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HHS seeks public input on improving care coordination and reducing the regulatory burdens of the HIPAA Rules

December 13, 2018

 Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), issued a Request for Information (RFI) seeking input from the public on how the Health Insurance Portability and Accountability Act (HIPAA) Rules, especially the HIPAA Privacy Rule, could be modified to further the HHS Secretary’s goal of promoting coordinated, value-based healthcare. This RFI is a part of the Regulatory Sprint to Coordinated Care, an initiative led by Deputy Secretary Eric Hargan.

HHS developed the HIPAA Rules to protect individuals’ health information privacy and security interests, while permitting information sharing needed for important purposes. However, in recent years, OCR has heard calls to revisit aspects of the Rules that may limit or discourage information sharing needed for coordinated care or to facilitate the transformation to value-based health care. The RFI requests information on any provisions of the HIPAA Rules that may present obstacles to these goals without meaningfully contributing to the privacy and security of protected health information (PHI) and/or patients’ ability to exercise their rights with respect to their PHI.

“This RFI is another crucial step in our Regulatory Sprint to Coordinated Care, which is taking a close look at how regulations like HIPAA can be fine-tuned to incentivize care coordination and improve patient care, while ensuring that we fulfill HIPAA’s promise to protect privacy and security,” said Deputy Secretary Hargan. “In addressing the opioid crisis, we’ve heard stories about how the Privacy Rule can get in the way of patients and families getting the help they need. We’ve also heard how the Rule may impede other forms of care coordination that can drive value. I look forward to hearing from the public on potential improvements to HIPAA, while maintaining the important safeguards for patients’ health information.”

“We are looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them,” said OCR Director Roger Severino. “We are committed to pursuing the changes needed to improve quality of care and eliminate undue burdens on covered entities while maintaining robust privacy and security protections for individuals’ health information.”

In addition to requesting broad input on the HIPAA Rules, the RFI also seeks comments on specific areas of the HIPAA Privacy Rule, including:

  • Encouraging information-sharing for treatment and care coordination
  • Facilitating parental involvement in care
  • Addressing the opioid crisis and serious mental illness
  • Accounting for disclosures of PHI for treatment, payment, and health care operations as required by the HITECH Act
  • Changing the current requirement for certain providers to make a good faith effort to obtain an acknowledgment of receipt of the Notice of Privacy Practices

Public comments on the RFI will be due by February 11, 2019.  The RFI may be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection/

Colorado hospital failed to terminate former employee’s access to electronic protected health information

December 12, 2018

Pagosa Springs Medical Center (PSMC) has agreed to pay $111,400 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a substantial corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.  PSMC is a critical access hospital, that at the time of OCR’s investigation, provided more than 17,000 hospital and clinic visits annually and employs more than 175 individuals.

The settlement resolves a complaint alleging that a former PSMC employee continued to have remote access to PSMC’s web-based scheduling calendar, which contained patients’ electronic protected health information (ePHI), after separation of employment. OCR’s investigation revealed that PSMC impermissibly disclosed the ePHI of 557 individuals to its former employee and to the web-based scheduling calendar vendor without a HIPAA required business associate agreement in place. 

Under the two-year corrective action plan, PSMC has agreed to update its security management and business associate agreement, policies and procedures, and train its workforce members regarding the same.

“It’s common sense that former employees should immediately lose access to protected patient information upon their separation from employment,” said OCR Director Roger Severino.  “This case underscores the need for covered entities to always be aware of who has access to their ePHI and who doesn’t.”

Covered entities that do not have or follow procedures to terminate information access privileges upon employee separation risk a HIPAA enforcement action. Covered entities must also evaluate relationships with vendors to ensure that business associate agreements are in place with all business associates before disclosing protected health information.  The resolution agreement and corrective action plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/pagosasprings.

HHS Announces CHPL Data Challenge Winners

December 06, 2018

The U.S. Department of Health and Humans Services’ Office of the National Coordinator for Health Information Technology (ONC) today announced the winners of the Certified Health IT Product List (CHPL) Data Challenge.

Winning submissions to the challenge all showed how the CHPL data could be used and applied across the healthcare industry and could help provide users of the CHPL different ways to use the information.  This information on the CHPL contains information about health information technology (health IT) systems and specifically details data on certified health IT. As of May 2018, the CHPL has more than 300 listings for active 2015 Edition certified health IT products.

“This challenge shows that there is more to the CHPL data than meets the eye. It is great to the see the creativity and ingenuity each participant put into their submissions,” said Steve Posnack, executive director, office of technology, ONC.

The winning submissions provided information about how their analyses were conducted, how their software works, and the application’s impact towards advancing the use of CHPL data. The winning submissions are:

ResearchAE. ResearchAE is a search engine for health and health IT datasets. They produced an application mapping CHPL’s API with meaningful use attestation, the Medicare Provider Enrollment, Chain, and Ownership System (PECOS), and National Plan and Provider Enumeration System (NPPES) data. Users are able to perform cross-sectional searches allowing users to analyze who is using ONC certified health IT and how it’s being used. The award for the winning submission is $20,000.

Shiro Labs. Shiro Labs created a web-based application that combines Medicare Quality Payment Program (QPP) data with CHPL data, allowing providers to better understand how ONC certified health IT complements their QPP reporting requirements. The runner up submission is awarded $10,000.

Darena Solutions. Darena Solutions, developers of MyMipsScore (https://www.mymipsscore.com/), created a mobile application, called CheckEHR. The interactive program allows users to view where certified health IT modules have the certification criteria to meet several healthcare delivery and quality goals, such as care coordination and patient engagement. The runner up submission is awarded $10,000.

One honorable mention was also awarded to Tom Nguyen who designed a search engine tool embedded in the Google Chrome systems he calls the CHPL Chrome Extension. This enhancement provides users with on screen notifications for ONC certified health IT, features to recommend new site searches, and allows them to quickly navigate to the CHPL’s listings.

View the winner presentations and demonstrations at Certified Health IT Product List (CHPL) Data Challenge.

