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Federal Agency Information
U.S. Dept. of Health and Human Services (DHHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services.
Office of the Inspector General (OIG) of the DHHS includes information about programs to combat waste, fraud and abuse in the Medicare program.
OIG's Reading Room posts advisory opinions under the Medicare/Medicaid Anti-Kickback Law and lists of persons excluded from the Medicare/Medicaid Programs.
Centers for Medicare & Medicaid Services (CMS) is the federal agency that administers Medicare, Medicaid, and the State Children's Health Insurance Program.
The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
Drug Enforcement Administration (DEA) enforces the controlled substances laws and regulations of the United States.
Drug Enforcement Administration (DEA) Office of Administrative Law Judges conducts formal hearings in accordance with the Administrative Procedure Act in connection with enforcement and regulatory cases brought by the DEA under the Controlled Substances Act and its attendant regulations.
National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency.
The National Library of Medicine (NLM) is the world's largest medical library. The Library collects materials and provides information and research services in all areas of biomedicine and health care.
Role in Procurement of CDC GUIDELINES
The National Safety Council formally dedicated its resources to fighting prescription drug overdose in 2012, although an NSC study five years earlier laid the groundwork for this important initiative. The study revealed prescription drug overdose was the fastest-rising cause of unintentional death in the U.S.
Since then, NSC has positioned itself as the resource for employers, families and prescribers on the opioid crisis. NSC has taken key steps towards eradicating this epidemic.
HOW DID WE GET HERE.?
May 27, 2016
August 26, 2016
August 29, 2016
Nov 17, 2016
Alan J. Sobol
Connecticut Law Tribune
October 23, 2015
Recent changes to our health care system have been at the forefront of the American news cycle for several years. But certain aspects have not received adequate attention. One example is the scrutiny federal and state authorities place on medical practitioners who over-prescribe pain medication controlled substances. As part of its efforts to combat the over prescription (diversion) of pain medication, the Department of Justice organized “Operation Footprint,” a nationwide law enforcement initiative led by the U.S. Attorney’s Offices, the IRS-Criminal Investigation, the DEA, and the U.S. Postal Inspection Service. In a recent press release following one of the largest medical fraud sweeps in history, the Special Agent in Charge of the U.S. Department of Health and Human Services stated that “Physicians who overprescribe narcotics not only waste valuable taxpayer dollars and defraud Medicare and Medicaid, they also threaten the health and safety of their patients.” And in 2014, while serving as the U.S. Attorney for the Eastern District of New York, Attorney General Loretta Lynch highlighted the Department of Justice’s focus on these cases: “We are committed to vigorous prosecution of doctors who abdicate their Hippocratic Oath, participate in the illegal distribution of prescription drugs and contribute to the rise of drug abuse and addiction in our communities.”
Despite these pronouncements, some health care practitioners, especially those who do not regularly practice pain management, are likely unaware of the criminal liability that can stem from the prescriptions they issue. Ignorance of the law, however, is not a defense. Thus, it is crucial for attorneys who represent health care professionals to ensure that their clients properly understand their responsibilities with respect to prescribing pain killing controlled substances.
As legislators grapple with the opioid epidemic, hospitals are also rethinking their prescription practices. We polled over 200 acute care pharmacy leaders to understand how they are making formulary decisions, and what's the impact on reducing opioid prescriptions and related complications.
Read the research brief to learn more about our analysis of more than 400 organizations to investigate the impact of multi-modal pain regimens, and how your organization may be able to save over $1 million by reducing opioid use during surgery.
- September 16, 2016
The Department of Justice (DOJ) is planning to launch a new initiative to combat the U.S. opioid epidemic, Kevin Johnson writes for USA Today.
Attorney General Loretta Lynch (D) outlined the plan, which has yet to be released, in an interview with USA Today. A memo detailing the plan is expected to be sent to all 94 U.S. attorney offices next week.
DOJ's new strategy will focus on identifying links between physician overprescribing and distribution networks across the United States.
Specifically, Lynch said prosecutors will be encouraged to share information across state lines about physicians' inappropriate prescribing practices, which could help to identify traffickers and trafficking routes more quickly. Lynch said prosecutors also will be urged to coordinate their enforcement efforts with public health officials in their districts.
