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Monday, December 21, 2015

CMS Implements SMART Act Functionality for Repayment

The Workers' Compensation community of stakeholders lobbied strenuously through 2012 for revision of the conditional payment process utilized by the Centers for Medicare and Medicaid (CMS). The SMART Act of 2012 codifies the process to comply with the Medicare Secondary Payer Act. CMS has now implemented an on-line process to facilitate reimbursement:

New Study Reports Flavorings Cause Lung Damage

A just published study reports flavoring chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a sample of 51 products, including fruit-, candy-, and cocktail-flavored e-cigarettes pose a health risk.

The Harvard Gazette reported that, "Diacetyl, a flavoring chemical linked to cases of severe respiratory disease, was found in more than 75 percent of flavored electronic cigarettes and refill liquids tested by researchers at Harvard T.H. Chan School of Public Health.

Congress extends the Zadroga 9/11 Health and Compensation Act

The United States Congress has voted to extend the James Zadroga 9/11 Health and Compensation Act as part of a major spending bill that now heads to the President’s desk to be signed into law. The bill will extend the World Trade Center Health Program to 2090 and provide full compensation to survivors and first responders through the September 11 Victim Compensation Fund.

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announced the opening of a docket to obtain public comment on the draft CDC Guideline for Prescribing Opioids for Chronic Pain (Guideline). The Guideline provides recommendations regarding initiation or continuation of opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessment of risk and addressing harms of opioid use.

The Guideline is intended to be used by primary care providers (e.g., family physicians or internists) who are treating patients with chronic pain (i.e., pain lasting longer than 3 months or past the time of normal tissue healing) in outpatient settings. The draft Guideline is intended to apply to patients aged 18 years of age or older with chronic pain outside of palliative and end-of-life care. The Guideline is not intended to apply to patients in treatment for active cancer.

The Guideline is not a federal regulation; adherence to the Guideline will be voluntary.

Dates
Written comments must be received on or before January 13, 2016.

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain
You may submit comments, identified by Docket No. CDC-2015-0112 by any of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
  • Mail: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341, Attn: Docket CDC-2015-0112.
  • Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

For Further Information Contact
Arlene I. Greenspan, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341; Telephone: 770-488-4696.

Supplementary Information
Background
CDC developed the draft Guideline to provide recommendations about opioid prescribing for primary care providers who are treating adult patients with chronic pain in outpatient settings, outside of active cancer treatment, palliative care, and end-of-life care. The draft Guideline summarizes scientific knowledge about the effectiveness and risks of long-term opioid therapy, and provides recommendations for when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up, and discontinuation; and assessing risk and addressing harms of opioid use. The draft Guideline identifies important gaps in the literature where further research is needed.

To develop the recommendations, CDC conducted a systematic review on benefits and harms of opioids and developed the draft Guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. CDC drafted recommendations and consulted with experts on the evidence to inform the recommendations. CDC hosted webinars in September 2015 and also provided opportunities for stakeholder and peer review of the draft Guideline. The Guideline is not a federal regulation; adherence to the Guideline will be voluntary. For additional information on prescription drug overdose, please visit http://www.cdc.gov/drugoverdose/prescribing/guideline.html.

Supporting and Related Material in the Docket
The docket contains the following supporting and related materials to help inform public comment:
The Guideline;

  1. the Clinical Evidence Review Appendix; 
  2. the Contextual Evidence Review Appendix; and 
  3. three documents that comprise the Comment Summaries and CDC Responses 
  • (Constituent Comment Summary, 
  • Peer Review Summary, and 
  • Stakeholder Review Group Summary). 


The Clinical Evidence Review Appendix and the Contextual Evidence Review Appendix include primary evidence, studies, and data tables that were used by CDC to develop the recommendations in the Guideline.

The Constituent Comment Summary reflects input obtained in response to webinars hosted on September 16 and September 17, 2015, during which CDC shared an overview of the development process and draft recommendation statements.

The Stakeholder Review Group Summary also reflects input obtained from stakeholders (comprised of professional and community organizations) following their review of a prior draft of the Guideline.

Finally, the Peer Review Summary reflects input obtained from three scientific peer reviewers following their review of a draft of the full Guideline, along with a summary of comments received and CDC responses.

