$1.3 trillion federal appropriations bill loaded with new health care spending Last Friday, President Trump signed a massive $1.3 trillion federal spending bill—the Omnibus Consolidated Appropriations Act of 2018. It is loaded with new spending for health care programs that were supported by the California Medical Association (CMA). Unfortunately, it did not include two bills that CMA was strongly promoting – the Affordable Care Act (ACA) market stabilization bill and a permanent solution for the nearly 700,000 Deferred Action for Childhood Arrivals program recipients. A brief summary of the federal spending bill is below. Bipartisan ACA Market Stabilization: CMA, the American Medical Association (AMA) and other physician groups strongly advocated to include the bipartisan ACA market stabilization bill in the omnibus spending package. Unfortunately, lawmakers could not reach a compromise. It would have funded for two-years the cost-sharing assistance that helps low-income families afford copayments and deductibles that President Trump eliminated in 2017. It would have also provided state waiver flexibility and reinsurance funding to cover high-cost, catastrophic cases. The Congressional Budget Office estimated that the bill would have reduced premiums by 20 percent in 2020. A compromise could not be reached because the Freedom Caucus insisted on placing abortion restrictions on the ACA plans in exchange for the two-year ACA stabilization bill. Opioids: The bill includes nearly $4 billion in new funding for prevention, treatment and law enforcement to address the opioid crisis. With the $6 billion in the Budget Act enacted by Congress in February, new 2018-2019 opioid funding totals $10 billion. The breakdown is as follows: $500 million for National Institutes of Health research on opioid addiction, development of opioid alternatives, pain management and addiction treatment. $27 million for Mental and Behavioral Health Education Training to recruit and train professionals in psychiatry, psychology, social work, marriage and family therapy, substance abuse prevention and treatment, and other areas. $105 million for the National Health Service Corps to expand access to opioid and substance use disorder treatment in rural and underserved areas. $100 million for a new Rural Communities Opioids Response Program to support prevention and treatment of substance use disorder in 220 counties and other rural communities identified by the Centers for Disease Control and Prevention (CDC) as being at high risk. $350 million (for a total of $475 million) to support CDC’s Opioid Prescription Drug Overdose Prevention activities. $10 million must be used to conduct a nationwide opioid education campaign to increase understanding of the epidemic and to increase prevention activities. Also requires CDC to promote the use of prescription drug monitoring programs (PDMP) and expand efforts to enhance the utility of state PDMPs to make them more interconnected, in real-time, and usable for public health surveillance and clinical decision making. CMA aggressively advocated for this provision to ensure that the federal government work with electronic health record (EHR) vendors to link EHRs to state PDMPs. $1 billion in new funding for State Opioid Response Grants $94 million for law enforcement and grants to combat opioid, heroin and other drug trafficking. $94 million to strengthen Food and Drug Administration (FDA) presence at international mail facilities and to fund equipment and technology to increase FDA capacity to inspect more incoming packages to detect illicit fentanyl. Gun Violence: The bill included $2.3 billion in funding associated with the STOP School Violence Act of 2018 to cover mental health services, security training and school safety programs to prevent gun violence. It also fully funds the FBI National Instant Criminal Background Check System. While CDC research promoting gun control is still prohibited, the Omnibus spending bill included a general clarification that there are no restrictions on general research related to gun violence. However, there was no funding appropriated for such research. Finally, it increased funding for the National Violent Death Reporting System to all 50 states to assist researchers and lawmakers. CMA continues to support California Senator Dianne Feinstein’s legislation that would ban assault weapons and high-capacity magazines, as well as efforts to require more extensive background checks and waiting periods. Mental Health Programs: Provides more than $2.3 billion in new funding for various mental health programs. Drug-Related Provisions: Physicians will continue to receive enhanced payments for the first few years a drug/biological is on the market to assist in the costs of adopting new drugs and technology. Graduate Medical Education: The Children’s Hospitals graduate medical education program received a $15 million funding increase, for a total of $315 million. Congress also provided an additional $15 million for the Rural Residency Program to expand the number of rural residency training programs with a focus on developing programs that can be self-sustainable. Other Notable Health Care Spending Increases: The National Institutes of Health received significant increase in funding to support research into Alzheimer’s disease, the Brain Initiative, the universal flu vaccine and antibiotic-resistance efforts. The CDC also received additional funding for diabetes programs. April 5, 2018 General Affordable Care Act, Drug Abuse, Federal Budget, Federal Legislative Advocacy, Firearms, Graduate Medical Education, Guns, Mental Health, Opioids 0 0 Comment Read More »
FDA restricts use of cough and cold medicines with codeine or hydrocodone for kids The U.S. Food and Drug Administration (FDA) said today that cough and cold medicines containing codeine and hydrocodone should not be prescribed to children and adolescents because of serious safety risks posed by the opioid ingredients. The FDA also announced that such products will now be required to carry "boxed warnings" – the FDA’s strongest warning – that highlight the risks misuse, abuse, addiction, overdose, death, and slowed or difficult breathing. According to the FDA, it is taking this action after an extensive review that determined the risks associated with these medicines outweigh their benefits in patients younger than 18. Click here for more information. January 30, 2018 General Food and Drug Administration, Opioids, Pediatrics 0 0 Comment Read More »
