House Democrats ask Trump to ensure affordability of future coronavirus vaccine

https://thehill.com/policy/healthcare/483888-house-democrats-ask-trump-to-ensure-affordability-of-future-coronavirus?utm_source=&utm_medium=email&utm_campaign=27749

House Democrats ask Trump to ensure affordability of future coronavirus vaccine

Dozens of House Democrats wrote to President Trump Thursday to ask that he ensure any future coronavirus vaccines and treatments be “accessible, available and affordable.” 

The Department of Health and Human Services (HHS) will help fund efforts by Janssen — a drug company owned by Johnson & Johnson — to create a coronavirus vaccine and treatment. HHS is also partnering with French drugmaker Sanofi to produce a potential coronavirus vaccine.

Rep. Jan Schakowsky (D-Ill.) led 45 House Democrats in warning that HHS should not give an exclusive license to any private manufacturer or risk making the vaccines or treatments unaffordable.

“Providing exclusive monopoly rights could result in an expensive medicine that is inaccessible, wasting public resources and putting public health at risk in the United States and around the globe,” the lawmakers wrote. 

“If HHS or any other federal agency moves forward with such a proposal, we urge you to instead issue a limited license and implement requirements that a vaccine or treatment be made available at an affordable price.”

The efforts are in the early stages, and it could take years for a vaccine to be available to the public. 

“Americans deserve to know that they will benefit from the fruits of their public investments,” the lawmakers wrote.

“That goal cannot be met if pharmaceutical corporations are given authority to set prices and determine distribution, putting profit-making interests ahead of public health priorities.”

But the concern from House Democrats comes as lawmakers increase their scrutiny of drugmakers over rising prescription costs.

“You have repeatedly called for action to lower drug prices and know that unjustifiably high drug prices are one of the most pressing public health concerns we face today,” the lawmakers wrote to Trump.

“We should not grant any manufacturer a blank check to monopolize a coronavirus vaccine or treatment developed with public, taxpayer support.”

 

 

 

Trump Medicaid proposal sparks bipartisan warnings

Trump Medicaid proposal sparks bipartisan warnings

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Republicans and Democrats alike are warning that a recent proposal from the Trump administration could lead to billions of dollars in cuts to Medicaid, forcing states to eliminate benefits, reduce enrollment or cut payments to health providers.

In a rare sign of unity, hospitals, insurers, patient advocates and members of both political parties are on the same page in their opposition to the Trump administration’s plan, and most have urged the administration to withdraw a proposal they say would “cripple” Medicaid, the federal-state partnership that provides health care for the poor.

The proposal hasn’t received as much attention as the administration’s other efforts to reform Medicaid, such as implementing work requirements, but it could have the most damaging effect because of how far-reaching it is, experts argue.

“This is high stakes,” said Matt Salo, executive director of the National Association of Medicaid Directors, whose board urged the administration to completely withdraw the proposal.

Trump allies have also voiced their concerns.

“The Medicaid fiscal accountability rule is a concern to my governor, and the stakeholders are worried the rule as proposed could lead to hospital closures, problems with access to care and threaten the safety net,” Sen. John Cornyn (R-Texas) told Department of Health and Human Services Secretary Alex Azar last week during a hearing on the agency’s fiscal 2021 budget request.

Sen. Mark Warner (D-Va.) warned during the same hearing that the proposal could “dramatically affect Medicaid eligibility” and “wreak havoc on budgets in red states and blue states all across the country.”

The proposal would overhaul the complex payment arrangements states use to raise money for their Medicaid programs — funding that is then matched by the federal government.

The administration argues some states use questionable methods of raising funds so they can leverage more money from Washington. One approach used by states consists of taxing providers who stand to benefit from more Medicaid funds flowing into the state.

But governors and state Medicaid directors argue those long-standing arrangements are both legal and necessary as states look for ways to keep up with escalating health care costs.

The proposal would allow the Centers for Medicare and Medicaid Services (CMS) to limit the extra payments from states to providers serving high numbers of uninsured patients or Medicaid patients. Opponents say such changes could result in providers deciding not to accept Medicaid patients.

Dozens of states wrote public comments to CMS Administrator Seema Verma, urging her to withdraw the proposal, including conservative states that are typically supportive of her work.

“If the rule is finalized as proposed, it will immediately disrupt the Medicaid program in Alabama and we believe across the country,” wrote Stephanie McGee Azar, commissioner of the Alabama Medicaid Agency, who is not related to Alex Azar. She added that it would have “unintended consequences that will affect access to care in Alabama to our most vulnerable populations.”

Florida Gov. Ron DeSantis’s (R) administration warned the effect of the proposal would be “immediate and crippling.”