Dated: December 9, 2015.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2015-31375 Filed 12-11-15; 8:45 am]


Friday, December 18, 2015

CDC Reports Increases in Drug and Opioid Overdose Deaths in US 2000-2014

Workers' Compensation has experienced the consequences of the national epidemic of drug and opioid deaths. The issue continues to be reported and addressed at the national levels. Unfortunately employers and workers' compensation insurance companies, as cost cost containment item, continue to use this information to merely restrict drug benefits to injured workers while not meeting the real challenge of the epidemic.


The United States is experiencing an epidemic of drug overdose (poisoning) deaths. Since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). CDC analyzed recent multiple cause-of-death mortality data to examine current trends and characteristics of drug overdose deaths, including the types of opioids associated with drug overdose deaths. During 2014, a total of 47,055 drug overdose deaths occurred in the United States, representing a 1-year increase of 6.5%, from 13.8 per 100,000 persons in 2013 to 14.7 per 100,000 persons in 2014. The rate of drug overdose deaths increased significantly for both sexes, persons aged 25–44 years and ≥55 years, non-Hispanic whites and non-Hispanic blacks, and in the Northeastern, Midwestern, and Southern regions of the United States. Rates of opioid overdose deaths also increased significantly, from 7.9 per 100,000 in 2013 to 9.0 per 100,000 in 2014, a 14% increase. Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as "prescription" opioid overdoses (1). Between 2013 and 2014, the age-adjusted rate of death involving methadone remained unchanged; however, the age-adjusted rate of death involving natural and semisynthetic opioid pain relievers, heroin, and synthetic opioids, other than methadone (e.g., fentanyl) increased 9%, 26%, and 80%, respectively. The sharp increase in deaths involving synthetic opioids, other than methadone, in 2014 coincided with law enforcement reports of increased availability of illicitly manufactured fentanyl, a synthetic opioid; however, illicitly manufactured fentanyl cannot be distinguished from prescription fentanyl in death certificate data. These findings indicate that the opioid overdose epidemic is worsening. There is a need for continued action to prevent opioid abuse, dependence, and death, improve treatment capacity for opioid use disorders, and reduce the supply of illicit opioids, particularly heroin and illicit fentanyl.

The National Vital Statistics System multiple cause-of-death mortality files were used to identify drug overdose deaths.* Drug overdose deaths were classified using the International Classification of Disease, Tenth Revision (ICD-10), based on the ICD-10 underlying cause-of-death codes X40–44 (unintentional), X60–64 (suicide), X85 (homicide), or Y10–Y14 (undetermined intent) (2). Among the deaths with drug overdose as the underlying cause, the type of opioid involved is indicated by the following ICD-10 multiple cause-of-death codes: opioids (T40.0, T40.1, T40.2, T40.3, T40.4, or T40.6); natural and semisynthetic opioids (T40.2); methadone (T40.3); synthetic opioids, other than methadone (T40.4); and heroin (T40.1). Some deaths involve more than one type of opioid; these deaths were included in the rates for each category (e.g., a death involving both a synthetic opioid and heroin would be included in the rates for synthetic opioid deaths and in the rates for heroin deaths). Age-adjusted death rates were calculated by applying age-specific death rates to the 2000 U.S standard population age distribution (3). Significance testing was based on the z-test at a significance level of 0.05.

During 2014, 47,055 drug overdose deaths occurred in the United States. Since 2000, the age-adjusted drug overdose death rate has more than doubled, from 6.2 per 100,000 persons in 2000 to 14.7 per 100,000 in 2014 (Figure 1). The overall number and rate of drug overdose deaths increased significantly from 2013 to 2014, with an additional 3,073 deaths occurring in 2014 (Table), resulting in a 6.5% increase in the age-adjusted rate. From 2013 to 2014, statistically significant increases in drug overdose death rates were seen for both males and females, persons aged 25–34 years, 35–44 years, 55–64 years, and ≥65 years; non-Hispanic whites and non-Hispanic blacks; and residents in the Northeast, Midwest and South Census Regions (Table). In 2014, the five states with the highest rates of drug overdose deaths were West Virginia (35.5 deaths per 100,000), New Mexico (27.3), New Hampshire (26.2), Kentucky (24.7) and Ohio(24.6).† States with statistically significant increases in the rate of drug overdose deaths from 2013 to 2014 included Alabama, Georgia, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Mexico, North Dakota, Ohio, Pennsylvania, and Virginia.

