FROM: DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
April 9, 2014
Historic release of data gives consumers unprecedented transparency on the medical services physicians provide and how much they are paid
Today, as part of the Obama administration’s work to make our health care system more transparent, affordable, and accountable, Health and Human Services (HHS) Secretary Kathleen Sebelius announced the release of new, privacy-protected data on services and procedures provided to Medicare beneficiaries by physicians and other health care professionals. The new data also show payment and submitted charges, or bills, for those services and procedures by provider.
“Currently, consumers have limited information about how physicians and other health care professionals practice medicine,” said Secretary Sebelius “This data will help fill that gap by offering insight into the Medicare portion of a physician’s practice. The data released today afford researchers, policymakers and the public a new window into health care spending and physician practice patterns.”
The new data set has information for over 880,000 distinct health care providers who collectively received $77 billion in Medicare payments in 2012, under the Medicare Part B Fee-For-Service program. With this data, it will be possible to conduct a wide range of analyses that compare 6,000 different types of services and procedures provided, as well as payments received by individual health care providers.
The information also allows comparisons by physician, specialty, location, the types of medical service and procedures delivered, Medicare payment, and submitted charges. Physicians and other health care professionals determine what they will charge for services and procedures provided to patients and these “charges” are the amount the physician or health care professional generally bills for the service or procedure.
"Data transparency is a key aspect of transformation of the health care delivery system,” said CMS Administrator Marilyn Tavenner. “While there’s more work ahead, this data release will help beneficiaries and consumers better understand how care is delivered through the Medicare program.”
Last May, CMS released hospital charge data allowing consumers to compare what hospitals charge for common inpatient and outpatient services across the country.
Showing posts with label HHS. Show all posts
Showing posts with label HHS. Show all posts
Thursday, April 10, 2014
Thursday, February 27, 2014
WHITE HOUSE, FDA ANNOUNCE NEW NUTRITION FACTS LABEL
FROM: THE WHITE HOUSE
The White House and FDA Announce Proposed Updates to Nutrition Facts Label
First Lady Michelle Obama and FDA Commissioner Margaret Hamburg announce proposed updates to the Nutrition Facts label as part of an effort to help families make healthier choices
Washington, DC – Today, First Lady Michelle Obama joined Secretary of Health and Human Services Kathleen Sebelius and FDA Commissioner Margaret Hamburg at the White House to announce proposed revisions to the Nutrition Facts label, which has been significantly updated only once since its initial release twenty years ago. The Nutrition Facts label is found on roughly 700,000 products. The updates announced today support the First Lady’s Let’s Move! initiative in its ongoing efforts to provide parents and families with access to information that helps them make healthier choices.
“Our guiding principle here is very simple: that you as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it’s good for your family,” said First Lady Michelle Obama. “So this is a big deal, and it’s going to make a big difference for families all across this country.”
The proposed updates are intended to reflect the latest scientific information about the link between diet and chronic diseases such as obesity and heart disease. The proposed label would also replace out-of-date serving sizes to better align with the amount consumers actually eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
“For 20 years consumers have come to rely on the iconic nutrition label to help them make healthier food choices,” said FDA Commissioner Margaret A. Hamburg, M.D. “To remain relevant, the FDA’s newly proposed Nutrition Facts label incorporates the latest in nutrition science as more has been learned about the connection between what we eat and the development of serious chronic diseases impacting millions of Americans.”
Some of the FDA’s proposed changes to the Nutrition Facts label are:
Require information about the amount of “added sugars” in a food product. Based on the 2010 Dietary Guidelines for Americans determination that calorie intake from added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include “added sugars” on the label to help consumers know how much sugar has been added to the product.
Update serving size requirements to reflect the amounts people currently eat. What and how much people eat and drink has changed since the serving sizes were first put into place in 1994. By law, serving sizes must be based on the portion consumers actually eat, rather than the amount they “should” be eating.
Present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting or in multiple sittings.
Refresh the format to emphasize certain elements, such as calories, serving sizes and Percent Daily Value, which are important in addressing current public health problems like obesity and heart disease.
The White House and FDA Announce Proposed Updates to Nutrition Facts Label
First Lady Michelle Obama and FDA Commissioner Margaret Hamburg announce proposed updates to the Nutrition Facts label as part of an effort to help families make healthier choices
Washington, DC – Today, First Lady Michelle Obama joined Secretary of Health and Human Services Kathleen Sebelius and FDA Commissioner Margaret Hamburg at the White House to announce proposed revisions to the Nutrition Facts label, which has been significantly updated only once since its initial release twenty years ago. The Nutrition Facts label is found on roughly 700,000 products. The updates announced today support the First Lady’s Let’s Move! initiative in its ongoing efforts to provide parents and families with access to information that helps them make healthier choices.
“Our guiding principle here is very simple: that you as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it’s good for your family,” said First Lady Michelle Obama. “So this is a big deal, and it’s going to make a big difference for families all across this country.”
The proposed updates are intended to reflect the latest scientific information about the link between diet and chronic diseases such as obesity and heart disease. The proposed label would also replace out-of-date serving sizes to better align with the amount consumers actually eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
“For 20 years consumers have come to rely on the iconic nutrition label to help them make healthier food choices,” said FDA Commissioner Margaret A. Hamburg, M.D. “To remain relevant, the FDA’s newly proposed Nutrition Facts label incorporates the latest in nutrition science as more has been learned about the connection between what we eat and the development of serious chronic diseases impacting millions of Americans.”
Some of the FDA’s proposed changes to the Nutrition Facts label are:
Require information about the amount of “added sugars” in a food product. Based on the 2010 Dietary Guidelines for Americans determination that calorie intake from added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include “added sugars” on the label to help consumers know how much sugar has been added to the product.
Update serving size requirements to reflect the amounts people currently eat. What and how much people eat and drink has changed since the serving sizes were first put into place in 1994. By law, serving sizes must be based on the portion consumers actually eat, rather than the amount they “should” be eating.
Present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting or in multiple sittings.
Refresh the format to emphasize certain elements, such as calories, serving sizes and Percent Daily Value, which are important in addressing current public health problems like obesity and heart disease.
Wednesday, February 26, 2014
HHS ANNOUNCES RECORD $19.5 BILLION RECOVERED FROM HEALTH CARE FRAUD CASES
FROM: DEPARTMENT OF HEALTH AND HUMAN SERVICES
February 26, 2014
Departments of Justice and Health and Human Services announce record-breaking recoveries resulting from joint efforts to combat health care fraud
Government teams recovered $4.3 billion in FY 2013 and $19.2 billion over the last five years
Attorney General Eric Holder and HHS Secretary Kathleen Sebelius today released the annual Health Care Fraud and Abuse Control (HCFAC) Program report showing that for every dollar spent on health care-related fraud and abuse investigations through this and other programs in the last three years, the government recovered $8.10. This is the highest three-year average return on investment in the 17-year history of the HCFAC Program.
The government’s health care fraud prevention and enforcement efforts recovered a record-breaking $4.3 billion in taxpayer dollars in Fiscal Year (FY) 2013, up from $4.2 billion in FY 2012, from individuals and companies who attempted to defraud federal health programs serving seniors or who sought payments from taxpayers to which they were not entitled. Over the last five years, the administration’s enforcement efforts have recovered $19.2 billion, up from $9.4 billion over the prior five-year period. Since the inception of the program in1997, the HCFAC Program has returned more than $25.9 billion to the Medicare Trust Funds and treasury.
These recoveries, released today in the annual HCFAC Program report, demonstrate President Obama’s commitment to making the elimination of fraud, waste and abuse, particularly in health care, a top priority for the administration. This is the fifth consecutive year that the program has increased recoveries over the past year, climbing from $2 billion in FY 2008 to over $4 billion every year since FY 2011.
The success of this joint Department of Justice and HHS effort was made possible in part by the Health Care Fraud Prevention and Enforcement Action Team (HEAT), created in 2009 to prevent fraud, waste and abuse in Medicare and Medicaid and to crack down on individuals and entities that are abusing the system and costing American taxpayers billions of dollars.
“With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder. “Thanks to initiatives like HEAT, our work to combat fraud has never been more cooperative or more effective. And our unprecedented commitment to holding criminals accountable, and securing remarkable results for American taxpayers, is paying dividends.”
“These impressive recoveries for the American taxpayer are just one aspect of the comprehensive anti-fraud strategy we have implemented since the passage of the Affordable Care Act,” said HHS Secretary Sebelius. “We’ve cracked down on tens of thousands health care providers suspected of Medicare fraud. New enrollment screening techniques are proving effective in preventing high risk providers from getting into the system, and the new computer analytics system that detects and stops fraudulent billing before money ever goes out the door is accomplishing positive results – all of which are adding to savings for the Medicare Trust Fund.”
The new authorities under the Affordable Care Act granted to HHS and the Centers for Medicare & Medicaid Services (CMS) were instrumental in clamping down on fraudulent activity in health care. In FY 2013, CMS announced the first use of its temporary moratoria authority granted by the Affordable Care Act. The action stopped enrollment of new home health or ambulance enrollments in three fraud hot spots around the country, allowing CMS and its law enforcement partners to remove bad actors from the program while blocking provider entry or re-entry into these already over-supplied markets.