Meanwhile, a letter signed by state Medicaid officials in Michigan, Missouri, New York, Oregon, Pennsylvania, South Carolina, Tennessee, Illinois, Louisiana, Colorado, Pennsylvania and Washington argued the proposal would likely “force states to cut Medicaid eligibility, benefits and/or provider payments, which would have the effect of decreasing low-income individuals’ access to important health care services.”

The public comment period closed Jan. 31. CMS now needs to go through the 4,000 comments before deciding whether to finalize the rule.

Verma and her supporters argue the proposal is not intended to cut Medicaid but instead aims to improve transparency and accountability in the $600 billion a year program.

“It’s not surprising providers and the states are objecting when they are getting federal money for free,” argued Brian Blase, who previously served on President Trump’s National Economic Council, where he worked on health care issues. “They don’t want transparency and they don’t want their financing gimmicks checked.”

Blase predicted the rule, if implemented as proposed, would reduce Medicaid spending by a “very small amount.”

Verma also pushed back on opponents, criticizing a study commissioned by the American Hospital Association that estimated the rule could reduce Medicaid funding by as much as $49 billion annually.

“This proposed rule is not intended to reduce Medicaid payments, and alarmist estimates that this rule, if finalized, will suddenly remove billions of dollars from the program and threaten beneficiary access are overblown and without credibility,” she wrote in a blog post last week.

Some experts disagree with her, pointing to other actions the administration has taken on Medicaid, including work requirements.

“I think one should view this rule not in isolation, but in combination with the broader agenda of this administration on Medicaid,” said Edwin Park, a research professor at Georgetown University McCourt School of Public Policy. “Their ultimate agenda is about cutting the Medicaid program, changing the Medicaid program as it currently stands.”

State officials have complained that they were not asked for their input before the proposal was released, nor did CMS conduct a regulatory analysis of potential effects.

A nonpartisan agency that advises Congress on Medicaid policy wrote to Alex Azar advising he not implement the rule because CMS has not fully assessed the possible effects.

“The Commission is concerned that the proposed changes could reduce payments to providers in ways that could jeopardize access to care for Medicaid enrollees,” the advisory group wrote.

For example, Maine’s Department of Health and Human Services has planned to make $86 million in supplemental payments to hospitals in fiscal 2020, which began July 1.

The rule “would require significant changes to MaineCare and could force the State to cut back on eligibility or services,” Jeanne Lambrew wrote in the department’s public comment.

The administration hasn’t given any signals that it plans to back down from the proposal, despite considerable pushback from stakeholders, states and bipartisan members of Congress.

“We will work with states to help them recreate their practices in ways that are in conformity with the statute and try to be fair and equitable in all our dealings with states,” Alex Azar told lawmakers last week on Capitol Hill.

 

 

 

 

Despite provider claims, hospital M&A not associated with improved care, NEJM finds

https://www.healthcaredive.com/news/despite-provider-claims-hospital-ma-not-associated-with-improved-care-ne/569671/

Dive Brief:

  • Hospital consolidation is associated with poorer patient experiences and doesn’t improve care, according to a study published Thursday in the New England Journal of Medicine, refuting a common provider justification for rampant mergers and acquisitions.
  • The study funded by HHS’ health quality research division, the Agency for Healthcare Research and Quality, found that acquired hospitals saw moderately worse patient experience, along with no change in 30-day mortality or readmission rates. ​Acquired hospitals did improve slightly in clinical process, though that can’t be directly chalked up to the results of an acquisition, researchers found.
  • It’s further evidence that bigger isn’t always better when it comes to hospitals, and adds onto a heap of previous studies showing provider mergers lead to higher prices for commercially insured patients.

Dive Insight:

Hospitals continue to turn to M&A to navigate tricky industry headwinds, including lowering reimbursement and flatlining admissions as patients increasingly turn to alternate, cheaper sites of care. Provider trade associations maintain consolidation lowers costs and improves operations, which trickles down to better care for patients.

Though volume of deals has ebbed and flowed, hospital M&A overall has steadily increased over the past decade. The hospital sector in 2018 saw 90 deals, according to consultancy Kaufman Hall, up 80% from just 50 such transactions in 2009.

Thursday’s study analyzed CMS data on hospital quality and Medicare claims from 2007 through 2016 and data on hospital M&A from 2009 to 2013 to look at hospital performance before and after acquisition, compared with a control group that didn’t see a change in ownership.

American Hospital Association General Counsel Melinda Hatton took aim at the study’s methods to refute its findings, especially its reliance on a common measure of patient experience called HCAHPS.

“Using data collected from patients to make claims about quality fails to recognize that it is often incomplete, as patients are not required to and do not always respond comprehensively,” Hatton told Healthcare Dive in a statement. “The survey does not capture information on the critical aspects of care as it is delivered today.”

