~* FAIL FIRST: What it is & why we don't want it *~
Across the country, some states are introducing anti-‘Fail First’ legislation. Fail First (also known as Step Therapy) is when an insurer requires that other therapies must be tried and must fail before a patient can obtain the medicine originally prescribed by their doctor.
This protocol is used as a cost-saving measure, but in the long run it can actually increase costs because creating a delay in care can increase resistance to treatment or cause other health complications. Delaying or denying access to treatment steals time and quality of life from patients, could permanently worsen their conditions, could create serious new health crises, and potentially result in premature deaths. This is not acceptable! Insurers should not be making medical decisions; it should be between you and your physician.
In my home state, citizens are being asked to support California bill AB 369, authored by Assemblyman Jared Huffman. I’m going to link a +Fact Sheet about AB 369+ at the bottom of this blog post which will jump to another page, so you can read all the details about this bill. It is scheduled to go before the Senate Health Committee Hearing on June 27. But I am being warned by Huffman’s chief of staff there is a rumor that the Committee Chairman may be holding all mandate bills. This means he would prevent the bill from moving forward, which means it would die. The rationale is we should wait to do any mandate bills until the Federal Healthcare Reform Act is finalized. We should not have to wait!
Our support is desperately needed to help push AB 369 through the committee. Our focus needs to be directed at Senate Health Committee Chair: Senator Ed Hernandez. We are being asked to FAX our letters of support to 916-324-0384 (fax line only).
Californians: Please do not forget to send your faxes in support of AB 369 BEFORE June 27!
Fail First bills are also pending in New Jersey and New York. Find out more by clicking on the name of the state.
To see if there is Fail First legislation pending in your state and what the status is, see the Legislation Map.
If you want to learn more about how Fail First policy is directly affecting patients like yourself, click the links below:
~* RX: Prescription Drug issues in your state *~
There are a number of drug related bills and issues pending across the country. I’ve linked to three of them below, but you can keep on top of everything on both Fail First and all Rx policy issues by visiting FAILFIRSTHURTS.org or join them on FACEBOOK.
~New York: Fight for Patient Protections Wages On and Patients and providers face barriers in prescription drug access
++ Read the full Fact Sheet about AB 369 by clicking below ++
California AB 369 – Improving Patient Care by Assembly member Jared Huffman
IN BRIEF
Prohibits a health plan from requiring a patient to try and fail on more than two medications before allowing the patient to have the pain medication prescribed by their doctor. This bill also allows a doctor to determine the duration of any step therapy or fail first protocol.
THE ISSUE
Chronic pain is a growing national public health crisis that affects an estimated 116 million people and has serious economic ramifications. Chronic pain affects more Americans than diabetes, heart disease, and cancer combined. Pain is one of the most common reasons for patients to see a health care provider; however, it is often under-treated, which can result in unnecessary physical and emotional suffering for patients, which reduces the quality of life for themselves and their families, increases health care costs because of prolonged treatment, and increases costs incurred by the State's businesses due to employee illness, diminished productivity and higher health insurance premiums. Unrelieved pain impairs the immune system, raises the likelihood of pneumonia and increased cardiac output and heart rates, and can cause psychological side-effects, such as depression.
A troubling and dangerous trend occurring with health plans is frequent denial of coverage to patients for proven and effective pain medications. In order to reduce their costs and improve their profit margins, many health plans utilize step therapy or "fail first" policies which forces patients to try several alternative medications, which in some cases include over-the-counter medicines, before they are permitted to get the medication that their physician ordered. Some patients are required to try up to five different medicines before receiving the one prescribed by their physician. The duration of this protocol is left up to the health plan and can last longer than 90 days. So even though a doctor might recommend drug A to treat a patient’s pain, a health plan requires the patient first try cheaper drugs B, C, D, etc., and only after the cheaper drugs are shown to be ineffective can the patient receive the medicine his or her doctor prescribed. Not only does this policy deny patients the medications they need when they need them, step therapy can actually increase the direct cost of healthcare in the long run due to excessive use of emergency rooms; unscheduled hospital admissions; potential permanent damage from being on the wrong medication; loss of employment, spouse, and family; and loss of life itself when a person with chronic pain commits suicide. Indirect costs include lost wages and productivity of both people with pain and their caregivers. The 2001 California Health Interview Survey reported that over 4 and a half million Californians reported pain interfered with “normal” work moderately to extremely. That’s nearly one in five. According to a 2011 study by the Institute of Medicine, the annual cost of chronic pain in the U.S., including health care expenditures and lost productivity, is $635 billion. Much of this cost is born by taxpayers, accounting for 14 percent of all Medicare spending and $99 billion in federal and state government costs.
EXISTING LAW
Requires any health plan that covers prescription drug benefits to provide specified coverage to its subscribers. At the Federal level, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) issued their 2010 Call Letter which limits step therapy by health plans for Medicare patients. Their regulations:
*limit step therapy to two trials and failures of formulary alternatives before providing access to the prescribed medicine;
*prohibit plans from requiring an enrollee to try and fail on an off-label drug (not approved by the FDA) before providing access to a drug approved by the FDA for that condition.