The Justice Department and HHS have improved their coordination through HEAT and are currently operating Medicare Fraud Strike Force teams in nine areas across the country. The strike force teams use advanced data analysis techniques to identify high-billing levels in health care fraud hot spots so that interagency teams can target emerging or migrating schemes as well as chronic fraud by criminals masquerading as health care providers or suppliers. The Justice Department’s enforcement of the civil False Claims Act and the Federal Food, Drug and Cosmetic Act has produced similar record-breaking results. These combined efforts coordinated under HEAT have expanded local partnerships and helped educate Medicare beneficiaries about how to protect themselves against fraud.
In Fiscal Year 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (46). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In FY 2013, the Justice Department opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants, and a total of 718 defendants were convicted of health care fraud-related crimes during the year. The department also opened 1,083 new civil health care fraud investigations.
The strike force coordinated a takedown in May 2013 that resulted in charges by eight strike force cities against 89 individuals, including doctors, nurses and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $223 million in false billings. As a part of the May 2013 takedown, HHS also suspended or took other administrative action against 18 providers using authority under the health care law to suspend payments until an investigation is complete.
In FY 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (48). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In March 2011, CMS began an ambitious project to revalidate all 1.5 million Medicare enrolled providers and suppliers under the Affordable Care Act screening requirements. As of September 2013, more than 535,000 providers were subject to the new screening requirements and over 225,000 lost the ability to bill Medicare due to the Affordable Care Act requirements and other proactive initiatives. Since the Affordable Care Act, CMS has also revoked 14,663 providers and suppliers’ ability to bill the Medicare program. These providers were removed from the program because they had felony convictions, were not operational at the address CMS had on file, or were not in compliance with CMS rules.
HHS and the Justice Department are leading historic efforts with the private sector to bring innovation to the fight against health care fraud. In addition to real-time data and information exchanges with the private sector, CMS’ Program Integrity Command Center worked with the HHS Office of the Inspector General and the FBI to conduct 93 missions to detect, investigate, and reduce improper payments in FY 2013.
From May 2013 through August 2013, CMS led an outreach and education campaign targeted to specific communities where Medicare fraud is more prevalent. This multimedia campaign included national television, radio, and print outreach and resulted in an increased awareness of how to detect and report Medicare fraud.
February 26, 2014
Departments of Justice and Health and Human Services announce record-breaking recoveries resulting from joint efforts to combat health care fraud
Government teams recovered $4.3 billion in FY 2013 and $19.2 billion over the last five years
Attorney General Eric Holder and HHS Secretary Kathleen Sebelius today released the annual Health Care Fraud and Abuse Control (HCFAC) Program report showing that for every dollar spent on health care-related fraud and abuse investigations through this and other programs in the last three years, the government recovered $8.10. This is the highest three-year average return on investment in the 17-year history of the HCFAC Program.
The government’s health care fraud prevention and enforcement efforts recovered a record-breaking $4.3 billion in taxpayer dollars in Fiscal Year (FY) 2013, up from $4.2 billion in FY 2012, from individuals and companies who attempted to defraud federal health programs serving seniors or who sought payments from taxpayers to which they were not entitled. Over the last five years, the administration’s enforcement efforts have recovered $19.2 billion, up from $9.4 billion over the prior five-year period. Since the inception of the program in1997, the HCFAC Program has returned more than $25.9 billion to the Medicare Trust Funds and treasury.
These recoveries, released today in the annual HCFAC Program report, demonstrate President Obama’s commitment to making the elimination of fraud, waste and abuse, particularly in health care, a top priority for the administration. This is the fifth consecutive year that the program has increased recoveries over the past year, climbing from $2 billion in FY 2008 to over $4 billion every year since FY 2011.
The success of this joint Department of Justice and HHS effort was made possible in part by the Health Care Fraud Prevention and Enforcement Action Team (HEAT), created in 2009 to prevent fraud, waste and abuse in Medicare and Medicaid and to crack down on individuals and entities that are abusing the system and costing American taxpayers billions of dollars.
“With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder. “Thanks to initiatives like HEAT, our work to combat fraud has never been more cooperative or more effective. And our unprecedented commitment to holding criminals accountable, and securing remarkable results for American taxpayers, is paying dividends.”
“These impressive recoveries for the American taxpayer are just one aspect of the comprehensive anti-fraud strategy we have implemented since the passage of the Affordable Care Act,” said HHS Secretary Sebelius. “We’ve cracked down on tens of thousands health care providers suspected of Medicare fraud. New enrollment screening techniques are proving effective in preventing high risk providers from getting into the system, and the new computer analytics system that detects and stops fraudulent billing before money ever goes out the door is accomplishing positive results – all of which are adding to savings for the Medicare Trust Fund.”
The new authorities under the Affordable Care Act granted to HHS and the Centers for Medicare & Medicaid Services (CMS) were instrumental in clamping down on fraudulent activity in health care. In FY 2013, CMS announced the first use of its temporary moratoria authority granted by the Affordable Care Act. The action stopped enrollment of new home health or ambulance enrollments in three fraud hot spots around the country, allowing CMS and its law enforcement partners to remove bad actors from the program while blocking provider entry or re-entry into these already over-supplied markets.
The Justice Department and HHS have improved their coordination through HEAT and are currently operating Medicare Fraud Strike Force teams in nine areas across the country. The strike force teams use advanced data analysis techniques to identify high-billing levels in health care fraud hot spots so that interagency teams can target emerging or migrating schemes as well as chronic fraud by criminals masquerading as health care providers or suppliers. The Justice Department’s enforcement of the civil False Claims Act and the Federal Food, Drug and Cosmetic Act has produced similar record-breaking results. These combined efforts coordinated under HEAT have expanded local partnerships and helped educate Medicare beneficiaries about how to protect themselves against fraud.
In Fiscal Year 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (46). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In FY 2013, the Justice Department opened 1,013 new criminal health care fraud investigations involving 1,910 potential defendants, and a total of 718 defendants were convicted of health care fraud-related crimes during the year. The department also opened 1,083 new civil health care fraud investigations.
The strike force coordinated a takedown in May 2013 that resulted in charges by eight strike force cities against 89 individuals, including doctors, nurses and other licensed medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $223 million in false billings. As a part of the May 2013 takedown, HHS also suspended or took other administrative action against 18 providers using authority under the health care law to suspend payments until an investigation is complete.
In FY 2013, the strike force secured records in the number of cases filed (137), individuals charged (345), guilty pleas secured (234) and jury trial convictions (48). Beyond these remarkable results, the defendants who were charged and sentenced are facing significant time in prison – an average of 52 months in prison for those sentenced in FY 2013, and an average of 47 months in prison for those sentenced since 2007.
In March 2011, CMS began an ambitious project to revalidate all 1.5 million Medicare enrolled providers and suppliers under the Affordable Care Act screening requirements. As of September 2013, more than 535,000 providers were subject to the new screening requirements and over 225,000 lost the ability to bill Medicare due to the Affordable Care Act requirements and other proactive initiatives. Since the Affordable Care Act, CMS has also revoked 14,663 providers and suppliers’ ability to bill the Medicare program. These providers were removed from the program because they had felony convictions, were not operational at the address CMS had on file, or were not in compliance with CMS rules.
HHS and the Justice Department are leading historic efforts with the private sector to bring innovation to the fight against health care fraud. In addition to real-time data and information exchanges with the private sector, CMS’ Program Integrity Command Center worked with the HHS Office of the Inspector General and the FBI to conduct 93 missions to detect, investigate, and reduce improper payments in FY 2013.
From May 2013 through August 2013, CMS led an outreach and education campaign targeted to specific communities where Medicare fraud is more prevalent. This multimedia campaign included national television, radio, and print outreach and resulted in an increased awareness of how to detect and report Medicare fraud.
Friday, February 21, 2014
FINAL RULE REGARDING ACA WAITING PERIOD FOR HEALTH INSURANCE COVERAGE
FROM: LABOR DEPARTMENT
Obama administration announces final rule regarding Affordable Care Act 90-day waiting period limitation
WASHINGTON — The U.S. Departments of Labor, Treasury, and Health and Human Services have announced the publication of final regulations implementing a 90-day limit on waiting periods for health coverage.
"This is a common sense measure that helps workers access employer-sponsored health insurance while providing employers flexibility," said Assistant Secretary of Labor for Employee Benefits Security Phyllis C. Borzi.
The final regulations require that no group health plan or group health insurance issuer impose a waiting period that exceeds 90 days after an employee is otherwise eligible for coverage. The rules do not require coverage be offered to any particular individual or class of individuals.
To ensure that eligibility conditions based solely on the passage of time are not used to evade the waiting period limit, the rules state that such conditions cannot exceed 90 days. Other conditions for eligibility are generally permissible, such as meeting certain sales goals, earning a certain level of commission, or successfully completing an orientation period.
Additionally, requiring employees to complete a certain number of hours before becoming eligible for coverage is generally allowed as long as the requirement is capped at 1200 hours. The rules also address situations in which it cannot be determined that a new employee will be working full-time.
The departments are issuing a companion proposed rule that would limit the maximum duration of an otherwise permissible orientation period to one month. This proposal will be open for public comment.
Obama administration announces final rule regarding Affordable Care Act 90-day waiting period limitation
WASHINGTON — The U.S. Departments of Labor, Treasury, and Health and Human Services have announced the publication of final regulations implementing a 90-day limit on waiting periods for health coverage.
"This is a common sense measure that helps workers access employer-sponsored health insurance while providing employers flexibility," said Assistant Secretary of Labor for Employee Benefits Security Phyllis C. Borzi.
The final regulations require that no group health plan or group health insurance issuer impose a waiting period that exceeds 90 days after an employee is otherwise eligible for coverage. The rules do not require coverage be offered to any particular individual or class of individuals.