The results contradict a widely decried AHA-funded study last year conducted by Charles River Associates that found consolidation improves quality and lowers revenue per admission in the first year prior to integration. The research came quickly under fire by academics and patient advocates over potential cherrypicked results.

A spate of previous studies found hospital tie-ups raise the price tag of care on payers and patients. Congressional advisory group MedPAC found both vertical and horizontal provider consolidation are correlated with higher healthcare costs, the brunt of which is often borne by consumers in the form of higher premiums and out-of-pocket costs.

A 2018 study published in the Quarterly Journal of Economics found prices rose 6% after hospitals were acquired, partially due to limiting market competition. Groups like the left-leaning Center for American Progress have called for increased scrutiny from antitrust regulators as a result, but — despite snowballing M&A — there’s been little change in antitrust regulation since the 1980s. The Federal Trade Commission won several challenges to hospital consolidation in the 2010s, but the agency only contests 2% to 3% of mergers annually, according to MedPAC analysts.

Providers, like most actors across the healthcare ecosystem, are increasingly under fire for high prices and predatory billing practices. President Donald Trump’s administration finalized a rule late last year that would force hospitals to reveal secret negotiated rates with insurers, relying on the assumption that transparency would shame both actors into lowering prices.

A cadre of provider groups led by the AHA sued HHS over the regulation, arguing it violates the First Amendment and would place undue burden on hospitals, while potentially stifling competition. The lawsuit is currently being reviewed by the U.S. District Court for the District of Columbia.

 

 

 

Federal investigators probe Ascension, Google project

https://www.beckershospitalreview.com/cybersecurity/federal-investigators-probe-ascension-google-project.html

Image result for nightingale project

The Office of Civil Rights of HHS is asking for more information about Google’s “Project Nightingale” with St. Louis-based Ascension, according to a Nov. 12 The Wall Street Journal report.

Investigators “will seek to learn more information about this mass collection of individuals’ medical records to ensure that HIPAA protections were fully implemented,” OCR Director Roger Severino told WSJ.

Ascension and Google partnered last year to gather and share patient information to create healthcare solutions. Physicians and patients from 21 Ascension locations were not informed that information was being shared with Google. It is estimated that Google will gather data on 50 million patients.

Patient data that is being secretly shared with Google includes lab results, diagnoses and hospitalization records, reports WSJ. In some instances, Google has access to patients’ complete health history, including names and dates of birth. 

Although Ascension employees have questioned the ethical and technological ways Google is gathering data, privacy experts said it appears to be acceptable under federal law. Hospitals are generally allowed to share data with business partners without informing patients if the information is used “only to help the covered entity carry out its healthcare functions.”

An Ascension spokesperson said patient data wouldn’t be used to sell ads, reports WSJ.

“We are happy to cooperate with any questions about the project. We believe Google’s work with Ascension adheres to industry-wide regulations (including HIPAA) regarding patient data, and comes with strict guidance on data privacy, security and usage,” a spokesperson for Google said in a statement to WSJ.

Legislators on Nov. 12 also commented on the project. Presidential hopeful Sen. Amy Klobuchar of Minnesota said that there needs to be government oversight for the amount of data Google is handling, adding there are “very few rules of the road in place regulating how it is collected and used.”

Google has mapped out plans to develop a search tool that would aggregate patient data into a central location. Ascension physicians would then be able to use the tool to more quickly access patient information.

Ascension leader Eduardo Conrado, executive vice president of strategy and innovations for Ascension, shared his reactions to the WSJ Nov. 11 report on Project Nightingale on Nov. 12. Find his commentary here.

 

 

 

More choices and stable premiums for ‘Obamacare’ next year

https://apnews.com/2843740a7cb84d8f8e0df0307abe5dde

Image result for More choices and stable premiums for ‘Obamacare’ next year

Consumers will have more health insurance choices next year under the much-debated Obama health care law and premiums will dip slightly for many, the Trump administration announced Tuesday.

President Donald Trump was elected on a promise to repeal “Obamacare.” But despite his repeated efforts the program has stabilized three years into his administration. That may be short-lived.

The administration is asking a federal appeals court in New Orleans to overturn the entire Affordable Care Act as unconstitutional, an overhang of uncertainty clouding its future.

For now, the Department of Health and Human Services is touting a second consecutive year of positive-sounding numbers. An additional 20 insurers will participate for 2020, expanding consumer choice in many states, officials said. Nearly 70 percent of customers will have three or more insurers from which to pick a plan.

About 10 million people are covered through the health law’s insurance markets, which offer taxpayer-subsidized private plans for people who aren’t covered on the job. Former President Barack Obama’s namesake law will be 10 years old next year.

