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In brief: Cybersecurity violation, Walgreens complaint, Homecare Champion nominees

In brief: Cybersecurity violation, Walgreens complaint, Homecare Champion nominees

WASHINGTON – The U.S. Department of Health and Human Services, Office for Civil Rights, has announced a $3 million settlement with Solara Medical Supplies concerning potential violations of HIPAA Security and Breach Notification rules caused by a phishing incident.   

In November 2019, OCR received a breach report concerning a phishing attack in which an unauthorized third party gained access to the email accounts of eight Solara employees between April and June 2019, resulting in the breach of the ePHI of 114,007 individuals. In January 2020, OCR received notification of a second breach by the company related to 1,531 notification letters sent to the wrong mailing addresses.  

OCR’s investigation determined that Solara failed to conduct a compliant risk analysis to identify the potential risks and vulnerabilities to ePHI in Solara's systems; failed to implement security measures sufficient to reduce the risks and vulnerabilities to ePHI to a reasonable and appropriate level; and failed to provide timely breach notification to individuals, HHS and the media.  

“Cyberattacks have skyrocketed exponentially in recent years,” said OCR Director Melanie Fontes Rainer. “Effective cybersecurity requires identifying potential risks and vulnerabilities to health information and implementing effective security measures to protect against them. Health care entities that fail to address identified cybersecurity issues leave themselves vulnerable to cyberattacks. OCR urges health care entities to prioritize securing their information systems and take all necessary steps to reduce and prevent cyberattacks and safeguard protected health information.”  

Under the terms of the settlement, Solara agreed to implement a corrective action plan that will be monitored by OCR for two years and pay $3 million to OCR. Under the corrective action plan, Solara will be required to take definitive steps to resolve potential violations of the HIPAA Security and Breach Notification Rules, including:  

  • Conducting an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the ePHI in its systems;  
  • Implementing a written risk management plan to address and mitigate security risks and vulnerabilities identified in the risk analysis;  
  • Developing, maintaining, and revising, as necessary, its written policies and procedures to comply with the HIPAA Rules; and  
  • Training its workforce on its HIPAA policies and procedures.  

The resolution agreement and corrective action plan may be found here.

Complaint alleges Walgreens dispensed ‘unlawful’ prescriptions  

WASHINGTON – The U.S. Department of Justice, in a civil complaint filed in the U.S. District Court for the Northern District of Illinois, alleges that Walgreens Boots Alliance, Walgreen Co. and various subsidiaries (collectively, Walgreens) dispensed millions of unlawful prescriptions in violation of the Controlled Substances Act (CSA) and then sought reimbursement for many of these prescriptions from various federal health care programs in violation the False Claims Act (FCA).  

Walgreens is one of the country’s largest pharmacy chains, with more than 8,000 pharmacies across the United States.  

“This lawsuit seeks to hold Walgreens accountable for the many years that it failed to meet its obligations when dispensing dangerous opioids and other drugs,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the DOJ’s Civil Division. “Our complaint alleges that Walgreens pharmacists filled millions of controlled substance prescriptions with clear red flags that indicated the prescriptions were highly likely to be unlawful, and that Walgreens systematically pressured its pharmacists to fill prescriptions, including controlled substance prescriptions, without taking the time needed to confirm their validity. These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores.”  

The government’s complaint alleges that, from approximately August 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid and/or were not issued in the usual course of professional practice. Among the millions of unlawful prescriptions that Walgreens allegedly filled were prescriptions for excessive quantities of opioids, prescriptions for early refills of opioids and prescriptions for drugs known as the “trinity,” which is made up of an opioid, a benzodiazepine and a muscle relaxant.  

The complaint also alleges that Walgreens pharmacists filled these prescriptions despite clear “red flags” that indicated that the prescriptions were highly likely to be unlawful. Walgreens allegedly ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from its own pharmacists and internal data.  

The complaint further alleges that Walgreens systematically pressured its pharmacists to fill prescriptions quickly without taking the time needed to confirm each prescription’s validity.   

AAHomecare announces Homecare Champion nominees 

WASHINGTON – AAHomecare has named 13 nominees for the 2025 Van G. Miller Homecare Champion Award.    

The association says this year’s group of nominees reflects the deep commitment and unwavering dedication to improving the home care industry. From advocacy efforts to innovative patient care strategies, these individuals embody the spirit of service that is at the heart of home care. Each nominee has demonstrated a longstanding record of service and is a champion of the values of compassion, generosity, and professionalism, it says. 
   
