Congress Is Starting to Ask About Drug Shortages Due to COVID-19
Your 340B Report for Thursday April 9, 2020
Hospitals in COVID-19 hotspots are experiencing shortages of anesthetics, sedatives, painkillers, and other drugs needed by patients on ventilators. A U.S. House Appropriations Committee member wants to know what HHS and the FDA are doing about it. | Shutterstock
Congress Is Starting to Ask About Drug Shortages Due to COVID-19
A member of the House Appropriations subcommittee on health has asked senior Trump administration health officials what they are doing about reports that demand for drugs necessary for patients on ventilators is outstripping supply.
Rep. Mark Pocan’s (D-Wis.) April 7 tweet and letter to Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Stephen Hahn is one of the first expressions of congressional concern to the administration about specific drug shortages due to the COVID-19 pandemic.
Until now, Congress has focused mainly on coronavirus-driven shortages of ventilators, personal protective equipment, and hospital ICU beds. Regarding drug shortages generally, the Coronavirus Aid, Relief, and Economic Security (CARES) Act Congress passed and President Trump signed into law March 27 authorized the FDA to speed up reviews for generic drugs in shortage and requires drug manufacturers to inform the FDA about active pharmaceutical ingredient supply disruptions. It also requires an annual drug shortages report and recommendations from the FDA.
For the most part, Congress has stayed out of the debate over President Trump’s promotion of hydroxychloroquine to treat COVID-19 despite hard evidence that it works. That drug is now on the FDA drug shortage list.
“There are specific drugs that patients need when placed on ventilators, including sedatives,” Pocan wrote to Azar and Hahn. “It has been reported that there was a 50 percent increase in demand for these drugs.” He pointed to recent articles by Vox.com and The New York Times about shortages in New York City and other COVID-19 hotspots of propofal, fentanyl, midazolam, ketamine, and other drugs used to anesthetize, sedate, and relieve pain in patients on ventilators.
Recent National Public Radio and Bloomberg stories about drug shortages cited a March 30 slide presentation by group purchasing organization Vizient on supply and demand trends for anesthetics, analgesics, and neuromuscular blockers—all critical for ventilator use—during the first three weeks of March. Vizient said there was a 51 percent increase in demand among its members for six anesthetics used in ventilation, while the percentage of orders filled for the drugs dropped to 63 percent. There was a 67 percent spike in demand for three pain killers with a fill rate that fell to 73 percent, and a 39 percent increase in demand for four neuromuscular blockers with a fill rate that dropped to 70 percent.
“These drugs maximize the work the ventilator can do, so the patient can heal and recover,” Dan Kistner, Vizient Senior Vice President of Pharmacy Solutions, told Bloomberg. “If we don’t focus on the drugs that are critical to making these ventilators go, then having the ventilators doesn’t matter.”
“If you have a car, but no gas, you can’t get anywhere,” he said.
During a webinar yesterday by pharmacy consulting company Visante, Dr. Arash Dabestani, Senior Pharmacy Director at NYU Langone Health in New York City, said his hospital is using high volumes of fentanyl, midazolam, and ketamine but not experiencing total shortages of those drugs per se. Instead, he said NYU Langone is having trouble maintaining stocks of those drugs in larger vials suitable for making IV drips for patients on ventilators. The supply of such vials for a given drug might be completely exhausted during one shift only to be replenished two or three shifts later, he explained, with the cycle repeating with the same or different drugs on different shifts as patients with COVID-19 continue to be admitted. In such circumstances, Dabestani said, it has been vital for NYU Langone to keep second and third alternative drugs in stock and to be nimble about using appropriate alternative drug therapies, such as administering fentanyl in patches instead of intravenously.
Are You Having Drug Shortages or Access Challenges? We Want to Know.
340B Report would like to know if hospitals or other health care providers are unable to purchase covered outpatient drugs through normal channels at 340B ceiling prices due to coronavirus-related shortages. The Health Resources and Services Administration (HRSA) recently relaxed reporting requirements for disproportionate share, children’s, and free-standing cancer hospitals forced by a shortage to buy covered drugs through a group purchasing organization because the drugs are unavailable at the 340B price or at wholesale acquisition cost.
Has HRSA’s relaxation policy given you the flexibility you need? What else in terms of government policy would be helpful to you at this time? Write to us at email@example.com.
COVID-19 Is Disrupting Some Patients’ Drug Therapies. How Should Providers Respond?
Specialty pharmacy services company Trellis Rx, a 340B Report sponsor, has published a guide for clinical pharmacists on how to cope with new allocation restrictions and quantity limits on drugs for asthma, HIV, rheumatoid arthritis, lupus, and other chronic diseases that could be effective in treating COVID-19.
Trellis Clinical Services Manager Brandon Hardin, who wrote the guide, notes the measures are intended to ensure that the drugs aren’t being stockpiled and are available to patients seriously ill with COVID-19 if needed. The restrictions, however, worry or frighten patients who depend on the same drugs to control their chronic conditions. “As a result, providers must not only rapidly determine alternative therapy options but also provide additional counseling to their patients—even as they themselves deal with the impact of COVID-19 on their practice,” Hardin says.
Hardin offers this advice from Trellis experts and clinical pharmacists at health systems around the country:
Take responsibility for sharing patient care guidelines published by medical associations. Trellis Vice President of Clinical Affairs Brandon Newman told Hardin: “This situation is rapidly evolving, so care teams need support staying informed. By keeping up to date on new evidence and recommendations, clinical pharmacists can help providers determine the best way to manage patients’ therapy regimens during this crisis.”