Premiums for a hypothetical 27-year-old choosing a standard plan will decline 4% on average in 2020 for states served by the federal HealthCare.gov website, the Trump administration said. About a dozen states run their own sign-up websites, but most rely on HealthCare.gov.

A low-cost midrange plan for that hypothetical 27-year-old will charge monthly premiums of $374 next year, officials said. The law’s income-based subsidies can drop that to around $50.

However, people who don’t qualify for income-based assistance must pay full price, and that’s before any deductibles and copays. Unsubsidized customers may just decide to go uninsured, particularly if they’re healthy.

A previous Republican Congress repealed the law’s unpopular penalty to get more people signed up — fines for going without coverage.

Six states will see premiums decline by 10% or more, officials said. They are Delaware, Montana, Nebraska, North Dakota, Oklahoma and Utah.

Three states — Indiana, Louisiana and New Jersey — will see premiums increase 10% or more.

Even as it pursues “Obamacare’s” demise in the courts, the Trump administration is trying to take credit for the program’s current stability.

“Until Congress gets around to replacing it, the president will do what he can to fix the problems created by this system for millions of Americans,” HHS Secretary Alex Azar said. “The president who was supposedly trying to sabotage this law has been better at running it than the guy who wrote it.”

Independent experts say it’s more complicated than that.

They credit the Trump administration for working with a dozen states to approve waivers that can bring down premiums by setting up a backstop system to pay bills from the costliest patients.

However, experts say the original design of the law’s subsidies is probably the major stabilizing force. People eligible for financial assistance are insulated from price spikes because they pay only a fixed percentage of their income. Because their own costs didn’t change much, customers with subsidies kept coming back to the market through years of double-digit increases in list-price premiums.

“As long as the subsidies are in place the changes that are happening … are not going to push this market off a cliff,” Standard & Poor’s director and lead analyst Deep Banerjee said.

Experts say yet another factor is that insurers that have stuck with the program have learned over time how to operate profitably.

Although the program is stable, enrollment has been slowly eroding since Trump took office, from 12.2 million in 2017 to 11.4 million this year. The slippage has come mainly in the HealthCare.gov states, where the federal government runs sign-up season. Slashing the ad budget was one of the Trump administration’s early actions.

The nonpartisan Government Accountability Office has recommended that the administration follow standard federal practices by setting sign-up goals and actively managing the program to meet enrollment targets. Seema Verma, head of the Centers for Medicare and Medicaid Services said the administration doesn’t believe such targets are needed and instead her agency has focused on keeping the HealthCare.gov website running smoothly and improving the enrollment experience for customers.

Verma also disclosed that the administration has made some “minor” changes in how it reports data about the program. While those tweaks appear to be in the weeds, they’re likely to get close attention from Democrats who accuse Trump of “sabotage” of the health law.

Sign-up season starts Nov. 1 in most states and runs through Dec. 15. States that run their own open enrollment may have different dates. Coverage starts Jan. 1.

The appeals court in New Orleans could issue its ruling during this time, but Azar said he’s not concerned even if the judges say the whole program should be tossed.

“Our messaging would be to keep calm and carry on,” he said, noting that the case is expected to go to the Supreme Court. “There will be no immediate disruption to anyone.”

 

 

Trump’s Lightweight Alternative to Medicare for All

https://www.realclearpolicy.com/articles/2019/10/11/trumps_lightweight_alternative_to_medicare_for_all_111288.html?utm_source=The+Fiscal+Times&utm_campaign=bc4ead3dce-EMAIL_CAMPAIGN_2019_10_11_09_27&utm_medium=email&utm_term=0_714147a9cf-bc4ead3dce-390702969

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President Trump and senior officials in his administration have been signaling for several months that they would release an updated GOP health-care plan, presumably to repeal and replace the Affordable Care Act (ACA) — which the president still criticizes as a “disaster.” Last week, the president gave a campaign-style speech denouncing Medicare for All and announcing a new executive order (EO) on improving Medicare. If the EO is the administration’s much-hyped health-care “plan,” it is a surprisingly lightweight offering.

The EO tasks the Secretary of Health and Human Services (HHS) and officials in the White House with producing several deliverables focused mainly on expanding options in Medicare Advantage (MA), which is the private insurance alternative to Medicare’s government-managed fee-for-service (FFS) option.