To ensure that eligibility conditions based solely on the passage of time are not used to evade the waiting period limit, the rules state that such conditions cannot exceed 90 days. Other conditions for eligibility are generally permissible, such as meeting certain sales goals, earning a certain level of commission, or successfully completing an orientation period.
Additionally, requiring employees to complete a certain number of hours before becoming eligible for coverage is generally allowed as long as the requirement is capped at 1200 hours. The rules also address situations in which it cannot be determined that a new employee will be working full-time.
The departments are issuing a companion proposed rule that would limit the maximum duration of an otherwise permissible orientation period to one month. This proposal will be open for public comment.
Thursday, February 6, 2014
NEW DRUG FUNDED TO FIGHT BIOTERRORISM, ANTIMICROBIAL-RESISTANT INFECTIONS
FROM: HEALTH AND HUMAN SERVICES
HHS funds drug for bioterrorism, antimicrobial-resistant infections
A new drug to help protect the public against two bioterrorism threats and provide a new option to treat antibiotic-resistant infections will advance in development under a public-private partnership, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced today.
“Antibiotic resistance adversely impacts our nation’s ability to respond effectively to a bioterrorism attack and to everyday public health threats,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), which will oversee the project. “By partnering with industry to develop novel antimicrobial drugs against biothreats that also treat drug-resistant bacteria, we can address health security and public health needs efficiently.”
BARDA will support the development of Carbavance under a five-year cost-sharing agreement with Rempex Pharmaceuticals Inc. (a wholly owned subsidiary of The Medicines Company) in San Diego. The agreement includes an initial commitment from BARDA of $19.8 million and can be extended to provide up to $90 million over the five years.
The two bioterrorism threats are melioidosis and glanders. With existing antibiotic treatments, approximately 40 percent of people who become ill from these bacteria die from the illness, and up to 90 percent die if not treated.
Melioidosis, also called Whitmore's disease, can be mistaken for other diseases such as tuberculosis and common forms of pneumonia. The bacteria that cause melioidosis can be found in water and soil, and cause infection when a person touches or inhales the bacteria. The infection is common in parts of Southeast Asia and Australia.
Glanders is a respiratory disease that can affect people, although it is primarily found in animals. The bacteria that cause glanders can affect skin, blood, lungs, or muscles, and may be transmitted through direct contact with infected animals or by inhaling contaminated aerosols or dust.
Melioidosis and glanders can become resistant to existing antibiotics.
In addition to showing promise as a treatment for melioidosis and glanders in a bioterrorism event, Carbavance potentially could be used commercially to treat complicated urinary tract infections, hospital-acquired pneumonia, ventilator-acquired pneumonia, and carbapenem-resistant Enterobacteriaceae (CRE), all of which can be resistant to existing antibiotics.
CRE are a family of bacteria that have been called nightmare bacteria because the bacteria are resistant to all or nearly all antibiotics, kill up to half of people who get serious infections with them, and can spread their resistance to other bacteria. CRE infections have been detected in nearly every state, and the incidence has risen sharply over the past five years.
Patients whose care requires devices such as ventilators, urinary (bladder) catheters, or intravenous (vein) catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRE infections.
The project includes preclinical and clinical studies, manufacture of enough of the drug for clinical studies, and other manufacturing-related activities needed to apply for U.S. Food and Drug Administration approval of the drug.
The project with Rempex is the latest in a BARDA program that supports development of broad-spectrum antimicrobials, technologies and platforms for biodefense needs that simultaneously address other public health challenges, such antibiotic-resistant infections.
BARDA is seeking additional proposals for advanced development of novel antimicrobials to treat illness caused by biological threat agents and that also could address the growing threat of antimicrobial resistance. Proposals are accepted through the Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.
BARDA utilizes a comprehensive, integrated portfolio approach to support the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, nuclear threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
HHS funds drug for bioterrorism, antimicrobial-resistant infections
A new drug to help protect the public against two bioterrorism threats and provide a new option to treat antibiotic-resistant infections will advance in development under a public-private partnership, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced today.
“Antibiotic resistance adversely impacts our nation’s ability to respond effectively to a bioterrorism attack and to everyday public health threats,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), which will oversee the project. “By partnering with industry to develop novel antimicrobial drugs against biothreats that also treat drug-resistant bacteria, we can address health security and public health needs efficiently.”
BARDA will support the development of Carbavance under a five-year cost-sharing agreement with Rempex Pharmaceuticals Inc. (a wholly owned subsidiary of The Medicines Company) in San Diego. The agreement includes an initial commitment from BARDA of $19.8 million and can be extended to provide up to $90 million over the five years.
The two bioterrorism threats are melioidosis and glanders. With existing antibiotic treatments, approximately 40 percent of people who become ill from these bacteria die from the illness, and up to 90 percent die if not treated.
Melioidosis, also called Whitmore's disease, can be mistaken for other diseases such as tuberculosis and common forms of pneumonia. The bacteria that cause melioidosis can be found in water and soil, and cause infection when a person touches or inhales the bacteria. The infection is common in parts of Southeast Asia and Australia.
Glanders is a respiratory disease that can affect people, although it is primarily found in animals. The bacteria that cause glanders can affect skin, blood, lungs, or muscles, and may be transmitted through direct contact with infected animals or by inhaling contaminated aerosols or dust.
Melioidosis and glanders can become resistant to existing antibiotics.
In addition to showing promise as a treatment for melioidosis and glanders in a bioterrorism event, Carbavance potentially could be used commercially to treat complicated urinary tract infections, hospital-acquired pneumonia, ventilator-acquired pneumonia, and carbapenem-resistant Enterobacteriaceae (CRE), all of which can be resistant to existing antibiotics.
CRE are a family of bacteria that have been called nightmare bacteria because the bacteria are resistant to all or nearly all antibiotics, kill up to half of people who get serious infections with them, and can spread their resistance to other bacteria. CRE infections have been detected in nearly every state, and the incidence has risen sharply over the past five years.
Patients whose care requires devices such as ventilators, urinary (bladder) catheters, or intravenous (vein) catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRE infections.
The project includes preclinical and clinical studies, manufacture of enough of the drug for clinical studies, and other manufacturing-related activities needed to apply for U.S. Food and Drug Administration approval of the drug.
The project with Rempex is the latest in a BARDA program that supports development of broad-spectrum antimicrobials, technologies and platforms for biodefense needs that simultaneously address other public health challenges, such antibiotic-resistant infections.
BARDA is seeking additional proposals for advanced development of novel antimicrobials to treat illness caused by biological threat agents and that also could address the growing threat of antimicrobial resistance. Proposals are accepted through the Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.
BARDA utilizes a comprehensive, integrated portfolio approach to support the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, nuclear threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Tuesday, January 14, 2014
HHS ANNOUNCES 2.2 MILLION AMERICANS SELECTED PLANS IN HEALTH INSURANCE MARKETPLACE
FROM: DEPARTMENT OF HEALTH AND HUMAN SERVICES
2.2 million Americans selected plans in the Health Insurance Marketplace from October through December
Thirty percent of those who selected plans were under age 35
Nearly 2.2 million people have selected plans from the state and federal marketplaces by Dec. 28, 2013 (the end of third reporting period for open enrollment), Health and Human Services Secretary Kathleen Sebelius announced today.
A new HHS report provides the first demographic information about enrollees. December alone accounted for nearly 1.8 million enrollees in state and federal marketplaces. Enrollment in the federal Marketplace in December was seven-fold greater than the combined total for October and November – and eight-fold greater for young adults ages 18 to 34.
“Americans are finding quality affordable coverage in the Marketplace, and best of all, because coverage began on New Year’s Day, the promise and hope of the Affordable Care Act is now a reality,” Secretary Sebelius said. “Our outreach efforts have ramped up, so whether it’s through public service announcements, events, our champions or other means, we are doing all we can to find, inform and enroll those who can benefit from the Marketplace. There is still plenty of time for you and your family to sign up in a private plan of your choice, so visit HealthCare.gov to learn more and sign up now.”
Key findings from today’s report include:
Nearly 2.2 million (2,153,421) people selected Marketplace plans from Oct. 1 through Dec. 28, 2013
These signups in the state and federal marketplaces represent a nearly five-fold increase from October-November, including nearly 1.8 million (1,788,739) people who selected a plan in December (compared with the previous two-month cumulative total of 364,682 through Nov. 30, 2013).
Of the almost 2.2. million:
54 percent are female and 46 percent are male;
30 percent are age 34 and under;
24 percent are between the ages of 18 and 34, and;
60 percent selected a Silver plan, while 20 percent selected a Bronze plan; and
79 percent selected a plan with Financial Assistance.
Today’s report also details state-by-state information where available. In some cases, only partial datasets were available for state marketplaces.
The report features cumulative data for the three-month period because some people apply, shop, and select a plan across monthly reporting periods. Enrollment is measured as those who selected a plan.
2.2 million Americans selected plans in the Health Insurance Marketplace from October through December
Thirty percent of those who selected plans were under age 35
Nearly 2.2 million people have selected plans from the state and federal marketplaces by Dec. 28, 2013 (the end of third reporting period for open enrollment), Health and Human Services Secretary Kathleen Sebelius announced today.
A new HHS report provides the first demographic information about enrollees. December alone accounted for nearly 1.8 million enrollees in state and federal marketplaces. Enrollment in the federal Marketplace in December was seven-fold greater than the combined total for October and November – and eight-fold greater for young adults ages 18 to 34.
