Biggest Communication Problem
Michael Dowling: No one said it would be easy
Hardly one month into 2021, the pressing priorities facing healthcare leaders are abundantly clear.
First, we will be living in a world preoccupied by COVID-19 and vaccination for many months to come. Remember: this is a marathon, not a sprint. And the stark reality is that the vaccination rollout will continue well into the summer, if not longer, while at the same time we continue to care for hundreds of thousands of Americans sickened by the virus. Despite the challenges we face now and in the coming months in treating the disease and vaccinating a U.S. population of 330 million, none of us should doubt that we will prevail. Despite the federal government’s missteps over the past year in managing and responding to this unprecedented public health crisis, historians will recognize the critical role of the nation’s healthcare community in enabling us to conquer this once-in-a-generation pandemic.
While there has been an overwhelming public demand for the vaccine during the past couple of weeks, there remains some skepticism within the communities we serve, including some of the most-vulnerable populations, so healthcare leaders will find themselves spending time and energy communicating the safety and efficacy of vaccines to those who may be hesitant. This is a good thing. It is our responsibility to share facts, further public education and influence public policy. COVID-19 has enhanced public trust in healthcare professionals, and we can maintain that trust if we keep our focus on the right things — namely, how we improve the health of our communities.
And as healthcare leaders diligently balance this work, we also have a great opportunity to reimagine what our hospitals and health systems can be as we emerge from the most trying year of our professional lifetimes. How do you want your hospital or system organized? What kind of structural changes are needed to achieve the desired results? What do you really want to focus on? Amid the pressing priorities and urgent decision-making needed to survive, it is easy to overlook the great reimagination period in front of us. The key is to forget what we were like before COVID-19 and reflect upon what we want to be after.
These changes won’t occur overnight. We’ll need patience, but here are my thoughts on five key questions we need to answer to get the right results.
1. How do you enhance productivity and become more efficient? Throughout 2021, most systems will be in recovery mode from COVID’s financial bruises. Hospitals saw double-digit declines in inpatient and outpatient volumes in 2020, and total losses for hospitals and health systems nationwide were estimated to total at least $323 billion. While federal relief offset some of our losses, most of us still took a major financial hit. As we move forward, we must reorganize to operate as efficiently as possible. Does reorganization sound daunting? If so, remember the amount of reorganization we mustered to work effectively in the early days of the pandemic. When faced with no alternative, healthcare moved heaven and earth to fulfill its mission. Crises bring with them great clarity. It’s up to leaders to keep that clarity as this tragic, exhausting and frustrating crisis gradually fades.
2. How do you accelerate digital care? COVID-19 changed our relationship with technology, personally and professionally. Look at what we accomplished and how connected we remain. We were reminded of how high-quality healthcare can go unhindered by distance, commutes and travel constraints with the right technology and telehealth programs in place. Health system leaders must decide how much of their business can be accommodated through virtual care so their organizations can best offer convenience while increasing access. Oftentimes, these conversations don’t get far before confronting doubts about reimbursement. Remember, policy change must happen before reimbursement catches up. If you wait for reimbursement before implementing progressive telehealth initiatives, you’ll fall behind.
3. How will your organization confront healthcare inequities? In 2020, I pledged that Northwell would redouble its efforts and remain a leader in diversity and inclusion. I am taking this commitment further this year and, with the strength of our diverse workforce, will address healthcare inequities in our surrounding communities head-on. This requires new partnerships, operational changes and renewed commitments from our workforce. We need to look upstream and strengthen our reach into communities that have disparate access to healthcare, education and resources. We must push harder to transcend language barriers, and we need our physicians and medical professionals of color reinforcing key healthcare messages to the diverse communities we serve. COVID-19’s devastating effect on communities of color laid bare long-standing healthcare inequalities. They are no longer an ugly backdrop of American healthcare, but the central plot point that we can change. If more equitable healthcare is not a top priority, you may want to reconsider your mission. We need leaders whose vision, commitment and courage match this moment and the unmistakable challenge in front of us.
4. How will you accommodate the growing portion of your workforce that will be remote? Ten to 15 percent of Northwell’s workforce will continue to work remotely this year. In the past, some managers may have correlated remote work and teams with a decline in productivity. The past year defied that assumption. Leaders now face decisions about what groups can function remotely, what groups must return on-site, and how those who continue to work from afar are overseen and managed. These decisions will affect your organizations’ culture, communications, real estate strategy and more.