Secretary Azar Announces Senior Advisor for Drug Pricing Reform

December 06, 2018

On Thursday, Health and Human Services Secretary Alex Azar announced that John O’Brien, will serve as Senior Advisor to the Secretary for Drug Pricing Reform. Previously, O’Brien had served as Advisor to the Secretary for health reform and drug pricing, as well as Deputy Assistant Secretary for Health Policy within the Office of the Assistant Secretary for Planning and Evaluation.

“John O’Brien has already been an integral leader in HHS’s efforts to bring down the high price of prescription drugs,” said Secretary Azar. “As a senior advisor, he will carry forward the legacy of our departed colleague Dan Best and build on the substantial progress that has already been made. John will continue to play an important role in our overall efforts to deliver Americans better, more affordable healthcare.”

Prior to his time at HHS, O’Brien, a pharmacist, was Vice President of Public Policy for CareFirst BlueCross BlueShield. He has also worked at the Centers for Medicare & Medicaid Services, the Notre Dame of Maryland University College of Pharmacy, and various pharmacy and pharmaceutical organizations.

O’Brien has a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health, a doctor of pharmacy degree from Nova Southeastern University, and studied pharmacy and public policy at the University of Florida.

New HHS Checklist Helps First Responders Ensure Language Access and Effective Communication During Emergencies

December 04, 2018

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) has unveiled a plain language checklist to help first responders provide services to individuals with limited English proficiency and individuals with disabilities during emergency response and recovery efforts. 

According to the U.S. Census Bureau, at least 350 languages are spoken across the country.  In addition, approximately 15 percent of adults report some trouble hearing, 8.1 million people are visually impaired, and 32 million adults are illiterate.  Federal civil rights laws, including Title VI of the Civil Rights Act of 1964 and Section 504 of the Rehabilitation Act of 1973 mandate that federally funded emergency response and recovery services must be accessible to people with limited English proficiency and people with disabilities. 

“Recent natural disasters have demonstrated the importance of ensuring accessibility to health and human services for everyone living in the United States, including people who are limited English proficient or with disabilities in need of interpretation and translation services,” said Director of the HHS Office for Civil Rights and Chair of the HHS Language Access Steering Committee, Roger Severino. “I commend our first responders for keeping Americans safe, and hope that this tool will assist them and the diverse communities they serve in emergency situations.”

The checklist resulted from efforts of the HHS Language Access Steering Committee, led by the HHS Office for Civil Rights.  It includes recommendations, specific action steps, and resources to assist first responders in providing on-the-ground language assistance and communicating effectively in disasters.  It complements an emergency preparedness checklist HHS released in 2016, and is an additional tool for responders and local partners who serve community members limited English proficiency or disabilities.  Practical tips range from how to identify language needs in a disaster-impacted community to effectively utilizing interpreters. 

In a recent blog, experts in the HHS Office of the Assistant Secretary for Preparedness and Response and OCR explore how public health, healthcare, and emergency response organizations can use the new checklist to enhance language access and create disaster health communications to better assist impacted communities. 

Visit the OCR website to view the checklist and read essential information on how federal civil rights laws and HIPAA laws apply in emergencies.

Florida contractor physicians’ group shares protected health information with unknown vendor without a business associate agreement

December 04, 2018

Advanced Care Hospitalists PL (ACH) has agreed to pay $500,000 to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) and to adopt a substantial corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. ACH provides contracted internal medicine physicians to hospitals and nursing homes in west central Florida.  ACH provided services to more than 20,000 patients annually and employed between 39 and 46 individuals during the relevant timeframe.

Between November 2011 and June 2012, ACH engaged the services of an individual that represented himself to be a representative of a Florida-based company named Doctor’s First Choice Billings, Inc. (First Choice). The individual provided medical billing services to ACH using First Choice’s name and website, but allegedly without any knowledge or permission of First Choice’s owner. 

On February 11, 2014, a local hospital notified ACH that patient information was viewable on the First Choice website, including name, date of birth and social security number.  In response, ACH was able to identify at least 400 affected individuals and asked First Choice to remove the protected health information from its website.  ACH filed a breach notification report with OCR on April 11, 2014, stating that 400 individuals were affected; however, after further investigation, ACH filed a supplemental breach report stating that an additional 8,855 patients could have been affected.

OCR’s investigation revealed that ACH never entered into a business associate agreement with the individual providing medical billing services to ACH, as required by HIPAA and failed to adopt any policy requiring business associate agreements until April 2014.  Although ACH had been in operation since 2005, it had not conducted a risk analysis or implemented security measures or any other written HIPAA policies or procedures before 2014.  The HIPAA Rules require entities to perform an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of an entity’s electronic protected health information.

“This case is especially troubling because the practice allowed the names and social security numbers of thousands of its patients to be exposed on the internet after it failed to follow basic security requirements under HIPAA,” said OCR Director Roger Severino.

In addition to the monetary settlement, ACH will undertake a robust corrective action plan that includes the adoption of business associate agreements, a complete enterprise-wide risk analysis, and comprehensive policies and procedures to comply with the HIPAA Rules. 

The resolution agreement and corrective action plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/ACH/index.html

HHS Secretary Azar Declares Public Health Emergency in Alaska Due to Earthquake Damage

December 04, 2018

Following President Trump’s lead in declaring an emergency in Alaska after the Nov. 30 earthquake, Health and Human Services (HHS) Secretary Alex Azar today declared a public health emergency in Alaska. The declaration triggers other legal authorities that give the HHS Centers for Medicare & Medicaid Services (CMS) beneficiaries, their healthcare providers and suppliers greater flexibility in meeting emergency health needs in the aftermath of the earthquake.

“HHS is working closely with state health authorities and monitoring the needs of healthcare facilities,” Secretary Azar said. “This declaration will help ensure that Americans who were affected by the earthquake and rely on Medicare, Medicaid, and the Children’s Health Insurance Program have continuous access to the care as the area recovers.”

With the declaration in place, CMS can use legal authority provided under the Social Security Act section 1135 to grant waivers that will aid healthcare facilities in providing uninterrupted care and services for the elderly and people with disabilities living in long-term care facilities. The waivers also support the Alaska Medicaid Agency’s administrative processes, ensuring that Medicaid funds continue to flow despite the temporary closure of the agency’s offices.

As part of the federal response to the earthquake, 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 disaster. 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.

