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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.
3 health care policy predictions now that Democrats have won control of the Senate
https://www.vox.com/policy-and-politics/22216716/georgia-senate-election-results-obamacare-vote
How Democratic wins in Georgia affect the odds on 3 health care policy proposals.
Democrats have won control of the Senate, and suddenly the possibilities for health care policy look a little wider than they did before the Georgia runoff elections.
Their Senate majority will be slim as can be, and their margin for error in the House is also quite small. So it’s not going to be easy to get anything done. But it seems likely that the Biden White House and a Democratic Congress will try to pass legislation to expand health coverage.
Regarding what Democrats’ health care agenda would look like if the party enjoyed full control of Congress and the White House, a senior party official told reporters this fall: “If we don’t take full advantage of this moment, we’ll be making a huge mistake.”
The question is how big they will go. A lengthy health care section will likely be part of any new Covid-19 relief and recovery bill. But will that be the end of it, or do Democrats want to try to pass another health care plan through budget reconciliation? Given Senate rules, that process is probably their best chance of passing a major bill.
Taking a cue from my Future Perfect colleagues and their 21 predictions for 2021, I thought I would lay out some of my expectations for the coming two years of health policy. These projections are based on my own reporting, but they are not meant to be definitive — and nothing is 100 percent guaranteed. It’s more like a list of issues I’ll be watching.
Democrats will expand eligibility for Obamacare subsidies: 85 percent chance
Democrats could attempt to take two bites at the health care apple: first as part of a Covid-19 relief bill, and second in a budget reconciliation package that can pass with a bare majority. I think there is a very strong chance both attempts would end up with provisions expanding eligibility for insurance tax subsidies.
The $2.4 trillion HEROES Act passed by the House, a likely starting point for Covid-19 negotiations between the House and the Senate, would have made anybody currently on unemployment insurance eligible for premium tax credits. That would help people who have lost their employer-sponsored coverage afford a new health care plan. A provision like that is likely to become part of whatever Covid-19 bill Congress comes up with.
A reconciliation bill could make that change permanent and universal. Back in spring 2020, Senate Democrats released a list of their health care priorities in response in response to Covid-19. At the top was a plan to raise the current cutoff for Obamacare subsidies, which stands at 400 percent of the federal poverty level.
Under current law, anybody with an annual income above that threshold, which is about $51,000 for an individual or $87,000 for a family of three, is ineligible for any assistance. Democrats have introduced plans to expand eligibility, either by doubling the income cap to 800 percent of the federal poverty level (like in this bill from Sen. Jeanne Shaheen) or by eliminating it entirely so that nobody pays more than a fixed percentage of their income on health insurance (as President-elect Joe Biden proposed). Democrats could also try to make low-income people in states that have not expanded Medicaid eligible for tax credits to buy private coverage.
The people squeezed under Obamacare have been the ones ineligible for the law’s financial aid. Expanding eligibility could insure up to 4 million people, and it seems like the bare minimum Democrats would want to do on health care with their new power.
The public option won’t be part of a Democratic health care bill: 75 percent chance
Much like the 2009 debate over Obamacare, a new government insurance plan would probably be the most hotly debated proposal if Democrats try to approve a major health care bill. Biden embraced the public option in his campaign, but passing it won’t be easy — in fact, I think it’s more likely than not that it doesn’t happen.
One problem for a public option is budget reconciliation. Unless Democrats are willing to eliminate the 60-vote legislative filibuster, they’ll have to use this special procedural tool in order to pass a bill with just 51 votes.
But budget reconciliation comes with limits on what provisions can be included, narrowly targeted to federal spending, and creating this new program may not qualify. Capital Alpha, a health care policy analysis group, thinks there is “virtually zero chance” a public option like that proposed by Biden during his campaign would be enacted because it likely doesn’t satisfy the reconciliation rules.
Progressives will push Democratic leadership to be as aggressive in pursuing a public option as possible, including in how they handle those procedural limits. But the moderate Senate Democrats who will ultimately dictate what the final package will look like have sounded ambivalent about the public option, and Democrats are wary of the party getting dragged into a messy health care fight.
Support for a public option would be substantial — about 70 percent of Americans say they’re for it, polls show — but so would the opposition. The health care industry will surely mobilize against the plan if Democrats look serious about pursuing it.
I suspect that, either because the moderates rule it out from the start or Democratic leaders balk at a drawn-out health care debate, politics will take the policy off the table.
