Here you will find the latest news and policy updates concerning Health Reform. The Patient Protection and Affordable Care Act (PPACA) signed into law by President Obama in 2010 is designed to ensure that American families and businesses have quality, affordable health care coverage options through new Health Insurance Exchanges to be established in every state by 2014.
In 2014, new competitive, private Health Insurance Exchanges will give small businesses and individuals the ability to pool together to purchase affordable, quality health insurance coverage. Consumers will be able to shop, compare and enroll online and will be able to purchase policies at the same rates offered to large corporations. The primary goal of these Exchanges is to make it easier for small businesses and consumers to purchase private insurance policies, make the market more competitive and reduce the number of Americans who are uninsured.
Athens Orthopedic Clinic PA ("Athens Orthopedic") has agreed to pay $1,500,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. Athens Orthopedic is located in Georgia and provides orthopedic services to approximately 138,000 patients annually.
On June 26, 2016, a journalist notified Athens Orthopedic that a database of their patient records may have been posted online for sale. On June 28, 2016, a hacker contacted Athens Orthopedic and demanded money in return for a complete copy of the database it stole. Athens Orthopedic subsequently determined that the hacker used a vendor's credentials on June 14, 2016, to access their electronic medical record system and exfiltrate patient health data. The hacker continued to access protected health information (PHI) for over a month until July 16, 2016.
On July 29, 2016, Athens Orthopedic filed a breach report informing OCR that 208,557 individuals were affected by this breach, and that the PHI disclosed included patients' names, dates of birth, social security numbers, medical procedures, test results, and health insurance information.
OCR's investigation discovered longstanding, systemic noncompliance with the HIPAA Privacy and Security Rules by Athens Orthopedic including failures to conduct a risk analysis, implement risk management and audit controls, maintain HIPAA policies and procedures, secure business associate agreements with multiple business associates, and provide HIPAA Privacy Rule training to workforce members.
"Hacking is the number one source of large health care data breaches. Health care providers that fail to follow the HIPAA Security Rule make their patients' health data a tempting target for hackers," said OCR Director Roger Severino.
In addition to the monetary settlement, Athens Orthopedic has agreed to a robust corrective action plan that includes two years of monitoring. The resolution agreement and corrective action plan may be found at https://www.hhs.govhttps://www.hhs.gov/sites/default/files/athens-orthopedic-ra-cap.pdf*.
* People using assistive technology may not be able to fully access information in this file. For assistance, contact the HHS Office for Civil Rights at (800) 368-1019, TDD toll-free: (800) 537-7697, or by emailing OCRMail@hhs.gov.
On September 15, the Department of Health and Human Services issued a memo on agency procedures, clarifying that all departmental rules, which are all issued by the Secretary, must now be signed by the Secretary.
The department released the following statement on this action:
“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed. This good-government action is only prospective in effect and minimizes litigation risk for the department’s public health actions, prevents potential future abuse of authority, and is consistent with congressional intent. The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document.”
Further background on this action is included below.
Why send this memo?
Upon taking office, Secretary Azar began a process of reviewing the department’s processes for rulemaking. This work has proceeded in parallel with work by the White House Office of Management and Budget to reform rulemaking in a way that follows congressional intent and increases public confidence and accountability for rulemaking. It is common, in government and the private sector, to review delegations of power on a regular basis.
Part of that process included a review to determine which officials had been delegated power to sign rules, in order to ensure that these delegations were proper. Agencies, including HHS, have had rules challenged in court on the grounds that they were signed by officials to whom rulemaking power was improperly delegated. HHS disagrees with these allegations.
The department’s Executive Secretariat and Office of the General Counsel determined that there was no central accounting of these delegations. Therefore, the memo establishes a clean slate: All agency rulemaking must be signed by the Secretary.
This action has no effect on the procedures used for agency rules. Under the department’s current procedures, all rulemaking goes through a departmental clearance process, which includes approval by the Secretary.
Why send this memo now?
The memo was the product of an extensive review process, still ongoing, of how to ensure that HHS’s rulemaking procedures are consistent with congressional intent, minimize litigation risk, and provide public accountability.
How were rules issued before the memo and how will they be issued after the memo?
