The Department of Justice announced its largest healthcare fraud takedown ever, charging 601 people for falsely billing Medicare, Medicaid and the U.S. military’s TRICARE program to the tune of more than $2 billion.
The massive enforcement initiative — which spanned 58 federal districts — swept up 165 doctors, nurses and other licensed health professionals, including 76 doctors accused of prescribing and distributing opioids and other prescription painkillers.
Since last July, HHS has barred 2,700 people from participating in federal healthcare programs, including 587 providers charged with opioid diversion and abuse.
Ashlee McFarlane, former federal prosecutor and partner at Gerger Khalil Hennessy, told Healthcare Dive via email that the takedown shows DOJ “is committing significant resources to criminally prosecuting anyone who prescribes drugs or distributes opioid prescriptions outside the normal course of medical practice. … Federal authorities are sending a message about opioid drug abuse in our nation and using the hammer of criminal prosecution to combat it.”
Indeed, 162 of the 165 medical professionals nabbed in the sting were charged with opioid-related crimes. The takedown serves as a cautionary tale for providers that avoiding any suggestion of over-prescribing and diversion isn’t just good for patients’ health — it can save them costly fines, loss of government reimbursement and even jail time.
The investigations included 84 opioid cases involving more than 13 million illegal doses of opioids, according to DOJ.
Among those caught in the crackdown were 124 defendants in DOJ’s South Florida district for false claims totaling more than $337 million. One sober living facility illegally recruited patients, paid kickbacks and conducted fraudulent urine testing, billing the government more than $106 million for alleged substance abuse treatments.
In a Michigan case, a doctor paid kickbacks to two home health agency owners, resulting in more than $12 million in false insurance claims. The widespread operations were led by DOJ’s Health Care Fraud Unit in conjunction with the Medicare Fraud Strike Force, a collaboration of DOJ’s criminal division, U.S. attorney’s offices, the Federal Bureau of Investigation and HHS’ Office of Inspector General.
“These are despicable crimes,” Attorney General Jeff Sessions said in a statement. “That’s why this Department of Justice has taken historic new steps to go after fraudsters, including hiring more prosecutors and leveraging the power of data analytics.”
In fiscal year 2017, the federal government won or negotiated more than $2.4 billion in healthcare fraud judgments and settlements.
In all, the government reclaimed $2.6 billion last year, including $1.4 billion for the Medicare Trust Funds and $406.7 million in federal Medicaid money. DOJ opened 967 criminal healthcare fraud investigations and filed 439 cases involving 720 defendants. Of those, 639 were convicted.
Allowing Medicare to negotiate directly with drugmakers to set prices could backfire and force the program to pay even higher prices for drugs, HHS Secretary Alex Azar told senators on Tuesday.
In a Senate Committee on Health, Education Labor & Pensions (HELP) hearing, Democratic lawmakers suggested drafting a bill allowing the HHS secretary to tell drugmakers it will pay the lowest of prices they are now offering to another country. For instance, if the UK is paying $30,000 for a drug and the U.S. is paying $150,000 for the same product, HHS could say it too would only pay the UK price.But former Eli Lilly executive Azar said drugmakers would take action to protect their U.S. profits if the CMS starts negotiating drug prices. The proposal wasn’t part of President Donald Trump’s recently unveiled drug pricing blueprint.
“A company could pull out of Canada and Europe as a result so there would no longer be the low price point,” Azar said. “They could then jack up prices, and we’d end up paying more.”
Sen. Doug Jones(D-Ala.) urged Azar to create a pilot to negotiate prices on a select type of drug to see if it could be a viable approach.
“Why don’t we give this a real-world trial instead of talking theoretically?” Jones said. “If it doesn’t work we can just stop it right?”
But Azar maintained that the move could lead to Medicare paying more, potentially limiting seniors’ access to needed drugs.
Azar’s pessimism was echoed by the drugmaker trade group Biotechnology Innovation Organization on Twitter during the hearing. The group urged the senators not to pursue the idea and pointed to a Congressional Budget Office analysis that found negotiating can only work if price controls and restricted access to some drugs is also in place.