5. How do you vigorously hold onto your cultural values amid all of this change? This will remain a test through 2021 and beyond. Culture is the personality of your organization. Like many health systems and hospitals, much of Northwell’s culture of connectedness, awareness, respect and empathy was built through face-to-face interaction and relationships where we continually reinforced the organization’s mission, vision and values. With so many employees now working remotely, how can we continue to bring out the best in all of our people? We will work to answer that question every day. The work you put in to restore, strengthen and revitalize your culture this year will go a long way toward cementing how your employees, patients and community come to see your organization for years to come. Don’t underestimate the power of these seemingly simple decisions.
While we’ve been through hell and back over the past year, I’m convinced that the healthcare community can continue to strengthen the public trust and admiration we’ve built during this pandemic. However, as we slowly round the corner on COVID-19, our future success will hinge on what we as healthcare organizations do now to confront the questions above and others head-on. It won’t be quick or easy and progress will be a jagged line. Let’s resist the temptation to return to what healthcare was and instead work toward building what healthcare can be. After the crisis of a lifetime, here’s our opportunity of a lifetime. We can all be part of it.
3 healthcare executive actions expected from Biden this week
President Joe Biden is expected to sign executive actions this week related to immigration, healthcare and climate, according to a memo obtained by The Hill.
The executive actions would follow 10 he signed Jan. 21 to combat COVID-19 spread.
Here are the three healthcare executive actions to expect Jan. 28, according to The Hill:
1. President Biden is set to rescind a policy banning foreign aid for abortion, known as the Mexico City policy. It prohibits the use of U.S. funds for foreign and national health organizations that perform or actively promote abortion, according to NBC News. The policy was announced by former President Ronald Reagan in 1984. According to The Hill, it has been rescinded by Democratic presidents and reinstated by Republican presidents, including former President Donald Trump, since then.
2. President Biden will also call for a review of the Title X family planning program, according to a memo obtained by The Hill. The federal program provides family planning and related preventive health services for low-income or uninsured people and others. In 2019, the Trump administration issued a final rule prohibiting providers that receive federal family planning money under the program from providing or promoting abortions. NBC News reported that the Biden administration is expected to back off this rule and “restore federal funding for Planned Parenthood,” which left the program in 2019.
3. President Biden plans to sign an executive action on Medicaid and initiate an open enrollment period under the ACA, according to a memo obtained by The Hill. The annual open enrollment period for 2021 closed in December. However, President Biden could initiate a special enrollment period.
Colchicine for Early COVID-19? Trial May Support Oral Therapy at Home
But some find science-by-press-release troubling.
Anti-inflammatory oral drug colchicine improved COVID-19 outcomes for patients with relatively mild cases, according to certain topline results from the COLCORONA trial announced in a brief press release.
Overall, the drug used for gout and rheumatic diseases reduced risk of death or hospitalizations by 21% versus placebo, which “approached statistical significance.”
However, there was a significant effect among the 4,159 of 4,488 patients who had their diagnosis of COVID-19 confirmed by a positive PCR test:
- 25% fewer hospitalizations
- 50% less need for mechanical ventilation
- 44% fewer deaths
If full data confirm the topline claims — the press release offered no other details, and did not mention plans for publication or conference presentation — colchicine would become the first oral drug proven to benefit non-hospitalized patients with COVID-19.
“Our research shows the efficacy of colchicine treatment in preventing the ‘cytokine storm’ phenomenon and reducing the complications associated with COVID-19,” principal investigator Jean-Claude Tardif, MD, of the Montreal Heart Institute, said in the press release. He predicted its use “could have a significant impact on public health and potentially prevent COVID-19 complications for millions of patients.”
Currently, the “tiny list of outpatient therapies that work” for COVID-19 includes convalescent plasma and monoclonal antibodies, which “are logistically challenging (require infusions, must be started very early after symptom onset),” tweeted Ilan Schwartz, MD, PhD, an infectious diseases researcher at the University of Alberta in Edmonton.
The COLCORONA findings were “very encouraging,” tweeted Martin Landray, MB ChB, PhD, of the Big Data Institute at the University of Oxford in England. His group’s RECOVERY trial has already randomized more than 6,500 hospitalized patients to colchicine versus usual care as one of the arms of the platform trial, though he did not offer any findings from that study.
“Different stage of disease so remains an important question,” he tweeted. “Maybe old drugs can learn new tricks!” Landray added, pointing to dexamethasone.