  • HHS is to propose regulations within a year to make it easier for Medicare beneficiaries to use medical savings accounts (Medicare’s version of health savings accounts) in conjunction with MA offerings and to facilitate cash rebates to MA enrollees when selecting options with particularly low premiums.
  • HHS is to suggest regulatory changes to make it easier for MA plans to offer innovative supplemental benefits, including telehealth services.
  • Working with the Council of Economic Advisers and others in the White House, HHS is to recommend how payment rates for medical services paid by the traditional FFS program could be tied more closely to the market rates paid by MA plans.
  • To provide more flexibility for MA plans, HHS is to recommend changes that scale back network adequacy requirements in states that limit provider competition and to account for the benefits of telehealth services.
  • The agency is to look for ways to allow MA plans to speed adoption of innovative medical technology and practices.
  • HHS also is to provide beneficiaries with “better” quality and cost data.

The EO uses general language throughout so it is difficult to know for sure what some of these administrative actions will mean. Overall, however, it is clear that what is called for are steps allowed under current law. As such, the changes are likely to be incremental and gradual.

The most promising proposal might be the push to encourage the payment of cash rebates to beneficiaries selecting low-cost MA options. Today, MA plans compete mainly by offering supplemental benefits beyond what Medicare covers. Cash rebates paid directly to the beneficiaries might usher in more direct price competition among MA plans, and between MA and FFS too.

The benchmarking of FFS rates to those negotiated by MA plans is a particularly obscure recommendation. Most FFS payment rates are grounded in statutory requirements. HHS may not have much authority to unilaterally adjust payments based on what is occurring among MA plans. Further, it is not clear if what the administration has in mind would raise or lower FFS spending.

While some of the concepts in the EO may be helpful, it is hard to see how they will have a dramatic effect on the health system, or on voters’ perception of the health system. The EO does nothing of consequence for Americans who are not enrolled in Medicare, nor does it offer much for 40 million Medicare beneficiaries enrolled in the traditional FFS program.

The EO may signal a play it safe approach by the administration. Instead of offering an actual plan or even just a vision for a reformed system, the administration may have decided that it is better to attack the Democratic party’s ideas rather than offer up a viable alternative course of action. Most of the political attention in 2020 will be focused upon whatever plan is pushed by the winning Democratic candidate anyway (either Medicare for All, or perhaps the introduction of a public option). The Trump administration seems more comfortable attacking either of those ideas than defending a Republican alternative.

That’s not a new development, of course. For years, Republicans have been more willing to state what they are against than what they are for.

But that strategy has its limits. As was demonstrated when the ACA passed in 2010, under the right circumstances, Democrats can pass a health-care bill even when all Republicans vote no. That might happen again, and perhaps soon, if the GOP fails to offer a convincing vision for fixing the problems – most especially rising costs — that concern many voters.

Most Republicans say they want the health system to rely on competition and consumer choice, not government control to discipline costs, but they have only vague ideas of what that would require in practice.

For the market to work, consumers need to be rewarded financially when they migrate to low-cost, high-value health care and away from costly and inefficient alternatives. That does not occur often enough today in large part because, under current law, the federal government provides larger subsidies when consumers in Medicare and job-based health care opt for more expensive coverage. Republicans shy away from fixing these problems because doing so would be politically controversial. Thus, they are left with offering safer, and less consequential, changes that represent modest progress at best.

Attacking Medicare for All or the public option is a short-term political strategy. Over the long run, the best way to beat those ideas is by enacting a viable, market-based reform plan that demonstrates cost discipline is possible without handing over all control to the federal government.

 

Health care’s fraud and abuse laws are getting overhauled

https://www.axios.com/health-care-fraud-abuse-stark-law-antikickback-changes-fd354212-9583-44c7-85e4-86e4690cc56e.html

Doctors dressed in blue operate on a patient in a surgical suite.

The Trump administration is proposing to loosen regulations that prohibit doctors from steering patients insured by federal programs to facilities where they have a financial interest and that outlaw health care companies from offering bribes and kickbacks in exchange for patient referrals.

Why it matters: The industry has long clamored for an overhaul to these laws, which companies say obstruct their goals of providing “value-based care.” But critics worry the broad and vague changes could engender more fraud and abuse than there already is.

Driving the news: The Department of Health and Human Services would create new exemptions for the physician self-referral law and the federal anti-kickback statute — decades-old, complex laws that forbid payments that encourage unnecessary care and increase taxpayer costs.

  • Hospitals, doctors, nursing homes and other entities would be able to create “value-based arrangements,” and those deals could include exchanging bonuses or other types of “remuneration” without running afoul of referral laws.
  • For example, under these exemptions, a hospital could provide a nursing home with a behavioral health nurse for certain discharged patients, or a hospital could donate cybersecurity technology to a physician’s office.
  • Many exemptions already exist, including for organizations called “accountable care organizations” that try to keep a patient’s care within a narrow set of hospitals and doctors, but these changes would go much further.

