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Thursday, July 18, 2019
Wednesday, July 17, 2019
Feds Try to Recoup Billions in Medicare Advantage Overbilling
Health insurers that treat millions of seniors have overcharged Medicare by nearly $30 billion the past three years alone, but federal officials say they are moving ahead with long-delayed plans to recoup at least part of the money.
Officials have known for years that some Medicare Advantage plans overbill the government by exaggerating how sick their patients are or by charging Medicare for treating serious medical conditions they cannot prove their patients have.
Getting refunds from the health plans has proved daunting, however. Officials with the Centers for Medicare & Medicaid Services repeatedly have postponed, or backed off, efforts to crack down on billing abuses and mistakes by the increasingly popular Medicare Advantage health plans offered by private health insurers under contract with Medicare. Today, such plans treat over 22 million seniors, there are more than 1 in 3 people who are on Medicare.
Now the CMS is trying again, proposing a series of enhanced audits tailored to claw back $1 billion in Medicare Advantage overpayments by 2020 — just a tenth of what it estimates the plans overcharge the government in a given year.
At the same time, the Department of Health and Human Services Inspector General’s Office has launched a separate nationwide round of Medicare Advantage audits.
As in past years, such scrutiny faces an onslaught of criticism from the insurance industry, which argues that the CMS audits especially are technically unsound and unfair and could jeopardize medical services for seniors.
America’s Health Insurance Plans, an industry trade group, blasted the CMS audit design when details emerged last fall, calling it “fatally flawed.”
Insurer Cigna Corp. warned in a May financial filing: “If adopted in its current form, [the audits] could have a detrimental impact” on all Medicare Advantage plans and “affect the ability of plans to deliver high quality care.”
But former Sen. Claire McCaskill, a Missouri Democrat who now works as a political analyst, said officials must move past powerful lobbying efforts to hold health insurers accountable and demand refunds for “inappropriate” billings.
“There’s a lot of things that could cause Medicare to go broke. This would be one of the contributing factors,” she said. “Ten billion dollars a year is real money.”
Catching Overbilling With A Wider Net
In the overpayment dispute, health plans want the CMS to scale back — if not kill off — an enhanced audit tool that, for the first time, could force insurers to cough up millions in improper payments they’ve received.
For over a decade, audits have been little more than an irritant to insurers because most plans go years without being chosen for review and often pay only a few hundred thousand dollars in refunds as a consequence. When auditors uncover errors in the medical records of patients they paid the companies to treat, the CMS has simply required a rebate for those patients for just the year audited — relatively small sums for plans with thousands of members.
The latest CMS proposal would raise those stakes enormously by extrapolating error rates found in a random sample of 200 patients to the plan’s full membership — a technique expected to trigger many multimillion-dollar penalties. Though controversial, extrapolation is common in medical fraud investigations — except for investigations into Medicare Advantage. Since 2007, the industry has successfully challenged the extrapolation method and, as a result, largely avoided accountability for pervasive billing errors.
“The public has a substantial interest in the recoupment of millions of dollars of public money improperly paid to health insurers,” CMS wrote in a Federal Register notice late last year announcing its renewed attempt at using extrapolation.
Penalties In Limbo
In a written response to questions posed by Kaiser Health News, CMS officials said the agency has already conducted 90 of those enhanced audits for payments made in 2011, 2012, and 2013 — and expects to collect $650 million in extrapolated penalties as a result.
Though that figure reflects only a minute percentage of actual losses to taxpayers from overpayments, it would be a huge escalation for the CMS. Previous Medicare Advantage audits have recouped a total of about $14 million, far less than it costs to conduct them, federal records show.
Though the CMS has disclosed the names of the health plans in the crossfire, it has not yet told them how much each owes, officials said. CMS declined to say when, or if, they would make the results public.
This year, the CMS is starting audits for 2014 and 2015, 30 per year, targeting about 5% of the 600 plans annually.
This spring, the CMS announced it would extend until the end of August the audit proposal’s public comment period, which was supposed to end in April. That could be a signal the agency might be looking more closely at industry objections.