"I'm not calling anybody out, because I think the people who look at this problem realize quickly how devastating it has been to families, to communities, to public health dollars, to law enforcement resources,'' Lynch said. "There is no one magic bullet for this.''
Michael Botticelli, director of National Drug Control Policy, on Thursday said the Obama administration also will call on Congress to approve funding for recent legislation that aims to curb opioid misuse. In addition, the effort will call on congressional lawmakers to approve $1.1 billion in grants to pay for treatment requested by the White House, which will host events next week to raise awareness about the issue.
"The biggest area where we have fallen short is filling the gap between people who need treatment and those able to get it,'' Botticelli said, adding, "We need more treatment capacity. ... This requires a response commensurate with the size of the epidemic."
Lynch said, "We've been looking at this for a long time with an awareness that you can't just have an enforcement strategy alone" (Johnson, USA Today, 9/16).
For many years, Purdue has dedicated vast resources to combating drug abuse from a range of approaches. The RADARS System, just one example, was developed by Purdue in 2001 to collect and analyze data on drug abuse, diversion, and addiction.
In 2006, Purdue transferred ownership to the Denver Health and Hospital Authority (DHHA) to facilitate access to RADARS surveillance data by pharmaceutical firms and government agencies.
Today, the RADARS System is an independent, non-profit operation of the Rocky Mountain Poison and Drug Center (RMPDC), a division of DHHA.
For many years, Purdue has been an industry leader in the fight against opioid abuse and diversion. We are also committed to supporting healthcare professionals on the responsible use of our products.
For information on appropriate use and prescribing of opioid analgesics as well as the risks of opioids, prescription drug abuse, prescription drug monitoring programs, and the opioid analgesic Risk Evaluation and Mitigation Strategy (REMS), please visit Ask Purdue Medical.
Opioid Analgesic REMS
The U.S. Food and Drug Administration (FDA) has mandated that opioid analgesics have a Risk Evaluation and Mitigation Strategy (REMS) to help ensure that the benefits of the drug outweigh its risks. Learn more about REMS for opioid analgesics.
Opioids With Abuse-Deterrent Properties
Purdue was the first company to introduce opioids with labeling claims for abuse-deterrent properties through development of novel formulations and abuse deterrence studies.
Released: July 13, 2017
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States.
The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications.
Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016.
As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA’s development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Informative Video Series About the True Cause of the Opioid Crisis.
#OurPain: Opioid crisis leaves legitimate pain patients struggling
When you hear the word "opioid" on the news, it is usually attached to other words, including "crisis" and "epidemic."
Read More »News
#OurPain: The other side of opioids
Millions of Americans who rely on opioid medications for pain relief are in anguish because of government pressure to reduce prescriptions across the board.
Read More »News
#OurPain: How money factors into the opioid debate
Pain doctors say they'd like to wean their patients off of opioids when feasible, but many of the alternative treatments are not covered by public or private insurance programs.
Read More »News
The Other Side of Opioids:
The years of service and injuries take their toll and for many, the only relief comes from opioids. But navigating the VA system is far from easy and fewer prescriptions are being written. Read More »News
I-TEAM: Opioid addiction versus dependency. Millions of chronic pain patients, already living in agony because of disease or injuries, now live in fear that their medicine will be taken away because they've been stigmatized as drug addicts. Read More »News
A prominent pain doctor who was part of the I-Team's special project about the war on opioids is now the focus of a DEA investigation. Read More »
Health Care and Medical Organizations
The American Society of Anesthesiologists is an educational, research and scientific association of physicians organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.
American Medical Association promotes the art and science of medicine and the betterment of public health and continues to be the leading advocate for physicians and their patients.
American Health Care Association provides information on long-term care including issue papers, links to U.S. Government reports and databases, and more.
American Academy of Family Physicians preserves and promotes the science and art of family medicine and ensures high-quality, cost-effective health care for patients of all ages.
American Health Information Management Association is the community of professionals engaged in health information management, providing support to members and strengthening the industry and profession.
Agency for Healthcare Research and Quality is a home to research centers that specialize in major areas of health care research such as quality improvement and patient safety, outcomes and effectiveness of care, clinical practice and technology assessment, and health care organization and delivery systems. It is also a major source of funding and technical assistance for health services research and research training at leading U.S. universities and other institutions
The American Academy of Medical Management serves as an educational resource in the U.S. for people working in the business side of health care.