Help save lives: Co-prescribe naloxone to patients at risk of opioid overdose For more than 40 years, the life-saving opioid overdose antidote naloxone has been used to reverse the effects of opioid overdose. Timely administration of naloxone has saved tens of thousands of lives. The American Medical Association Opioid Task Force, of which the California Medical Association (CMA) is a member, recently issued updated guidance encouraging physicians to consider co-prescribing naloxone when clinically appropriate for patients who are at risk for opioid overdose or might be in a position to help someone else at risk. The updated guidance includes several important questions that physicians should consider to help determine whether they should co-prescribe naloxone to a patient—or to a family member or close friend of the patient. Is the patient receiving a high dose of opioids? Does the patient also have a prescription for a benzodiazepine? Does the patient have a history of substance-use disorder? Does the patient have an underlying mental health or other medical condition that makes him or her more susceptible to overdose? The document also includes links to multiple resources for physicians to use in their practice, such as recommendations for use in different settings, best practices and product comparisons. The task force guidance is available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. October 19, 2017 General Drug Prescribing, Opioids 0 0 Comment Read More »
Saturday, Oct. 28, is National Prescription Drug Take Back Day Saturday, October 28, 2017, is National Prescription Drug Take Back Day. On this day, hundreds of locations throughout California will be accepting and properly disposing of unused prescription drugs, including controlled substances. Proper disposal of unused prescription drugs helps prevent diversion and misuse associated with these medications. This one-day event will provide patients with free, anonymous collection of unwanted and expired medicines. The last National Take Back event collected 450 tons of unwanted prescription drugs at almost 9,700 collection sites nationwide. In addition to providing a safe, convenient and responsible means of disposal, the event also aims to educate the general public about the potential for abuse of these medications. A significant component of the prescription drug abuse and diversion problem stems from misuse of unused drugs. According to the Substance Abuse and Mental Health Administration, over 71 percent of prescription pain medications are obtained from family and friends, and 5 percent took the medication from a friend or relative without asking. Physicians can take action by encouraging their patients to participate in Take Back Day. To find a collection site near your practice, click here. The California Medical Association (CMA) has produced a flyer to educate patients about proper disposal of prescription medication and National Prescription Drug Take Back Day, which can be placed in offices and waiting rooms. This and other resources are available on CMA's safe prescribing webpage at www.cmanet.org/safe-prescribing. October 19, 2017 General Opioids, Prescription Drugs 0 0 Comment Read More »
FDA says harm of untreated opioid addiction outweighs risks of concomitant benzodiazepine use Medication-assisted treatment (MAT) for opioid addiction is an important tool that has the potential to help millions of Americans with an opioid use disorder. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. However, health care providers and patients face significant challenges when determining how best to treat opioid use disorder, especially when the MAT drugs contain methadone or buprenorphine – which are also opioids. The U.S. Food and Drug Administration (FDA) recently issued a statement saying that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). However, the agency is requiring changes to MAT drug labels to help decrease the risks of combining these drugs. The new labeling recommends that health care providers develop a treatment plan that closely monitors any concomitant use of these drugs, and carefully taper the use of benzodiazepines, while considering other treatment options to address mental health conditions that the benzodiazepines might have been initially prescribed to address. The FDA’s Drug Safety Communication recommends that health care providers take steps such as: Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly. Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT. Tapering the benzodiazepine or CNS depressant to discontinuation if possible. Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions. Recognizing that patients may require MAT medications indefinitely and that their use should continue as long as patients are benefiting and their use contributes to the intended treatment goals. Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment. Monitoring for illicit drug use, including urine or blood screening. Patients taking MAT drugs should continue to take these medicines as prescribed, and should stop taking other prescribed medicines without first talking to their health care professional. Physicians are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, available online at www.fda.gov/MedWatch/report. You can also call (800) 332-1088 to request a paper reporting form. For more information about opioid safety, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. October 13, 2017 General Drub Abuse, Drug Prescribing, Medical Solutions to Drug Abuse, Opioids 0 0 Comment Read More »
NASEM issues major report on pain management and opioid use The National Academies of Science, Engineering, and Medicine (NASEM) issued a report last week, "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use," detailing the dual public health challenges of undertreated pain and opioid use disorder. The report, requested by the U.S. Food and Drug Administration (FDA), highlights actions health care professionals and government agencies could take to stem the prevalence of opioid misuse without denying access to opioids for patients suffering from pain. The 18-member committee that worked over a year on the report recommended actions that include expanding access to treatment for opioid use disorder, weighing societal impacts in opioid-related regulatory decisions and investing in research to better understand the nature of pain and development of treatment alternatives. The report also urged public health agencies to work toward universal access to evidence-based interventions for pain management and substance abuse, including comprehensive pain management treatment programs and full coverage of medications approved to treat opioid use disorder. “This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing,” said committee chair Richard J. Bonnie, Harrison Foundation Professor of Medicine and Law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia in Charlottesville. “We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel.” The committee also recommended that the FDA develop a systems approach for opioid approval decisions that incorporates the public health consequences into its existing risk-benefit model. Download the report here. For more information about opioid safety, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. July 24, 2017 General Drug Prescribing Opioids, Opioids, Pain Medicine, Prescription Drugs 0 0 Comment Read More »