Additionally, the HHS Office for Civil Rights (OCR) has guidance available for territory agencies and community organizations to help ensure equal access to emergency services and the appropriate sharing of medical information during emergencies, including how federal civil rights laws apply in an emergency and how HIPAA laws apply in an emergency. OCR also provides a HIPAA Disclosures for Emergency Preparedness Decision Tool.

In declaring the public health emergency in Alaska and authorizing flexibilities for CMS beneficiaries, Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to Nov. 30, 2018.

Reforming America’s Healthcare System Through Choice and Competition

December 04, 2018

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

U.S. DEPARTMENT OF THE TREASURY

U.S. DEPARTMENT OF LABOR

The President
The White House
Washington, DC 20500

Dear Mr. President:

On October 12, 2017, through Executive Order 13813, you directed the Administration, to the extent consistent with the law, to facilitate the development and operation of a health care system that provides high-quality care at affordable prices for the American people by promoting choice and competition.  We are pleased to provide you with this report, prepared by the Department of Health and Human Services (HHS) in collaboration with the Departments of the Treasury and Labor, the Federal Trade Commission, and several offices within the White House.  This report describes the influence of state and federal laws, regulations, guidance, and polices on choice and competition in health care markets and identifies actions that states or the Federal Government could take to develop a better functioning health care market.

As health care spending continues to rise, Americans are not receiving the commensurate benefit of living longer, healthier lives.  Health care bills are too complex, choices are too restrained, and insurance premiums and out-of-pocket costs are climbing faster than wages and tax revenue.  Health care markets could work more efficiently and Americans could receive more effective, high-value care if we remove and revise certain federal and state regulations and policies that inhibit choice and competition.

The Administration has already taken significant steps to improve health care markets by addressing government rules and programs that limit choice and competition and produce higher prices for the American people.  Among the most significant actions:

  • In October 2018, the Departments of HHS, the Treasury, and Labor proposed a rule that would provide employers with significant new flexibility in how they fund health coverage through Health Reimbursement Arrangements (HRAs).  If finalized, this flexibility would empower individuals to take greater control over what health insurance benefits they receive.  The Treasury estimates that more than 10 million employees would benefit from this change within the next decade.
  • In August 2018, the Departments of HHS, the Treasury, and Labor finalized a rule to expand Americans’ ability to purchase short-term, limited-duration insurance—coverage for which premiums are generally much more affordable than Affordable Care Act (ACA) plans.  Millions of Americans, including middle-class families who cannot afford ACA plans, will benefit from the additional choice and competition resulting from this reform.
  • In June 2018, the Labor Department finalized a rule to expand the ability of employers, including sole proprietors without common law employees, to join together and offer health coverage through Association Health Plans.  For many employers, employees, and their families, these employee benefit plans will offer greater flexibility and more affordable benefits.
  • In May 2018, HHS released “American Patients First,” a historic blueprint for actions to bring down the high price of drugs and reduce out-of-pocket costs. HHS has taken a number of actions that were laid out in the blueprint to empower consumers and promote competition, building on accomplishments such as the Food and Drug Administration’s record pace of generic drug approvals.
  • In December 2017, you signed the Tax Cuts and Jobs Act, which eliminated the onerous and regressive individual mandate tax penalty.  This freed Americans to finance their health care needs in the way that works best for them.
  • The Administration has enacted reforms to deliver better value through choice and competition in the Medicare program, including payment changes that establish site-neutral payment policies for a number of Medicare services, a simplification of how physicians are paid for evaluation and management visits, new consumer-transparency measures, and flexibility for insurers to offer more options and benefits in Medicare Advantage.
  • HHS and the Treasury have issued revised guidance under section 1332 of the ACA that significantly expands the ability of states to reform their individual insurance markets while ensuring that people with pre-existing conditions are protected.

While the Administration has made much progress in reforming the American health care system significant obstacles remain.  This report identifies four areas where federal and state rules inhibit adequate choice and competition and offers recommendations for improving public policy in each of these four areas.

Health Care Workforce and Labor Markets:  Reduced competition among clinicians leads to higher prices for health care services, reduces choice, and negatively impacts overall health care quality and the efficient allocation of resources.  Government policies have suppressed competition by reducing the available supply of providers and restricting the range of services that they can offer.  This report recommends policies that will broaden providers’ scope of practice while improving workforce mobility, including telehealth, to encourage innovation and to allow providers more easily to meet patients’ needs.  The report also recommends that the Federal Government streamline funding for graduate medical education to allocate taxpayer dollars efficiently and to address physician supply shortages.

Health Care Provider Markets:  State policies that restrict entry into provider markets can stifle innovative and more cost-effective ways to provide care while limiting choice and competition.  These policies have resulted in higher health care prices and fewer incentives for providers to improve quality.  This report makes several recommendations to promote choice and competition in provider markets, including state action to repeal or scale back Certificate of Need laws and encourage the development of value-based payment models that offer flexibility and risk-based incentives for providers, especially without unduly burdening small or rural practices.

Health Care Insurance Markets:  Government mandates often reduce choice and competition in insurance markets and increase overall premiums.  In the individual and small group markets, many consumers face limited coverage options that cover services they do not want or need and that drive up premiums, while others have been completely priced out of the market.  Regulations that limit coverage choices should be changed so that states have more flexibility to develop policies that account for diverse consumer preferences.  This report recommends scaling back government mandates, eliminating barriers to competition, and allowing consumers maximum opportunity to purchase health insurance that meets their needs.

Consumer-Driven Health Care:  Our health care system’s excessive reliance on third-party payment insulates consumers from the true price of health care and offers them little incentive to search for low-cost, high-quality care.  When federal and state health policies give consumers more control over their health care dollars, they can use that power to demand greater value.  For example, promoting and expanding Health Saving Accounts (HSAs) and HRAs would expand personal control and introduce more consumer power into the health care market.  The report recommends expanding access to HSAs, implementing reference pricing where appropriate, and developing price and quality transparency initiatives to ensure that newly empowered health care consumers can make well-informed decisions about their care.

