Starting Nov. 27, all drugs must be able to be tracked electronically on the unit level.
A bipartisan group of 28 members of Congress is urging the US Food and Drug Administration to address drugmakers' concerns that they may not fully comply with the Drug Supply Chain Security Act when it takes effect in late November.
Under DSCA, starting on Nov. 27, all drugs must be able to be tracked electronically on the unit level. Drugs that do not comply cannot be distributed or dispensed to patients.
In a letter this week to FDA Commissioner Robert M. Califf, MD, the lawmakers expressed support for DSCSA and write that it "will ultimately improve the ability to trace pharmaceutical products and remove potentially dangerous products from the pharmaceutical supply chain."
"However, it is our understanding that some supply chain participants are facing difficulties meeting DSCSA's full implementation requirements," the letter states. "Based on what we are hearing from healthcare supply chain stakeholders about readiness for the November 27th deadline, absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages."
They're urging the FDA to ensure that DSCSA requirements do not disrupt the drug supply chain.
The members issued a joint press statement, which includes support from the nation's major supply chain and pharmacy associations.
The letter is endorsed by the Healthcare Distribution Alliance, American Pharmacists Association, National Association of Boards of Pharmacy, National Community Pharmacists Association, and National Association of Chain Drug Stores.
Kristen Freitas, director of Federal Government Affairs for the Healthcare Distribution Alliance (HDA), praised lawmakers for pressing "the FDA to ensure that the final implementation of DSCSA is done efficiently and effectively to minimize the very real, yet avoidable, risk to patient care if the supply chain is disrupted."
More than 83% of patients in the study completed multiple remote urine screenings within the first 30 days of entering treatment.
Telehealth urine screenings are an effective, accurate and easily accessible method for monitoring patients battling opioid use disorder, according to a new study published Friday in JAMA Health Forum.
The study, conducted by opioid addiction care provider Ophelia and led by company CMO Robin Williams, MD, found that more than 83% of the 3,395 patients living in 14 states who were involved in the two-year study completed multiple urine drug screenings (UDS) within the first 30 days of entering treatment. That number increased to 97.6% after 90 days and 99.7% after six months.
The patients self-administered a UDS off-screen during telehealth visits and clinicians visually inspected results and discussed them with the patient in real-time over video.
The validity of urine specimens was assessed by confirming that temperature, creatinine, nitrite, pH, oxidants, glutaraldehyde, and specific gravity were all within normal ranges, the study says.
Ophelia CEO / Founder Zack Gray says "the findings clearly show that remotely administered UDS is feasible and associated with low rates of unexpected results."
"This is consistent with the premise that long-standing and stringent requirements such as requiring in-person visits and frequent drug testing in order to receive buprenorphine can be relaxed without jeopardizing the quality or safety of care for most patients," he says.
Drug testing is common in opioid use disorder care mainly because of payer reimbursement mandates. However, patients frequently complain that the routine drug tests are invasive and demeaning.
"At Ophelia, we use drug testing to advance our patients' goals, not to drive revenue from payers," Gray says. "We've never disenrolled someone from our treatment program due to a positive drug test. Our clinical protocols encourage the use of UDS to help assess progress and guide the care team in treatment plan adjustments, foster open communication between patient and clinician, and monitor for buprenorphine diversion."
Gray says Ophelia plans additional studies to determine the efficacy and safety of telehealth-based opioid treatments.
The settlement comes after a federal court determined that Surescripts holds a 95% 'supershare' for e-prescribing services.
The Federal Trade Commission announced Thursday that it has reached a settlement with Surescripts that bans the health information technology provider from illegal monopolistic business practices and demanding non-compete agreements with employees.
The FTC sued Surescripts in 2019, alleging that the Arlington, VA-based company used "illegal vertical and horizontal restraints" to maintain e-prescribing monopolies over routing and eligibility markets.
The settlement, which was approved by the Commission on a 3-0 vote, comes after a U.S. District Court ruling in Washington, D.C. that determined that Surescripts holds a 95% "supershare" of monopoly power in e-prescribing services.