Before the memo, the process required that all rules issued by the department go through departmental and White House clearance and receive approval by the Secretary. The rules were typically signed by the Secretary and by the head of the agency involved. In some cases, other officials to whom authority had been delegated signed the rules.
After the memo, all rules issued by the department will continue to go through departmental and White House clearance and will continue to be approved by the Secretary. All rules will now be signed by the Secretary and by the head of the agency involved.
Does this memo add any delays to agencies’ ability to take actions during COVID-19?
No. All actions affected by this memo already go through a clearance process with the entire department and the White House Office of Management and Budget, an in-depth process where the action is thoroughly vetted.
The Secretary’s signing of a rule does not add a further layer of policy review on top of the current review process, because the current process ensures that rulemakings reflect the policy of the department and the administration.
Does this memo apply to vaccine or drug approvals or emergency use authorizations?
No, the memo only applies to rules, which follow different procedures and legal requirements than product approvals and authorizations, which are adjudications.
Does this memo apply to guidance?
No, this memo affects only rules, not guidances. Guidances from HHS follow a separate set of procedures.
Is this an attempt to exert greater political power over HHS agencies’ decision making and procedures?
No, this action has no effect on HHS agencies’ decision making and procedures in any way, which will be overseen by the same department processes. The action aims to ensure that rulemaking by HHS and its divisions—which cover vital public health matters—is consistent with congressional intent, minimizes litigation risk, and ensures public accountability.
Former heads of agencies with delegated rulemaking authority, such as the Food and Drug Administration, have recognized that questions around delegations of rulemaking power can create litigation risk. For instance, in 2019, Commissioner Scott Gottlieb signed and retroactively ratified the 2016 deeming rule around tobacco products, which had originally been signed by a more junior official. In fact, the former Commissioner’s action in that instance further highlighted the need for this particular comprehensive review to ensure that there was no procedural infirmity in HHS agency rules.
Does this send the wrong message at a time when Americans should have confidence that decisions are being made based on science and evidence?
Since the action has no effect on the substantive rulemaking process, the only reason it would undermine public confidence in rulemaking is if commentators misrepresent it to the public, as some unfortunately have.
Americans, especially during a public health emergency, deserve to have confidence in the procedures used to make legally binding rules, including confidence that these rules follow proper procedures and minimize litigation risk. That is the goal of this action.
Was the memo targeted at the Food and Drug Administration or any particular divisions of HHS?
No, the memo covers all Operating and Staff Divisions of HHS. Large agencies that release a significant amount of rules, such as the Food and Drug Administration, already have robust processes for sending any rules through departmental and White House clearance. Those processes will remain unchanged, except that they will now conclude with the Secretary’s signing the rule in all cases.
Does this have any impact on actions taken under previous delegations?
No, this memo has no impact on actions taken under previous delegations. It is prospective in effect.
The U.S. Department of Health and Human Services (HHS) and the President’s Council on Sports, Fitness and Nutrition (PCSFN) are pleased to recognize the National Youth Sports Strategy (NYSS) Champion organizations for their work promoting youth sports participation and supporting the NYSS. The NYSS is the first federal roadmap with actionable strategies to increase participation in youth sports, encourage regular physical activity, including active play, and promote good nutrition for all Americans. The NYSS aims to unite U.S. youth sports culture around a shared vision: that one day all youth will have the opportunity, motivation, and access to play sports — regardless of their race, ethnicity, sex, ability, or ZIP code. NYSS Champions represent organizations that are working toward achieving this vision.
“The National Youth Sports Strategy Champions are helping us advance toward the vision President Trump called for in his executive order on youth sports: the day when all American youth have the opportunity, motivation, and access to play sports, whoever they are and wherever they live. Barriers to youth sports participation and the need for opportunities for physical exercise have only increased during the COVID-19 pandemic, and we look forward to continued work with the NYSS Champions to address these challenges,” noted HHS Secretary Alex Azar.
As a NYSS Champion, each organization has demonstrated its support of youth sports and commitment to the NYSS vision. NYSS Champions are recognized on health.gov as part of a growing network of organizations partnering with HHS to improve the youth sports landscape in America. Organizations will be formally announced today at the virtual PCSFN Annual Meeting.