Azar has referred to such a system as “socialized medicine” in the past and opposed similar proposals.
During the hearing, he noted that patients in other countries with similar policies have less access to drugs.
Azar praised President Trump’s proposal to move some Medicare Part B drugs into Part D so more treatments will fall under Part D’s price negotiating process. The CMS contracts with private health insurance companies to manage Part D benefits and negotiate discounts with drugmakers.
The idea could save as much as $30 billion and gives seniors choices to determine what coverage best suits their medication needs, he said.
Sens. Bob Casey (D-Pa.) and Elizabeth Warren (D-Mass.) were wary of the change and cited an Avalere study released last month that found average out-of-pocket costs were about 33% higher for Part D-covered new cancer therapies than for those covered in Part B.
Azar refused to respond to Warren’s multiple questions over whether seniors could face higher costs due to the change. Instead, he said he hoped the savings generated could be used to offset any new out-of-pocket costs a patient may face.
But that didn’t assuage Warren’s fears. “If a so-called negotiation ends up raising Medicare drug prices [for beneficiaries], its not a negotiation at all, it’s just a bad deal for seniors,” she said.
The White House has urged HHS not to finalize a rule that will require hospitals and physician practices to create standards and procedures to protect their employees’ religious and moral beliefs until it can elaborate how the policy will affect the industry.
HHS received more than 72,000 comments on the rulemaking before the March deadline. The agency is still drafting a final version of the rule, but proactively asked the Office of Management and Budget to allow it to confirm that providers were both complying with the rule and notifying staff and patients of their rights.
OMB denied both requests, saying in a notice that HHS did not provide industry comments on how these changes would affect their business. Under federal law, agencies have to disclose the comments they receive, their responses and any changes made to proposed regulation because of the feedback received.
HHS also didn’t provide OMB with adequate estimates of the time it would take providers to implement the rule. Prior to publication of the overall final rule, HHS must address these deficiencies, according to the OMB.
Officials from both the HHS and the OMB did not respond to requests for comment.
Requiring hospitals to provide assurances and certifications that they were complying with the proposed rule would create unnecessary burdens and costs, according to Cesar Lopez, associate general counsel at the Texas Hospital Association.
“Healthcare entities already comply with a myriad of state and federally mandated notice requirements; creating additional, unnecessary notification burdens in a time of decreased funding and ever-expanding regulatory requirements would be onerous,” Lopez said in a comment letter.
Hospitals have also questioned the need for the rule since they believe adequate protections for their staff’s religious beliefs are already in place.
“The proposed regulatory regime places unnecessary additional administrative and other burdens upon employers, while also inadequately considering the rights of patients and responsibilities of healthcare entities,” David McCune, vice president of corporate compliance at St. Louis-based BJC HealthCare, said in a comment letter. “It creates potential inconsistencies between existing, well-established bodies of federal and state anti-discrimination law.”
After facing scrutiny from the Senate and the White House, HHS Friday pushed back a decision on the 340B Drug Pricing Program that would impose civil monetary penalties for drug manufacturers that knowingly and intentionally overcharge hospitals for outpatient drugs to July 2019.
According to a statement, HHS is delaying the decision to “allow a more deliberate process of considering alternative and supplemental regulatory provisions” and to provide “sufficient time for any additional rulemaking.”
The decision has already received blowback from advocacy organizations and hospital associations such as 340B Health and the American Hospital Association.
The 340B program has grown in size and seen more scrutiny since its creation in 1992. It has become the subject of some controversy since President Donald Trump took office, prompting a lawsuit between HHS and the hospital industry and recurrent Senate hearings on the program’s vague intent, the lack of transparency surrounding its rules and the level of oversight by the Health Resources and Services Administration (HRSA).
The original intent of 340B was to lower the price of drugs for safety net hospitals, enabling providers to offer better care for low-income patients. But growth of the program since its implementation has created opacity and confusion around its purpose, fueled by a lack of specificity in guidance around hospital eligibility criteria.