Healthcare industry consultant Jessica Smith said the CMS might be taking additional time to make sure the audit protocol can pass muster. “Once they have their ducks in a row, CMS will come back hard at the health plans. There is so much money tied to this.”
But Sean Creighton, a former senior CMS official who now advises the industry for healthcare consultant Avalere Health, said payment error rates have been dropping because many health plans “are trying as hard as they can to become compliant.”
Still, audits are continuing to find mistakes. The first HHS inspector general audit, released in late April, found that Missouri-based Essence Healthcare Inc. had failed to justify fees for dozens of patients it had treated for strokes or depression. Essence denied any wrongdoing but agreed it should refund $158,904 in overcharges for those patients and ferret out any other errors.
Essence also faces a pending whistleblower suit filed by Charles Rasmussen, a Branson, Mo., doctor who alleges the health plan illegally boosted profits by overstating the severity of patients’ medical conditions. Essence has called the allegations “wholly without merit” and “baseless.”
Essence started as a St. Louis physician group, then grew into a broader holding company in 2007 backed by prominent Silicon Valley venture capitalist John Doerr with his brother, St. Louis doctor and software designer Thomas Doerr. Neither would comment on the allegations.
How We Got Here
The CMS uses a billing formula called a “risk score” to pay for each Medicare Advantage member. The formula pays higher rates for sicker patients than for people in good health.
Congress approved risk scoring in 2003 to ensure health plans did not shy away from taking sick patients who could incur higher-than-usual costs from hospitals and other medical facilities. But some insurers quickly found ways to boost risk scores — and their revenues.
In 2007, after several years of running Medicare Advantage as what one CMS official dubbed an “honor system,” the agency launched “Risk Adjustment Data Validation,” or RADV, audits. The idea was to cut down on undeserved payments that cost the CMS nearly $30 billion over the past three years.
The audits of 37 health plans revealed that on average auditors could confirm just 60% of the more than 20,000 medical conditions CMS had paid the plans to treat.
Extra payments to plans that had claimed some of its diabetic patients had complications, such as eye or kidney problems, were reduced or invalidated in nearly half the cases. The overpayments exceeded $10,000 a year for more than 150 patients, though health plans disputed some of the findings.
But the CMS kept the findings under wraps until the Center for Public Integrity, an investigative journalism group, sued the agency under the Freedom of Information Act to make them public.
Despite the alarming results, the CMS conducted no audits for payments made during 2008, 2009, and 2010 as they faced industry backlash over CMS’ authority to conduct them, and the threat of extrapolated repayments. Some inside the agency also worried that health plans would abandon the Medicare Advantage program if the CMS pressed them too hard, records released through the FOIA lawsuit show.
CMS officials resumed the audits for 2011 and expected to finish them and assess penalties by the end of 2016. That has yet to happen amid the continuing protests from the industry. Insurers want the CMS to adjust downward any extrapolated penalties to account for coding errors that exist in standard Medicare. CMS stands behind its method — at least for now.
At a minimum, argues AHIP, the health insurers association, CMS should back off extrapolation for the 90 audits for 2011-13. Should CMS agree, it would write off more than half a billion dollars that could be recovered for the U.S. Treasury.
Weight Loss Programs Tied to Improvement in Biomarkers for NAFLD
Target Audience and Goal Statement: Hepatologists, weight loss specialists, endocrinologists, hematologists, primary care physicians
The goal was to estimate the association of weight loss interventions with biomarkers of liver disease in non-alcoholic fatty liver disease (NAFLD).
Question Addressed:
- Were weight loss interventions associated with changes in biomarkers of liver disease in people with NAFLD?
Synopsis and Perspective:
About 25% of adults worldwide and two-thirds of those with obesity have NAFLD. This disease is diagnosed when more than 5% of a person’s liver is comprised of fat. NAFLD encompasses a histological spectrum of conditions ranging from excess fat deposits in the liver (steatosis, non-alcoholic fatty liver) to non-alcoholic steatohepatitis (NASH), fibrosis, and cirrhosis. Beyond the liver, NAFLD is associated with heightened risks for cardiovascular morbidity, hepatocellular carcinoma, and mortality. Obesity remains the most common risk factor for this condition.