“We know children who engage in regular physical activity experience important physical and mental health benefits, which are more important now during the COVID-19 pandemic than perhaps ever before,” said ADM Brett Giroir, M.D., assistant secretary for health at HHS. “I’m thrilled to acknowledge the work of the NYSS Champions who are furthering the mission of the NYSS and helping to foster a lifelong love of sports and physical activity for our Nation’s youth.”
NYSS Champions is led by the Office of Disease Prevention and Health Promotion (ODPHP) and the Executive Director of the PCSFN. The partnership opportunity is open to organizations that support the vision of the NYSS. More information on how to apply is available at https://health.gov/news/202006/announcing-opportunity-become-national-youth-sports-strategy-champion.
The PCSFN is a Federal Advisory Committee supported by ODPHP and plays a vital role in keeping the Nation healthy. ODPHP and the Executive Director of the PCSFN accomplish this by setting national health goals and objectives and supporting programs, services, and education activities that improve the health of all Americans. ODPHP is part of the Office of the Assistant Secretary for Health within HHS. Visit ODPHP to learn more.
Health and Human Services (HHS) Secretary Alex Azar today declared a public health emergency in Oregon due to wildfires, following President Trump's emergency declaration for the state. The public health emergency declaration and related waiver determination give healthcare providers and suppliers greater flexibility in meeting the health needs of Medicare and Medicaid beneficiaries affected by the wildfires.
"We are working closely with Oregon health authorities and monitoring the needs of healthcare facilities to support their efforts to save lives and protect health during these dangerous wildfires," Secretary Alex Azar said. "With this declaration and waiver, the Trump Administration is helping to ensure that Oregonians who rely on Medicare and Medicaid have continuous access to the care they need during this disaster and as communities recover."
Air quality and extensive smoke produced by the wildfires can present a significant health threat for people with asthma and other lung conditions and can increase demands on the healthcare system, a particular concern as healthcare providers respond to COVID-19 cases in the state. The air quality index in many areas has been reported at or above 300 which can cause health problems even among otherwise healthy people.
HHS has deployed an Incident Management Team (IMT) to Oregon and regional emergency coordinators (RECs) to the state's emergency operations centers. These federal personnel coordinate with state and local health authorities and emergency response officials. The IMT also manages any federal public health and medical personnel and equipment deployed in response to the state's request for assistance.
HHS also activated the National Disaster Medical System, including members from a Disaster Mortuary Operational Response Team to provide technical assistance to state officials and Urban Search and Rescue Teams and specialists from the NDMS Victim Information Center Team.
Data and tools available through the HHS emPOWER Program, a partnership between ASPR and CMS, is supporting Oregon counties in this emergency response. The program provides valuable information on the number of Medicare beneficiaries who rely on electricity dependent medical equipment and certain healthcare services, including dialysis and home oxygen, to help anticipate, plan for, and respond to, the needs of at-risk beneficiaries in potentially impacted areas. Oregon is one of the first five states in the nation to work with ASPR and CMS to expand emPOWER to include Medicaid and Children's Health Insurance Program (CHIP) beneficiary data as well.
In addition, the Substance Abuse and Mental Health Services Administration's Disaster Distress Helpline is available to assist residents in the impacted areas in coping with the stress of the wildfires. The Disaster Distress Helpline provides immediate 24/7, 365-days-a-year crisis counseling and support to people experiencing emotional distress related to natural or human-caused disasters.
This toll-free, multilingual, and confidential crisis support service is available to all residents in the United States and its territories. Stress, anxiety, and other depression-like symptoms are common reactions in disasters. Call 1-800-985-5990 toll free or text TalkWithUs to 66746 to connect with a trained crisis counselor.
In declaring the public health emergency in Oregon and authorizing flexibilities in serving CMS beneficiaries, Secretary Azar acted pursuant to his authority under the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to Sept. 8, 2020.
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today released two documents outlining the Trump Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible.
The documents, developed by HHS in coordination with DoD and the Centers for Disease Control and Prevention (CDC), provide a strategic distribution overview along with an interim playbook for state, tribal, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their respective jurisdictions.