A small open-label, randomized trial from Greece had also shown less clinical status deterioration in hospitalized patients on colchicine.
“I think this is an exciting time. Many groups have been pursuing lots of different questions related to COVID and its complications,” commented Richard Kovacs, MD, immediate past-president of the American College of Cardiology. “We’re now beginning to see the fruit of those studies.”
The COLCORONA announcement came late Friday, following closely on the heels of the topline results from the ACTIVE-4a, REMAP-CAP, and ATTACC trials showing a significant morbidity and mortality advantage to therapeutic-dose anticoagulation in non-ICU patients in the hospital for COVID-19.
COLCORONA was conducted remotely, without in-person contact, with participants across Canada, the U.S., Europe, South America, and South Africa. It randomized participants double-blind to colchicine 0.5 mg or a matching placebo twice daily for the first 3 days and then once daily for the last 27 days.
Participants were ages 40 and older, not hospitalized at the time of enrollment, and had at least one risk factor for COVID-19 complications: age 70-plus, obesity, diabetes, uncontrolled hypertension, known asthma or chronic obstructive pulmonary disease, known heart failure, known coronary disease, fever of ≥38.4°C (101.12°F) within the last 48 hours, dyspnea at presentation, or certain blood cell abnormalities.
It had been planned as a 6,000-patient trial, but whether it was stopped for efficacy at a preplanned interim analysis or for some other reason was not spelled out in the press release. Whether the PCR-positive subgroup was preplanned also wasn’t clear. Key details such as confidence intervals, adverse effects, and subgroup results were omitted as well.
While a full manuscript is reportedly underway, “we don’t know enough to bring this into practice yet,” argued Kovacs.
The centuries-old drug has long been used for gout and arthritis and more recently for pericarditis along with showing promise in cardiovascular secondary prevention.
However, the drug isn’t as inexpensive in the U.S. as in Canada, Kovacs noted.
Some physicians also warned about the potential for misuse of the findings and attendant risks.
Dhruv Nayyar, MD, of the University of Toronto, tweeted that he has already had “patients inquiring why we are not starting colchicine for them. Science by press release puts us in a difficult position while providing care. I just want to see the data.”
Angela Rasmussen, MD, a virologist with the Georgetown Center for Global Health Science and Security’s Viral Emergence Research Initiative in Washington, agreed, tweeting: “When HCQ [hydroxychloroquine] was promoted without solid data, there was at least one death from an overdose. We don’t need people self-medicating with colchicine.”
As was the case with hydroxychloroquine before the papers proved little efficacy in COVID-19, Kovacs told MedPage Today: “We always get concerned when these drugs are repurposed that we might see an unintended run on the drug and lessen the supply.”
Citing the well-known diarrheal side effect of colchicine, infectious diseases specialist Edsel Salvana, MD, of the University of Pittsburgh and University of the Philippines in Manila, tweeted a plea for use only in the trial-proven patient population with confirmed COVID-19 — not prophylaxis.
The dose used was on par with that used in cardiovascular prevention and other indications, so the diarrhea incidence would probably follow the roughly 10% rate seen in the COLCOT trial, Kovacs suggested.
In the clinic, too, there are some cautions. As Elin Roddy, MD, a respiratory physician at Shrewsbury and Telford Hospital NHS Trust in England, tweeted: “Lots of drug interactions with colchicine potentially — statins, macrolides, diltiazem — we have literally been running up to the ward to cross off clarithromycin if RECOVERY randomises to colchicine.”
Drug Prices: We’ve Seen This Movie Before
As happened with cars in the 1960s, price competition among brand-name drugs is hard to find.
Before 1973, when the Arab oil embargo upended the U.S. auto industry, Americans witnessed an annual ritual by carmakers. In the late summer, the Big Three — Ford, Chrysler, and General Motors — would release sticker prices for their products, always showing increases, of course.
Almost always, the increases from each company for similar models were nearly identical. If one company’s was out of line — substantially bigger or smaller than its erstwhile competitors’ — it quickly made an adjustment. Explicit collusion to fix prices was never proven, but the effect for consumers was the same.
Now, researchers report that something very similar seems to be occurring for big-market brand-name drugs, including anti-diabetic medications and blood thinners.
Average wholesale prices for products in five classes — direct-acting oral anticoagulants (DOACs), P2Y12 inhibitors, glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl dipeptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein-2 (SGLT-2) inhibitors — increased in “lock-step” each year from 2015 to 2020, according to Joseph Ross, MD, of Yale University in New Haven, Connecticut, and colleagues writing in JAMA Network Open.