The Homecare Champion Nominees for 2025 are:   

  • Beth Bowen, executive director of ACMESA   
  • Serina Breen, CEO of Freedom Mobility Center   
  • Jason Canzano, managing director of Acelleron Medical Products   
  • Devin DeLozier, director of strategic accounts Payer Relations for Tactile Medical   
  • Lawrence Dickson, president of Abacoa Medical Supplies   
  • Bill Fredericks, president & CEO of Allcare Medical Supply   
  • Anthony Greco, senior consultant of sales for Cardinal Health at-Home   
  • Bill Guidetti, EVP sales & operations for Apria   
  • Thom Harvill, payer relations manager for Quipt Home Medical   
  • Derek Lampert, CEO of Drive DeVilbiss Healthcare   
  • Diana Lopatinsky, president of A-Z Medical Supply   
  • John Quinlan, owner & president of Quinlan's Pharmacy and Medical Equipment   
  • Rose Schafhauser, executive director of MAMES   

The winner will be announced after the Awards Committee convenes and will then be honored at the AAHomecare Update at Medtrade on Feb. 19 at 2:15 p.m. 

To learn more about the nominees and their contributions, visit aahomecare.org/Homecare-Champions.   

CMS revises CGM supplies policy  

WASHINGTON – CMS last week issued a revised policy (CR 13049) to update documentation requirements for replacement supplies of beneficiary-owned CGMs. Effective Feb. 18, 2025, contractors reviewing claims for CGM supplies will no longer need to verify that the original requirements for the CGM receiver were met. Once Medicare has paid for the CGM receiver, medical necessity for the receiver is considered established. A supplier only needs to provide medical necessity documentation for the on-going supplies. This aligns CGM policies with other DME items such as CPAP devices. AAHomecare says the updated policy change will streamline coverage for beneficiaries and considerably reduce the administrative burden for suppliers. The association has been working with the DME MACs and CMS on this issue over the last few months and thanks CMS for recognizing the challenges faced by suppliers and for listening to industry feedback in making this important change.    

Soleo reaccredited by URAC  

FRISCO, Texas – Soleo Health has earned its Specialty Pharmacy Reaccreditation by URAC. By earning this reaccreditation, the company was acknowledged for its dedication to patient satisfaction and ability to ensure positive clinical outcomes, while demonstrating the highest value and quality in delivering enhanced clinical services to its many patients, providers, payers and pharma partners. “This URAC reaccreditation underscores Soleo Health’s dedication to delivering the highest levels of quality care and service to our patients,” said Drew Walk, CEO. “Meeting all URAC’s benchmarks clearly represents our company’s and team’s commitment to enhancing the lives of our patients with complex conditions, including rare and ultra-rare diseases.” To receive URAC’s reaccreditation, Soleo Health displayed its full-service pharmacy capabilities in serving patients with complex conditions who need oral, injected or infused medications that typically require special handling and other expertise.   

ADA, Xeris partner on glucagon campaign   

CHICAGO and ARLINGTON, Va. - The American Diabetes Association and a national supporter, Xeris Pharmaceuticals, have formed a multi-year strategic partnership to reinforce the importance of prescribing glucagon for all individuals with diabetes who are treated with insulin and/or insulin secretagogues or those at high risk of hypoglycemia. "Severe hypoglycemia is life-threatening, and people with diabetes on blood glucose-lowering medication are at risk for hypoglycemia,” said Charles Henderson, ADA CEO. “Thus, we must act with urgency to educate people about the importance of having a treatment plan in place that includes having glucagon on hand. Through this important partnership, we can save lives by ensuring individuals with diabetes who are treated with insulin have access to glucagon, preferably a ready-to-use formulation, so they can make a plan and be ready." Hypoglycemia is conservatively responsible for more than 202,000 emergency department visits annually with approximately 25% being admitted to the hospital. The ADA, with support from Xeris, seeks to rectify the low rates of appropriate glucagon prescriptions by developing education materials and training resources for health care professionals and people living with diabetes, as well as through a national awareness campaign, to educate people on who is at risk for severe hypoglycemia and should have glucagon, preferably ready-to-use, as a safety net.  

AOPA to donate $1M to advance O&P  
ALEXANDRIA, Va. – The American Orthotic and Prosthetic Association will donate $1 million over the next five years to the Orthotics and Prosthetics Foundation for Education and Research. The donation will support the O&P Foundation’s mission to advance the art and science of orthotic and prosthetic rehabilitation by enhancing clinical practices through professional training awards, promoting educational opportunities through academic scholarships, strengthening the body of knowledge through research grants and fellowships, and inspiring excellence through recognition of scholarly achievements. “AOPA’s mission has always been to strengthen the O&P profession,” said Rick Riley, AOPA president. “On behalf of our members, AOPA’s board of directors approved this substantial multi-year donation to demonstrate the association’s commitment to a long-term strategic partnership with the O&P Foundation. We encourage others to similarly demonstrate their trust and support by donating to the O&P Foundation. Together, we can accelerate research, education and training that will benefit O&P professionals and their patients in the future.” The O&P Foundation plays a pivotal role in advancing the field by funding research initiatives and educational scholarships, as well as providing professional awards that empower practitioners to provide the highest standard of care.

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