In 2014, 61% (28,647, data not shown) of drug overdose deaths involved some type of opioid, including heroin. The age-adjusted rate of drug overdose deaths involving opioids increased significantly from 2000 to 2014, increasing 14% from 2013 (7.9 per 100,000) to 2014 (9.0) (Figure 1). From 2013 to 2014, the largest increase in the rate of drug overdose deaths involved synthetic opioids, other than methadone (e.g., fentanyl and tramadol), which nearly doubled from 1.0 per 100,000 to 1.8 per 100,000 (Figure 2). Heroin overdose death rates increased by 26% from 2013 to 2014 and have more than tripled since 2010, from 1.0 per 100,000 in 2010 to 3.4 per 100,000 in 2014 (Figure 2). In 2014, the rate of drug overdose deaths involving natural and semisynthetic opioids (e.g., morphine, oxycodone, and hydrocodone), 3.8 per 100,000, was the highest among opioid overdose deaths, and increased 9% from 3.5 per 100,000 in 2013. The rate of drug overdose deaths involving methadone, a synthetic opioid classified separately from other synthetic opioids, was similar in 2013 and 2014.

Discussion

More persons died from drug overdoses in the United States in 2014 than during any previous year on record. From 2000 to 2014 nearly half a million persons in the United States have died from drug overdoses. In 2014, there were approximately one and a half times more drug overdose deaths in the United States than deaths from motor vehicle crashes (4). Opioids, primarily prescription pain relievers and heroin, are the main drugs associated with overdose deaths. In 2014, opioids were involved in 28,647 deaths, or 61% of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000. The 2014 data demonstrate that the United States' opioid overdose epidemic includes two distinct but interrelated trends: a 15-year increase in overdose deaths involving prescription opioid pain relievers and a recent surge in illicit opioid overdose deaths, driven largely by heroin.

Natural and semisynthetic opioids, which include the most commonly prescribed opioid pain relievers, oxycodone and hydrocodone, continue to be involved in more overdose deaths than any other opioid type. Although this category of opioid drug overdose death had declined in 2012 compared with 2011, and had held steady in 2013, there was a 9% increase in 2014.

Drug overdose deaths involving heroin continued to climb sharply, with heroin overdoses more than tripling in 4 years. This increase mirrors large increases in heroin use across the country (5) and has been shown to be closely tied to opioid pain reliever misuse and dependence. Past misuse of prescription opioids is the strongest risk factor for heroin initiation and use, specifically among persons who report past-year dependence or abuse (5). The increased availability of heroin, combined with its relatively low price (compared with diverted prescription opioids) and high purity appear to be major drivers of the upward trend in heroin use and overdose (6).

The rate of drug overdose deaths involving synthetic opioids nearly doubled between 2013 and 2014. This category includes both prescription synthetic opioids (e.g., fentanyl and tramadol) and non-pharmaceutical fentanyl manufactured in illegal laboratories (illicit fentanyl). Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl. Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl (7), although this cannot be confirmed with mortality data. For example, five jurisdictions (Florida, Maryland, Maine, Ohio, and Philadelphia, Pennsylvania) that reported sharp increases in illicit fentanyl seizures, and screened persons who died from a suspected drug overdose for fentanyl, detected similarly sharp increases in fentanyl-relateddeaths (7).§ Finally, illicit fentanyl is often combined with heroin or sold as heroin. Illicit fentanyl might be contributing to recent increases in drug overdose deaths involving heroin. Therefore, increases in illicit fentanyl-associated deaths might represent an emerging and troubling feature of the rise in illicit opioid overdoses that has been driven by heroin.

The findings in this report are subject to at least three limitations. First, several factors related to death investigation might affect estimates of death rates involving specific drugs. At autopsy, toxicological laboratory tests might be performed to determine the type of drugs present; however, the substances tested for and circumstances under which the tests are performed vary by jurisdiction. Second, in 2013 and 2014, 22% and 19% of drug overdose deaths, respectively, did not include information on the death certificate about the specific types of drugs involved. The percent of overdose deaths with specific drugs identified on the death certificate varies widely by state. Some of these deaths might have involved opioids. This increase in the reporting of specific drugs in 2014 might have contributed to some of the observed increases in drug overdose death rates involving different types of opioids from 2013 to 2014. Finally, some heroin deaths might be misclassified as morphine because morphine and heroin are metabolized similarly (8), which might result in an underreporting of heroin overdose deaths.