Surescripts CEO Frank Harvey welcomed the settlement, which included no fines, but claims that the FTC's case "relied on significant factual errors about Surescripts' business and mischaracterizations about the economic realities of the e-prescribing market."
FTC Bureau of Competition Director Holly Vedova says in a media release that "the proposed order is a victory in creating a fair and competitive playing field in the e-prescription drug market."
"In large part because of Surescripts' conduct, virtually everyone today who has a prescription filled electronically does so via the Surescripts networks."
"The proposed order would eliminate the anticompetitive restraints Surescripts has imposed on its customers since 2010 and would create conditions that allow competition to flourish for the benefit of anyone who gets a prescription filled at a pharmacy," Vedova says.
The FTC alleged in its complaint that Surescripts intentionally kept e-prescription routing and eligibility customers on both sides of each market from "multihoming" competing platforms, and using strongarmed "anticompetitive exclusivity agreements, threats, and other exclusionary tactics to achieve its goal."
A federal court this past March granted the FTC's motion for partial summary judgment and referred the suit to mediation.
"Surescripts is proud to have pioneered electronic prescribing that has brought enormous value to patients and care providers alike. For more than two decades, Surescripts has delivered innovations that increase patient safety, lower costs and ensure quality care," Harvey says.
"We're pleased that this agreement brings an end to the FTC's litigation, formalizing changes to our business practices that we started several years ago, including the elimination of loyalty provisions in contracts. We are committed to continuous innovation and remain focused on serving our customers who make up the Surescripts Network Alliance and ultimately the patients they serve."
"The FTC's case relied on significant factual errors about Surescripts' business and mischaracterizations about the economic realities of the e-prescribing market," Harvey says. "Since 2009, Surescripts has reduced average E-Prescribing transaction fees by 77%, and since 2016, Surescripts has improved the accuracy of electronic prescriptions more than 200%.
"As a trusted health information network, Surescripts helps doctors, pharmacists and other healthcare providers communicate with each other as a team, sharing information to increase patient safety, lower costs and ensure quality care. We look forward to continuing to simplify health intelligence sharing and bring even greater innovation and experience to the healthcare industry."
Settlement Details
The FTC's proposed order has a 20-year term that would ban Surescripts from exclusionary conduct and expands the prohibitions beyond routing and eligibility to include Surescripts' medication history services and the company's on-demand formulary services.
The proposed order would prohibit Surescripts from:
Entering, maintaining, or enforcing contracts that impose a majority share requirement on its routing and eligibility customers, including through all-unit discounting.
Implementing other problematic provisions it has used in the past to prevent or limit the ability of customers to do business with Surescripts' competitors.
Stopping customers from promoting competitors' services; preventing and limiting customers' ability to communicate with competitors; and requiring that customers provide Surescripts a right of first refusal.
Entering into, maintaining, or enforcing agreements that prevent rivals from competing with Surescripts in routing and eligibility.
Discriminating against or threatening customers who refuse to agree to a majority share requirement.
Enforcing non-compete agreements that would prevent employees from working for a competing e-prescriber.
The three hospitals are the 120-bed Bravera Health Brooksville in Brooksville, 128-bed Bravera Health Seven Rivers in Crystal River, and 124-bed Bravera Health Spring Hill.
The deal is expected to close this year, pending regulatory approvals and closing conditions.
The divestiture of the hospitals was previously announced as a potential deal by CHS in its Q1 earnings call, when it also reported a $51 million net loss on revenue of $3.1 billion.
The three not-for-profit hospitals are in Citrus and Hernando counties, neighboring Tampa / Hillsborough County, and combined provided care for more than 300,00 patients last year.
John Couris, president and CEO of not-for-profit, private Florida Health Sciences Center, DBA Tampa General, says that "with this acquisition, TGH is not only expanding its geographic footprint to meet the needs of our state’s growing population, but TGH is also increasing access for Floridians to the world-class rare and complex specialized care we offer."