“As part of Operation Warp Speed, we have been laying the groundwork for months to distribute and administer a safe and effective COVID-19 vaccine as soon as it meets FDA’s gold standard,” said HHS Secretary Alex Azar. “This in-depth, round-the-clock planning work with our state and local partners and trusted community organizations, especially through CDC, will ensure that Americans can receive a safe and effective vaccine in record time.”
The strategic overview lays out four tasks necessary for the COVID-19 vaccine program:
On August 14, CDC executed an existing contract option with McKesson Corporation to support vaccine distribution. The company also distributed the H1N1 vaccine during the H1N1 pandemic in 2009-2010. The current contract with McKesson, awarded as part of a competitive bidding process in 2016, includes an option for the distribution of vaccines in the event of a pandemic.
“CDC is drawing on its years of planning and cooperation with state and local public health partners to ensure a safe, effective, and life-saving COVID-19 vaccine is ready to be distributed following FDA approval,” said CDC Director Robert Redfield. “Through the Advisory Committee on Immunization Practices, CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021.”
Detailed planning is ongoing to ensure rapid distribution as soon as the FDA authorizes or approves a COVID-19 vaccine and CDC makes recommendations for who should receive initial doses. Once these decisions are made, McKesson will work under CDC’s guidance, with logistical support from DoD, to ship COVID-19 vaccines to administration sites.
“The Department of Defense is using its world-class logistical expertise to plan for distributing a safe and effective vaccine at warp speed,” said General Gustave Perna. “Americans can trust that our country’s best public health and logistics experts are working together to get them vaccines safely as soon as possible.”
Download the Strategy for Distributing a COVID-19 Vaccine*
Download the COVID-19 Vaccination Program Interim Playbook
Download the COVID-19 Vaccine Distribution Process Infographic
About Operation Warp Speed:
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About HHS & CDC:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.
CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.
About DoD:
The Department of Defense’s enduring mission is to provide combat-credible military forces needed to deter war and protect the security of our nation. The Department provides a lethal and effective Joint Force that, combined with our network of allies and partners, sustains American influence and advances shared security and prosperity.
* People using assistive technology may not be able to fully access information in this file. For assistance, please contact digital@hhs.gov.
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announces that it has settled five more investigations in its HIPAA Right of Access Initiative this year. OCR announced this initiative as an enforcement priority in 2019 to support individuals' right to timely access to their health records at a reasonable cost under the HIPAA Privacy Rule. The five settlements announced below bring OCR's total to seven completed enforcement actions under the Right of Access Initiative.
Housing Works, Inc.
Housing Works Inc. (Housing Works) has agreed to pay $38,000 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA Privacy Rule's right of access provision. Housing Works is a New York City based non-profit organization that provides health care, homeless services, advocacy, job training, reentry services, and legal aid support for people living with and affected by HIV/AIDS.
In July 2019, OCR received a complaint alleging that, in June 2019, Housing Works failed to provide the complainant with a copy of his medical records. OCR provided Housing Works with technical assistance on the HIPAA Right of Access requirements and closed the complaint. In August 2019, OCR received a second complaint alleging that Housing Works still had not provided the complainant with access to his records. OCR initiated an investigation and determined that Housing Work's failure to provide the requested medical records was a potential violation of the HIPAA right of access standard. As a result of OCR's investigation, the complainant received his medical records in November 2019.
All Inclusive Medical Services, Inc.
All Inclusive Medical Services, Inc. (AIMS) has agreed to pay $15,000 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA Privacy Rule's right of access provision. AIMS, based in Carmichael, California, is a multi-specialty family medicine clinic that provides a variety of services including internal medicine, and pain management and rehabilitation.
In April 2018, OCR received a complaint alleging that in January 2018, AIMS refused to give a patient access to her medical records when it denied her requests to inspect and receive a copy of her records. OCR initiated an investigation and determined that AIMS's actions were potential violations of the HIPAA right of access standard. As a result of OCR's investigation, AIMS sent the patient her medical records in August 2020.
Beth Israel Lahey Health Behavioral Services
Beth Israel Lahey Health Behavioral Services (BILHBS) has agreed to pay $70,000 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA Privacy Rule's right of access provision. BILHBS is the largest network of mental health and substance use disorder services in eastern Massachusetts.