To reverse the epidemic of opioid drug overdose deaths and prevent opioid-related morbidity, efforts to improve safer prescribing of prescription opioids must be intensified. Opioid pain reliever prescribing has quadrupled since 1999 and has increased in parallel with overdoses involving the most commonly used opioid pain relievers (1). CDC has developed a draft guideline for the prescribing of opioids for chronic pain to address this need.¶

In addition, efforts are needed to protect persons already dependent on opioids from overdose and other harms. This includes expanding access to and use of naloxone (a safe and effective antidote for all opioid-related overdoses)** and increasing access to medication-assisted treatment, in combination with behavioral therapies (9). Efforts to ensure access to integrated prevention services, including access to syringe service programs when available, is also an important consideration to prevent the spread of hepatitis C virus and human immunodeficiency virus infections from injection drug use.

Public health agencies, medical examiners and coroners, and law enforcement agencies can work collaboratively to improve detection of outbreaks of drug overdose deaths involving illicit opioids (including heroin and illicit fentanyl) through improved investigation and testing as well as reporting and monitoring of specific drugs, and facilitate a rapid and effective response that can address this emerging threat to public health and safety (7). Efforts are needed to distinguish the drugs contributing to overdoses to better understand this trend.

1Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC.

Corresponding author: Rose A. Rudd, rvr2@cdc.gov, 770-488-3712.

References

  1. Paulozzi LJ, Jones C, Mack K, Rudd R. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999–2008. MMWR Morb Mortal Wkly Rep 2011;60:1487–92.
  2. Bergen G, Chen LH, Warner M, Fingerhut LA. Injury in the United States: 2007 chartbook. Hyattsville, MD: National Center for Health Statistics; 2008 Available at http://www.cdc.gov/nchs/data/misc/injury2007.pdf Adobe PDF file.
  3. Murphy SL, Xu JQ, Kochanek KD. Deaths: final data for 2010. National vital statistics reports. Hyattsville, MD: National Center for Health Statistics; 2013. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_04.pdf Adobe PDF file.
  4. CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2015. Available athttp://wonder.cdc.gov.
  5. Jones CM, Logan J, Gladden RM, Bohm MK. Vital signs: demographic and substance use trends among heroin users—United States, 2002–2013. MMWR Morb Mortal Wkly Rep 2015;64:719–25.
  6. Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The changing face of heroin use in the United States: a retrospective analysis of the past fifty years. JAMA Psychiatry 2014;71:821–6.
  7. CDC. Increases in fentanyl drug confiscations and fentanyl-related overdose fatalities. HAN Health Advisory. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. Available at http://emergency.cdc.gov/han/han00384.asp.
  8. Davis GG. Complete republication: National Association of Medical Examiners position paper: recommendations for the investigation, diagnosis, and certification of deaths related to opioid drugs. J Med Toxicol 2014;10:100–6.
  9. Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies—tackling the opioid-overdose epidemic. N Engl J Med 2014;370:2063–6.
Rose A. Rudd, MSPH1; Noah Aleshire, JD1; Jon E. Zibbell, PhD1; R. Matthew Gladden, PhD1
* Additional information available at http://www.cdc.gov/nchs/nvss/mortality_public_use_data.htm.
Additional information available at http://www.cdc.gov/drugoverdose/data/statedeaths.html.
§ Additional information available at http://pub.lucidpress.com/NDEWSFentanyl/External Web Site Icon.
¶ Additional information available at http://www.cdc.gov/drugoverdose/prescribing/guideline.html.

