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HHS Announces Guide for Appropriate Tapering or Discontinuation of Long-Term Opioid Use

Today, the U.S. Department of Health and Human Services published a new Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. Individual patients, as well as the health of the public, benefit when opioids are prescribed only when the benefit of using opioids outweighs the risks.  But once a patient is on opioids for a prolonged duration, any abrupt change in the patient’s regimen may put the patient at risk of harm and should include a thorough, deliberative case review and discussion with the patient. The HHS Guide provides advice to clinicians who are contemplating or initiating a change in opioid dosage.

“Care must be a patient-centered experience. We need to treat people with compassion, and emphasize personalized care tailored to the specific circumstances and unique needs of each patient,” said Adm. Brett P. Giroir, M.D., assistant secretary for health. “This Guide provides more resources for clinicians to best help patients achieve the dual goals of effective pain management and reduction in the risk for addiction.”

Clinicians have a responsibility to coordinate patients’ pain treatment and opioid-related problems. In certain situations, a reduced opioid dosage may be indicated, in joint consultation with the care team and the patient. HHS does not recommend opioids be tapered rapidly or discontinued suddenly due to the significant risks of opioid withdrawal, unless there is a life-threatening issue confronting the individual patient.

Compiled from published guidelines and practices endorsed in the peer-reviewed literature, the Guide covers important issues to consider when changing a patient’s chronic pain therapy. It lists issues to consider prior to making a change, which include shared decision-making with the patient; issues to consider when initiating the change; and issues to consider as a patient’s dosage is being tapered, including the need to treat symptoms of opioid withdrawal and provide behavioral health support. For more information, go to: www.hhs.gov/opioids.

About the Office of the Assistant Secretary for Health

The Office of the Assistant Secretary for Health (OASH) oversees the U.S. Department of Health and Human Services’ key public health offices and programs, a number of Presidential and Secretarial advisory committees, 10 regional health offices across the nation, and the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps. OASH is committed to leading America to healthier lives.

Follow the Assistant Secretary for Health on Twitter @HHS_ASH, and sign up for HHS Email Updates.



Thu, 10 Oct 2019 11:00:00 -0400


HHS Proposes Stark Law and Anti-Kickback Statute Reforms to Support Value-Based and Coordinated Care

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute.

The proposed rules provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients. The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse.

The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which seeks to promote value-based care by examining federal regulations that impede efforts among providers to better coordinate care for patients.

“President Trump has promised American patients a healthcare system with affordable, personalized care, a system that puts you in control, provides peace of mind, and treats you like a human being, not a number. But too often, government regulations have stood in the way of delivering that kind of care,” said HHS Secretary Alex Azar. “Regulatory reform has been a key piece of President Trump’s agenda not just for faster innovation and economic growth, but also better, higher-value healthcare. Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve.”

“These proposed rules would be a historic reform of how healthcare is regulated in America,” said HHS Deputy Secretary Eric Hargan. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based healthcare system, while maintaining the important protections patients need. Here at HHS, CMS and the Office of Inspector General recognized the need for reform and have acted to produce serious and thoughtful sets of proposals.”

The Stark Law’s new value-based exceptions, under the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS), acknowledge that incentives are different in a healthcare system that pays for value, rather than the volume, of services provided. They include proper safeguards that ensure the Stark Law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients.

“We serve patients poorly when government regulations gather dust in the attic: they become ever more stale and liable to wreak havoc throughout the healthcare system,” said CMS Administrator Seema Verma. “Administrative costs are driving up the cost of healthcare in America – to the tune of hundreds of billions of dollars. The Stark proposed rule is an important next step in President Trump’s healthcare agenda for Americans. We are updating our antiquated regulations to decrease burden for providers and helping bring down these increasingly escalating costs.”

The proposed changes to the regulations related to the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law issued by the Office of Inspector General (OIG) would, if finalized, address the longstanding concern these laws unnecessarily limit the ways in which healthcare providers can coordinate care for patients. The changes would offer flexibility for beneficial innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes would also make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.

“Any patient can tell you how difficult it is to coordinate their own care. This proposed rule would help patients to focus on their health, enable providers to better coordinate high-quality healthcare, and empower both to achieve improved health outcomes,” said Acting Inspector General Joanne M. Chiedi. “We are proposing strong safeguards to protect patients from fraud and abuse by bad actors who might seek to misuse the new flexibilities.”