Democrats will approve Medicare negotiations for prescription drugs: 55 percent chance
Democrats have campaigned for several election cycles now on a promise to give Medicare more power to negotiate drug prices with pharma companies. This promise was a part of the drug pricing bill that House Democrats passed in the last Congress, a plan that was estimated to cut federal spending by $456 billion over 10 years.
Savings are the reason the policy could be handy for Democrats in crafting a budget reconciliation plan. Democrats will need to include provisions that save the government money to help pay for the new provisions that cost money, like expanding eligibility for tax subsidies.
“We have long believed that pharma faces the greatest risk of drug pricing reforms in conjunction with Democrats’ efforts to expand coverage,” Capital Alpha wrote in a recent analysis.
Those twin incentives — delivering on a campaign promise and finding offsets — could help overcome what would surely be fierce industry opposition.
But the politics of drug pricing have shifted during the Covid-19 pandemic, which is why I think there’s only a slightly better than even chance that Congress will approve Medicare negotiations. Pharma has delivered the Covid-19 vaccines in record time, improving the industry’s relationship with the public in the process. This, in turn, has lowered expectations among the experts for how aggressive Democrats will be on drug prices.
“I think now you don’t have all those stories about insulin and EpiPen, plus you have positive stories about vaccines and other drugs,” Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told me in December. “You don’t have as fertile an environment for more extreme drug measures.”
Thus, my feeling that the odds for Medicare negotiations are closer to 50/50.
Expect a Different Senate Healthcare Agenda if Dems Win Georgia Senate Races
If Democratic candidates Raphael Warnock and Jon Ossoff both win Senate seats in Tuesday’s runoff election, and give the Democrats majority power in that chamber, it will change not only what type of healthcare policies are passed by the Senate but which healthcare bills get brought up in the first place.
“The big thing that it means is that [Senate Majority Leader] Mitch McConnell (R-Ky.) no longer controls what bills even get a vote” in the full chamber, said one policy advocate who asked to speak on background. “Last year, a bill on prescription drug pricing passed on a somewhat bipartisan basis out of the Senate Finance Committee,” with the blessing of committee chairman Chuck Grassley (R-Iowa), “and it never even got a vote. It certainly would have passed the House. So it’s not so much that you’re going to see a lot of partisan bills passed with [Vice President Kamala] Harris casting the tie-breaking vote … it’s that things will actually get voted on.”
Leadership of Senate committees also will change, noted Dan Mendelson, founder of Avalere Health, a consulting firm here. And because of that, “you’d see the Senate Finance Committee focused on coverage, and you’d see kind of an aggressive push to figure out how do we expand exchanges, expand Medicaid, and get more people covered in the U.S.”
One of the top priorities will be shoring up the Affordable Care Act (ACA), he continued. “There is no consensus on how to replace the law if it’s struck down by the Supreme Court. Legislation is necessary on an urgent basis.” Some other issues, such as drug costs, “are more likely to be addressed through regulatory approaches rather than legislative ones initially,” Mendelson said.
Marie Fishpaw, director of domestic policy studies at the Heritage Foundation, a right-leaning think tank here, suggested that expanded federal control of healthcare would be under consideration. “Last Congress, a majority of Democrats in the House of Representatives and 15 Democratic senators have already signaled their support for Medicare for All, so we can expect the left will push for more government control of healthcare should they get more power in Congress,” she said in an email. “Whether that happens by expanding Obamacare with a public option or setting up Medicare for All, it all leads to the same outcome in which government officials in Washington have more decision-making power over the kind of healthcare that Americans receive.”
Joe Antos, PhD, scholar in healthcare and retirement policy at the American Enterprise Institute, another right-leaning think tank, said in an email that “with Harris as the tie breaker, Biden will need to avoid issues where Democrats are not solidly behind him (at least Democratic senators). Drug pricing limits and another COVID spending bill are the most likely to be enacted, perhaps fairly quickly.”
The COVID bill will include “another trillion or two,” Antos said, because “despite all the moaning on TV about lack of state funding, the problem isn’t money — it’s organization and the skilled people to wield the needle. I think there would be more money for states and public health.”
As for the ACA, Biden “might try to reinstate the individual mandate with a penalty/tax, but that would only be a political show since the mandate really hasn’t mattered much in increasing number with insurance (after the first 2 years of ACA enrollment),” said Antos. “Increasing access to the premium subsidy is a possibility, but the true left won’t like it.” On the regulatory side, Antos predicted that Biden will “rewrite Medicaid guidance and reject waiver projects that tighten Medicaid rules,” such as waivers seeking to add work requirements for Medicaid.