These increases ranged from annual averages of 6.6% for DDP4 inhibitors to 13.5% for P2Y12 inhibitors — far outpacing not only inflation in general, but even the 2.1% average for all prescription drugs.
Within each class, Kendall τb correlation coefficients for average wholesale prices were as follows:
- DOACs: 0.98
- SGLT-2 inhibitors: 0.98
- DPP-4 inhibitors: 0.96
- GLP-1 agonists: 0.92
- P2Y12 inhibitors: 0.75
“These results suggest there was little price competition among the sponsors of these products,” Ross and colleagues wrote.
Although the analysis came with significant limitations — it didn’t account for rebates or other discounts, for example — the researchers said some patients must suffer from these increases.
“Rebates, list prices, and net prices have been growing for brand-name medications, and rebate growth has been shown to positively correlate with list price growth, thereby impacting costs faced by patients paying a percentage of (or the full) list price,“ the group noted. “Therefore, the lock-step price increases of brand-name medications, without evidence of price competition, raise concerns and would be expected to adversely affect patient adherence to medications and thus clinical outcomes.”
For the car buyers, the solution to lock-step price increases was imposed from outside: soaring gas prices in the mid-1970s prompted demand for vehicles with better fuel economy than domestic makers were prepared to sell. That opened the market to Japanese cars that not only got better mileage, but were also more reliable and (in many cases) cheaper than Big Three products. Thus ended Detroit’s ability to set prices.
How to rein in Big Pharma is less clear. For their part, Ross and colleagues suggested policies to limit such lock-step price hikes, shortened patent exclusivity periods, and faster introduction of generic equivalents.
7 plead guilty in $931M telemedicine fraud scheme
The owner of two pharmacies and a management company in Florida pleaded guilty Jan. 25 to his role in a $931 million healthcare fraud scheme. He is the seventh defendant to plead guilty in the scheme, according to the U.S. Justice Department.
Larry Smith pleaded guilty to conspiracy to commit healthcare fraud, and his sentencing is set for Oct. 25. In his written plea agreement, Mr. Smith admitted to conspiring with others to defraud pharmacy benefit managers into paying for fraudulent prescriptions. As part of the plea agreement, Mr. Smith agreed to pay restitution of $24.9 million and forfeit approximately $3.1 million.
An indictment charged Mr. Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers by submitting $931.4 million in bills for fraudulent prescriptions purchased from a telemarketing company. After improperly soliciting patient information, the marketing companies received approvals through telemedicine prescribers then sold the prescriptions to pharmacies in exchange for kickbacks, said Derrick Jackson, special agent in charge at HHS’ Office of Inspector General in Atlanta.
In September 2018, HealthRight, a telemedicine company, and its CEO Scott Roix pleaded guilty to conspiracy to commit healthcare fraud for their roles in the scheme. They agreed to pay $5 million in restitution. Mr. Roix’s sentencing is scheduled for Oct. 25.
Mihir Taneja, Arun Kapoor, Maikel Bolos and Sterling-Knight Pharmaceuticals also pleaded guilty in December 2020, according to the Justice Department.
Biden to reopen ACA insurance marketplaces as pandemic has cost millions of Americans their coverage
President Biden is scheduled to take executive actions as early as Thursday to reopen federal marketplaces selling Affordable Care Act health plans and to lower recent barriers to joining Medicaid.
The orders will be Biden’s first steps since taking office to help Americans gain health insurance, a prominent campaign goal that has assumed escalating significance as the pandemic has dramatized the need for affordable health care — and deprived millions of Americans coverage as they have lost jobs in the economic fallout.
Under one order, HealthCare.gov, the online insurance marketplace for Americans who cannot get affordable coverage through their jobs, will swiftly reopen for at least a few months, according to several individuals inside and outside the administration familiar with the plans. Ordinarily, signing up for such coverage is tightly restricted outside a six-week period late each year.
Another part of Biden’s scheduled actions, the individuals said, is intended to reverse Trump-era changes to Medicaid that critics say damaged Americans’ access to the safety-net insurance. It is unclear whether Biden’s order will undo a Trump-era rule allowing states to impose work requirements, or simply direct federal health officials to review rules to make sure they expand coverage to the program that insures about 70 million low-income people in the United States.