Visibility into prices is one gap in clarity that remains unaddressed, and an HHS ruling on ceiling price and civil monetary penalties for manufacturers that overcharge eligible hospitals was much anticipated by the hospital industry. It’s not the first time a decision has been delayed.
Tom Nickels, executive vice president at AHA, voiced the association’s displeasure in another delay in a statement, emphasizing that the 340B program is “critical as ever” in providing healthcare to vulnerable populations.
“The 340B ceiling price and civil monetary penalties rule were intended to shine needed light on drug manufacturer price increases and hold drug manufacturers accountable for price overcharging. These reasons are why we continue to be disappointed in the delays — including five times since the beginning of last year alone — of the final rule and in the short shrift given to the review of the latest public comments,” Nickels said. “The irony is not lost on us that drug manufacturers continue to lobby for increased reporting for hospitals and others while refusing any transparency on their part.”
Part of the problem surrounding ceiling price is that providers don’t know how much they should have to pay for certain drugs, or how much their competitors are paying. Delaying the decision for another year will “allow drug makers to continue to saddle hospitals, clinics and health systems with higher and higher prices,” asserted 340B Health in a statement.
“HHS should begin enforcing these rules immediately,” the statement reads. “The time for delay is over. It is time for action.”
The pharmaceutical industry has so far welcomed the decision to delay the 340B rule. “PhRMA supports HHS putting revised, thoughtful regulations on ceiling price calculations and [civil monetary penalties] into effect as quickly as possible to ensure that rules on these topics are clear for both covered entities and manufacturers,” Nicole Longo, a spokeswoman for the organization, told Healthcare Dive. “We urge HRSA to finalize smart ceiling price and CMP regulations that eliminate needless regulatory burdens and advance the goals of the 340B law.”
Longo said PhRMA also supports HRSA’s implementation of the 340B ceiling price database, which will provide pricing transparency for covered organizations, and has encouraged HRSA to “move expeditiously” to make the database operational.
The CMS issued a final rule late Monday aimed at giving states and health insurers more flexibility and reducing regulatory burdens in the individual and small group health insurance markets.
The final rule allows states to define essential health benefits that individual and small group insurers must offer; gives insurers more options when reporting their medical loss ratios; and eliminates standardized plan options to maximize innovation.
In separate guidance also issued Monday, the CMS said it is expanding hardship exemptions for consumers so that people who live in counties with one or no exchange insurer will be exempt from paying the Affordable Care Act’s penalty for not having coverage.
Health insurers have anxiously been waiting for the rule, which is usually released in mid-March. It follows on the heels of other actions taken by the Trump administration aimed at easing Affordable Care Act regulations in the name of promoting consumer choice, including a proposal to extend the duration of short-term medical plans and expanding access to association health plans that don’t comply with ACA consumer protections.
“Obamacare has serious flaws that ultimately need Congressional action in order to correct, but until the law changes, we won’t stand idly by as Americans suffer, and today’s announcement will offer some relief to Americans who have seen higher premiums and fewer choices since Obamacare was implemented,” CMS Administrator Seema Verma said during a press call on Monday.
In the final rule, the CMS kept much of what it proposed in October. The agency went ahead with its earlier proposal to gives states flexibility to determine the essential health benefits that exchange insurers must offer, but pushed the effective data to 2020 instead of 2019. The extra leeway allow insurers to “create plans that more directly address the needs of (states’) citizens and not a one-size fits all D.C. mandate,” Verma said.
The CMS said states may either adopt another state’s 2017 benchmark plan; pick and choose a few elements of another state’s benchmark plan; or completely build a new essential benefits package from scratch so long as the new plan is not too generous and is in line with a “typical employer plan.” The benchmark plan defines what benefits insurers in the state must offer.
Verma said states are still subject to the ACA requirement that insurers offer 10 essential health benefits, and the flexibility doesn’t mean they may exclude coverage for essential benefits like maternity care or mental health benefits.
Policy experts have warned that allowing states to pick their essential health benefits would lead to a proliferation of skimpier plans on the market. Insurers had complained that the added state flexibility would increase insurance company costs.