Like Mendelson, Antos expects to see Biden push for action to lower prescription drug prices — possibly legislatively. “He would even get some Republican votes for limiting what Medicare will pay for Part B drugs and maybe even Part D drugs,” he said. “This isn’t Medicare ‘negotiating’ drug prices — it’s just old-fashioned price setting, which Medicare has done for decades.” Such a thing would be easier to implement in Part B “since we are already in a price-setting regime.” And, because the price controls would only be in effect for Medicare, “prices paid by everyone else will likely rise,” Antos added.
Less likely to succeed is Biden’s proposal for an advisory board that would consider drugs’ therapeutic value in its recommendations on prices. That is “a complex version of the Independent Payment Advisory Board, which never got off the ground,” Antos said.
Biden also may try to ease rules related to funding of reproductive healthcare organizations like Planned Parenthood that provide abortions, but legislative action in that regard would be a tough slog, Antos said, even with a nominally Democrat-controlled Senate. But Biden “could do something administratively” as the Trump administration has done in the other direction.
Senate confirmations of Cabinet members, such as California Attorney General Xavier Becerra as Secretary of Health and Human Services, would also be smoother under a majority-Democratic Senate, said Mendelson.
And what if the Republicans retain the Georgia Senate seats — and their majority? “The primary strategy the Republican leadership has pushed is to slow things down and to kill major legislation, and that goal gets facilitated if there’s a Republican majority,” he added. With McConnell keeping control of the Senate’s agenda, “things will run much more slowly and there will be a mentality of not doing things.”
But it could go the other way as well, Mendelson noted. “The optimistic scenario is that Senate Republicans feel like they have something lose in the midterms in 2022, and they need to build some sort of record of legislative accomplishments.” In that case, premium support for ACA marketplace enrollees and bringing down costs in the small-group insurance market might be in play, he said.
No Easy Fixes for Drug Supply Chain Problems
Better leadership is needed on both ends of the chain, expert says.
The U.S. drug supply chain works well in the middle, but the beginning and end leave much room for improvement, according to Stephen Schondelmeyer, PharmD, PhD, of the University of Minnesota in Minneapolis.
“When a manufacturer imports a drug into the U.S. and sells it to wholesalers and then it goes to group purchasing organizations and through hospital institutional systems, that system works very well,” Schondelmeyer said last week at a public workshop of the National Academies of Science, Engineering, and Medicine’s Committee on Security of Medical Product Supply Chain. “But where problems occur is when the API [active pharmaceutical ingredient] is not being produced or is not available, or is not shipped to the finished dose manufacturer to make enough.” With the current “just in time” manufacturing system, “inventories may only last a month” before supplies dry up, he said.
Leadership on this issue “is certainly needed at the top, but also needed at the end,” said Schondelmeyer, who is co-principal investigator of the Resilient Drug Supply Project at the university’s Center for Infectious Disease Research and Policy.
For example, he said, “I routinely meet with groups of pharmacy directors at major hospital systems. I have heard stories from pharmacy directors … who have said they had remdesivir allocated by their state; it showed up in their hospital’s lab. Nobody in the lab knew what it was or why it arrived, and it sat there for several days before they figured out this was a drug and pharmacy should be managing this … You can run a marathon, but if you don’t finish the last 200 yards, you don’t finish the marathon, and that’s what happened with remdesivir.”
“We need to be predicting not only demand changes but what things can create a supply disruption, because a lot of shortages we have are from supply disruption,” Schondelmeyer said. In the COVID-19 era, this could include unexpected political moves such as export bans — such as those recently put in place in India and the United Kingdom — which could mean that “we could find whole categories of drugs not available in the U.S., and we don’t have the capacity to replace that supply, in the short run at least,” he said.
Pharmaceuticals are a very unique market, he added. “We established a pharmaceutical market based on monopolies when drugs first come on the market, via intellectual property, and even later on, when you’re down to two or three generics they function like an oligopoly. We have a marketplace that has extreme asymmetries of information, where people selling a drug know a lot more than people buying the drug. We have to establish an infrastructure to understand the pharmaceutical market and the flow of products so we can correct the market when it’s not working.”
“Our current system of fixing drug shortages is a ‘fail and fix’ system,” he said. The list of shortages “is a list of products that have already failed. I think we should have a system that has supply chain maps that identify critical stages — even pre-API — that can suggest where we might have a failure, and do something before the failure occurs. I suggest we move from ‘fail and fix’ to ‘predict and prevent.'”
Schondelmeyer said he and his colleagues are trying to build such supply chain maps, “but really the government should be doing that … I don’t fault the FDA; the FDA may or may not be the right place to do that.” But more agencies and other players need to be involved because “no one player in the market can solve this problem alone.”