“Americans are finding quality affordable coverage in the Marketplace, and best of all, because coverage began on New Year’s Day, the promise and hope of the Affordable Care Act is now a reality,” Secretary Sebelius said. “Our outreach efforts have ramped up, so whether it’s through public service announcements, events, our champions or other means, we are doing all we can to find, inform and enroll those who can benefit from the Marketplace. There is still plenty of time for you and your family to sign up in a private plan of your choice, so visit HealthCare.gov to learn more and sign up now.”
Key findings from today’s report include:
Nearly 2.2 million (2,153,421) people selected Marketplace plans from Oct. 1 through Dec. 28, 2013
These signups in the state and federal marketplaces represent a nearly five-fold increase from October-November, including nearly 1.8 million (1,788,739) people who selected a plan in December (compared with the previous two-month cumulative total of 364,682 through Nov. 30, 2013).
Of the almost 2.2. million:
54 percent are female and 46 percent are male;
30 percent are age 34 and under;
24 percent are between the ages of 18 and 34, and;
60 percent selected a Silver plan, while 20 percent selected a Bronze plan; and
79 percent selected a plan with Financial Assistance.
Today’s report also details state-by-state information where available. In some cases, only partial datasets were available for state marketplaces.
The report features cumulative data for the three-month period because some people apply, shop, and select a plan across monthly reporting periods. Enrollment is measured as those who selected a plan.
Saturday, January 11, 2014
HHS WORKS ON LIVING OPTIONS FOR OLDER PEOPLE WITH DISABILITIES
FROM: HEALTH AND HUMAN SERVICES
HHS strengthens community living options for older Americans and people with disabilities
The Centers for Medicare & Medicaid Services (CMS) issued a final rule today to ensure that Medicaid’s home and community-based services programs provide full access to the benefits of community living and offer services in the most integrated settings. The rule, as part of the Affordable Care Act, supports the Department of Health and Human Services’ Community Living Initiative. The initiative was launched in 2009 to develop and implement innovative strategies to increase opportunities for Americans with disabilities and older adults to enjoy meaningful community living.
Under the final rule, Medicaid programs will support home and community-based settings that serve as an alternative to institutional care and that take into account the quality of individuals’ experiences. The final rule includes a transitional period for states to ensure that their programs meet the home and community-based services settings requirements. Technical assistance will also be available for states.
“People with disabilities and older adults have a right to live, work, and participate in the greater community. HHS, through its Community Living Initiative, has been expanding and improving the community services necessary to make this a reality,” said HHS Secretary Kathleen Sebelius. “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.”
In addition to defining home and community-based settings, the final rule implements the Section 1915(i) home and community-based services State Plan option. This includes new flexibility provided by the Affordable Care Act that gives states additional options for expanding home and community-based services and to target services to specific populations. It also amends the 1915(c) home and community-based services waiver program to add new person-centered planning requirements, allow states to combine multiple target populations in one waiver, and streamlines waiver administration.
HHS strengthens community living options for older Americans and people with disabilities
The Centers for Medicare & Medicaid Services (CMS) issued a final rule today to ensure that Medicaid’s home and community-based services programs provide full access to the benefits of community living and offer services in the most integrated settings. The rule, as part of the Affordable Care Act, supports the Department of Health and Human Services’ Community Living Initiative. The initiative was launched in 2009 to develop and implement innovative strategies to increase opportunities for Americans with disabilities and older adults to enjoy meaningful community living.
Under the final rule, Medicaid programs will support home and community-based settings that serve as an alternative to institutional care and that take into account the quality of individuals’ experiences. The final rule includes a transitional period for states to ensure that their programs meet the home and community-based services settings requirements. Technical assistance will also be available for states.
“People with disabilities and older adults have a right to live, work, and participate in the greater community. HHS, through its Community Living Initiative, has been expanding and improving the community services necessary to make this a reality,” said HHS Secretary Kathleen Sebelius. “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.”
In addition to defining home and community-based settings, the final rule implements the Section 1915(i) home and community-based services State Plan option. This includes new flexibility provided by the Affordable Care Act that gives states additional options for expanding home and community-based services and to target services to specific populations. It also amends the 1915(c) home and community-based services waiver program to add new person-centered planning requirements, allow states to combine multiple target populations in one waiver, and streamlines waiver administration.
Tuesday, December 24, 2013
HHS SAYS 123 ACCOUNTABLE CARE ORGANIZATIONS SHOULD IMPROVE MEDICARE
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
More partnerships between doctors and hospitals strengthen coordinated care for Medicare beneficiaries
123 New Accountable Care Organizations Join Program to Improve Care for Medicare beneficiaries
Doctors, hospitals and other health care providers have formed 123 new Accountable Care Organizations (ACOs) in Medicare, providing approximately 1.5 million more Medicare beneficiaries with access to high-quality coordinated care across the United States, Health and Human Services Secretary Kathleen Sebelius announced today.
Doctors, hospitals and health care providers establish ACOs in order to work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. Since passage of the Affordable Care Act, more than 360 ACOs have been established, serving over 5.3 million Americans with Medicare. Beneficiaries seeing health care providers in ACOs always have the freedom to choose doctors inside or outside of the ACO. ACOs share with Medicare any savings generated from lowering the growth in health care costs when they meet standards for high quality care.
“Accountable Care Organizations are delivering higher-quality care to Medicare beneficiaries and are using Medicare dollars more efficiently,” Secretary Sebelius said. “This is a great example of the Affordable Care Act rewarding hospitals and doctors that work together to help our beneficiaries get the best possible care.”
“This program puts the control in the hands of physicians and allows them to take the lead in an innovative way to deliver the right care to the right patient at the right time,” said Kelly A. Conroy, executive director of the Palm Beach ACO and South Florida ACO. “We are honored to be a Medicare Shared Savings Program Accountable Care Organization, and after 18 months in the program, can proudly say that we have seen measurable success. We are so impressed with our participating physicians’ enthusiasm towards the cultural shift, and it demonstrates that physicians are primed for the future of medicine.”
The ACOs must meet quality standards to ensure that savings are achieved through improving care coordination and providing care that is appropriate, safe, and timely. The Centers for Medicare & Medicaid Services (CMS) evaluates ACO quality performance using 33 quality measures on patient and caregiver experience of care, care coordination and patient safety, appropriate use of preventive health services, and improved care for at-risk populations.
The new ACOs include a diverse cross-section of health care providers across the country, including providers delivering care in underserved areas. More than half of ACOs are physician-led organizations that serve fewer than 10,000 beneficiaries. Approximately 1 in 5 ACOs include community health centers, rural health clinics, and critical access hospitals that serve low-income and rural communities.
Affordable Care Act provisions have a substantial effect on reducing the growth rate of Medicare spending. Growth in Medicare spending per beneficiary hit historic lows during the 2010-2012 period, and this trend has continued into 2013. Projections by both the Office of the Actuary at CMS and the Congressional Budget Office estimate that Medicare spending per beneficiary will grow at approximately the rate of growth of the economy for the next decade, breaking a decades-old pattern of spending growth outstripping economic growth.
The next application period for organizations interested in participating in the Shared Savings Program beginning January 2015 will be in summer 2014.
More partnerships between doctors and hospitals strengthen coordinated care for Medicare beneficiaries
123 New Accountable Care Organizations Join Program to Improve Care for Medicare beneficiaries
Doctors, hospitals and other health care providers have formed 123 new Accountable Care Organizations (ACOs) in Medicare, providing approximately 1.5 million more Medicare beneficiaries with access to high-quality coordinated care across the United States, Health and Human Services Secretary Kathleen Sebelius announced today.
Doctors, hospitals and health care providers establish ACOs in order to work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. Since passage of the Affordable Care Act, more than 360 ACOs have been established, serving over 5.3 million Americans with Medicare. Beneficiaries seeing health care providers in ACOs always have the freedom to choose doctors inside or outside of the ACO. ACOs share with Medicare any savings generated from lowering the growth in health care costs when they meet standards for high quality care.
“Accountable Care Organizations are delivering higher-quality care to Medicare beneficiaries and are using Medicare dollars more efficiently,” Secretary Sebelius said. “This is a great example of the Affordable Care Act rewarding hospitals and doctors that work together to help our beneficiaries get the best possible care.”
“This program puts the control in the hands of physicians and allows them to take the lead in an innovative way to deliver the right care to the right patient at the right time,” said Kelly A. Conroy, executive director of the Palm Beach ACO and South Florida ACO. “We are honored to be a Medicare Shared Savings Program Accountable Care Organization, and after 18 months in the program, can proudly say that we have seen measurable success. We are so impressed with our participating physicians’ enthusiasm towards the cultural shift, and it demonstrates that physicians are primed for the future of medicine.”
The ACOs must meet quality standards to ensure that savings are achieved through improving care coordination and providing care that is appropriate, safe, and timely. The Centers for Medicare & Medicaid Services (CMS) evaluates ACO quality performance using 33 quality measures on patient and caregiver experience of care, care coordination and patient safety, appropriate use of preventive health services, and improved care for at-risk populations.
The new ACOs include a diverse cross-section of health care providers across the country, including providers delivering care in underserved areas. More than half of ACOs are physician-led organizations that serve fewer than 10,000 beneficiaries. Approximately 1 in 5 ACOs include community health centers, rural health clinics, and critical access hospitals that serve low-income and rural communities.