We know the United States health care system too often fails to deliver the value it should.  This report identifies barriers on the federal and state levels to market competition that stifle innovation, lead to higher prices, and do not incentivize improvements in quality.  It recommends policies that will foster a health care system that delivers high-quality care at affordable prices through greater choice, competition, and consumer-directed health care spending.  While American consumers and many providers would significantly benefit from the reforms laid out in this report, there are entrenched and powerful special interest groups that reap large profits from the status quo.  It will take bold leadership to confront these incumbents and implement reforms, but under your direction, we are convinced we can significantly improve the American health care system.

We look forward to working with you as we create a more effective and efficient health care market that provides information for consumers as they make health care decisions for their families, rewards quality, encourages innovation, and delivers care at prices the American people can afford.

Sincerely,

Alex M. Azar II
Secretary
U.S. Department of Health and Human Services

Steven T. Mnuchin
Secretary
U.S. Department of the Treasury

Alexander Acosta
Secretary
U.S. Department of Labor

Download the report

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

Statement from HHS Secretary Alex Azar ahead of World AIDS Day

December 01, 2018

HHS Secretary Alex Azar issued the following statement ahead of the 30th anniversary of World AIDS Day:

“The observance of World AIDS Day is an annual reminder of the need to remain vigilant in our efforts to combat the HIV/AIDS pandemic, and also of the potential we have for further progress. Advances in HIV prevention, treatment, and care services have enabled us to significantly reduce the rate of HIV infections and improve the health of those living with HIV. We have seen progress both at home, through initiatives such as the Ryan White HIV/AIDS Program, and abroad, through the success of the U.S. President’s Emergency Plan for AIDS Relief, which marks its 15th anniversary this year. We must also continue our work to remove the stigma that surrounds HIV so that no one is afraid to learn their HIV status, and receive treatment or take steps to prevent infection.

“Bringing federal resources to the battle against infectious diseases such as HIV has been a special focus of my public career, and the Trump administration is strongly committed to achieving the goals of our National HIV/AIDS Strategy. By ensuring access to and the availability of the effective tools we have today, such as pre-exposure prophylaxis (PrEP) and daily antiretrovirals, and strong support for new methods of HIV prevention and treatment that are in the research pipeline, we are optimistic that we can continue our advances toward ending the HIV/AIDS pandemic.”

For more information on HIV, go to HIV.gov

HHS Secretary Azar Praises Release of State Relief and Empowerment Waiver Concepts

November 30, 2018

On Thursday, the Centers for Medicare & Medicaid Services (CMS) released four State Relief and Empowerment Waiver concepts that states can utilize, under Section 1332 of the Affordable Care Act (ACA), to design new approaches to make healthcare coverage more affordable and accessible in their communities.

HHS Secretary Alex Azar issued the following statement regarding the waiver concepts:

“The Trump Administration is committed to empowering states to think creatively about how to secure quality, affordable healthcare choices for their citizens. Part of that commitment is providing guidance on how states can use the waiver authorities within the ACA to open up more state-based, consumer-directed, fiscally sustainable healthcare options. The specific examples laid out today show how state governments can work with HHS to create more choices and greater flexibility in their health insurance markets, helping to bring down costs and expand access to care.”

Read the CMS fact sheet on State Relief and Empowerment Waiver concepts: https://www.cms.gov/CCIIO/Programs-and-Initiatives/State-Innovation-Waivers/Downloads/Waiver-Concepts-Fact-Sheet.pdf

HHS Announces Winners of Easy EHR Issue Reporting Challenge

November 29, 2018

As part of ongoing efforts to improve the safe use of health information technology (health IT) and electronic health records (EHRs), the U.S. Department of Health and Human Services announced today the winners of the Easy EHR Issue Reporting Challenge. Winners of this challenge created software tools that could help clinicians report EHR usability and safety issues faster, more efficiently, and in alignment with their regular clinical workflow.

“Helping reduce the burden of health IT continues to be a key area of focus at the Office of the National Coordinator for Health Information Technology (ONC) and we anticipate the winning submissions to the Easy EHR Issue Reporting Challenge will help with those efforts,” said Don Rucker, M.D., national coordinator for health information technology. “Once the winning submissions reach production, we expect to see how reporting safety issues can be less burdensome for healthcare providers.”

The winners include:

  • First place - James Madison Advisory Group. James Madison Advisory Group’s unique solution for reporting possible safety events launches through a system tray icon or hotkey on any Windows 8 or higher installation. Use of the tray icon or hotkey keeps the user from exiting the EHR workflow, regardless of the EHR platform. The tool exports in the HHS Agency for Healthcare Research and Quality (AHRQ) Common Formats XML and PDF, captures screenshots, and simplifies the report delivery process. The winning submission is awarded $45,000.
  • Second place – Pegwin. Pegwin provides a software platform that can create and send a safety or usability report in as few as three clicks. Using contextual menus and design intuitive to the user, the software makes completion of Common Formats reporting as automated as possible. The second place submission is awarded $25,000.
  • Third place – Jared Schwartz and team. Jared Schwartz and his team uses a browser plug-in to Google Chrome that can integrate with IT ticketing systems, enabling more consistent capture of safety issues. The user can also provide additional information immediately or save for a more convenient time. The third place submission is awarded $10,000.

“Improving the safety of health IT remains an important priority,” said Andy Gettinger, M.D., ONC chief clinical officer. “We believe that making it easier for end users to report will help in that goal.”

Many EHR users have indicated the need for more efficient and user-friendly mechanisms to facilitate reporting safety concerns quickly and easily, with little or no disruption to their clinical workflow.  The challenge submissions are intended to help EHR users identify, document, and report potential health IT safety issues when they occur. By promoting heath IT safety issue reporting, the industry will be in better position to determine root causes, provide feedback to EHR developers, and produce best practice guidance.

Additional information about the Easy EHR Issue Reporting Challenge is available at https://www.cccinnovationcenter.com/challenges/easy-ehr-issue-reporting-challenge/.

HHS Issues Draft Strategy to Reduce Health IT Burden

November 29, 2018

The U.S. Department of Health and Human Services (HHS) today issued a draft strategy designed to help reduce administrative and regulatory burden on clinicians caused by the use of health information technology (health IT) such as electronic health records (EHRs).

The draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs was led by the HHS Office of the National Coordinator for Health Information Technology (ONC), in partnership with the Centers for Medicare & Medicaid Services (CMS), and was required in the 21st Century Cures Act. The draft strategy reflects the input and feedback received by ONC and CMS from stakeholders, including clinicians, expressing concerns that EHR burden negatively affects the end user and ultimately the care delivery experience. This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients.

“Usable, interoperable health IT was one of the first elements of the vision I laid out earlier this year for transforming our health system into one that pays for value,” said HHS Secretary Alex Azar. “With the significant growth in EHRs comes frustration caused, in many cases, by regulatory and administrative requirements stacked on top of one another. Addressing the challenge of health IT burden and making EHRs useful for patients and providers, as the solutions in this draft report aim to do, will help pave the way for value-based transformation.”

Stakeholders have indicated to ONC and CMS that when they use their EHRs, clinicians have to rely on checkboxes, templates, cut-and-paste functions, and other workarounds that hinder the intended benefits of EHRs. Clinicians have reported they are spending more time entering data into the EHR, leaving less time to interact with their patients. Required documentation guidelines have led to “note bloat,” making it harder to find relevant patient information and effectively coordinate a patient’s care.

“Information technology has automated processes in every industry except health care, where the introduction of EHRs resulted in additional burden on clinicians,” said Don Rucker, national coordinator for health information technology. “Health IT tools need to be intuitive and functional so that clinicians can focus on their patients and not documentation. This draft strategy identifies ways the government and private sector can alleviate burden. I look forward to input from the public to improve this strategy.”

“Over the past year, we hosted listening sessions, received written feedback, and heard from a wide range of clinical stakeholders about the current health IT systems and the requirements specifying documentation, reimbursement, and quality reporting that are burdensome and should be re-examined,” said Seema Verma, CMS administrator. “CMS has demonstrated through bold regulatory action the importance of reducing clinician burden.”  

Based on the input received by ONC and CMS, the draft strategy outlines three overarching goals designed to reduce clinician burden:

  1. Reduce the effort and time required to record health information in EHRs for clinicians;
  2. Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and
  3. Improve the functionality and intuitiveness (ease of use) of EHRs.

The public comment period on the draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs ends on Monday January 28, 2019 at 11:59:59 PM ET.

“All of us share the responsibility to improve how we treat the nation’s patients, and we now have the opportunity to work together to find solutions to reduce burden associated with the use of EHRs so clinicians can spend more time with their patients,” said Rucker.

Allergy practice pays $125,000 to settle doctor’s disclosure of patient information to a reporter

November 27, 2018

Allergy Associates of Hartford, P.C. (Allergy Associates), has agreed to pay $125,000 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 Rule. Allergy Associates is a health care practice that specializes in treating individuals with allergies, and is comprised of three doctors at four locations across Connecticut.

In February 2015, a patient of Allergy Associates contacted a local television station to speak about a dispute that had occurred between the patient and an Allergy Associates’ doctor. The reporter subsequently contacted the doctor for comment and the doctor impermissibly disclosed the patient’s protected health information to the reporter.

OCR’s investigation found that the doctor’s discussion with the reporter demonstrated a reckless disregard for the patient’s privacy rights and that the disclosure occurred after the doctor was instructed by Allergy Associates’ Privacy Officer to either not respond to the media or respond with “no comment.” Additionally, OCR’s investigation revealed that Allergy Associates failed to take any disciplinary action against the doctor or take any corrective action following the impermissible disclosure to the media.

“When a patient complains about a medical practice, doctors cannot respond by disclosing private patient information to the media,” said OCR Director Roger Severino. “Because egregious disclosures can lead to substantial penalties, covered entities need to pay close attention to HIPAA’s privacy rules, especially when responding to press inquiries.”

In addition to the monetary settlement, Allergy Associates will undertake a corrective action plan that includes two years of monitoring their compliance with the HIPAA Rules. The resolution agreement and corrective action plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/allergyassociates/index.html

HHS Activates Aid for Uninsured Californians in Need of Medications Lost in Wildfires

November 21, 2018

Uninsured citizens in California’s Butte, Los Angeles and Ventura counties are eligible for no-cost replacements of critical medications lost or damaged by the current wildfires in those counties. This relief comes from the Emergency Prescription Assistance Program (EPAP), managed by the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

“EPAP provides vital assistance to people without insurance who rely upon certain prescription medicines and equipment to protect their health after disasters,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “I encourage citizens in impacted areas of California who qualify for this assistance to take advantage of it.”

At no cost to uninsured patients, those needing certain prescription medications during an emergency can obtain a 30-day supply at any EPAP participating pharmacy through Dec. 31, 2018. Most prescription drugs are covered under the program.

Uninsured patients also may use EPAP to replace specific medical supplies or medical equipment, such as canes and walkers, damaged or lost as a direct result of the wildfires or as a secondary result of loss or damage caused while in transit to an emergency shelter.

More than 72,000 pharmacies participate nationwide, including more than 200 in California. EPAP provides an efficient mechanism for enrolled pharmacies to process claims for prescription medication, specific medical supplies, and some forms of durable medical equipment for eligible individuals in a federally identified disaster area. All pharmacies in the United States are eligible to participate. Pharmacies in the California can call 888-571-8182, toll-free, to be added to the program.

Uninsured California residents affected by the current wildfires can call 855-793-7470, to learn if their medication or specific durable medical equipment is covered by EPAP and to find a participating pharmacy or visit www.phe.gov/epap.

HHS is providing additional assistance to the state. Secretary Alex Azar declared a public health emergency in California on Nov. 13, 2018, authorizing flexibilities for CMS beneficiaries and providers retroactive to Nov. 8, 2018.

The Centers for Medicare & Medicaid Services (CMS) has temporarily waived or modified certain Medicare and Medicaid requirements to give healthcare providers, facilities and suppliers the flexibility needed to provide continued access to care during the wildfire emergency. In addition to issuing broad waivers, CMS can grant provider-specific requests for hospitals and other California healthcare facilities as needed.

HHS deployed approximately 60 medical and public health staff, including doctors, nurses, and paramedics from the National Disaster Medical System and behavioral health experts who are working alongside local professionals to provide care in shelters, as well as regional emergency coordinators (RECs) and environmental health experts who are coordinating with state and local health authorities and emergency response officials. Additional personnel from the U.S. Public Health Service Commissioned Corps are on alert to provide medical care or additional public health support if needed.