In April 2019, OCR received a complaint alleging that BILHBS failed to respond to a February 2019 request from a personal representative seeking access to her father's medical records. OCR initiated an investigation and determined that BILHBS' failure to provide the requested medical records was a potential violation of the HIPAA right of access standard. As a result of OCR's investigation, BILHBS sent the personal representative the requested medical records in October 2019.
King MD
King MD has agreed to pay $3,500 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA Privacy Rule's right of access provision. King MD is a small health care provider of psychiatric services in Virginia.
In October 2018, OCR received a complaint alleging that King MD failed to respond to an individual's August 2018 request for access to her medical records. OCR provided King MD with technical assistance on the HIPAA right of access requirements and closed that complaint. In February 2019, OCR received a second complaint alleging that the practice still had not provided the individual with access to her medical records. OCR initiated an investigation and determined that the practice's failure to provide the requested medical records was a potential violation of the HIPAA right of access standard. As a result of OCR's investigation, King MD sent the individual her medical records in July 2020.
Wise Psychiatry, PC
Wise Psychiatry, PC (Wise Psychiatry) has agreed to pay $10,000 to OCR and to adopt a corrective action plan to settle a potential violation of the HIPAA Privacy Rule's right of access provision. Wise Psychiatry is a small health care provider that provides psychiatric services in Colorado.
In February 2018, OCR received a complaint alleging that Wise Psychiatry failed to provide a personal representative with access to his minor son's medical records. The complainant requested access in November 2017. OCR provided Wise Psychiatry with technical assistance on the HIPAA right of access requirements and closed that complaint in April 2018. In October 2018, OCR received a second complaint alleging that Wise Psychiatry still had not provided the personal representative with access to his minor son's medical records. OCR initiated an investigation and determined that Wise Psychiatry's failure to provide the requested medical records was a potential violation of the HIPAA right of access standard. As a result of OCR's investigation, Wise Psychiatry sent the personal representative his son's medical records in May 2019.
Sending a Message about the Importance of Access to Health Records
OCR's enforcement actions are designed to send a message to the health care industry about the importance and necessity of compliance with the HIPAA Rules. OCR considers a variety of factors in determining the amount of a settlement including the nature and extent of the potential HIPAA violation; the nature and extent of the harm resulting from the potential HIPAA violation; the entity's history with respect to compliance with the HIPAA Rules; the financial condition of the entity, including its size and the impact of the COVID-19 public health emergency; and other matters as justice may require.
"Patients can't take charge of their health care decisions, without timely access to their own medical information," said OCR Director Roger Severino. "Today's announcement is about empowering patients and holding health care providers accountable for failing to take their HIPAA obligations seriously enough," Severino added.
Housing Works will undertake a corrective action plan that includes one year of monitoring. The resolution agreement and correction action plan is at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/housing-works-signed-ra-cap.pdf*
AIMS will undertake a corrective action plan that includes two years of monitoring. The resolution agreement and correction action plan is at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/aims-resolution-agreement.pdf*
BILHBS will undertake a corrective action plan that includes one year of monitoring. The resolution agreement and corrective action plan is at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/beth-israel-lahey-health-behavioral-services-ra-cap.pdf*
King MD will undertake a corrective action plan that includes two years of monitoring. The resolution agreement and corrective action plan is at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/king-md-ra-cap.pdf*
Wise Psychiatry will undertake a corrective action plan that includes one year of monitoring. The resolution agreement and corrective action plan is at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/wise-psychiatry-resolution-agreement-corrective-action-plan.pdf*
For previous settlements under the Right of Access Initiative, see https://www.hhs.gov/about/news/2019/09/09/ocr-settles-first-case-hipaa-right-access-initiative.html and https://www.hhs.gov/about/news/2019/12/12/ocr-settles-second-case-in-hipaa-right-of-access-initiative.html.
* People using assistive technology may not be able to fully access information in this file. For assistance, contact the HHS Office for Civil Rights at (800) 368-1019, TDD toll-free: (800) 537-7697, or by emailing OCRMail@hhs.gov.
Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) awarded approximately $25 million to 80 award recipients across 36 states and two territories as part of the Rural Communities Opioid Response Program (RCORP). RCORP is a multi-year HRSA initiative to reduce morbidity and mortality of substance use disorder (SUD) and opioid use disorder (OUD) in high-risk rural communities. Today’s announcement builds upon HRSA’s RCORP awards made this August, reflecting a total fiscal year 2020 investment of nearly $115 million.
“The Trump Administration continues to provide historic levels of support for Americans with substance use disorders, especially those in rural areas, because the COVID-19 pandemic hasn’t put a pause on our country’s opioid crisis,” said HHS Secretary Alex Azar. “These grants are part of the Rural Action Plan that HHS launched in response to President Trump’s Executive Order on rural health, which lays out a path forward to transform and improve rural healthcare in tangible ways.”
HRSA’s Federal Office of Rural Health Policy (FORHP) awarded nearly $15 million to 30 award recipients through the Rural Communities Opioid Response Program-Neonatal Abstinence Syndrome (RCORP-NAS). Each recipient will receive up to $500,000 over three-years to reduce the incidence and impact of neonatal abstinence syndrome in rural communities by improving systems of care, family supports, and social determinants of health.
In addition, through the Rural Communities Opioid Response Program-Planning (RCORP-Planning), $10 million is being awarded to 50 award recipients to strengthen and expand the capacity of rural communities to provide SUD/OUD prevention, treatment, and recovery services to high-risk populations. Award recipients will use the funds to build partnerships and develop comprehensive plans to address SUD/OUD workforce and service delivery challenges in their communities.
"We are excited to celebrate these awards during National Recovery Month,” said HRSA Administrator Tom Engels. “RCORP-Planning will continue to help rural communities build the coalitions needed to fight opioid use disorder, and RCORP-NAS will provide needed funding to rural residents grappling with the opioid epidemic to help many people reach recovery.”
Through the RCORP initiative, the funding will help rural communities address barriers to care and additional strains that COVID-19 has placed on both rural individuals with SUD and on rural organizations providing prevention, treatment, and recovery services.
For a list of today's award recipients, visit HRSA’s RCORP-Planning and RCORP-NAS pages.
To learn about HRSA-supported resources, visit HRSA's Opioid Crisis page.
For more information about the national opioid crisis, visit: https://www.hhs.gov/opioids/.
Today, under the leadership of President Trump, the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Health, issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older, subject to certain requirements.
"This action builds upon our Administration's progress toward delivering a safe, effective, and widely available vaccine by 2021," said Assistant Secretary for Health ADM Brett P. Giroir, M.D. "Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people."
To qualify as "covered persons" under 42 U.S.C. § 247d-6d((i)(8)(B) when administering COVID-19 vaccines authorized or licensed by the U.S. Food and Drug Administration (FDA) to persons ages 3 or older, state-licensed pharmacists and pharmacy interns licensed or registered by their state board of pharmacy must satisfy the following requirements:
The authorization preempts any state and local laws that prohibit or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above. The authorization does not preempt state and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.
Access a copy of the guidance*
Information on Operation Warp Speed
Clinical resources on vaccines, including continuing education training on best practices
* Persons using assistive technology may not be able to fully access information in this file. For assistance, please contact the Office of the Assistant Secretary for Health at ashmedia@hhs.gov.
Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded over $79 million in construction and other capital support for 165 HRSA-funded health centers impacted by Hurricanes Florence and Michael, Typhoon Mangkut, and Super Typhoon Yutu, and wildfires and earthquakes occurring in calendar year 2018, and tornadoes and floods occurring in calendar year 2019.
“HRSA-funded health centers play a vital role on the front lines in their communities every day, and even more so during a crisis,” said HHS Secretary Alex Azar. “This funding is the latest in the Trump Administration’s efforts to support Americans affected by the past several years of hurricanes, wildfires, typhoons, and earthquakes, and builds on other HHS investments to strengthen health centers’ readiness to serve their communities after disasters.”
HRSA’s Capital Assistance for Disaster Response and Recovery Efforts (CADRE) funding will help ensure access to health care services for communities impacted by disasters and increase health center capacity to respond to and recover from future emergencies. CADRE funding was made available by the Additional Supplemental Appropriations for Disaster Relief Act in 2019.