Provide regular updates on drug shortages and supply chain challenges. Jennifer Rubinstein, a clinical pharmacist at Legacy Health in Portland, Ore., told Hardin: “When I found out about a projected shortage of a specialty drug commonly prescribed to our pediatric rheumatology patients, I quickly worked with providers to determine other therapy options. We identified another medication patients can administer at home, which keeps them from having to come into the hospital for infusions during this time.”
Proactively track disease-specific metrics and patient-reported outcomes. “Having strategies to ensure patients are achieving desired therapeutic results on their new medications is critical,” Trellis vice president Newman said. “Pharmacists are well-positioned to collect patient-reported outcomes over the phone during the COVID-19 public health crisis, and they can leverage this information to help care teams proactively identify patients that need interventions or additional support.”
Over-communicate with patients. Patients prescribed alternative therapies due to supply disruptions “need even more support than usual,” Hardin observed. Frequent check-ins by phone can help patients manage side effects, ensure they adhere to their therapies, and remove obstacles to getting refills in a timely manner. “This is a challenging time for everyone, but especially for patients who are having to change their therapy regimens,” said Daniel Jude, a clinical pharmacist at North Memorial Health in Minneapolis, Minn.
Health Centers Get First Infusion of Stimulus Funding, Safety Net Hospitals Concerned About Being Short-changed
The Trump administration has begun releasing billions of dollars in emergency assistance to hospitals and health centers coping with the COVID-19 pandemic. Providers say they need even more financial help.
House Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) issued a statement yesterday calling for a fourth COVID-19 emergency assistance bill, including “$100 billion for hospitals, community health centers and health systems, providing desperately needed resources to the frontlines of this crisis, including production and distribution of national rapid testing and Personal Protective Equipment.”
The Health Resources and Services Administration (HRSA) Bureau of Primary Care (BPC) yesterday announced it awarded $1.3 billion to nearly 1,400 health centers under the CARES Act. A day earlier, the National Association of Community Health Centers (NACHC) said it has asked HHS Secretary Alex Azar for “an immediate down payment” of at least $3.1 billion from the $100 billion in the CARES Act for providers dealing with COVID-19 “to enable FQHCs to keep their doors open.”
NACHC said health centers will need even more funding if the pandemic lasts more than three months. The group said it asked Congress for “$7.6 billion in emergency funding over the next six months to assist health centers in the detection, prevention, and diagnosis of COVID-19. These funds would also provide resources needed to address health center revenue losses and enable them to remain open and alleviate pressure on hospitals as the number of COVID-19 cases surge nationwide.”
Also on April 7, Centers for Medicaid & Medicaid Services Administrator Seema Verma announced that HHS this week “will be putting out” $30 billion from the $100 billion in CARES Act emergency assistance to providers. “This is going to be based on Medicare revenue. There are no strings attached. So the healthcare providers that are receiving these dollars can essentially spend that in any way that they see fit,” Verma said. She did not say how the grants would be allocated among hospitals and other providers.
“We recognize that, in terms of getting these dollars out, because it’s based on Medicare revenues, there are providers out there—pediatricians, children’s hospitals, OB-GYNs, even our nursing homes—that a lot of their revenue comes from other sources—Medicaid or other payer sources,” she continued. “And so those organizations will be addressed in the second tranche of funding.”
America’s Essential Hospitals President and CEO Bruce Siegel said on April 7 that while his group’s members are eager for the $30 billion to be released, “an allocation methodology that consists only of Medicare fee-for-service revenue could tilt the playing field against some essential hospitals, which care for disproportionate numbers of uninsured and Medicaid patients. It is especially concerning because their narrow margins and front-line role mean these hospitals are among those in greatest need of funding support during this public health emergency.” Siegel said his group appreciated that Verma “acknowledged this distribution approach will fall short for many providers and that the agency will follow this release of funding with another focused on Medicaid-dependent providers.”
As we reported Tuesday, the Trump administration intends to use an unspecified part of the $100 billion to cover providers’ costs of delivering COVID-19 care to the uninsured. The American Hospital Association said in response the money isn’t meant to provide coverage for the uninsured but instead is meant to help them cover expenses and revenue losses due to the pandemic.
The Kaiser Family Foundation, also on April 7, estimated that, under the administration’s policy, it would take between $13.9 billion to $41.8 billion from the $100 billion fund to reimburse hospitals for treating uninsured COVID-19 patients. “Given the uncertainty of our estimates of the total funding that will be needed to reimburse hospitals, and the fact that infections may come in several waves over the next year, it is unclear whether the new fund will be able to cover the costs of the uninsured in addition to other needs, such as the purchase of medical supplies and the construction of temporary facilities,” KFF said.
Also yesterday, business management consulting firm Guidehouse (formerly Navigant) released a study finding that 25 percent of rural hospitals “are at a high risk of closing unless their financial situations improve.” Of those, “82 percent are considered highly essential to their communities,” it said.
“These rural hospital and community struggles will only be exacerbated by a pandemic like COVID-19 or any downturn in the economy, both in the short- and long-term,” the business said.
Update: New York State Medicaid Changes and 340B
New York Gov. Andrew Cuomo (D) signed legislation April 3 that will transfer the Medicaid managed care pharmacy benefit to Medicaid fee for service, with reimbursement for 340B-purchased drugs based on actual acquisition cost. Providers warn that the change will deprive them of millions of dollars in 340B revenues they can ill afford to lose, especially in light of the COVID-19 pandemic’s financial impact.