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.

SAMHSA also has resources available to assist residents with the behavioral health impacts of disasters, including tips for parents and educators on talking with children after traumatic events. Children respond to trauma in many different ways, and the tips cover signs of stress reactions in different age groups and how to help.

The Centers for Disease Control and Prevention (CDC) is working with the California Department of Public Health and other partners on public information materials to help residents and responders protect their lungs from the effects of wildfire smoke.

HHS and state partners are encouraging people in the way of wildfire smoke to listen to local authorities and take precautions to protect their health. CDC cautions that children, pregnant women, older adults, and people with existing respiratory or cardiovascular illnesses are especially susceptible to the effects of smoke. CDC recommends that if told to do so, residents stay indoors and keep air as clean as possible by shutting windows and doors, setting air conditioning systems to the “re-circulate” setting, and operating air cleaners equipped with a high-efficiency particulate air (HEPA) filter documented not to produce excess ozone.

HHS, through its Office of the Assistant Secretary for Preparedness and Response (ASPR), leads the federal government’s public health and medical response and recovery support for states and territories after disasters. 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. ASPR’s mission is to save lives and protect Americans from 21st century health security threats.

Information on disaster health and HHS actions is available on www.phe.gov/emergency. Public Service Announcements with wildfire health tips are available on https://www.cdc.gov/disasters/psa/index.html.

HHS Deputy Secretary Hargan Announces DSIIS Participants and First Meeting Date

November 21, 2018

Today, Health and Human Services Deputy Secretary Eric Hargan announced the initial core participants of the Deputy Secretary’s Innovation and Investment Summit (DSIIS) and December 18, 2018 as the date of the first meeting. As announced on September 19, 2018, the DSIIS will be a yearlong collaboration between healthcare innovation and investment professionals and HHS personnel who will meet quarterly to discuss the innovation and investment landscape within the healthcare sector, emerging opportunities, and the government’s role in facilitating more investment and accelerated innovation.

“Collaboration between HHS and private sector investors and innovators is critical to advancing new solutions and evolving healthcare in America,” said Deputy Secretary Hargan. “We believe this will produce new approaches that will improve the health and well-being of the American people. As the healthcare community innovates, HHS must also be innovative in how we engage with that community.”

HHS received over 250 nominations of highly qualified, prospective DSIIS core participants from all of the healthcare subsectors.  Each nominee was evaluated based on areas of educational focus, executive or other organizational leadership experience, private equity experience, venture capital experience, lending experience within the healthcare sector, and applicable experience, expertise, knowledge and leadership in innovation and investment in the healthcare sector.

The following experienced leaders in digital health, life sciences, medical devices, payor organizations, provider organizations, and health technology investing and innovation have been selected as initial DSIIS core participants.

Anna Haghgooie-Managing Director, Sandbox Industries

Annie Lamont-Managing Director, Oak HC/FT

Anthony Davis-Co-Founder and President, Linden Partners

Barry Uphoff-Founder and Managing Partner, Martis Capital

Bill Geary-Co-Founder and Partner, Flare Capital

Brian Thompson-CEO, UnitedHealthcare Medicare & Retirement

Dean Harrison-President and CEO, Northwestern Memorial HealthCare

Ezra Perlman-Co-President, Francisco Partners

Jim Rogers-Chair, Department of Business Development, Mayo Clinic

Matt Hermann-Senior Managing Director, Ascension Ventures

Mo Makhzoumi-Head of Global Health, New Enterprise Associates

Robbert Vorhoff-Managing Director and Global Head of Healthcare, General Atlantic

Scott Hilinski–Managing Director, Nautic Partners

Stephen Kraus-Partner, Bessemer Ventures

Todd Fruchterman-President/GM, 3M

This group will not be recommending or giving any direction on healthcare innovation and investments made by HHS.  This group will collaborate with HHS in an open discussion over the coming year to compare perspectives, analyze the most promising opportunities, and identify barriers related to innovation and investment in healthcare.  As previously announced, HHS will also bring in participants with subject matter expertise to provide additional perspectives during more focused discussions.

FAQs are available here: 

https://www.hhs.gov/about/leadership/eric-d-hargan/dsiis-faq/index.html

Additional information on DSIIS is available here:

https://www.hhs.gov/about/news/2018/09/19/hhs-deputy-secretary-hargan-announces-collaboration-accelerate-innovation-and-investment-healthcare.html

Secretary Azar Comments on Data Showing Rising E-Cigarette Use Among Youth

November 15, 2018

Health and Human Services Secretary Alex Azar issued the following statement regarding the sharp uptick in e-cigarette use among youth reported in the 2018 National Youth Tobacco Survey:

“America’s youth are facing a public health crisis that threatens an entire generation: skyrocketing use of nicotine products, brought on by access to flavored products in particular. Use of these products, including e-cigarettes, menthol cigarettes, and cigars, put our youth at risk for a lifetime of nicotine addiction.

E-cigarettes present an important, potentially lifesaving opportunity to help currently addicted adult smokers quit combustible cigarettes. But in trying to build this off-ramp from a deadly addiction, we cannot let e-cigarettes become an on-ramp for kids to enter a lifetime of nicotine addiction and tobacco use.

New data from the National Youth Tobacco survey show the number of teenagers using e-cigarettes almost doubling in just the last year. But we can use a targeted approach to tackle this challenge: The data also show that kids not only choose flavored products more often than adults do, but also that flavors are a major reason they use these products in the first place. Flavors increase the likelihood of kids progressing from experimentation to regular use, and a portion of them will go on to use combustible tobacco products, with the huge added dangers of tobacco-related disease.

FDA’s enforcement efforts and policy framework would restrict access to most flavored e-cigarettes and limit the chances of youth beginning to use these products, while ensuring the products are available to adult smokers as an alternative to combustible cigarettes.

Our obligation at HHS is always to the public health, and we believe FDA’s goals strike the right public health balance in addressing the multifaceted challenge we have before us today.”