Below are examples involving coordinated care, value-based care, data sharing, and patient engagement activities that, depending on the facts, could currently be difficult to fit under existing protections and could potentially be protected by the Stark Law, Anti-Kickback Statute, or Civil Monetary Penalties Law proposals if all applicable conditions are met:

  • In an effort to coordinate care and better manage the care of their shared patients, a specialty physician practice could share data analytics services with a primary care physician practice.
  • Hospitals and physicians could work together in new ways to coordinate care for patients being discharged from the hospital. The hospital might provide the discharged patients’ physicians with care coordinators to ensure patients receive appropriate follow up care, data analytics systems to help physicians ensure that their patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions.
  • A physician practice could provide smart pillboxes to patients without charge to help them remember to take their medications on time.  The practice could also provide a home health aide to teach the patient and the patient’s caregiver how to use the pillbox.  The pillbox could automatically alert the physician practice and caregiver when a patient misses a dose so they could follow up promptly with the patient.  
  • A local hospital could improve its cybersecurity and the cybersecurity of nearby providers that it works with frequently.  To do so, it could donate, for free, cybersecurity software to each physician that refers patients to its hospital.  The hospital and the physicians often share information about their patients, so it is important that there are no weak links that might compromise everyone else.  The software would help ensure that hackers cannot attack the physician’s computers.  Improving each physician’s cybersecurity would help prevent hackers from spreading the attack to other physicians and the hospital.
  • To improve health outcomes for patients with end-stage kidney disease, a nephrologist, dialysis facility, or other provider could furnish the patients with technology that is capable of monitoring the patient’s health and two-way, real-time interactive communication between the patient, facility, and physician.  In addition, the facility could equip the physicians with data analytics software to help them monitor patients’ health outcomes. 

Read OIG’s proposed rule.*

Read CMS’s proposed rule.*

More on the changes to the Stark Law.

More on the changes to the Federal Anti-Kickback Statute.

* People using assistive technology may not be able to fully access information in this file. For assistance, contact digital@hhs.gov.



Wed, 09 Oct 2019 08:00:00 -0400


HHS Explores Lung-on-a-Chip Technology in Developing Chemical Injury Treatments

The U.S. Department of Health and Human Services (HHS) will support tests of organ-on-a-chip technology to determine how it can be used to understand injuries caused by inhaled chlorine gas, a potential national security threat, and to develop treatments for those injuries.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will provide technical expertise and approximately $13.5 million over the next two years to Wake Forest Institute for Regenerative Medicine (WFIRM) of Winston-Salem, North Carolina, to validate how the group’s lung-on-a-chip technology, also known as an organ tissue equivalent, works in modeling the effects of chlorine gas on human lungs. BARDA can support additional work over the next five years, providing funding up to a total of approximately $24 million.

“We are continually looking for disruptive technologies that accelerate the development of medical products to save lives in incidents involving some of the most horrific health security threats our country faces,” explained BARDA Director Rick Bright, Ph.D. “Organ-on-a-chip technology has the potential not only to inform our decisions about the most promising investigational products to pursue, but also to revolutionize the speed and cost-efficiency of developing those products.”

The lung-on-a-chip platform is part of WFIRM’s overall Body-on-a-Chip program, a miniaturized system of human organs that can be used to model the body’s response to harmful agents. To create the system, human cells are used to create tiny 3D organ-like structures called tissue equivalents that mimic the function of the heart, liver, lung, or blood vessels.

Placed on a two-inch chip, these structures are connected to a system of fluid channels and sensors to provide online monitoring of individual organs-on-a-chip and the overall system. Circulating a blood substitute keeps the cells alive and can be used to introduce chemical or biological agents, as well as potential therapies, into the system. Researchers monitor the responses of the organ-on-a-chip to a stimulus, such as chlorine gas.

Scientists’ observations on the effects of chlorine gas on human lungs is limited to accidents and chemical warfare incidents, both of which are uncommon. Although animal models are available and well-studied, these may not accurately reflect the human response and can be expensive to use. WFIRM’s study will determine whether the lung-on-a-chip reacts similarly to the way human lungs respond, and will expand the scientific understanding of lung injuries from inhaled chlorine.

The program will bring together experts in tissue biology, engineering, genomics, and bioinformatics – the combination of biology, mathematics, statistics, and computer science – to identify the effects of chlorine gas on the lungs and to determine the usefulness of the organ-on-a-chip technology in developing treatments for the resulting lung injuries.

Depending on the outcome of these early studies, BARDA and its partners may use organ-on-a-chip technology to test potential treatments for lung or other organ injuries that are caused by other chemical, biological, radiological, or nuclear (CBRN) agents. 

If used in developing products to treat or cure injuries or illnesses, organ-on-a-chip technology may reduce the number of animal studies needed for regulatory approval of these products. The need for fewer studies could reduce the development time and costs for many national security medical countermeasures.

Chlorine gas was used as a weapon during World War I and has been used repeatedly during the ongoing Syrian civil war. In addition, the amount of chlorine manufactured, along with its ready availability, makes this chemical a potential national security threat to the United States. Further, chlorine is one of the most-used industrial gases in the United States and causes multiple deaths and injuries due to accidents. In 2005, a train accident in Graniteville, South Carolina caused a tank car containing chlorine gas to leak, causing nine deaths and at least 250 injuries.