The sale leaves Franklin, TN-based CHS with seven hospitals in Florida. The for-profit hospital chain has shed more than 100 community hospitals since 2015 after a string of financial losses and now owns or leases 77 hospitals in 15 states, with more than 1,000 care venues.
"Tampa General Hospital is a well-respected healthcare system with a demonstrated commitment to delivering quality care to the patients they serve across the communities they serve," Bravera Health Seven Rivers CEO Linda Stockton says. "Our tradition of delivering medical services close to home will continue thanks to the dedication and skill of our medical staff and employees."
HIDA and scores business organizations are raising concerns about the disruptions that would occur in a walk-out.
The Aug. 1 strike threatened by 340,000 United Parcel Services workers would quickly and adversely affect medical supply chains, the Health Industry Distributors Association is warning.
HIDA was one of scores business organizations from across the nation that signed a letter sent Friday to President Joe Biden, raising concerns about the disruptions to the economy that would occur if the rank-and-file workers leave the job.
"UPS is a vital lifeline for America, moving between 5% and 6% of U.S. GDP, or $3.8 billion in goods, per day," the letter states. "America also relies on critical medical deliveries enabled by the predictability and reliability of the UPS network, such as vaccines, medical devices, and life-saving medication."
"A strike would lead to months-long backlogs in the supply chain and the interruption of deliveries of critical medical supplies and other essential items."
The letter cites a study estimating that a 15-day UPS strike would harm the health and safety of U.S. consumers by $55.5 billion; even a 5-day strike at UPS, by this account, would harm the country by $15.8 billion – or $3.7 billion per day.
HIDA President / CEO Matthew J. Rowan says in a media release that "the potential impact on healthcare is very real,"
"The supply chain relies on small parcel delivery to get supplies to patients in their homes, doctors' offices, first responders, and clinics," he says. "We strongly urge the parties and the Biden administration to avoid a work stoppage at all costs."
UPS and the International Brotherhood of Teamsters severed negotiations on July 5, at loggerheads over issues that include wage hikes for experienced part-time workers who make up about half of UPS' unionized workforce.
The two sides said this week that they would resume talks on July 25 after UPS announced that it was "prepared to increase our industry-leading pay and benefits, but need to work quickly to finalize a fair deal that provides certainty for our customers, our employees and businesses across the country."
Bloomberg cites estimates that a strike would cost UPS about $170 million a day. Reuters reports that 28 U.S. senators and 178 U.S. representatives have said they will not to intervene if a strike takes place.
Letters to providers highlight concerns stemming from use of technologies that may share a user's sensitive health data.
Federal regulators are warning hospitals and telehealth providers about the risks that patients' health data could be "impermissibly disclosed" by online tracking technology wired into providers' websites and mobile apps.
The Federal Trade Commission and the Department of Health and Human Services' Office for Civil Rights cited potential violations of the Health Insurance Portability and Accountability Act (HIPAA) in a joint letter sent this week to 130 hospital systems and telehealth providers.
The watchdogs raised concerns about the privacy risks linked to online tracking platforms such as the Meta/Facebook pixel and Google Analytics that gather user personal data, often without their knowledge and in ways that are hard to avoid when users visit a website or mobile app.
"If you are a covered entity or business associate ("regulated entities") under HIPAA, you must comply with the HIPAA Privacy, Security, and Breach Notification Rules (HIPAA Rules), with regard to protected health information (PHI) that is transmitted or maintained in electronic or any other form or medium," the letter says.
"Even if you are not covered by HIPAA, you still have an obligation to protect against impermissible disclosures of personal health information under the FTC Act and the FTC Health Breach Notification Rule," the letter continues. "This is true even if you relied upon a third party to develop your website or mobile app and even if you do not use the information obtained through use of a tracking technology for any marketing purposes."
HHS highlighted these concerns in a bulletin late last year that reminded HIPAA entities of their responsibilities to protect health data from unauthorized disclosures.