Tick-Borne Disease Working Group Calls for More Resources for Research, Prevention, Diagnostics and Treatment

November 14, 2018

The Tick-Borne Disease Working Group, a federal advisory committee established by Congress in the 21st Century Cures Act, issued its first report today. The report recommends a multi-pronged response to address these diseases that affect more than 300,000 Americans each year.

Top recommendations included increases in federal resources to meet urgent research and patient care needs, such as enhanced surveillance, prevention, diagnostic and treatment options. The Working Group identified the following priorities:

  • Improve early and accurate diagnosis and treatment.
  • Strengthen national surveillance.
  • Understand immunological mechanism (for example, pathogen-host interaction) of immune protection for Lyme disease and other tick-borne diseases.
  • Develop new rapid and accurate lab tests.
  • Develop antibiotic combination and/or therapeutic options for treating acute and persistent illness.
  • Encourage the development of strategic plans for tick-borne disease federal investments.
  • Dedicate funding to tick-borne diseases and evaluate related activities using performance indicators and clear metrics for success.
  • Characterize how tick-borne disease affects U.S. national security, military readiness, and the health and wellness of active duty service members, veterans and their families.


“Patients whose lives are devastated by ongoing effects of tick-borne illnesses are counting on emerging scientific research, evidence-based policy and the healthcare establishment – including the federal government – to provide solutions,” said Adm. Brett P. Giroir, M.D., assistant secretary for health, U.S. Department of Health and Human Services. “I thank the Working Group for its efforts to produce this report, which will inform our efforts to prevent, diagnose, treat and cure these potentially debilitating diseases.”

Tick-borne diseases have become a serious, potentially deadly, and rapidly growing threat to public health. Lyme disease alone is estimated to affect more than 300,000 Americans each year, with the number of cases having doubled since 2004. However, only about one-tenth of those cases are reported to local and state health departments and the CDC. Many patients and advocates submitted comments to the Working Group, describing debilitating symptoms from tick-borne diseases that require prolonged treatment often resulting in large medical bills that are not reimbursed by medical insurers. New pathogens continue to be discovered, further increasing public health risks and costs for the U.S.

“This report is an important first step in bringing together all relevant stakeholders to develop solutions to this critical – and growing – public health problem in the U.S. today,” said Working Group Chair John N. Aucott, M.D., associate professor, Johns Hopkins University School of Medicine, and director, Johns Hopkins Lyme Disease Research Center. “The bottom line is: we need to find better ways to care for our patients and these recommendations will help us do that.”

The Working Group is administered by HHS. Its 14 members represent a variety of stakeholders, including providers, scientists and researchers, patients and family members, patient advocates and federal members. Members were charged with providing expertise and reviewing all HHS efforts related to tick-borne diseases to help ensure interagency coordination, minimize overlap, and to examine research priorities. The next Working Group report is due to Congress and the HHS Secretary by December 2020.

HHS Secretary Azar Declares Public Health Emergency in California due to Wildfires

November 14, 2018

Health and Human Services (HHS) Secretary Alex Azar today declared a public health emergency in California due to wildfires. The declaration follows President Trump’s emergency declaration for the state and gives the HHS Centers for Medicare & Medicaid Services beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs created by the wildfires.

“We are working closely with state health authorities and monitoring the needs of healthcare facilities to provide whatever they may need to save lives and protect health,” Secretary Azar said. “This declaration will help ensure that Americans who are threatened by these dangerous wildfires and who rely on Medicare, Medicaid, and the Children’s Health Insurance Program have continuous access to the care they need.”

So far, the wildfires have forced the evacuation of at least two hospitals and eight other healthcare facilities. A smoke advisory was issued for portions of Los Angeles County. Smoke can present a significant health threat for people with asthma and other lung conditions.

HHS has deployed regional emergency coordinators (RECs) to coordinate with state and local health authorities and emergency response officials. RECs serve as HHS’ primary representatives for emergency response and recovery throughout the country at the regional level and work with federal, state, local, tribal and territorial officials and healthcare representatives to plan for public health and medical emergencies.

Staff from HHS’ National Disaster Medical System and the U.S. Public Health Service Commissioned Corps are prepared to provide medical care and public health support if needed.

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 California and authorizing flexibilities for CMS beneficiaries, Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to Nov. 8, 2018.

HHS Releases Physical Activity Guidelines for Americans, 2nd edition

November 12, 2018

(Chicago) – Today, Adm. Brett P. Giroir, M.D., assistant secretary for health, announced the release of the U.S. Department of Health and Human Services’ second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s Scientific Sessions meeting. The second edition provides evidence-based recommendations for youth ages 3 through 17 and adults to safely get the physical activity they need to stay healthy. There are new key guidelines for children ages 3 through 5 and updated guidelines for youth ages 6 through 17, adults, older adults, women during pregnancy and the postpartum period, adults with chronic health conditions, and adults with disabilities.

The United States currently has low levels of adherence to the guidelines -- only 26 percent of men, 19 percent of women, and 20 percent of adolescents meet the recommendations. According to the guidelines, these low levels of physical activity among Americans have health and economic consequences for the nation, with nearly $117 billion dollars in annual healthcare costs and 10 percent of all premature mortality attributable to failure to meet levels of aerobic physical activity recommended in the guidelines. Adults need 150 minutes of moderate-to-vigorous aerobic activity each week, with muscle strengthening activities on two days during the week to stay healthy. Youth ages 6 through 17 need 60 minutes of moderate-to-vigorous physical activity each day.

“The new guidelines demonstrate that, based on the best science, everyone can dramatically improve their health just by moving – anytime, anywhere, and by any means that gets you active,” said Adm. Giroir. “That’s why we need to come together as a nation to get Americans moving. When we move more, we have better cardiovascular health, we are stronger and less susceptible to disease, and we feel better. The updated guidelines include evidence-based strategies that leaders across the nation can use to help Americans fit more physical activity into their daily lives.”

The second edition, based on a comprehensive scientific review, reflects new knowledge about immediate and long-term health benefits from physical activity, as well as new evidence that physical activity can help manage chronic conditions that many Americans have.  

“The American Heart Association has long recognized physical activity as a proven way to lower chances of heart disease and live a longer, healthier life. Our organization is committed to developing programs and advocating for polices that make it easier for everyone to get more physically active, regardless of where they live,” said Ivor Benjamin, M.D., American Heart Association president. “In 2008, the American Heart Association adopted the Physical Activity Guidelines and again we are proud to lead the call for health groups across the country to view these guidelines as beneficial to both public health and a worthy tool for clinicians.”