Free CME: Medication assisted treatment for opioid use disorders The Substance Abuse and Mental Health Services Administration is offering two free training sessions on the use of medication assisted treatment for opioid use disorders. The training, “The Effective Use of Medication Assisted Treatment in an Opioid Dependent Population,” will be held in Sacramento on July 18 and repeated in Orange County on July 20. Registration is first-come, first-served. Attendance is capped at 100 participants – you must register by July 3. Physicians can receive up to 7 continuing medical education (CME) credits. To register, click on the links below: Sacramento (July 18) Orange County (July 20) The California Medical Association (CMA) strongly supports efforts to increase access to much-needed medication-assisted treatment for opioid use disorders. For more information, visit CMA's safe-prescribing resource page at www.cmanet.org/safe-prescribing. There you will find: Resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. CMA’s white papers on prescribing opioids Links to relevant documents in CMA’s health law library Continuing medical education courses and webinars Current information on the state's prescription drug monitoring database June 22, 2017 General Continuing Medical Education, Drug Abuse, Medical Solutions to Drug Abuse, Opioids, CME 0 0 Comment Read More »
FDA wants opioid pulled from market due to risk of abuse Last week, the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is concerned that the benefits of the drug may no longer outweigh its risks. This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available data and follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012 in an attempt to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. Postmarketing data has shown, however, a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.” The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product. For more information about preventing opioid abuse, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. June 21, 2017 General Food and Drug Administration, Prescription Drugs, Drug Abuse, Opioids 0 0 Comment Read More »
DHCS gets federal grant to increase access to opioid treatment in California The California Department of Health Care Services (DHCS) has received a $90 million grant from the federal government to expand drug treatment services in California, primarily in counties and tribal communities that have higher rates of opioid-related overdose deaths. One key initiative will target those areas with an innovative approach to increase access to medications used to treat opioid addiction. DHCS will use a large portion of the grant from the U.S. Substance Abuse and Mental Health Services Administration to expand Californians’ access to medication-assisted treatment for opioid use disorders, particularly using buprenorphine. With more than 2.2 million people nationwide in 2015 who met the diagnostic criteria for an opioid use disorder, increasing appropriate access to life-saving addiction treatment services is one component of a balanced approach to addressing opioid-related morbidity and mortality rates. Treatment of opioid use disorder with medication-assisted treatment has been shown to be cost-effective, safe and successful when used appropriately. The California Medical Association (CMA) strongly supports efforts to increase access to much-needed medication-assisted treatment for opioid use disorders. DHCS also will use the grant to fund additional approaches to reduce opioid misuse, such as enhancing the wider distribution of naloxone, which can reverse the toxic effects of an opioid overdose; coordinating local coalitions to act together to reduce opioid abuse; and providing education and training to help reduce the stigma associated with addiction. For more information, visit CMA's safe-prescribing resource page at www.cmanet.org/safe-prescribing. There you will find: Resources on prescribing controlled substances safely and effectively to relieve pain, while simultaneously reducing the risk of prescription medication misuse, addiction and overdose. CMA’s white papers on prescribing opioids Links to relevant documents in CMA’s health law library Continuing medical education courses and webinars Current information on the state's prescription drug monitoring database May 22, 2017 General Drug Abuse, Medical Solutions to Drug Abuse, Opioids, Prescription Drugs 0 0 Comment Read More »
Large insurers drop barriers to prescribing medications for opioid use disorder Three of the nation's largest insurers—Aetna, Cigna, and Anthem Blue Cross—have in recent months announced that they will no longer require physicians to seek prior approval before prescribing medication to treat opioid use disorder. These policy changes come as more than 2.2 million people meet the diagnostic criteria for an opioid use disorder. Treatment of opioid use disorder with opioid maintenance therapies has been shown to be cost-effective, safe and successful when used appropriately. Increasing access to treatment is crucial to addressing opioid misuse and overdose, and the California Medical Association urges all insurers to make patient care a priority over administrative hurdles. Prior authorization often has a negative impact on patient care when there is a delay or interruption in ongoing treatment due to a health plan utilization authorization. According to the American Medical Association, 75 percent of surveyed physicians described prior authorization burdens as high or extremely high. More than a third of physicians reported having staff that work exclusively on prior authorization. Nearly 60 percent of physicians reported that their practices wait, on average, at least one business day for prior authorization decisions, and more than 25 percent of physicians said they wait three business days or longer. Contact: Samantha Pellon, (916) 551-2887 or spellon@cmanet.org. March 2, 2017 General Aetna, Anthem Blue Cross, Cigna, Opioids, Preauthorization 0 0 Comment Read More »