Affordable Care Act provisions have a substantial effect on reducing the growth rate of Medicare spending. Growth in Medicare spending per beneficiary hit historic lows during the 2010-2012 period, and this trend has continued into 2013. Projections by both the Office of the Actuary at CMS and the Congressional Budget Office estimate that Medicare spending per beneficiary will grow at approximately the rate of growth of the economy for the next decade, breaking a decades-old pattern of spending growth outstripping economic growth.
The next application period for organizations interested in participating in the Shared Savings Program beginning January 2015 will be in summer 2014.
Friday, December 13, 2013
HHS ON HIGH SCHOOL SPORTS AND PAINKILLERS
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Sports can be tough competition for high school boys, and sometimes pain from an injury is bad enough for a doctor to prescribe painkillers. But a researcher warns that opioid drugs can cause problems if they’re not watched closely.
At the University of Michigan, Philip Veliz looked at national survey data on 1,540 teens. He found boy athletes were more likely than non-athletes to report having used and misused opioids in the previous year. Veliz suspects injuries led to the prescriptions.
He says drug use needs careful supervision:
"Parents should be the ones monitoring these medications and they should be the ones who dispense the medications to their adolescents."
The study in the Journal of Adolescent Health was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Sports can be tough competition for high school boys, and sometimes pain from an injury is bad enough for a doctor to prescribe painkillers. But a researcher warns that opioid drugs can cause problems if they’re not watched closely.
At the University of Michigan, Philip Veliz looked at national survey data on 1,540 teens. He found boy athletes were more likely than non-athletes to report having used and misused opioids in the previous year. Veliz suspects injuries led to the prescriptions.
He says drug use needs careful supervision:
"Parents should be the ones monitoring these medications and they should be the ones who dispense the medications to their adolescents."
The study in the Journal of Adolescent Health was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Thursday, December 12, 2013
HHS SAYS ALMOST 365,000 HAVE SELECTED HEALTH INSURANCE MARKETPLACE PLANS
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
December 11, 2013
Nearly 365,000 Americans selected plans in the Health Insurance Marketplace in October and November
1.9 million customers made it through the process but have not yet selected a plan; an additional 803,077 assessed or determined eligible for Medicaid or CHIP
Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that nearly 365,000 individuals have selected plans from the state and federal Marketplaces by the end of November. November alone added more than a quarter million enrollees in state and federal Marketplaces. Enrollment in the federal Marketplace in November was more than four times greater than October’s reported federal enrollment number.
Since October 1, 1.9 million have made it through another critical step, the eligibility process, by applying and receiving an eligibility determination, but have not yet selected a plan. An additional 803,077 were determined or assessed eligible for Medicaid or the Children’s Health Insurance Program (CHIP) in October and November by the Health Insurance Marketplace.
“Evidence of the technical improvements to HealthCare.gov can be seen in the enrollment numbers. More and more Americans are finding that quality, affordable coverage is within reach and that they'll no longer need to worry about barriers they may have faced in the past – like being denied coverage because of a pre-existing condition,” Secretary Kathleen Sebelius said. “Now is the time to visit HealthCare.gov, to ensure you and your family have signed up in a private plan of your choice by December 23 for coverage starting January 1. It's important to remember that this open enrollment period is six months long and continues to March 31, 2014.”
The HHS issue brief highlights the following key findings, which are among many newly available data reported today on national and state-level enrollment-related information:
November’s federal enrollment number outpaced the October number by more than four times.
Nearly 1.2 million Americans, based only on the first two months of open enrollment, have selected a plan or had a Medicaid or CHIP eligibility determination;
Of those, 364,682 Americans selected plans from the state and federal Marketplaces; and
803,077 Americans were determined or assessed eligible for Medicaid or CHIP by the Health Insurance Marketplace.
39.1 million visitors have visited the state and federal sites to date.
There were an estimated 5.2 million calls to the state and federal call centers.
The report groups findings by state and federal marketplaces. In some cases only partial datasets were available for state marketplaces. The report features cumulative data for the two month period because some people apply, shop, and select a plan across monthly reporting periods. These counts avoid potential duplication associated with monthly reporting. For example, if a person submitted an application in October, and then selected a Marketplace plan in November, this person would only be counted once in the cumulative data.
December 11, 2013
Nearly 365,000 Americans selected plans in the Health Insurance Marketplace in October and November
1.9 million customers made it through the process but have not yet selected a plan; an additional 803,077 assessed or determined eligible for Medicaid or CHIP
Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that nearly 365,000 individuals have selected plans from the state and federal Marketplaces by the end of November. November alone added more than a quarter million enrollees in state and federal Marketplaces. Enrollment in the federal Marketplace in November was more than four times greater than October’s reported federal enrollment number.
Since October 1, 1.9 million have made it through another critical step, the eligibility process, by applying and receiving an eligibility determination, but have not yet selected a plan. An additional 803,077 were determined or assessed eligible for Medicaid or the Children’s Health Insurance Program (CHIP) in October and November by the Health Insurance Marketplace.
“Evidence of the technical improvements to HealthCare.gov can be seen in the enrollment numbers. More and more Americans are finding that quality, affordable coverage is within reach and that they'll no longer need to worry about barriers they may have faced in the past – like being denied coverage because of a pre-existing condition,” Secretary Kathleen Sebelius said. “Now is the time to visit HealthCare.gov, to ensure you and your family have signed up in a private plan of your choice by December 23 for coverage starting January 1. It's important to remember that this open enrollment period is six months long and continues to March 31, 2014.”
The HHS issue brief highlights the following key findings, which are among many newly available data reported today on national and state-level enrollment-related information:
November’s federal enrollment number outpaced the October number by more than four times.
Nearly 1.2 million Americans, based only on the first two months of open enrollment, have selected a plan or had a Medicaid or CHIP eligibility determination;
Of those, 364,682 Americans selected plans from the state and federal Marketplaces; and
803,077 Americans were determined or assessed eligible for Medicaid or CHIP by the Health Insurance Marketplace.
39.1 million visitors have visited the state and federal sites to date.
There were an estimated 5.2 million calls to the state and federal call centers.
The report groups findings by state and federal marketplaces. In some cases only partial datasets were available for state marketplaces. The report features cumulative data for the two month period because some people apply, shop, and select a plan across monthly reporting periods. These counts avoid potential duplication associated with monthly reporting. For example, if a person submitted an application in October, and then selected a Marketplace plan in November, this person would only be counted once in the cumulative data.
Wednesday, December 11, 2013
HHS ANNOUNCES $50 MILLION IN MENTAL HEALTH FUNDING THROUGH AFFORDABLE CARE ACT
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR IMMEDIATE RELEASE
December 10, 2013
HHS announces Affordable Care Act mental health services funding
$50 million from the health care law will expand mental health and substance use disorder services in approximately 200 Community Health Centers nationwide
The U.S. Department of Health and Human Services (HHS) today announced that it plans to issue a $50 million funding opportunity announcement to help Community Health Centers establish or expand behavioral health services for people living with mental illness, and drug and alcohol problems. Community Health Centers will be able to use these new funds, made available through the Affordable Care Act, for efforts such as hiring new mental health and substance use disorder professionals, adding mental health and substance use disorder services, and employing team-based models of care.
“Most behavioral health conditions are treatable, yet too many Americans are not able to get needed treatment,” said Health Resources and Services Administration (HRSA) Administrator Mary K. Wakefield, Ph.D., R.N. “These new Affordable Care Act funds will expand the capacity of our network of community health centers to respond to the mental health needs in their communities.”
“These new funds will further the Department’s work to develop integrated primary and behavioral health care services to better meet the needs of people with mental health and substance use conditions,” said Substance Abuse and Mental Health Services Administration Administrator, Pamela S. Hyde.
It is estimated these awards will support behavioral health expansion in approximately 200 existing health centers nationwide.
Over the past year the Obama administration has taken a number of steps to reduce the barriers that too often prevent people from getting the help they need for behavioral health problems.
The Affordable Care Act expands mental health and substance use disorder benefits and parity protections for approximately 60 million Americans.
The President’s Fiscal Year 2014 Budget includes a new $130 million initiative to help teachers recognize signs of mental illness in students and refer them to services, support innovative state-based programs to improve mental health outcomes for young people ages, and train 5,000 more mental health professionals. For more information please visit: http://www.whitehouse.gov/omb/budget/factsheet/improving-mental-health-prevention-and-treatment-services.
The Administration has also finalized rules under the Mental Health Parity and Addiction Equity Act. Because of these parity protections, many insurance plans will now include coverage for mental health and substance use conditions that is comparable to their medical and surgical coverage.
The Administration also launched www.mentalhealth.gov a new website featuring easy-to-understand information about basic signs of mental health problems, how to talk about mental health, and how to find help.
FOR IMMEDIATE RELEASE
December 10, 2013
HHS announces Affordable Care Act mental health services funding
$50 million from the health care law will expand mental health and substance use disorder services in approximately 200 Community Health Centers nationwide
The U.S. Department of Health and Human Services (HHS) today announced that it plans to issue a $50 million funding opportunity announcement to help Community Health Centers establish or expand behavioral health services for people living with mental illness, and drug and alcohol problems. Community Health Centers will be able to use these new funds, made available through the Affordable Care Act, for efforts such as hiring new mental health and substance use disorder professionals, adding mental health and substance use disorder services, and employing team-based models of care.
“Most behavioral health conditions are treatable, yet too many Americans are not able to get needed treatment,” said Health Resources and Services Administration (HRSA) Administrator Mary K. Wakefield, Ph.D., R.N. “These new Affordable Care Act funds will expand the capacity of our network of community health centers to respond to the mental health needs in their communities.”