BARDA’s chemical countermeasures program is engaged with 16 different partners to develop therapeutics to protect from and to treat injuries caused by a variety of chemical threats, including three other partners whose products are being tested to treat chlorine-related injuries.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.​​



Tue, 08 Oct 2019 11:15:00 -0400


With End of New York Outbreak, United States Keeps Measles Elimination Status

The United States has maintained its measles elimination status of nearly 20 years. The New York State Department of Health yesterday declared the end of the state’s nearly year-long outbreak that had put the U.S. at risk of losing its measles elimination status.

“We are very pleased that the measles outbreak has ended in New York and that measles is still considered eliminated in the United States. This result is a credit to the cooperative work by local and state health departments, community and religious leaders, other partners, and the CDC,” said HHS Secretary Alex Azar. “But this past year’s outbreak was an alarming reminder about the dangers of vaccine hesitancy and misinformation. That is why the Trump Administration will continue making it a priority to work with communities and promote vaccination as one of the easiest things you can do to keep you and your family healthy and safe.”

The CDC confirmed 1,249 cases of measles between January 1 and October 4, 2019. This year marks the greatest number of measles cases in the country since 1992. While cases have been reported in 31 states, 75% of measles cases were linked to outbreaks in New York City and New York state, most of which were among unvaccinated children in Orthodox Jewish communities. These outbreaks have been traced to unvaccinated travelers who brought measles back from other countries at the beginning of October 2018.

Since measles outbreaks continue to occur in countries around the world, there is always a risk of measles importations into the U.S. When measles is imported into a highly vaccinated community, outbreaks either do not happen or are usually small. However, if measles is introduced into an under-vaccinated community, it can spread quickly and it can be difficult to control. Measles elimination status is lost immediately if a chain of transmission in a given outbreak is sustained for more than 12 months. CDC has been working with the Pan American Health Organization (PAHO) throughout the year to keep stakeholders updated on measles surveillance. CDC will also meet with PAHO’s Regional Verification Commission in the coming months to review the U.S. surveillance data and verify measles elimination status.

In the last year, the United Kingdom, Greece, Venezuela, and Brazil have lost their measles elimination status. Data from the World Health Organization indicates that during the first six months of the year there have been more measles cases reported worldwide than in any year since 2006. From January 1 – July 31, 2019, 182 countries reported 364,808 cases of measles. That increase is part of a global trend seen over the past few years as other countries struggle with achieving and maintaining vaccination rates.

A significant factor contributing to the outbreaks this year has been misinformation in some communities about the safety of the measles-mumps-rubella (MMR) vaccine. Some organizations are deliberately targeting these communities with inaccurate and misleading information about vaccines. CDC continues to encourage parents to speak to their family’s healthcare provider about the importance of vaccination. CDC also encourages local leaders to provide accurate, scientific-based information to counter misinformation.

“Our Nation’s successful public health response to this recent measles outbreak is a testament to the commitment and effectiveness of state and local health departments, and engaged communities across the country,” said CDC Director Robert R. Redfield, M.D. “CDC encourages Americans to embrace vaccination with confidence for themselves and their families. We want to emphasize that vaccines are safe. They remain the most powerful tool to preserve health and to save lives. The prevalence of measles is a global challenge, and the best way to stop this and other vaccine preventable diseases from gaining a foothold in the U.S. is to accept vaccines.”

Before the measles vaccine was introduced in the U.S., nearly all children got measles by the time they were 15 years of age. It is estimated three to four million people were infected, and among the 500,000 measles cases reported annually, 48,000 were hospitalized and 500 people died. 



Fri, 04 Oct 2019 10:15:00 -0400


HHS Secretary Azar Statement on Executive Order to Protect and Improve Medicare

Health and Human Services Secretary Alex Azar issued the following statement regarding the Executive Order signed by President Trump today directing HHS to take a number of actions to improve the Medicare program:

“President Trump’s Executive Order delivers on the clear promise he’s made to Americans about their healthcare: protect what works in our system and fix what’s broken. America’s seniors are overwhelmingly satisfied with the care they receive through traditional Medicare and Medicare Advantage, and the President is continuing to take action to strengthen and improve these programs. The President has directed HHS to take a number of specific, significant steps that will meaningfully improve the financing of Medicare, advance the care American seniors receive from their doctors, and improve the health they enjoy.

"The steps include expanding options and providing savings for seniors on Medicare Advantage; eliminating unnecessary burdens on providers; focusing Medicare payments on time spent with patients rather than on procedures performed; accelerating access to the latest medical technologies; cutting waste, fraud, and abuse; and expanding freedom and control for seniors on Medicare. All of these steps together will help create a healthcare system that puts patients at the center. These kinds of improvements, rather than a total government takeover of the healthcare system, are the path to our ultimate goal: better health for all Americans. That’s the President’s promise, and that’s what he has been delivering for American patients.”



Thu, 03 Oct 2019 12:45:00 -0400

Latest Top (5) News

Latest Top (5) News