Between the lines: The overarching concern is everyone’s definition of “value” is different. How will regulators know whether providers are acting in good faith to coordinate care, or if they are using “value-based care” as a cover to control patient referrals and enrich themselves?

A major exclusion: Pharmaceutical companies, medical device firms, labs and medical equipment makers are cut out from the changes because the federal government is afraid those companies would “misuse the proposed safe harbors.”

  • Pharma lobbyists, in particular, have pushed hard to change the law so drug companies could directly subsidize drug copays for Medicare and Medicaid patients, even though federal officials have said that practice “masks the high prices those companies charge for their drugs.”
  • HHS Secretary Alex Azar told reporters the government may consider separate regulations for value-based drug contracts, even though the evidence of those deals’ effectiveness is limited at best.

The bottom line: These changes come at the same time that hospitals, physicians, pharmaceutical companies and others are paying out billions of dollars every year in fraud settlements.

  • Public comments are due Dec. 31, and if this comment process is anything like the initial requests that asked for guidance, the industry will be heavily involved.

 

 

 

DOJ breaks up alleged genetic testing fraud scheme estimated at $2.1 billion

https://www.healthcarefinancenews.com/news/doj-breaks-alleged-genetic-testing-fraud-scheme-estimated-21-billion?mkt_tok=eyJpIjoiWkdNMU56WmxabVl3TWpRMSIsInQiOiI0dlhaYUJpT2xBU0FqeDNmWkRlZHVZYnRsZ2xBK3pxMmN6RG5kS3Q1UWgrWFYyNllIK2lLZEYzclRDWUYyTFwvOGdhUzRVSnlscG5MQjBtY0NwT2d1TjZHdXJYRUlYRGszVEhrQmY5b0xhRDlFTWNTNUEwWnVvWGUwZXE3ME9kdGgifQ%3D%3D

The defendants ordered unnecessary tests that were reimbursed by Medicare, with laboratories sharing the profit, DOJ says.

The U.S. Department of Justice has charged 35 people with unlawfully charging Medicare $2.1 billion in what it said is one of the largest healthcare fraud schemes in history.

The 35 alleged offenders were charged in five separate federal districts, and were linked to dozens of telemedicine firms and laboratories focused on genetic testing for cancer. The people charged, including nine doctors and one other medical professional, cumulatively billed Medicare billions for cancer genetic tests, the DOJ said in a press release.

The charges were a culmination of coordinated law enforcement activities over the past month that were led by the Criminal Division’s Health Care Fraud Unit, resulting in charges against more than 380 individuals who allegedly billed federal healthcare programs for more than $3 billion, and allegedly prescribed and dispensed approximately 50 million controlled substance pills in Houston, across Texas, the West Coast, the Gulf Coast, the Northeast, Florida and Georgia, and the Midwest.

These include charges against 105 defendants for opioid-related offenses, and charges against 178 medical professionals.

The investigation targeted an alleged scheme involving the payment of illegal kickbacks and bribes by CGx laboratories in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for expensive, and medically unnecessary, cancer genetic tests.

According to the DOJ, the targets of the scheme were primarily seniors, who were approached at health fairs, at their homes during door-to-door visits, or through telemarketing calls. The “recruiters,” as they were called, would approach seniors about supposedly free cancer screenings or generic cheek swab tests, and the recruiters would then obtain the seniors’ Medicare information for the purposes of fraudulent billing or identify theft.

The recruiter would then get a doctor to sign off on a genetic so a lab would process it, and then pay a kickback in exchange for ordering the test. The lab would process the test and bill Medicare, and once it was reimbursed, would share the proceeds with the recruiter, according to the charges.

Often, the test results were not provided to the beneficiaries, or were worthless to their actual doctors. Some of the defendants allegedly controlled a telemarketing network that lured hundreds of thousands of elderly and/or disabled patients into a criminal scheme that affected victims across the U.S.

The defendants allegedly paid doctors to prescribe CGx testing, either without any patient interaction or with only a brief phone conversation with patients they had never met or seen.

WHAT’S THE IMPACT

In addition to the DOJ charges, the Centers for Medicare and Medicaid Services, Center for Program Integrity said it took adverse administrative action against cancer genetic testing companies and medical professionals who submitted more than $1.7 billion in claims to the Medicare program.

The DOJ Criminal Division, along with the U.S. Department of Health and Human Services Office of Inspector General and the FBI, spearheaded the investigation.

The DOJ calls the scheme one of the largest it has ever handled.

THE LARGER TREND

Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $16 billion.

In addition, CMS, working in conjunction with the Health and Human Services Office of the Inspector General, are taking steps to increase accountability and decrease the presence of fraudulent providers.