The College of American Pathologists, the principal organization of board-certified pathologists, serves and represents the interest of patients, pathologists, and the public by fostering excellence in the practice of pathology and laboratory medicine.
Institute of Medicine is a nonprofit organization for science-based advice on matters of biomedical science, medicine, and health. The Institute provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance.
Joint Commission on Accreditation of Health Care Organizations (JCAHO), an independent and not-for-profit organization, is the predominant standards-setting and accrediting body in health care.
National Committee for Quality Assurance is a private, not-for-profit organization dedicated to improving health care quality. The organization is frequently referred to as a watchdog for the managed care industry.
Health Law Organizations
The American Health Lawyers Association (AHLA) is an educational organization devoted to legal issues in the healthcare field.
Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses the security and privacy of health data and establishes national standards for electronic health care transactions.
State Legislative Database Search offers key-word searching of all Internet accessible state legislatures.
US Code of Federal Regulations is a consolidation and codification by subject matter of the general and permanent laws of the United States.
Telemedicine, Technology & Health Law is Alan S. Goldberg's site on telemedicine, health law, fraud and abuse and related issues.
THOMAS provides Congressional legislative information via the Internet.
Kaiser Family Foundation provides access to resources and information on major areas of health care policy, including narrated slide lectures, research, data, and policy analysis.
Health Care News and Current Events
America's Health Insurance Plans is the national trade association representing the health insurance industry. Their website provides information about health care news and policy updates.
FierceHealthcare provides healthcare management news for healthcare industry executives.
Modern Healthcare provides healthcare business and policy news, research and information.
Federal agencies, state governments, insurance providers, and physicians all influence the supply of opioid medications.
Federal regulators have introduced new limits on opioid prescriptions, reducing the total nationwide in 2017 by 25 percent from the peak in 2012, according to the CDC. The agency issued guidelines in 2016 advising physicians not to prescribe opioids as a first-line therapy. The DEA reduced production quotas for pharmaceutical manufacturers by at least 25 percent that year for opioids categorized as schedule II drugs, or those that are currently accepted for medical purposes but carry high risk of misuse; these include oxycodone, fentanyl, and morphine. The agency has since proposed additional cuts, in line with a call by Trump to reduce the number of filled prescriptions by one-third in three years.
Reporting by the Washington Post and 60 Minutes, however, found that a law passed in 2016 after heavy lobbying by pharmaceutical companies has effectively stripped the DEA of its ability to freeze suspicious shipments of narcotics. A December 2018 congressional report on painkiller shipments to West Virginia found that lack of oversight by the DEA fueled the black market and worsened the epidemic in the state.
In 2018, the Justice Department ramped up efforts to prosecute those involved in overprescribing and trafficking. In April of that year, it partnered with nearly all state attorneys general to share opioid prescription information in order to investigate drug crimes and, in its largest-ever move to crack down on health-care fraud, it brought charges against more than 150 doctors, nurses, pharmacists, and others for their alleged roles in distributing opioids.
Additionally, many U.S. states have passed legislation limiting opioid prescriptions since the start of 2016. States including Mississippi, New Jersey, Ohio, and Oklahoma, as well as thousands of cities, are suing pharmaceutical companies, alleging they overstated the benefits of prescription opioids and concealed the risks. In a landmark case brought by Oklahoma, Johnson & Johnson was ordered to pay the state $572 million in August 2019 for its role in the epidemic. In another case, the Sackler family, the owners of Purdue Pharma, reached a $3 billion settlement with state and municipal governments that allowed the company to file for bankruptcy in order to thwart thousands of other lawsuits against it, though some states are challenging the move.
ILLICITLY MANUFACTURED FENTANYL (IMF) is the TRUE culprit causing the OVERDOSE EPIDEMIC.
This deadly synthetic substance is being added to most street drugs like heroin, cocaine, meth, and look alike counterfeit pills. It's so potent, one pill can cause an overdose!
Learn More about ILLICIT Fentanyl Below.0
Most fentanyl coming to the United States is produced in China, U.S. officials say, and commonly transited through Mexico. Chinese authorities “have struggled to adequately regulate thousands of chemical and pharmaceutical facilities operating legally and illegally in the country,” says a 2017 report [PDF] issued by a congressionally mandated commission.