The commission has backed up its warnings to third-party players with recent multimillion-dollar fines and legal actions against BetterHelp, GoodRx and Premom.
Samuel Levine, director of the FTC's Bureau of Consumer Protection, says "the FTC is again serving notice that companies need to exercise extreme caution when using online tracking technologies and that we will continue doing everything in our powers to protect consumers' health information from potential misuse and exploitation."
The collaborative hopes to minimize administrative burdens by automating clinical documentation during virtual and in-patient care.
Teladoc Health and Microsoft are expanding their collaboration to include Microsoft Azure OpenAI Service, Azure Cognitive Services, and the Nuance Dragon Ambient eXperience (DAX) into the Teladoc Health Solo platform, the two companies announced this week.
The goal of the expanded collaboration is to automate clinical documentation during virtual exams to help ease the burden on clinicians while improving the quality of shared medical information and the care it supports.
Teladoc Health Medical Group also plans to use Nuance DAX Express for care visits provided directly by Teladoc Health, the Purchase, NY-based virtual provider says.
“Administrative burden and staff shortages are major reasons why clinicians are leaving the profession,” says Teledoc Health CMO Vidya Raman-Tangella, MD. “We are focused on using AI to reassert and build the doctor-patient relationship at a time when technology frequently does the opposite.”
Rama-Tangella says the expanded collaborative addresses the worsening burnout crisis among physicians that has been the result of increased electronic paperwork.
Tom McGuinness, corporate vice president, Global Health & Life Sciences, Microsoft, says Teledoc’s integration of Azure OpenAI Service and Nuance DAX “gives clinicians the tools they need to deliver quality, coordinated care, easing administrative burdens and allowing them to spend more focused time with their patients.”
When used with the Teladoc Health Solo platform, Nuance DAX, an ambient clinical documentation solution, will automatically document patient encounters at the point of care for clinician review and signoff, which gives clinicians more facetime with patients.
The Teladoc Health Medical Group will also use Nuance DAX Express, a workflow-integrated, AI powered clinical documentation application that combines Nuance’s conversational and ambient AI with the new AI model, GPT4, in the Azure OpenAI Service.
The use of Nuance DAX Express will report encounters to other virtual and community-based clinicians to better coordinate care.
Diana Nole, executive vice president and general manager of healthcare at Nuance, says DAC Express “addresses the pressing challenge of reducing clinicians’ administrative workloads in some of the most demanding and dynamic care environments in healthcare.”
Teladoc Health first collaborated with Microsoft in 2021 to streamline the technology and administrative processes associated with providing virtual care, integrating the company’s Solo platform within Microsoft Teams and as a strategic partner expanding virtual health for Microsoft Cloud for Healthcare.
"Patient portals offer a wide range of benefits, including decreasing unnecessary hassles for providers and patients and improving access to both the medical staff and a child's medical information," Mott Poll co-director Sarah Clark, MPH, says in a media release.
"Given all the conveniences portals offer, it's surprising that over half of parents have not set one up for their child, most commonly because they don't see a need for it. This report suggests many parents may not be aware of all the potential benefits of using a patient portal for children."
Nearly one-third of parents who did not have a patient portal for their child say they do not see the need, a quarter say they don't know how to access it, and 20% say they prefer other ways to communicate.
Few parents cite privacy concerns or technical problems, but some don't know if their provider offers a portal option.
Parents who use a portal enjoy the benefits. One-third say they've received advice about their child's illness, injury or symptoms through the platform. Nearly all of these parents say they got the level of guidance they anticipated within a reasonable amount of time and usually from the person they expected.
The majority of portal users have tapped it to make appointments, view tests, complete forms, get prescription refills, request immunization records or get referrals.
"Our poll suggests that pediatric health providers should continue efforts to inform families about the benefits of patient portals, and parents who haven't set one up should take steps to learn more about portal advantages and how to establish one for their child," Clark says.
Some providers have expressed concerns about parents' unrealistic expectations for portal queries, especially for urgent care. Clark says providers can help manage those expectations, and that parents who get instructions from their provider on how to use portals are more enthusiastic.