The newest Medicare fraud scheme is the second to be uncovered in the last month. Earlier in September, a telemedicine CEO pleaded guilty to one count of conspiracy to defraud the United States and pay and receive healthcare kickbacks and one count of conspiracy to commit money laundering in a scheme estimated at $424 million.

ON THE RECORD

“Unfortunately, audacious schemes such as those alleged in the indictments are pervasive and exploit the promise of new medical technologies such as genetic testing and telemedicine for financial gain, not patient care,” said Deputy Inspector General for Investigations Gary L. Cantrell of HHS-OIG. “Instead of receiving quality care, Medicare beneficiaries may be victimized in the form of scare tactics, identity theft, and in some cases, left to pay out of pocket.  We will continue working with our law enforcement partners to investigate those who steal from federal healthcare programs and protect the millions of Americans who rely on them.”

“Healthcare fraud and related illegal kickbacks and bribes impact the entire nation,” said Assistant Director Terry Wade of the FBI’s Criminal Investigative Division. “Fraudulently using genetic testing laboratories for unnecessary tests erodes the confidence of patients and costs taxpayers millions of dollars. These investigations revealed some medical professionals placing their greed before the needs of the patients and communities they serve. Today’s law enforcement actions reinforce that the FBI, along with its partners, will continue to pursue and stop this type of illegal activity.”

 

Texas docs, pharmacists charged in alleged opioid pill mill scheme

https://www.healthcaredive.com/news/texas-docs-pharmacists-charged-in-alleged-opioid-pill-mill-scheme/563270/

Dive Brief:

  • The U.S. Department of Justice said Wednesday it charged 58 people in Texas in connection with their alleged roles in various schemes to defraud government health programs, including distributing and dispensing medically unnecessary opioids, billing Medicaid for non-emergency ambulance services that were never actually provided and paying kickbacks and laundering money through durable medical equipment companies.
  • The allegations involved multiple programs including Medicare, Medicaid, TRICARE, the Department of Labor-Office of Worker’s Compensation programs as well as private insurance companies.
  • Separately, DOJ brought charges against a total of 34 people for their alleged participation in Medicare and Medicaid fraud schemes in other states, including California, Arizona and Oregon. Seventeen of the people charged in those schemes were doctors or licensed medical professionals.

Dive Insight:

Created in 2007, the Medicare Fraud Strike Force​ has units operating in 23 districts, and has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $14 billion. It’s a joint effort between DOJ and HHS to deter healthcare fraud.

According to the most recent statistics, from January, the strike force has brought 2,117 criminal actions, secured 2,754 indictments and recovered $3.3 billion in connection with its investigations.

HHS declared the opioid crisis a national emergency in 2017. And the DOJ is increasingly focusing on fraud related to opioids, including going after medical professionals allegedly involved in the unlawful distribution of opioids and other prescription narcotics.

“Sadly, opioid proliferation is nothing new to Americans,” U.S. Attorney Ryan K. Patrick of the Southern District of Texas said in a statement announcing the charges. “What is new is the reinforced fight being taken to dirty doctors and shady pharmacists,” he said.

The coordinated healthcare fraud enforcement operation across Texas resulted in charges involving networks of “pill mill” clinics that led to $66 million in losses and the distribution of 6.2 million pills, the government said. Sixteen doctors and pharmacists were among those charged.

And that’s on top of last month, when the Health Care Fraud Unit’s Houston Strike Force charged dozens of people in a trafficking network that diverted more than 23 million oxycodone, hydrocodone and carisoprodol pills.

The Texas actions also involved healthcare fraud other than opioid diversion, including fraudulent physician orders for durable medical equipment, fraudulent claims for ambulance services and stealing protected healthcare information.

The separate actions in California, Arizona and Oregon involved schemes that ran the gamut from billing for medically unnecessary compounded drugs, unnecessary cardiac treatments and testing, billing for chiropractic services never provided and a hospice kickback scheme.

 

 

 

Trade Secrets Challenge Could Trip Up Trump Hospital Prices Plan

https://news.bloomberglaw.com/health-law-and-business/trade-secrets-challenge-could-trip-up-trump-hospital-prices-plan

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A legal fight is looming over a Trump administration proposal that would require hospitals to list their standard prices for medical services and their negotiated rates with insurance companies—prices some believe are proprietary.

Hospital and insurance groups are likely to sue if the administration moves forward with a final rule, and the litigation could raise thorny legal questions about a company’s right to be competitive and a patient’s right to make informed health-care choices.

One way hospitals and insurance groups may try to fight the rule is by claiming their negotiated prices are trade secrets, health attorneys say.

“We’ve been looking in our research group at whether health-care prices can be trade secrets, and the law is very unsettled on this issue,” said Jaime King, associate dean and professor of law at the University of California Hastings College of Law in San Francisco.