Schondelmeyer displayed percentages of various drug types that were in shortage. Among 156 “critical acute care drugs” — those that must be used within hours or days of an illness’s onset to avoid serious outcomes or death — the FDA found 25.6% were in shortage, while the American Society of Hospital Pharmacists (ASHP) found that 41.7% of them were in shortage, “and this was even before COVID-19,” he said. Among a list of 40 “critical COVID-19 drugs,” the FDA has listed 45% of them as being in shortage, while the ASHP rated 75% as being in shortage. “Most were in short supply even before COVID-19 hit,” he added. “These are alarming levels of shortage and they have persisted.”
Many people suggest that the supply chain problem can be solved by moving manufacturing for particular drug products from overseas to a U.S. plant, but that doesn’t quite solve the problem, said Schondelmeyer. “If we manufactured our entire supply of drugs in the U.S., it doesn’t solve the problem if you put all the manufacturing in one facility and it gets wiped out by a hurricane,” he said, recalling what happened when a hurricane hit Puerto Rico, the home of several medical product manufacturers. “Hospitals were scrambling to get things like normal saline. So simply bringing production back to the U.S. but concentrating it in one place doesn’t solve the problem — it just moves the problem.”
Khatereh Calleja, president and CEO of the Healthcare Supply Chain Association, agreed. “We’ve got to focus on this very issue of geographic diversity,” Calleja said. “Otherwise we’re creating a risk when we create that concentration.”
When people are discussing the supply chain, having a common language among institutions is also important, said Chris Liu, director of enterprise services for the state of Washington, “In hospitals, ‘conservation’ of PPE [personal protective equipment] means something different at every hospital you go to,” he said.
Another thing that needs to be taken on is the vulnerability of drug precursors, said James Lawler, director of international programs and innovation at the University of Nebraska’s Global Center for Health Security. “It’s one thing if the plant that makes the final small-molecule antibiotic … is in the U.S., but if all the precursor chemicals they require to synthesize that product come from overseas, you haven’t necessarily fixed your supply chain vulnerability.”
Covid Prescription
Virtual visits have declined, but the emails haven’t
https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8
While telemedicine visits have decreased sharply since their early pandemic peak, we’re hearing from providers across the country that patient demand for email communication has persisted.
Many patients have missed meaningful in-person interactions with their doctors. But once they sign up for the portal and realize they can email, they don’t want to go back to spending time on hold or scheduling a visit to get a prescription refill or the answer to a simple question.
Email and messaging saves patients a lot of time, but the sheer amount has quickly become unmanageable for many doctors. “Last year I got half a dozen emails per week from patients,” one primary care physician told us. “Now I’m spending two hours a day answering MyChart messages, and I’m still not keeping up.”
And as many are quick to point out, there is little to no compensation for time spent emailing. Health systems and physician practices can’t “roll back” this service—removing this satisfier would expose them to losing patients altogether.
In the near term, systems must invest in the staff and infrastructure to create a centralized process to triage messages. And longer-term, they must align physician compensation and payment models away from visit-based economics and toward comprehensive patient communication and management.
Administration Sketches Healthcare Plan, Signs Executive Order
Critics question value of provision addressing preexisting condition coverage.
President Trump presented his “America First Healthcare Plan” during a speech to healthcare professionals in Charlotte, North Carolina, on Thursday — a plan that mentioned preexisting condition coverage protections and surprise billing but did not seem to include comprehensive changes to the healthcare system.
“Under the America First Healthcare Plan, we will ensure the highest standard of care anywhere in the world, cutting-edge treatments, state-of-the-art medicine, groundbreaking cures, and true health security for you and your loved ones,” Trump said. “And we will do it rapidly, and it’s in very good order, and some of it has already been implemented.”
Executive Order Provisions
The president signed an executive order outlining the plan, but the order contained initiatives in only a few areas, including:
- Preexisting condition coverage. The order says simply: “It has been and will continue to be the policy of the United States to ensure that Americans with preexisting conditions can obtain the insurance of their choice at affordable rates.” The order does not direct any government agency to enact a regulation nor request Congress to pass legislation. In August 2018, the Trump administration allowed the sale of “short-term, limited duration” insurance plans that could last for up to 3 years; these often exclude coverage for preexisting conditions but also typically cost less than comprehensive coverage.
- Surprise billing. “Recognizing that both chambers of the Congress have made substantial progress towards a solution to end surprise billing, the Secretary of Health and Human Services (HHS) shall work with the Congress to reach a legislative solution by December 31, 2020,” the order says. “In the event a legislative solution is not reached by December 31, 2020, the Secretary of Health and Human Services shall take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.”
