An Advocate Aurora Health pharmacist who intentionally damaged 570 doses of COVID-19 vaccine was sentenced to three years in prison, according to NBC affiliate WTMJ of Milwaukee.
Steven Brandenburg worked at Aurora Medical Center in Grafton, Wis., when he removed Moderna COVID-19 vaccine vials from refrigeration twice in December. He told investigators he believed the vaccine could harm patients or change their DNA.
He was arrested Dec. 31 on charges of first-degree recklessly endangering society, adulterating a prescription drug and criminal damage to property.
Fifty-seven people received the vaccines after they were left out, but they will likely experience no harm, according to officials with Aurora Health Care, based in both Milwaukee and Downers Grove, Ill.
After Aurora Health Care investigated the incident, Mr. Brandenburg was fired. He and the Wisconsin Pharmacy Examining Board agreed on his license suspension during a Jan. 13 meeting.
Mr. Brandenburg on Jan. 26 agreed to plead guilty to two counts of attempting to tamper with consumer products with reckless disregard.
On June 8, Mr. Brandenburg was sentenced to three years in prison. After serving his sentence, he will face another three years of supervised release.
Mr. Brandenburg told the court he was “desperately sorry and ashamed” about tampering with the vaccines. He also said Aurora Health Care is a “pillar of the community” and “did not deserve” the incident, according to WTMJ.
COVID-19 accelerated a number of trends already brewing in the healthcare industry, and that’s not likely to change this year, according to a new report from CVS Health.
The healthcare giant released its annual Health Trends Report on Tuesday, and the analysis projects several industry trends that are likely to define 2021 in healthcare, ranging from technology to behavioral health to affordability.
“We are facing a challenging time, but also one of great hope and promise,” CVS CEO Karen Lynch said in the report. “As the pandemic eventually passes, its lessons will serve to make our health system more agile and more responsive to the needs of consumers.”
Here’s a look at four of CVS’ predictions:
1. A looming mental health crisis
Behavioral health needs were a significant challenge in healthcare prior to COVID-19, but the number of people reporting declining mental health jumped under the pandemic.
Cara McNulty, president of Aetna Behavioral Health, said in a video attached to the report that it will be critical to “continue the conversation around mental health and well-being” as we emerge from the pandemic and to reduce stigma so people who need help seek it out.
“We’re normalizing that it’s important to take care of our mental well-being,” she said.
Data released in December by GoodRx found that prescription fills for depression and anxiety medications hit an all-time high in 2020. GoodRx researchers polled 1,000 people with behavioral health conditions on how they were navigating the pandemic, and 63% said their depression and/or anxiety symptoms worsened.
McNulty said symptoms to look for when assessing whether someone is struggling with declining mental health include whether they’re withdrawn or agitated or if there’s a notable difference in their self-care routine.
2. Pharmacists take center stage
CVS dubbed 2021 “the year of the pharmacist” in its report.
The company expects pharmacists to be a key player in a number of areas, especially in vaccine distribution as that process inches toward broader access. They also offer a key touchpoint to counsel patients about their care and direct them to appropriate services, CVS said.
CVS executives said in the report that they see a significant opportunity for pharmacists to have a positive impact on the social determinants of health.
“We’ve found people are not only open and willing to share social needs with their pharmacists but in many cases, they listen to and act on the advice and recommendations of pharmacists,” Peter Simmons, vice president of transformation, pharmacy delivery and innovation at CVS Health, said in the report.
3. Finding ways to mitigate the cost of high-price therapies
Revolutionary drugs and therapies are coming to market with eye-popping price tags; it’s not uncommon to see new pharmaceuticals priced at $1 million or more. For pharmacy benefit managers, this poses a major cost challenge.
To address those prices, CVS expects value-based contracting to take off in a big way. And drugmakers are comfortable with the idea, according to the report. Novartis, for example, is offering insurers a five-year payment plan for its $2 million gene therapy Zolgensma, with refunds available if the drug doesn’t achieve desired results.
CVS said the potential for these therapies is clear, but many payers want to see some type of results before they fork over hundreds of thousands.
“Though the drug may promise to cure these patients for life, these are early days in their use,” said Joanne Armstrong, M.D., enterprise head of women’s health and genomics at CVS Health, in the report. “What we’re saying is, show us the clinical value proposition first.”
CVS said it’s also offering a stop-loss program for gene therapy to self-funded employers contracted with Aetna and/or Caremark to assist them in capping the expenses associated with these drugs.
4. Getting into the community to address diabetes
Diabetes risk is higher among vulnerable populations, such as Black patients, and addressing it will require local and community-based solutions, CVS executives said in the report. Groups at the highest risk for the disease are less likely to live in areas with easy access to a supermarket, for example, which boosts their risk of unhealthy eating, according to the report.
The two key hurdles to addressing this issue are access and affordability. The rise in retail clinics and ambulatory care centers can get at the access issue, as they can offer a way to better meet patients where they are.