The Centers for Medicare & Medicaid Services issued the proposed rule July 29 as part of a Trump administration push to make health-care costs more transparent.

It would require hospitals to list their standard prices and what individual insurers have agreed to pay for 70 “shoppable” medical services—like psychotherapy, blood tests, MRIs and ultrasounds—that can be scheduled in advance.

The government’s goal is to give consumers the information they need to compare what hospitals charge for similar services and to help them understand their potential financial liability for services they obtain at the hospital. Hospitals that fail to comply would be fined.

Listing the negotiated price an insurance company will pay on a patient’s behalf will show consumers how effective different health insurers are at negotiating lower out-of-pocket costs, attorneys say.

“We believe that this, in turn, will enable health-care consumers to make more informed decisions, increase market competition, and ultimately drive down the cost of health-care services, making them more affordable for all patients,” the CMS said in its proposal.

Legal Authority Questioned

The American Hospital Association was quick to object, contending in a prepared statement that the plan “exceeds the administration’s legal authority.” If the proposal is finalized, the trade group said it would look at its legal options.

“I think it’s reasonable for hospital groups to be looking at potential challenges if the rule is finalized as proposed,” said Philo Hall, senior counsel in Epstein, Becker and Green LLP’s health-care and life sciences practice.

The Affordable Care Act amended the Public Health Service Act by requiring hospitals to make public their “standard prices” for items and services. Attorneys say the CMS is now interpreting standard prices to also include the privately negotiated rates for each individual insurer.

But neither Congress, the Department of Health and Human Services, nor hospital groups have ever considered the standard prices provision in the ACA to include commercial and financial information that is treated as confidential in a highly competitive industry, said Hall. Hall served as counsel to the George W. Bush administration’s HHS Secretary Michael Leavitt and worked closely in that role with Alex Azar, the current HHS chief.

“The concern that the government is overstepping is not frivolous,” said Michael Adelberg, a former senior CMS official who now leads the health-care strategy practice of the Faegre, Baker, Daniels Consulting.

“I don’t know if you can say to two entities ‘You can engage in a contract in a competitive market, but the most important terms of that contract are public,’” he said. “I don’t know if you can do that.”

In a statement, America’s Health Insurance Plans said the CMS proposal would make it harder for insurance companies to bargain for lower rates. The group said even the Federal Trade Commission agrees that making hospitals disclose their privately negotiated rates would create a floor—not a ceiling—for what hospitals would be willing to accept.

When the HHS Office of the National Coordinator for Health Information Technology indicated in a proposal that it was considering adding network discounts and pricing data to the definition of electronic health information, UnitedHealth Group told the agency the details of the negotiated rates and the overall cost of its networks is a trade secret.

“Although federal courts have upheld regulations compelling the disclosure of Medicare cost report information, there is a significant difference between government payment information held by the government and the internal, proprietary information that the proposed regulation would compel UHC to disclose,” the insurance company said in comments in June.

CMS Could Prevail

The CMS proposal is similar to an HHS rule that would have required pharmaceutical companies to disclose the list price of their drugs in TV advertisements. A federal district court judge in July said the rule exceeded the administration’s regulatory authority and blocked it from taking effect.

In the drug pricing rule, the agency pointed to two provisions in the Social Security Act that tell the HHS secretary to make rules necessary for the “efficient administration of the Medicare and Medicaid program” as the source of authority.

But the U.S. District Court for the District of Columbia said there’s nothing in the law’s text, structure, or context to indicate Congress intended to give the HHS the power to issue a rule that forces drugmakers to disclose their list prices.

Attorneys say the agency’s authority to issue the hospital pricing rule is more explicit in the ACA.

“In this case, we have a different statutory provision that delegates the agency with a more specific task,” a former HHS attorney, who asked not to be identified, said in a conversation with Bloomberg Law.

“We’re not talking about a general statute concerning the efficient administration of the Medicare program to drug companies,” the former HHS attorney said. “We’re talking about an explicit statutory provision that directs the agency to require federally funded hospitals to disclose their ‘standard charges.’”

On that, the former HHS attorney said, the CMS could prevail. But it depends on how the agency defines “standard charges.” The agency could ultimately decide not to include negotiated rates after it considers the public comments.

In a statement, the CMS said its proposal is consistent with the ACA and responsive to patients and their advocates who say knowledge of negotiated rates is necessary for individuals to be able to determine their out-of-pocket costs for hospital services.

“All Americans have the right to know the price of their health care up front,” an agency spokesperson said. “Health-care prices shouldn’t be a mystery and consumers will be able to shop for health care just like they do for everything else they buy.”