Notable updates:

  • The previous guidelines stated that only 10-minute bouts of physical activity counted toward meeting the guidelines. This requirement has been removed because all activity counts.
  • There are immediate health benefits, attainable from a single bout of activity, including reduced anxiety and blood pressure, improved quality of sleep, and improved insulin sensitivity.
  • There are more long-term benefits from physical activity, including improved brain health, reduced risk of eight types of cancer (previously two), reduced risk for fall-related injuries in older adults, and reduced risk of excessive weight gain.
  • Physical activity helps manage more chronic health conditions.
    • It can decrease pain for those with osteoarthritis, reduce disease progression for hypertension and type 2 diabetes, reduce symptoms of anxiety and depression, and improve cognition for those with dementia, multiple sclerosis, ADHD, and Parkinson’s disease.
  • There are new key guidelines for preschool children to be active throughout the day to enhance growth and development. 

For more information about the latest Physical Activity Guidelines for Americans visit www.health.gov/paguidelines.

HHS activates aid for uninsured citizens of the Commonwealth of the Northern Mariana Islands needing medicine after Super Typhoon Yutu

November 08, 2018

Uninsured citizens of the Commonwealth of the Northern Mariana Islands (CNMI), a U.S. territory, are eligible for no-cost replacements of critical medications lost or damaged by Super Typhoon Yutu. This relief comes from the Emergency Prescription Assistance Program (EPAP), managed by the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

“We are committed to doing everything we can to protect Americans from the potential health impacts of disasters, and Emergency Prescription Assistance Program is one part of that effort,” said HHS Assistant Secretary for Preparedness and Response, Robert Kadlec, M.D. “EPAP provides vital assistance to people without insurance who rely upon certain prescription medicines and equipment to protect their health after disasters. I encourage citizens in Northern Mariana Islands who qualify for this assistance to take advantage of it.”

At no cost to uninsured patients, those needing certain prescription medications during an emergency can obtain a 30-day supply at any EPAP participating pharmacy through Nov. 24, 2018. Most prescription drugs are covered under the program.

Uninsured patients also may use EPAP to replace specific medical supplies or medical equipment, such as canes and walkers, damaged or lost as a direct result of Super Typhoon Yutu or as a secondary result of loss or damage caused while in transit from the emergency site to an emergency shelter.

More than 72,000 pharmacies participate nationwide. All of the pharmacies in the CNMI are open and the following pharmacies in Saipan participate in the EPAP:

  • Brabu Pharmacy, 101 Akari Road
  • Phi Pharmacy, 1 Navy Hill Road
  • Phi I, Joeten Dandan Center

Emergency Prescription Assistance Program provides an efficient mechanism for enrolled pharmacies to process claims for prescription medication, specific medical supplies, and some forms of durable medical equipment for eligible individuals in a federally identified disaster area. All pharmacies in the United States are eligible to participate. Pharmacies in the CNMI can call 888-571-8182, toll-free, to be added to the program.

Uninsured CNMI residents affected by Super Typhoon Yutu can call 855-793-7470, to learn if their medication or specific durable medical equipment is covered by EPAP and to find a participating pharmacy or visit www.phe.gov/epap.

HHS also has personnel from Disaster Medical Assistance Teams and the U.S. Public Health Service Commissioned Corps working alongside local healthcare providers to care for patients at CNMI clinics, shelters and community centers. In the initial days after the storm, these teams also provided emergency medical care at the hospital in Saipan. In the first two weeks, these personnel have seen more than 2,100 patients, primarily for clean-up related injuries such as lacerations and puncture wounds, and primary care needs.

The U.S. Food and Drug Administration has information available to help citizens understand the safe use of medical products, including insulin and devices, exposed to flooding or unsafe water after Super Typhoon Yutu. This information includes the safe use of temperature-sensitive drugs when refrigeration is temporarily unavailable.

Centers for Disease Control and Prevention subject matter experts are working with the territory health department to determine any long-term public health or environmental health effects of Super Typhoon Yutu and are making public health information available, such as tips on safe clean up and preventing common post-disaster diseases.

The Centers for Medicare & Medicaid Services (CMS) has taken measures necessary to give healthcare providers, facilities and suppliers the flexibility needed to provide continued access to care following the catastrophic storm. CMS temporarily waived or modified certain Medicare and Medicaid requirements. CMS has issued waivers as necessary, and the CMS Regional Office can grant other provider-specific requests for the hospital and other CNMI healthcare facilities.

CMS also worked with the Kidney Community Emergency Response network and dialysis providers to check on the well-being of dialysis patients and reschedule their dialysis services at open dialysis facilities after the super typhoon.

The Substance Abuse and Mental Health Services Administration (SAMHSA) activated its Disaster Distress Helpline, a 24/7, 365-day-a-year, national hotline dedicated to providing immediate crisis counseling for people who are experiencing emotional distress related to any natural or human-caused disaster. The Disaster Distress Helpline is toll-free, multilingual, and confidential. Stress, anxiety, and other depression-like symptoms are common reactions after a disaster. Call 1-800-985-5990 to connect with a trained crisis counselor.

SAMHSA also has resources available to assist residents with the behavioral health impacts of disasters, including tips for parents and educators on talking with children after traumatic events. Children respond to trauma in many different ways, and the tips cover signs of stress reactions in different age groups and how to help.

Following President Trump’s emergency declaration for Super Typhoon Yutu, HHS Secretary Alex Azar declared a public health emergency in CNMI on Oct. 25, 2018, to authorize flexibilities for CMS beneficiaries. These flexibilities are retroactive to Oct. 24, 2018.

HHS, through its Office of the Assistant Secretary for Preparedness and Response (ASPR), leads the federal government’s public health and medical response and recovery support for states and territories after disasters. 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. ASPR’s mission is to save lives and protect Americans from 21st century health security threats.

Information on disaster health and HHS actions is available on www.phe.gov/emergency. Public Service Announcements with post-storm health tips are available on https://www.cdc.gov/disasters/psa/index.html.

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