“HRSA funded health centers are uniquely positioned to deliver needed services during an emergency,” said HRSA Administrator Tom Engels. “This funding will ensure affected health centers have the resources they need to maintain operations during a crisis, while continuing to provide quality care to our nation’s most vulnerable populations.”
For 55 years, HRSA-funded health centers have delivered affordable, accessible, quality, and value-based primary health care to millions of people regardless of their ability to pay. HRSA funds nearly 1,400 health centers operating almost 13,000 sites, providing care to nearly 30 million people across the nation, in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.
For a list of award recipients, visit https://bphc.hrsa.gov/program-opportunities/cadre/fy2020-awards.
For more information about CADRE, visit https://bphc.hrsa.gov/program-opportunities/cadre.
Today, under the leadership of President Trump, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is announcing the details of a $2 billion Provider Relief Fund (PRF) performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. Last week, HHS announced it had delivered an additional $2.5 billion in payments to nursing homes to help with upfront COVID-19-related expenses for testing, staffing, and personal protective equipment (PPE) needs. Other resources are also being dedicated to support training, mentorship and safety improvements in nursing homes.
"The Trump Administration has focused resources throughout our response on protecting the most vulnerable, including older Americans in nursing homes," said HHS Secretary Alex Azar. "By tying these new funds for nursing homes to outcomes, while providing the support they need to improve quality and infection control, we will help support quality care, slow the spread of the virus, and save lives."
Nursing homes have been particularly hard hit by this pandemic. By tying continued relief payments to patient outcomes, the Trump Administration is demonstrating its commitment to preserving the lives and safety of America's seniors, who are especially vulnerable to COVID-19. Nursing homes will not have to apply to receive a share of this $2 billion incentive payment allocation; HHS will be measuring nursing home performance through required nursing home data submissions and distributing payments based on these data.
Qualifications
In order to qualify for payments under the incentive program, a facility must have an active state certification as a nursing home or skilled nursing facility (SNF) and receive reimbursement from the Centers for Medicare & Medicaid Services (CMS). HHS will administer quality checks on nursing home certification status through the Provider Enrollment, Chain and Ownership System (PECOS) to identify and remove facilities that have a terminated, expired, or revoked certification or enrollment. Facilities must also report to at least one of three data sources that will be used to establish eligibility and collect necessary provider data to inform payment: Certification and Survey Provider Enhanced Reports (CASPER), Nursing Home Compare (NHC), and Provider of Services (POS).
Performance and Payment Cycle
The incentive payment program is scheduled to be divided into four performance periods (September, October, November, December), lasting a month each with $500 million available to nursing homes in each period. All nursing homes or skilled nursing facilities meeting the previously noted qualifications will be eligible for each of the four performance periods. Nursing homes will be assessed based on a full month's worth of the aforementioned data submissions, which will then undergo additional HHS scrutiny and auditing before payments are issued the following month, after the prior month's performance period.
Methodology
Using data from the Centers for Disease Control and Prevention (CDC), HHS will measure nursing homes against a baseline level of infection in the community where a given facility is located. CDC's Community Profile Reports (CPRs) include county-level information on total confirmed and/or suspected COVID-19 infections per capita, as well as information on COVID-19 test positivity. Against this baseline, facilities will have their performance measured on two outcomes:
To measure facility COVID-19 infection and mortality rates, the incentive program will utilize data from the National Healthcare Safety Network (NHSN) LTCF COVID-19 module. CMS issued guidance in early May requiring that certified nursing facilities submit data to the NHSN COVID-19 Module. Data from this module will be used to assess nursing home performance and determine incentive payments.
HHS will continue to provide more updates as it works to assist providers in slowing the spread of infection while simultaneously offering financial support to these frontline heroes combating the pandemic. Funding for this nursing home incentive effort was made possible from the $175 billion Provider Relief program funded through the bipartisan CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. Incentive payments will be subject to the same Terms and Conditions applicable to the initial infection control payments announced last week (available here).
For updates and to learn more about the Provider Relief Program, visit: hhs.gov/providerrelief.