The rule also eliminates standardized options starting in 2019 to encourage innovative plan designs among insurers. It also gives states more authority in reviewing qualified health plans for certification standards and eliminates the exchanges’ meaningful difference requirement.
And instead of requiring insurers planning to increase premiums by 10% or more to submit their rates to regulators for review, the rule increases that rate review threshold to premium increases of 15%.
Importantly, the rule also eases up state and insurer medical-loss-ratio requirements. The CMS will allow states to request changes to the minimum individual market MLR that insurers must meet if states can demonstrate that a lower MLR would help stabilize its market. Insurers covering individuals and employees of small businesses have had to spend at least 80% of their premiums on quality improvement activities and medical claims.
To relieve insurers of the burden that comes with identifying, tracking, and reporting expenses related to quality improvement activities, the CMS’ rule would also give insurers the option to continue reporting actual quality improvement activity expenses as they do today, or insurers could opt to report a single amount equal to 0.8% of the insurer’s earned premium for the year for a minimum of three consecutive years.
The agency further said it will implement strong checks to make sure individuals applying for insurance coverage earn the incomes they claim in order to qualify for premium tax credits.
Under additional guidance that the CMS released on Monday, a huge chunk of the Obamacare market won’t have to pay the individual mandate penalty for 2018 because they live in a bare county or a region with just one exchange insurer and can claim new exemptions from the penalty for as far back as 2016.
This represents the most sweeping forgiveness of the individual mandate penalty to buy comprehensive coverage on the Affordable Care Act exchanges, extended a few weeks before the tax filing deadline.
The CMS guidance broadens what is known as a “hardship” exemption from the individual mandate to buy insurance. It also extends the exemption to people who only have access to an insurance plan that covers abortion. Three states — California, Oregon and New York — require nearly all their insurance plans to cover abortion services according to the National Women’s Law Center. Those three states account for a big chunk of the Affordable Care Act enrollment numbers.
For 2018, California alone has more than 420,000 individual market enrollees, according to figures released by Covered California, the state’s marketplace. New York has more than 250,000 enrollees in qualified health plans.
The individual mandate penalty has been zeroed out for 2019, but this policy would impact all those still subject to the penalty for 2018 if they don’t buy a qualified health plan on the federally facilitated exchange or a state-based exchange whose exemptions are processed by the federal marketplace.
Those who live in a county with just one issuer can write a written explanation of why they are applying for the exemption if documentary evidence “is not readily available,” according to the guidance.
CMS Administrator Seema Verma declined to say whether the Trump administration would limit how payers in the Affordable Care Act (ACA) marketplace use government subsidies, the Washington Examiner reported.
The question comes as some ACA payers continue the practice of “silver loading,” which is when an insurer puts all the losses associated with the end of cost-sharing reduction (CSR) payments on only silver plans. HHS Secretary Alex Azar also said recently that he hasn’t been involved in discussions about whether to stop silver loading.
Verma also told reporters the agency continues to uphold the ACA despite its well-known opposition to the law.
President Donald Trump ended CSR payments to ACA payers in October. They had been given to insurers for only silver plans, to help contain out-of-pocket costs for lower-income Americans. Silver plans make up more than half of ACA plans.
Without those CSR payments, payers could either increase premiums on silver plans, which is called silver loading, or spread the losses across the four plan levels in the marketplace. Keeping the largest premium increases to the silver plans kicks in other government subsidies and tax credits for lower-income members.
Middle-class and upper-middle-class members still see their premiums skyrocket. Most people with an ACA plan get subsidies to help control the cost, but those who make too much then take the brunt of the premium increase.
Meanwhile, Verma’s comments about the CMS following ACA law in its decisions was evident when the agency recently rejected Idaho’s request to sidestep ACA regulations in the marketplace. CMS went against Idaho’s plan because the state wouldn’t be enforcing the ACA rules.
That said, Verma also suggested at the time that Idaho could achieve its goals by expanding short-term catastrophic plans. The Trump administration supports transforming short-term plans from three-month plans for which few people are eligible to 12-month plans with the option to extend the plan for another 12 months. The administration’s proposal would also open up the plans to everyone.