- Price transparency. “Within 180 days of the date of this order, the Secretary of Health and Human Services shall update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including whether the hospital is in compliance with the Hospital Price Transparency Final Rule whether, upon discharge, the hospital provides patients with a receipt that includes a list of itemized services received during a hospital stay; and how often the hospital pursues legal action against patients, including to garnish wages, to place a lien on a patient’s home, or to withdraw money from a patient’s income tax refund,” the order reads.
Trump also announced another initiative, this one aimed at seniors. “Under my plan, 33 million Medicare beneficiaries will soon receive a card in the mail containing $200 that they can use to help pay for prescription drugs … The cards will be mailed out in coming weeks,” Trump said. The $6.6 billion cost of the cards will be paid for under the auspices of a Medicare demonstration program. These funds are ostensibly available via savings generated through Trump’s “most favored nation” executive order allowing Medicare to pay no more for certain prescription drugs than the price paid by other developed countries, a White House official said. That executive order has not yet been implemented, however, and court challenges are expected.
Final Rule Issued on Drug Importation
Trump also noted that the FDA issued a final rule on Thursday implementing the president’s July executive order earlier this month to allow for importation of certain less expensive prescription drugs from Canada. “This means a state or whatever — can go to Canada and buy drugs for a fraction of the price that they’re charging right now,” he said.
He also highlighted individual actions his administration had taken that mostly affected particular groups, including lowering insulin prices for certain Medicare beneficiaries, investing in childhood cancer research, and expanding health reimbursement accounts that employers can use to reimburse employees for medical expenses. The COVID-19 pandemic received scant mention other than a reference to slashing red tape to accelerate development of treatments for the disease, and a sentence about how the pandemic had greatly increased the use of telehealth.
During a telephone briefing with reporters Thursday afternoon, HHS Secretary Alex Azar highlighted the surprise billing provision. “The President is saying that all the relevant players — hospitals, doctors, insurance companies — had better get their act together and get legislation passed through Congress that protects patients against surprise medical bills from anybody — hospitals or doctors, doesn’t matter,” he said.
“Those special interest groups need to sort it out and figure out how that would work,” he continued. “There have been legislative packages that have come quite close on the Hill that are bipartisan, but…. the president is saying the time is now. And if they do not get legislation passed by January 1st, he is instructing me to use the full regulatory power of the U.S. government to protect patients against surprise medical bills.”
Sen. Lamar Alexander (R-Tenn.), outgoing chairman of the Senate Health, Education, Labor, & Pensions (HELP) Committee, praised the surprise billing announcement. “The president is right to call on Congress to pass legislation this year to end surprise medical billing,” Alexander said in a statement, adding that a bill currently going through the House and Senate addresses the issue effectively. “Ending surprise medical bills is a problem that requires a permanent solution passed by Congress this year. The American people can’t afford to wait any longer.”
Preexisting Condition Provision Panned
The preexisting condition provision drew scorn from Democratic legislators. The provision “offers no protection not already available through the existing Affordable Care Act (ACA) and no protection for millions of Americans with preexisting conditions if Trump is successful in packing the Supreme Court to destroy the ACA,” Rep. Lloyd Doggett (D-Texas), chairman of the House Ways & Means Health Subcommittee, said in a statement.
But Azar said during the briefing that the ACA’s clause requiring insurers to cover preexisting conditions does no good if people aren’t able to afford insurance in the first place. “If you’re a couple, aged 55, living in Missouri, making $70,000 a year, Obamacare is going to cost you $30,000 in premiums and a $12,000 deductible,” he said.
Azar promised that the administration “will work with Congress or otherwise to ensure” that people with pre-existing conditions are protected, but he did not indicate how that would be made affordable to individuals without government subsidies of the sort Republicans have long opposed.
Bob Laszewski, president of Health Policy and Strategy Associates in Alexandria, Virginia, questioned how much good the executive order’s preexisting condition provision would do. “Trump and the Republicans couldn’t pass an alternative to Obamacare in 2017 when they controlled the White House and both houses of Congress,” he wrote in a blog post. “But, now he can just sign an executive order and everything is fixed? He has signed a number of healthcare-related executive orders and just about all of them are tied up in the byzantine federal regulatory process, or have faded away. This is just an election-year gimmick in an attempt to persuade voters that Trump has healthcare policy under control. There are a lot of governments in the world that operate by executive fiat. Ours is not one of them.”
HENRY KOTULA 