BACKGROUND
According to the NCHS, many people who suffer from chronic pain endure significant distress in finding appropriate treatment for their pain. Once an effective course of therapy for their pain is found, there is often a limitation placed by health plans on the patient’s ability to access this treatment. These treatments are often changed by the health plans without full knowledge of the patient’s case and possible other conditions and/or drug interactions that may have factored into the physician’s choice of medicine. While doctors’ offices must contact the health plan to advocate for the pain management option they’ve prescribed, the patient is forced to wait without the recommended treatment until the matter is resolved. According to a 2009 national survey published in Health Affairs, physicians reported spending on average three hours weekly interacting with health plans; nursing and clerical staff spent much larger amounts of time – approximately 55 hours per week. When time is converted into dollars, it is estimated that the national time cost to practices of interactions with health plans is at least $23 billion to $31 billion each year.
According to a national survey released in November, 2010 by the American Medical Association, requiring physicians to ask for preauthorization from health plans harms patient care, and creates an expensive and confusing claims process. The survey found that:
*57% of physicians experience a 20% rejection rate from insurers on first-time preauthorization requests for medications;
*69% of physicians typically wait several days to receive preauthorization from an insurer for medications, while 10% wait more than one week;
*67% of physicians have trouble determining which medications require preauthorization.
Findings from a study published in the October 2009 issue of the American Journal of Managed Care concluded that although prior authorizations (PA) accomplished the objective of controlling access to an anticonvulsant medication (pregabalin), the overall effect was an increase in the use of opioid medication and alternative therapies associated with increased disease-related healthcare costs. The study explored the effect of Medicaid policies instituting a PA for pregabalin use in diabetic peripheral neuropathy and postherpetic neuralgia in two states with PA policies compared with four states without such policies. The states with PA policies restricting access were found to have a significantly lower proportion of patients with any pregabalin use compared with the state without restricted access. However, the PA was shown to be associated with significantly increased probability of the use of opioids, nonopioid analgesics, certain nontricyclic antidepressants, and anxiolytics, as well as with significantly greater disease-specific costs. This study of PA policy was applied to a patient population with chronic conditions involving moderate-to-severe pain and high incentive to seek alternative pain management treatments that provide therapeutic relief.
According to Richard Payne, M.D., Professor and Chief of Pain Management at the University of Texas M.D. Anderson Cancer Center, “Pain is a multibillion-dollar public health problem and the number-one reason for patients to see a health care provider, accounting for 42 million patient visits per year, yet studies show that pain is under-treated in as many as 46 percent of patients, based on comparison of reported severity with the potency of the prescribed analgesic.”
An article by David E. Joranson and Aaron M. Gilson in an issue of Federation Bulletin: The Journal of Medical Licensure and Discipline, which is the quarterly publication of the Federation of State Medical Boards (Volume 85, Number 2, 1998), states the pain management problem succinctly: “A number of health authorities have concluded that pain often is inadequately treated in a wide range of patient groups, including trauma and surgery patients, patients with cancer, those who are dying, as well as those who are living with a variety of chronic painful conditions.”
Findings from a study published in the February 2009 issue of the American Journal of Managed Care suggest that step therapy programs may increase overall health care costs for employers. In the study, researchers analyzed insurance claims data from 2003 through 2006 for 11,851 people with employer-sponsored health coverage that incorporated a step therapy protocol for anti-hypertensive drugs and compared their use of health care services to a group of 30,882 anti-hypertensive drug users who did not participate in a step therapy program. What the researchers found was that the group of patients treated for hypertension under the step therapy program had 3.1% lower drug costs. But these savings were wiped out by the increase in hospital admissions and emergency room visits.
An October, 2010 survey by the Global Healthy Living Foundation, a non-profit patient advocacy group, shows that up to 70 percent of prescription medications are changed by health plans, denying patients the drugs their doctors prescribe. In the survey, which included 10,612 participants, 48% were required to “fail first” for 30 to 60 days. In addition, 13% responded that the “fail first” drug worked, while 87% responded that the “fail first” drug did not work.
THE BILL
AB 369 prohibits a health plan from requiring a patient to try and fail on more than two medications before allowing the patient to have the pain medication prescribed by their doctor. This bill also allows the prescribing doctor to determine the duration of any step therapy or fail first protocol. The bill addresses the problems specifically related to pain medications in that persons with pain understand almost immediately if a medication is or is not successful.
AUTHOR’S STATEMENT
AB 369 would bring California one step closer to changing practices that have resulted in higher long-term health care costs and the unnecessary physical and emotional suffering that patients endure. As a matter of health policy, Californians can no longer afford to leave issues as critical as patient care in the hands of bureaucrats and health insurance executives. We must instead place patient care back in the hands of physicians who are in the best position of knowing the medical history and needs of the patients.
SUPPORT
For Grace (Sponsor)
American Academy of Pain Medicine
American Cancer Society
American Chronic Pain Association
Association of Northern California Oncologists
California Academy of Pain Medicine
California Academy of Physician Assistants
California Alliance for Retired Americans
California Arthritis Foundation
California Chronic Care Coalition
California Hepatitis C Task Force
California Medical Association
California NeuroAlliance
California Neurology Society
California Nurses Association
California Orthopedic Association
California Podiatric Medical Association
California Professional Firefighters
California Psychological Association
California Society of Anesthesiologists
California Society of Physical Medicine and Rehabilitation
Congress of California Seniors
Disability Rights California
Global Healthy Living Foundation
Medical Oncology Association of Southern California
National Fibromyalgia and Chronic Pain Association
National Multiple Sclerosis Society
Pharmacists Planning Service
Power of Pain Foundation
Reflex Sympathetic Dystrophy Syndrome Association
Southern California Cancer Pain Initiative
US Pain Foundation
Numerous Individuals
OPPOSITION
California Association of Health Plans
California Association of Joint Powers Authorities
California Chamber of Commerce
Health Net
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