“These new funds will further the Department’s work to develop integrated primary and behavioral health care services to better meet the needs of people with mental health and substance use conditions,” said Substance Abuse and Mental Health Services Administration Administrator, Pamela S. Hyde.
It is estimated these awards will support behavioral health expansion in approximately 200 existing health centers nationwide.
Over the past year the Obama administration has taken a number of steps to reduce the barriers that too often prevent people from getting the help they need for behavioral health problems.
The Affordable Care Act expands mental health and substance use disorder benefits and parity protections for approximately 60 million Americans.
The President’s Fiscal Year 2014 Budget includes a new $130 million initiative to help teachers recognize signs of mental illness in students and refer them to services, support innovative state-based programs to improve mental health outcomes for young people ages, and train 5,000 more mental health professionals. For more information please visit: http://www.whitehouse.gov/omb/budget/factsheet/improving-mental-health-prevention-and-treatment-services.
The Administration has also finalized rules under the Mental Health Parity and Addiction Equity Act. Because of these parity protections, many insurance plans will now include coverage for mental health and substance use conditions that is comparable to their medical and surgical coverage.
The Administration also launched www.mentalhealth.gov a new website featuring easy-to-understand information about basic signs of mental health problems, how to talk about mental health, and how to find help.
Saturday, November 23, 2013
HHS SAYS SMOKER WHO LOOK HEALTHY MAY STILL BE SICK
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICE
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Even a smoker who looks healthy – and whose doctor might even find no sign of health damage from smoking – might already be sick. Researcher Ronald Crystal of Weill Cornell Medical College in New York City saw it when he compared airway cells from nonsmokers and from smokers who had no sign of lung disease, based on standard clinical tests.
Crystal says some hypothetical man smoking outside a building might think he’s OK, but he’s not:
“When you look at the cells lining his airways, the biology of those cells are markedly different, and they are clearly abnormal.”
Crystal says quitting can let lungs heal from smoke damage, but some cells never fully recover – so it’s best never to start.
The study in the journal Stem Cell was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Last revised: November 21, 2013
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Even a smoker who looks healthy – and whose doctor might even find no sign of health damage from smoking – might already be sick. Researcher Ronald Crystal of Weill Cornell Medical College in New York City saw it when he compared airway cells from nonsmokers and from smokers who had no sign of lung disease, based on standard clinical tests.
Crystal says some hypothetical man smoking outside a building might think he’s OK, but he’s not:
“When you look at the cells lining his airways, the biology of those cells are markedly different, and they are clearly abnormal.”
Crystal says quitting can let lungs heal from smoke damage, but some cells never fully recover – so it’s best never to start.
The study in the journal Stem Cell was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Last revised: November 21, 2013
HHS SAYS STUDY SHOWS OVERWEIGHT KIDS HAVE INCREASED HYPERTENSION RISK AS ADULTS
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
A study indicates that young people who are overweight or obese have a higher risk of high blood pressure, or hypertension, when they grow up.
At Riley Hospital for Children at Indiana University Health, researcher Sara Watson saw this in 27 years of data on more than 1,100 teenagers:
“Children and adolescents who were overweight had double the risk of having hypertension as young adults. Those who were obese had quadruple the risk.”
Put another way, 6 percent of normal weight youth grew up to have hypertension, but 14 percent of overweight children and 26 percent of obese children did.
Watson says it looks increasingly like heart disease starts young.
The study presented at an American Heart Association meeting was supported by the National Institutes of Health.
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
A study indicates that young people who are overweight or obese have a higher risk of high blood pressure, or hypertension, when they grow up.
At Riley Hospital for Children at Indiana University Health, researcher Sara Watson saw this in 27 years of data on more than 1,100 teenagers:
“Children and adolescents who were overweight had double the risk of having hypertension as young adults. Those who were obese had quadruple the risk.”
Put another way, 6 percent of normal weight youth grew up to have hypertension, but 14 percent of overweight children and 26 percent of obese children did.
Watson says it looks increasingly like heart disease starts young.
The study presented at an American Heart Association meeting was supported by the National Institutes of Health.
Friday, November 15, 2013
HHS SECRETARY SEBELIUS MAKES STATEMENT ON DIABETES DAN AND MONTH RECOGNITION
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
2013 World Diabetes Day and National Diabetes Month
A statement by HHS Secretary Kathleen Sebelius
On November 14, World Diabetes Day—and during National Diabetes Month-- we join with individuals living with diabetes, their families, advocates, and health care professionals to raise awareness of this devastating disease around the world.
Combating diabetes is a serious public health issue. More than 340 million people worldwide have diabetes. Recognizing the urgency of this public health problem globally, this May the World Health Assembly adopted a global target to stop the rise in diabetes by 2025.
As the seventh leading cause of death in the United States, diabetes affects nearly 26 million Americans of all ages. Another 79 million adults are estimated to have prediabetes, a condition that places them at increased risk for developing type 2 diabetes, heart disease and stroke.
While we have made progress in research leading to improved treatment of diabetes, the burden of this complex disease continues to rise. Diabetes is the leading cause of kidney failure, lower-limb amputations not caused by injury, and new cases of blindness among adults in the United States. Diabetes also is a major cause of heart disease and stroke.
Preventing type 2 diabetes and its complications can improve the quality of life for millions of people and save billions of dollars. The direct and indirect costs of diabetes in 2007 were as much as $174 billion.
Yet, while type 2 diabetes is often preventable, more and more people – including young people -- are at risk for type 2 diabetes due partly to the obesity epidemic and aging of the U.S. population.
Currently there is no way to prevent type 1 diabetes, which is most commonly diagnosed in children and young adults. However, researchers continue their work to identify risk factors and explore preventive measures.
It is important to keep in mind the theme of HHS’s National Diabetes Education Program for National Diabetes Month this year: Diabetes is a family affair. Diabetes strikes not only individuals, but families, communities, and our Nation.
Encouraging research shows that taking small steps, such as adding vegetables and fruits to your diet and getting 30 minutes of moderate-intensity physical activity five days a week, can help manage type 2 diabetes and improve health. These lifestyle changes can support weight loss, which can go a long way in helping a person at high risk for type 2 diabetes delay or prevent its onset.
Involve your entire family. Cook a balanced meal. Share a brisk walk, talk with your family about your health and your family’s diabetes risk. Schools, work sites, and places of worship can also be part of the diabetes prevention and management solution.
Preventive care is critical to improving health and identifying early signs of disease or risk-factors. That is why the Affordable Care Act ensures that, in non-grandfathered health plans, Americans at higher risk for developing type 2 diabetes can receive diabetes screening, diet counseling and obesity screening with no out-of-pocket cost. Additionally, screening for gestational diabetes is available at no additional charge for pregnant women. In 2014, Americans cannot be denied health coverage because they have diabetes or any other pre-existing condition.
Initiatives such as First Lady Michelle Obama’s Let’s Move program, the Centers for Disease Control and Prevention (CDC)’s National Diabetes Prevention Program and the National Diabetes Education Program (a partnership of the National Institutes of Health and CDC) are helping Americans of all ages take action to improve their health and that of the nation.
2013 World Diabetes Day and National Diabetes Month
A statement by HHS Secretary Kathleen Sebelius
On November 14, World Diabetes Day—and during National Diabetes Month-- we join with individuals living with diabetes, their families, advocates, and health care professionals to raise awareness of this devastating disease around the world.
Combating diabetes is a serious public health issue. More than 340 million people worldwide have diabetes. Recognizing the urgency of this public health problem globally, this May the World Health Assembly adopted a global target to stop the rise in diabetes by 2025.
As the seventh leading cause of death in the United States, diabetes affects nearly 26 million Americans of all ages. Another 79 million adults are estimated to have prediabetes, a condition that places them at increased risk for developing type 2 diabetes, heart disease and stroke.
While we have made progress in research leading to improved treatment of diabetes, the burden of this complex disease continues to rise. Diabetes is the leading cause of kidney failure, lower-limb amputations not caused by injury, and new cases of blindness among adults in the United States. Diabetes also is a major cause of heart disease and stroke.
Preventing type 2 diabetes and its complications can improve the quality of life for millions of people and save billions of dollars. The direct and indirect costs of diabetes in 2007 were as much as $174 billion.
Yet, while type 2 diabetes is often preventable, more and more people – including young people -- are at risk for type 2 diabetes due partly to the obesity epidemic and aging of the U.S. population.
Currently there is no way to prevent type 1 diabetes, which is most commonly diagnosed in children and young adults. However, researchers continue their work to identify risk factors and explore preventive measures.
It is important to keep in mind the theme of HHS’s National Diabetes Education Program for National Diabetes Month this year: Diabetes is a family affair. Diabetes strikes not only individuals, but families, communities, and our Nation.
Encouraging research shows that taking small steps, such as adding vegetables and fruits to your diet and getting 30 minutes of moderate-intensity physical activity five days a week, can help manage type 2 diabetes and improve health. These lifestyle changes can support weight loss, which can go a long way in helping a person at high risk for type 2 diabetes delay or prevent its onset.
Involve your entire family. Cook a balanced meal. Share a brisk walk, talk with your family about your health and your family’s diabetes risk. Schools, work sites, and places of worship can also be part of the diabetes prevention and management solution.