More than third of parents who did not receive portal training guidance also had the lowest satisfaction ratings on communication with their child's provider.
"Instructions from the practice on how to optimize portal benefits appear to be the key to helping parents use it effectively and appropriately and increase families' satisfaction with the experience," Clark said.
DOJ says the EHR vendor 'falsely obtained certification for its software.'
NextGen Healthcare Inc. will pay $31 million to resolve whistleblower allegations that the electronic health records (EHR) vendor lied about its software's capabilities and paid kickbacks to users who shilled their product, the Department of Justice announced.
NextGen has denied the allegations, which occured nearly a decade ago, and says it settled with DOJ to avoid lengthy and costly litigation.
In a civil complaint filed with the settlement, DOJ says NextGen "falsely obtained certification for its software in connection with the 2014 Edition certification criteria published by the Department of Health and Human Service's Office of the National Coordinator."
Specifically, DOJ alleges that NextGen "relied on an auxiliary product designed only to perform the certification test scripts, which concealed from the certifying entity that NextGen's EHR lacked critical functionality."
Because of that, DOJ says the EHR that NextGen sold to providers lacked mandated functions, including the ability to record vital sign data, translate data into required medical vocabularies, and create complete clinical summaries.
DOJ also alleges that NextGen violated the Anti-Kickback Statute when it gave credits worth as much as $10,000 to existing customers whose recommendation of NextGen's EHR software led to a new sale. The kickbacks also included tickets to sporting events and other entertainment.
"Electronic health records play a pivotal role in the provision of safe, effective healthcare, and the testing and certification process of the EHR Incentive Program was intended to provide assurances to providers that their EHR can perform certain important functions," U.S. Attorney Nikolas P. Kerest for the District of Vermont, the lead prosecutor of the case, says in a media release. "With this settlement, our office has now resolved five investigations into misconduct by EHR companies, demonstrating our commitment to ensuring that EHR companies are held responsible for their misrepresentations."
The settlement resolves claims brought under whistleblower provisions of the False Claims Act by Toby Markowitz and Elizabeth Ringold, healthcare professionals at a facility that used NextGen's software, who will receive $5.6 million.
NextGen Responds
NextGen issued the following statement in response to the settlement.
"The company denies that any of its conduct violated the law, and the settlement agreement does not include any admissions of wrongdoing. This agreement relates to claims from more than a decade ago. The settlement resolves the matter without monitoring or changes to NextGen Healthcare's products or compliance policies. To avoid the distraction and expense of litigation, we believe it is in the best interest of the company to put this historical matter behind us and keep our attention focused on innovating solutions that enable better healthcare outcomes for all."
Caremark Cost Saver will be a free service for CVS Caremark enrollees in 2024.
CVS Caremark and GoodRx announced this week the launch of a new collaborative to help lower out-of-pocket drug costs for CVS Caremark members.
Under the Caremark Cost Saver program, set to launch on January 1, 2024, commercially insured plan members will automatically access GoodRx's prescription pricing for lower prices on generic medications.
The amount paid will be applied to plan members' deductible and out-of-pocket thresholds. No action is required by plan members, who can use their existing benefit card at their in-network pharmacy.
"This collaborative prescription discount solution enables us to dynamically shop for the best price on (consumers') behalf," David Joyner, executive vice president, CVS Health and president, CVS Caremark says in a media release. "By lowering out-of-pocket costs for our clients' members, Caremark Cost Saver will help patients afford to take their medicine as directed."
Scott Wagner, Interim CEO of Santa Monica, CA-based GoodRx, says the new programs means that "patients don't have to choose between using their pharmacy benefit or using GoodRx to save on their prescriptions."
"Now they can do both right at the counter so they have confidence they are always paying the lowest available price," he says. "This collaboration can make a meaningful difference for the tens of millions of Americans that CVS Caremark serves."
The collaborative provided no estimates on the potential dollar savings it could generate for consumers.