At CVS’ MinuteClinics, patients can walk in and receive a number of services to assist them in managing diabetes, including screenings, consultations with providers and connections to diabetes educators who can assist with lifestyle changes.
Retail locations can also assist with medication costs, creating a one-stop-shop experience that’s easier for many diabetes patients to slot into their daily lives, CVS said.
“Diabetes is a case study in how a more connected experience can translate to simpler, affordable and more accessible care for underserved communities,” said Dan Finke, executive vice president of CVS Health and president of its healthcare benefits division.
The owners of more than a dozen pharmacies in New York City and Long Island have been arrested and charged for their roles in an alleged $30 million healthcare fraud and money laundering scheme, the Department of Justice announced Dec. 21.
Peter Khaim and Arkadiy Khaimov are accused of submitting fraudulent claims for expensive cancer drugs by exploiting emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic. The drugs were allegedly never provided, ordered or authorized by a medical professional.
Mr. Khaim and Mr. Khaimov allegedly used COVID-19 emergency override billing codes to submit fraudulent claims to Medicare for cancer medication Targretin Gel 1%. The medication has an average wholesale price of about $34,000 for each 60 gram tube, according to the Justice Department.
Prosecutors charged Mr. Khaim and Mr. Khaimov with conspiracy to commit healthcare fraud and wire fraud, conspiracy to commit money laundering and aggravated identity theft, according to the Justice Department. Mr. Khaimov was separately charged with concealment of money laundering.
- CMS issued a another round of sweeping regulatory rollbacks Thursday that will temporarily change how some providers care for patients and get compensated during the ongoing pandemic.
- Practitioners such as therapists previously restricted from providing telehealth services for reimbursement can now do so, and CMS is also upping payments for telephone-only telehealth visits. Accountable care organizations also scored a major win in the Thursday rule drop, with CMS pledging they wouldn’t be dinged financially for lower-than-expected health outcomes in their patient populations from COVID-19.
- Other major changes are related to COVID-19 testing for Medicare and Medicaid beneficiaries. A written practitioner’s order is no longer needed for diagnostic testing for Medicare payment purposes. The agency also said it will cover serology, or antibody testing, including certain FDA-authorized tests that patients self-collect at home.
The new rules come out of the recent public health emergency declaration, building on others announced in late March and early April. This round of changes, which take effect immediately, focuses on expanding testing capacity to help reopen the U.S. economy, according to CMS, along with delivering expanded care to seniors.
Major provider lobbies the American Hospital Association and American Medical Association praised the changes, noting that Medicare patients have been canceling needed medical appointments because of physical distancing and transportation challenges.
The Trump administration, which allowed traditional Medicare to temporarily cover telehealth in March, continues to expand virtual care access. CMS is expanding the types of specialists allowed to provide telehealth services for reimbursement to include physical therapists, occupational therapists, speech language pathologists and others. In the past, only doctors, nurse practitioners, physician assistants and certain others could do so.
Earlier changes included waiving the video requirement for telehealth patients without access to interactive audio-video technology – particularly those in rural areas. CMS is increasing payments for telephone visits from a range of about $14-$41 to about $46-$110, according to the release.
The rollbacks are a “major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” the AMA said.
Michael Abrams, managing partner of Numerof & Associates, a healthcare consulting firm, said the current, rapid adoption of telehealth is an experiment, and depending on the results, waivers could eventually become permanent.
“Once you increase pricing, you almost never roll it back,” Abrams said. “If this new pricing on telehealth visits makes it more attractive, attractive enough to substitute telehealth for in-office visits, that not only lowers the cost of care, but makes it very much more accessible, particularly for those whose ability to see a physician is limited.”
In a victory for ACOs, CMS said the value-based organizations wouldn’t incur any financial penalties because of COVID-19 testing and treatment for their patient populations. Roughly 60% of ACOs said previously they were likely to drop out of their risk-based model to avoid potential losses, according to the National Association of ACOs.
CMS is also allowing ACOs to remain at the same level of risk for another year, instead of bumping them up to the next risk level. NAACOs said it was “appreciative” of the changes in a statement, though they asked for additional relief for providers in two-sided risk arrangements.
Other loosened restrictions include those on who can administer COVID-19 diagnostic tests for payment to include any healthcare professional authorized to do so under state law, including pharmacists. Medicare and Medicaid recipients can now get tested at parking lot sites operated by pharmacies and other entities for reimbursement.
Outpatient hospital services such as wound care, drug administration, and behavioral health services can now be delivered in temporary expansion locations, including parking lot tents, converted hotels or patients’ homes for reimbursement, so long as they’re temporarily designated as part of a hospital.
Hospital outpatient departments that relocate off-campus are paid at lower rates under current law, but CMS is making a temporary exception to continue paying those physicians at their standard rates.
The agency will also pay for certain partial hospitalization services – that is, individual psychotherapy, patient education, and group psychotherapy – that are delivered in temporary expansion locations, including patient homes.
CMS is also now requiring nursing homes to inform residents, their families, and representatives of COVID-19 outbreaks in their facilities.