Preventive care is critical to improving health and identifying early signs of disease or risk-factors. That is why the Affordable Care Act ensures that, in non-grandfathered health plans, Americans at higher risk for developing type 2 diabetes can receive diabetes screening, diet counseling and obesity screening with no out-of-pocket cost. Additionally, screening for gestational diabetes is available at no additional charge for pregnant women. In 2014, Americans cannot be denied health coverage because they have diabetes or any other pre-existing condition.
Initiatives such as First Lady Michelle Obama’s Let’s Move program, the Centers for Disease Control and Prevention (CDC)’s National Diabetes Prevention Program and the National Diabetes Education Program (a partnership of the National Institutes of Health and CDC) are helping Americans of all ages take action to improve their health and that of the nation.
Wednesday, November 13, 2013
HHS ANNOUNCES OVER 100,000 AMERICANS SELECTED HEALTH PLANS IN FIRST REPORTING PERIOD
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
106,185 Americans selected health plans in first reporting period of open enrollment
975,407 customers through the process but have not yet selected a plan; an additional 396,261
assessed or determined eligible for Medicaid or CHIP
Detailing results of the first reporting period (Oct. 1-Nov. 2, 2013) of the Health Insurance Marketplace’s Open Enrollment, Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that 106,185 individuals have selected plans from the Marketplace, and another 975,407 have made it through the process by applying and receiving an eligibility determination, but have not yet selected a plan. An additional 396,261 have been determined or assessed eligible for Medicaid or the Children’s Health Insurance Program (CHIP).
“The promise of quality affordable coverage is increasingly becoming reality for this first wave of applicants to the Health Insurance Marketplaces,” Secretary Sebelius said. “There is no doubt the level of interest is strong. We expect enrollment will grow substantially throughout the next five months, mirroring the pattern that Massachusetts experienced. We also expect that the numbers will grow as the website, HealthCare.gov, continues to make steady improvements.”
The following key findings are among many newly available data reported today in an issue brief from HHS that highlights national and state-level enrollment-related information:
502,466 Americans, in just the first month of implementation, are positioned to have health coverage in 2014;
Of those, 106,185 Americans have selected plans from the state and federal Marketplaces; and
396,261 Americans have been determined or assessed eligible for Medicaid or CHIP;
975,407 have made it through the process by applying and receiving an eligibility determination and have not yet selected a plan.
Today’s report includes breakouts of enrollment-related data by state, including each of the 50 states and the District of Columbia. The report groups the states into the Federally-facilitated Marketplace (FFM) (defined as those states where HHS is running the Marketplace or states where HHS is doing so in partnership), and state-based Marketplaces (SBMs). In some cases only a partial SBM dataset was available.
In total, 106,185 Americans selected a Qualified Health Plan (QHP) through the Marketplace during the first reporting period of Open Enrollment. Enrollment figures include those who have selected a plan and have or have not yet paid the first month’s premium. Of the people who have selected a plan, 79,391 (74.8 percent) enrolled though a SBM, while the other 26,794 people (25.2 percent) enrolled through the FFM. Additionally, 396,261 Americans have been assessed or determined eligible for Medicaid or CHIP. SBMs that provided data for the report accounted for 212,865 (53.7 percent) of those determinations, while the FFM accounted for 183,396 (46.3 percent) of them. Forthcoming data will enumerate those who applied directly to a state Medicaid/CHIP office.
The report characterizes past experiences in health insurance enrollment patterns, noting typical low initial enrollment in, for example, the Federal Employees Health Benefits Program Medicare Part D, Massachusetts’ Commonwealth Care, the Children’s Health Insurance Program and the Pre-existing Condition Insurance Plan created under the Affordable Care Act.
The report also addresses Marketplace customer service, outreach and web traffic. It found that there have been an estimated 26,876,527 visitors on the SBM and FFM websites. There have also been an estimated 3,158,436 calls to the SBM and FFM call centers.
106,185 Americans selected health plans in first reporting period of open enrollment
975,407 customers through the process but have not yet selected a plan; an additional 396,261
assessed or determined eligible for Medicaid or CHIP
Detailing results of the first reporting period (Oct. 1-Nov. 2, 2013) of the Health Insurance Marketplace’s Open Enrollment, Health and Human Services (HHS) Secretary Kathleen Sebelius announced today that 106,185 individuals have selected plans from the Marketplace, and another 975,407 have made it through the process by applying and receiving an eligibility determination, but have not yet selected a plan. An additional 396,261 have been determined or assessed eligible for Medicaid or the Children’s Health Insurance Program (CHIP).
“The promise of quality affordable coverage is increasingly becoming reality for this first wave of applicants to the Health Insurance Marketplaces,” Secretary Sebelius said. “There is no doubt the level of interest is strong. We expect enrollment will grow substantially throughout the next five months, mirroring the pattern that Massachusetts experienced. We also expect that the numbers will grow as the website, HealthCare.gov, continues to make steady improvements.”
The following key findings are among many newly available data reported today in an issue brief from HHS that highlights national and state-level enrollment-related information:
502,466 Americans, in just the first month of implementation, are positioned to have health coverage in 2014;
Of those, 106,185 Americans have selected plans from the state and federal Marketplaces; and
396,261 Americans have been determined or assessed eligible for Medicaid or CHIP;
975,407 have made it through the process by applying and receiving an eligibility determination and have not yet selected a plan.
Today’s report includes breakouts of enrollment-related data by state, including each of the 50 states and the District of Columbia. The report groups the states into the Federally-facilitated Marketplace (FFM) (defined as those states where HHS is running the Marketplace or states where HHS is doing so in partnership), and state-based Marketplaces (SBMs). In some cases only a partial SBM dataset was available.
In total, 106,185 Americans selected a Qualified Health Plan (QHP) through the Marketplace during the first reporting period of Open Enrollment. Enrollment figures include those who have selected a plan and have or have not yet paid the first month’s premium. Of the people who have selected a plan, 79,391 (74.8 percent) enrolled though a SBM, while the other 26,794 people (25.2 percent) enrolled through the FFM. Additionally, 396,261 Americans have been assessed or determined eligible for Medicaid or CHIP. SBMs that provided data for the report accounted for 212,865 (53.7 percent) of those determinations, while the FFM accounted for 183,396 (46.3 percent) of them. Forthcoming data will enumerate those who applied directly to a state Medicaid/CHIP office.
The report characterizes past experiences in health insurance enrollment patterns, noting typical low initial enrollment in, for example, the Federal Employees Health Benefits Program Medicare Part D, Massachusetts’ Commonwealth Care, the Children’s Health Insurance Program and the Pre-existing Condition Insurance Plan created under the Affordable Care Act.
The report also addresses Marketplace customer service, outreach and web traffic. It found that there have been an estimated 26,876,527 visitors on the SBM and FFM websites. There have also been an estimated 3,158,436 calls to the SBM and FFM call centers.
HHS REPORTS THAT POVERTY AFFECTS BRAIN GROWTH IN CHILDREN
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Poverty, parenting, and kids’ brains
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Researchers say poverty can interfere with a child’s brain growth – but that attentive parenting can offset at least some of the damage. Child psychiatrist Joan Luby of Washington University School of Medicine in St. Louis saw this in data on brain scans of 145 8- to 12-year-olds.
Luby says poor children tended to have smaller hippocampuses, important in learning and memory – possibly from stresses of poverty on the developing brain. But she says her study indicates the main driver was how nurturing parents were:
“It suggests that even in circumstances of great adversity, supportive parenting can be an important protective factor.”
The study in the journal JAMA Pediatrics was supported by the National Institutes of Health.
Poverty, parenting, and kids’ brains
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Researchers say poverty can interfere with a child’s brain growth – but that attentive parenting can offset at least some of the damage. Child psychiatrist Joan Luby of Washington University School of Medicine in St. Louis saw this in data on brain scans of 145 8- to 12-year-olds.
Luby says poor children tended to have smaller hippocampuses, important in learning and memory – possibly from stresses of poverty on the developing brain. But she says her study indicates the main driver was how nurturing parents were:
“It suggests that even in circumstances of great adversity, supportive parenting can be an important protective factor.”
The study in the journal JAMA Pediatrics was supported by the National Institutes of Health.
Friday, October 25, 2013
CDC SAYS 1 IN 6 BETWEEN THE AGES OF 2 AND 19 ARE OBESE
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
One in 6 obese
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
A study by the Centers for Disease Control and Prevention finds some signs that the weight gains of America’s young people are tapering off. The researchers saw this in data from 2008 to 2011 on almost 12 million low-income youngsters in 40 states.
But it doesn’t mean the weights are all healthy. The CDC says 1 in 6 people between the ages of 2 and 19 is obese. And researcher Ashleigh May says the excess weight produces a health burden:
“During childhood, things like high cholesterol, high blood sugar, asthma, and even mental health problems can occur. And children who are overweight or obese are more likely to become overweight or obese adults.’’
The study is in CDC’s Morbidity and Mortality Weekly Report.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Last revised: October 24, 2013
One in 6 obese
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
A study by the Centers for Disease Control and Prevention finds some signs that the weight gains of America’s young people are tapering off. The researchers saw this in data from 2008 to 2011 on almost 12 million low-income youngsters in 40 states.
But it doesn’t mean the weights are all healthy. The CDC says 1 in 6 people between the ages of 2 and 19 is obese. And researcher Ashleigh May says the excess weight produces a health burden:
“During childhood, things like high cholesterol, high blood sugar, asthma, and even mental health problems can occur. And children who are overweight or obese are more likely to become overweight or obese adults.’’