Thursday, December 17, 2015

Concussions: Protecting Players

Washington, DC—Professional and amateur sports leagues have finally begun to make key changes to protect players against traumatic brain injuries, largely as a result of major litigation against the National Football League (NFL) and other organizations, according to a new report by the American Association for Justice (AAJ). The civil justice system, through a small number of lawsuits, has driven a radical change in the health care approach to professional and student athletes. The report comes just days before the theatrical release of the movieConcussion, starring Will Smith as Dr. Bennet Omalu, a neuropathologist who first discovered a specific form of brain disease in former NFL players.
A copy of the report and highlights can be found here: http://concussion.justice.org/
“When medical research began to show the long-term impacts of repeated concussions, almost no one did anything. Worse, many, including the NFL, largely denied a problem existed. It was only when injured players took sports leagues, colleges and school districts to court that this serious safety issue was acknowledged and addressed,” said AAJ president Larry A. Tawwater. “If it weren’t for the civil justice system, the leagues would probably still be ignoring this issue, and players and their families would be suffering from more untreated long-term brain injuries.”
The AAJ report, Concussions and the Courthousechronicles decades of concussion incidents in sports from soccer to hockey to football, and the ever-strengthening research on the cognitive effects of repeated brain trauma.
The report shows how high-profile lawsuits against sports leagues, school districts, and colleges finally pushed administrators and the insurance companies that back their organizations to introduce strict protocols and concussion management policies. Most prominently, the lawsuit by former NFL players against the organization forced a dramatic change in attitudes. Sideline concussion protocols, independent spotters and medical examiners, and baseline neurological testing have become common in professional sports.
“Today, we continue this conversation to not only protect those former NFL players, but also all athletes – including millions of children – involved in contact sports, so that they can avoid this public health concern involving repeated head trauma,” said attorney Jason Luckasevic, who brought concussions in sports to international attention when he filed the first two lawsuits against the NFL on behalf of retired players. “I believe there is a need to make sure our athletes are not at increased risk for chronic brain damage as a result of the careless actions of leagues.”
The effects of repeated brain trauma on minors are particularly alarming. In 2006, 13-year-old Zackery Lystedt suffered a concussion during a junior high school football game, and sat out just three plays before returning to the game. He later collapsed and was airlifted to a hospital, where doctors removed portions of his skull to relieve pressure in his brain. It would be nine months before Lystedt could speak again and 13 months before he could move his arms or legs.
“I don’t think people understand the implications of a mismanaged concussion,” said Victor Lystedt, Zackery’s father. “Knowing that this happens to many student athletes, we need to educate as many people as we possibly can. We want people to understand that a concussion is a brain injury. We can’t see them or touch them, but we know that they are catastrophic if not managed correctly.
In 2009, Washington state passed the so-called Zackery Lystedt Law, becoming the first state in the nation to enact a comprehensive youth sports concussion safety law. The law, also known as “When in Doubt, Sit Them Out,” was drafted by Richard Adler, Lystedt’s attorney. Since then, every state except Wyoming has enacted some form of the “When In Doubt, Sit Them Out” law.
“You can’t necessarily prevent brain injuries in sports, but you can prevent the bad outcomes of not treating them properly,” Adler said. “The laws have had a tremendous effect in raising awareness and preventing death and catastrophic losses to families. That’s the greatest thing that’s occurred.”
The AAJ report examines the laws in each of the 50 states on concussions in youth sports. The report calls on all states to pass laws to require that:
  • Students who may have suffered a concussion be cleared by a health professional that is either a licensed physician, or someone trained specifically in Traumatic Brain Injury management;
  • Parents of students who have suffered a concussion are notified; and
  • Medical trainers be present at all games involving collision sports.
The American Association for Justice works to preserve the constitutional right to trial by jury and to make sure people have a fair chance to receive justice through the legal system when they are injured by the negligence or misconduct of others—even when it means taking on the most powerful corporations. Visit http://www.justice.org

Insurance Carrier Subject to Lawsuit for Failing to Reimburse CMS

Workers' Compensation insurance carriers have a duty to reimburse the Centers of Medicare and Medicaid Services for conditional medical payments. Failure to do so may result in a private cause of action by the injured worker or his representative for double damages. Once the lawsuit is filed the workers' compensation insurance company cannot mitigate the double recovery penalty by making payment.

A private cause of action was permitted to go forward seeking double damages by an estate against a workers' compensation insurance carrier for failing to reimburse CMS for conditional medical payments. The District Court, Charles R. Simpson, III , Senior District Judge, held that an issue of fact as to whether insurer did nothing to reimburse Medicare prior to estate's commencement of private action precluded summary judgment.

The Court held that a genuine issue of material fact existed as to whether workers' compensation insurer did nothing to appropriately reimburse Medicare for medical expenses that Medicare had paid for a work-related injury until estate of deceased employee brought private action under the Medicare Secondary Payer Act (MSPA), precluding summary judgment on whether estate was entitled to double recovery under the MSPA. 42 U.S.C.A. § 1395y(b)(3)(A).

"The private cause of action provision allows for damages “in an amount double the amount otherwise provided” – the purpose being to encourage beneficiaries to bring claims even if Medicare has already paid the beneficiaries' expenses. Once a private cause of action claim has been lodged against a defendant, a defendant cannot escape the double damages provided for in that provision by paying single damages to Medicare."

Estate of McDonald v. Indemnity Insurance Company of..., --- F.Supp.3d ---- (2015), CIVIL ACTION NO. 3:12CV–577–CRS, 2015 WL 6997440, Filed April 14, 2015.