other things, pushes states to provide early treatment for psychosis, sets up a grant program to provide assertive community treatment (as in a team of professionals on call 24 hours a day) for people with serious mental illnesses like schizophrenia, gives communities more flexibility in how they use federal grants and requires the U.S. attorney general to create drug and mental health court pilot programs.
Though Alexander called the legislation "a Christmas miracle," Congress will never have enough money to fund everything researchers need and everything those seeking a cure want. Because when you have your health, you have everything. But this bipartisan bill offers hope to those seeking to regain or retain their health.