The study is in CDC’s Morbidity and Mortality Weekly Report.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Last revised: October 24, 2013
Friday, October 18, 2013
FUNDING BIODEFENSE INFRASTRUCTURE
FROM: U.S. DEFENSE DEPARTMENT
DOD Funding Contributes to U.S. Biodefense Infrastructure
By Cheryl Pellerin
American Forces Press Service
WASHINGTON, Oct. 16, 2013 - The Defense Department has contributed core capabilities to a national center funded as a public-private partnership by the Department of Health and Human Services to enhance the U.S. response to infectious diseases and biological, chemical, radiological and nuclear threats.
The HHS Texas A&M Center for Innovation in Advanced Development and Manufacturing is a response in part to pandemics such as the 2009-2010 H1N1 flu -- for which traditional biomanufacturing methods took 26 weeks to produce initial vaccine doses – and the future threat of biological attacks and other public health emergencies.
According to expert witnesses testifying here Oct. 11 before the House Armed Services Committee's subcommittee on intelligence, emerging threats and capabilities, some kinds of advances in biomanufacturing processes and DNA technologies have lowered the bar for states, and even individuals, who seek to produce biological weapons.
One of the witnesses was Dr. Brett P. Giroir, principal investigator at the Texas A&M Center for Innovation, and interim vice president and chief executive officer of the Texas A&M Health Sciences Center.
"Literally, what once took weeks during medical school to produce in a multimillion-dollar laboratory can be done [today] in an afternoon on a benchtop by someone with a relatively less degree of scientific training," he told the panel. "So the barriers to entry have decreased."
Giroir's work at the Texas A&M Center for Innovation began in 2008 after nine years at the Defense Advanced Research Projects Agency.
During his first five years at DARPA, Giroir was a member of the Defense Sciences Research Council, for which he chaired or co-chaired intensive studies on chemical, biological, radiological and nuclear security and countermeasures, decontamination and warfighter performance under extreme conditions, he said in written testimony.
Then, as deputy director and later director of the DARPA Defense Sciences Office, he and a team of scientists, physicians and engineers developed a platform of research initiatives called Accelerating Critical Therapeutics, or ACT, he said.
ACT was designed to provide new, highly effective medical countermeasures and an unprecedented, flexible and rapid response to address the growing threat of genetically modified or chimeric organisms -- single organisms with two or more sets of genetically distinct cells -- for which no vaccines or countermeasures existed.
One aspect of the DARPA portfolio that was extremely challenging, even for DARPA, he said, was the ability to develop low-cost, highly flexible and adaptable biomanufacturing technologies that could provide tens of millions of doses of vaccines or medical countermeasures such as chemical-weapon antidotes within weeks of notification.
Such a capability didn't exist in the civilian or military experience, Giroir said, and profound technical and financial barriers kept the problem unsolved for several years.
"In 2008, when my assignment at DARPA was completed, I joined the Texas A&M system [and] secured a $50 million investment from the state of Texas to demonstrate those flexible manufacturing capabilities originally envisioned at DARPA," Giroir told the panel.
"Beginning in 2009," he added, "Texas A&M designed, developed, constructed and is now operating a revolutionary first-in-class, 150,000-square-foot facility that has pioneered highly flexible, adaptable and even mobile manufacturing platforms at a capital cost of about 80 percent less than the current state of the art."
The facility is called the National Center for Therapeutics, or NCTM, and a key feature there is the use of modular and mobile stand-alone biopharmaceutical clean rooms, called modular clear rooms, or MCRs. The initial MCR concept was funded by DOD through DARPA and the Army Research Office, Giroir said.
NCTM is the core facility and main site for developing and manufacturing medical countermeasures and vaccines against chemical, biological, radiological and nuclear threats for the Texas A&M Center for Innovation, he added.
Another part of the Center for Innovation's biomanufacturing infrastructure is the Caliber Biotherapeutics Facility, Giroir said. Caliber was developed and built through Texas A&M and G-CON Manufacturing, with funding from the DARPA Blue Angel Program.
According to a 2012 DARPA news release, the Blue Angel Program demonstrated a flexible and agile capability for DOD to rapidly react to and neutralize any natural or intentional pandemic disease.
Building on a previous DARPA program, Blue Angel targeted new ways to produce large amounts of high-quality, vaccine-grade protein in less than three months in response to emerging and novel biological threats. One of the research avenues explored plant-made proteins for producing a candidate vaccine.
In a milestone development under the program, researchers at Medicago Inc. in North Carolina produced in one month more than 10 million doses of an animal-model H1N1 flu-vaccine candidate based on virus-like particles, the DARPA statement said.
The work was part of a rapid-fire test that ran from March 25, 2012, to April 24, 2012, and showed that a single dose of the H1N1 vaccine candidate induced protective antibody levels in an animal model when combined with a standard immunological additive, according to DARPA.
The Texas A&M Center for Innovation has partnered with Caliber Biotherapeutics to make Caliber's plant-made pharmaceutical facility available for HHS task orders, including vaccines, Giroir told the panel.
"The facility has the capability to produce up to 20 kilograms of purified protein per month through its highly automated, Nicotiana benthamiana, a close relative of tobacco, plant-based production system," Giroir said.
"We consider this program to be the most responsive, secure and capable plant-made vaccine program currently available worldwide," he added.
Giroir said the Center for Innovation's high-level objectives are:
-- To provide a national vaccine response against pandemic flu, defined as 50 million doses delivered in 4 months, with initial doses available to the federal government in 12 weeks;
-- To perform what's called advanced development -- the final steps -- in manufacturing vaccines and medical countermeasures against chemical, biological, radiological and nuclear threats as tasked by HHS; and
-- To train the future domestic U.S. workforce.
To achieve these objectives, Texas A&M leads a multidisciplinary team with expertise that spans research to clinical trials, including GlaxoSmithKline, or GSK Vaccines, the world's largest vaccine developer, Giroir said.
The center also is expanding domestic U.S. infrastructure, he added, building a new, dedicated pandemic flu vaccine facility to meet its 50-million-dose requirements, and building a new live-virus vaccine facility at biosafety level 3, designed specifically for research with hazardous biological agents.
Giroir said Texas A&M is highly motivated to continue its history of service to the nation by supporting DOD and supplying improved vaccines and countermeasures to the warfighter.
"Of particular interest would be DOD partnerships to develop and manufacture products for their stockpile and special immunizations programs," he added, "and perhaps more importantly, to be the cornerstone for an emergency response to genetically modified or chimeric organisms [and] other unexpected agents that we believe are a growing, real threat to our national security and public health."
Because the center's contract with HHS indicates that 50 percent of its capabilities are available for non-HHS projects, there is an immediate opportunity for DOD to use center capacity and expertise already funded by HHS, Giroir said.
"We believe such collaborations would not only reduce DOD operational risks," he added, "but would reduce DOD expenditures, potentially by hundreds of millions of dollars, that could then be reallocated to provide additional vaccines, countermeasures and capabilities to our warfighters."
Friday, September 27, 2013
HHS ON DIABETES RESEARCH
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Fruits of the diabetes research
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Like sweets? Fruits are sweet, and a study indicates these sweets can lower the risk of diabetes. At the Harvard School of Public Health, researcher Qi Sun saw signs of this in data from 1984 to 2008 on more than 187,000 people.
He compared people who ate at least two servings a week of certain whole fruits – particularly blueberries, grapes and apples – with people who ate less than one serving a month. The fruit eaters had a 23 percent lower risk of diabetes.
So Sun says:
“We recommend people to increase consumption of whole fruits intake to facilitate prevention of type 2 diabetes.”
The study in the journal BMJ was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Fruits of the diabetes research
From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.
Like sweets? Fruits are sweet, and a study indicates these sweets can lower the risk of diabetes. At the Harvard School of Public Health, researcher Qi Sun saw signs of this in data from 1984 to 2008 on more than 187,000 people.
He compared people who ate at least two servings a week of certain whole fruits – particularly blueberries, grapes and apples – with people who ate less than one serving a month. The fruit eaters had a 23 percent lower risk of diabetes.
So Sun says:
“We recommend people to increase consumption of whole fruits intake to facilitate prevention of type 2 diabetes.”
The study in the journal BMJ was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.
Tuesday, September 24, 2013
HHS RECOMMENDATIONS FOR "AFTER THE STORM"
FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.
We often hear about how to get prepared for natural disasters: Make a plan, have a kit, practice it. But what about after the storm? When you pick up the pieces and start to recover, be ready to face situations you didn’t see coming.
Dr. Nicole Lurie is HHS’ assistant secretary for preparedness and response.
“Have you let your friends and loved ones know that you’re okay? Plan to text or email, or use social media to let everybody know you’re okay. Have you found out if your friends and loved ones themselves are okay?”
How are the kids doing? Talk to them about stress, and limit their TV watching, if it involves images of the storm and devastation.
And recognize that it may take some time for your life to return to normal.
“Do what you can to get you and your family back to a normal routine.”
From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.
We often hear about how to get prepared for natural disasters: Make a plan, have a kit, practice it. But what about after the storm? When you pick up the pieces and start to recover, be ready to face situations you didn’t see coming.
Dr. Nicole Lurie is HHS’ assistant secretary for preparedness and response.
“Have you let your friends and loved ones know that you’re okay? Plan to text or email, or use social media to let everybody know you’re okay. Have you found out if your friends and loved ones themselves are okay?”
How are the kids doing? Talk to them about stress, and limit their TV watching, if it involves images of the storm and devastation.
And recognize that it may take some time for your life to return to normal.
“Do what you can to get you and your family back to a normal routine.”
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