The actions are part of a series of rapid executive orders the president is issuing in his initial days in office to demonstrate he intends to steer the machinery of government in a direction far different from that of his predecessor.
Biden has been saying for many months that helping people get insurance is a crucial federal responsibility. Yet until the actions planned for this week, he has not yet focused on this broader objective, shining a spotlight instead on trying to expand vaccinations and other federal responses to the pandemic.
The most ambitious parts of Biden’s campaign health-care platform would require Congress to provide consent and money. Those include creating a government insurance option alongside the ACA health plans sold by private insurers, and helping poor residents afford ACA coverage if they live in about a dozen states that have not expanded their Medicaid programs under the decade-old health law.
A White House spokesman declined to discuss the plans. Two HHS officials, speaking on the condition of anonymity about an event the White House has not announced, said Monday they were anticipating that the event would be held on Thursday.
According to a document obtained by The Washington Post, the president also intends to sign an order rescinding the so-called Mexico City rule, which compels nonprofits in other countries that receive federal family planning aid to promise not to perform or encourage abortions. Biden advisers last week previewed an end to this rule, which for decades has reappeared when Republicans occupied the White House and vanished under Democratic presidents.
The document also says Biden will disavow a multinational antiabortion declaration that the Trump administration signed three months ago.
The actions to expand insurance through the ACA and Medicaid come as the Supreme Court is considering two cases that could shape the outcome. One case is an effort to overturn rulings by lower federal courts, which have held that state rules, requiring some residents to work or prepare for jobs to qualify for Medicaid, are illegal. The other case involves an attempt to overturn the entire ACA.
According to the individuals inside and outside the administration, the order to reopen the federal insurance marketplaces will be framed in the context of the pandemic, essentially saying that anyone eligible for ACA coverage who has been harmed by the coronavirus will be allowed to sign up.
“This is absolutely in the covid age and the recession caused by covid,” said a health-care policy leader who has been in discussions with the administration. “There is financial displacement we need to address,” said this person, who spoke on the condition of anonymity to describe plans the White House has not announced.
The reopening of HealthCare.gov will be accompanied by an infusion of federal support to draw attention to the opportunity through advertising and other outreach efforts. This, too, reverses the Trump administration’s stance that supporting such outreach was wasteful. During its first two years, it slashed money for advertising and for community groups known as navigators that helped people enroll.
It is not clear whether restoring outreach will be part of Biden’s order or will be done more quietly within federal health-care agencies.
Federal rules already allow people to qualify for a special enrollment period to buy ACA health plans if their circumstances change in important ways, including losing a job. But such exceptions require people to seek permission individually, and many are unaware they can do so. Trump health officials also tightened the rules for qualifying for special enrollment.
In contrast, Biden is expected to open enrollment without anyone needing to seek permission, said Eliot Fishman, senior director of health policy for Families USA, a consumer health-advocacy group.
In the early days of the pandemic, the health insurance industry and congressional Democrats urged the Trump administration to reopen HealthCare.gov, the online federal ACA enrollment system on which three dozen states rely, to give more people the opportunity to sign up. At the end of March, Trump health officials decided against that.
During the most recent enrollment period, ending the middle of last month, nearly 8.3 million people signed up for health plans in the states using HealthCare.gov. The figure is about the same as the previous year, even though it includes two fewer states, which began operating their own marketplaces.
Leaders of groups helping with enrollment around the country said they were approached for help this last time by many people who had lost jobs or income because of the pandemic.
The order involving Medicaid is designed to alter course on experiments — known as “waivers” — that allow states to get federal permission to run their Medicaid programs in nontraditional ways. The work requirements, blocked so far by federal courts, are one of those experiments. Another was an announcement a year ago by Seema Verma, the Trump administration’s administrator of the Centers for Medicare and Medicaid Services, that states could apply for a fundamental change to the program, favored by conservatives, that would cap its funding, rather than operating as an entitlement program with federal money rising and falling with the number of people covered.
“You could think about it as announcing a war against the war on Medicaid,” said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.
Dan Mendelson, founder of Avalere Health, a consulting firm, said Biden’s initial steps to broaden insurance match his campaign position that the United States does not need to switch to a system of single-payer insurance favored by more liberal Democrats.
The orders the president will sign “are going to do it through the existing programs,” Mendelson said.
Cartoon – Help Wanted
Cartoon – Chances of Bipartisan Health Reform
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Cartoon – Sensible Healthcare Reform
HENRY KOTULA 