Action Points
- Weight loss interventions were associated with clinically meaningful improvements in biomarkers of liver disease, but not a change in fibrosis, based on a systematic review and meta-analysis of 22 randomized clinical trials (n=2,588) of nonalcoholic fatty liver disease (NAFLD).
- Note that the evidence appeared to support changing the current clinical guidelines and recommending formal weight loss programs to treat people with nonalcoholic fatty liver disease.
Data published in JAMA Internal Medicine on 2,588 participants with NAFLD across 22 randomized clinical trials (RCTs in 12 countries) have now confirmed that, when compared with too little or no weight loss support, various weight loss interventions were associated with improvements in NAFLD biomarkers and greater weight loss.
“The accumulated evidence supports changing the clinical guidelines and routine practice to recommend formal weight loss programs to treat people with NAFLD,” Koutoukidis’ group wrote.
Multiple inclusion criteria were used in this systematic review and meta-analysis, including the need to report at least one biomarker of liver disease, the Enhanced Liver Fibrosis score, the NAFLD fibrosis score, the Fatty Liver Index, liver stiffness, radiologically or histologically measured steatosis, inflammation, ballooning, fibrosis, and the NAFLD Activity Score (NAS).
A total of 22 studies (20 full-text articles and 2 conference abstracts) included 26 interventions. Of the included trials, 6 were conducted in middle-income countries and the remaining trials were conducted in high-income countries. Behavioral weight loss programs were used as interventions in 15 trials, pharmacotherapy in 6 trials, and surgery in 1 trial. Pharmacotherapies included orlistat (Xenical), liraglutide (Victoza), or sibutramine hydrochloride (Meridia), and the 1 surgical trial examined the implications of placing a gastric balloon. The median intervention duration was 6 months. Intensity was defined by the extent of behavioral support, prescribed energy deficit, or pharmacotherapy dose.
Two-thirds of participants were male (mean age of 45; mean BMI of 33.7) and about 7% had type 2 diabetes. Three studies did not report on sex and 4 studies did not report on diabetes status.
Compared with no or lower weight-loss interventions, formal weight loss interventions were associated with greater weight change (–3.61 kg; 95% CI –5.11 to –2.12, I2=95%). Difference in weight loss varied considerably across studies by intervention intensity, ranging from –14.5 kg in a 2013 study of diet and exercise versus no intervention to a 0 kg difference in a 2017 comparison of liraglutide versus lifestyle modification.
Weight loss was significantly associated with the following improvements in :
- Alanine aminotransferase (ALT): –9.81 U/L (95% CI –13.12 to –6.50, I2=97%)
- Histologically or radiologically measured liver steatosis: standardized mean difference –1.48 (95% CI –2.27 to –0.70, I2=94%)
- Histologic NAFLD activity score: –0.92 (95% CI –1.75 to –0.09, I2=95%)
- Presence of nonalcoholic steatohepatitis: (OR, 0.14; 95% CI 0.04-0.49, I2=0%)
However, researchers did not observe a histologically significant change for liver fibrosis (–0.13; 95% CI –0.54 to 0.27, I2=68%). They stated that 12 studies were at high risk of bias in at least 1 domain. But estimates and precision of most outcomes did not materially change, based on a sensitivity analysis of 3 trials at low risk of bias.
Because most studies were short to medium-term duration, the long-term association of these interventions with the liver were unclear, the researchers said. Although sibutramine is no longer licensed, removal of this trial from the analysis did not materially affect the results, they added. Steatosis results might have been affected by different methods of assessing the outcome, but the researchers felt that there was “no basis for assuming the different methods would bias the findings by trial arm.”
Other study limitations included that results were limited by statistical heterogeneity and that fewer studies reported biomarkers other than ALT. Only a minority of the trials reported on histologic outcomes.
Source Reference: JAMA Internal Medicine 2019; DOI: 10.1001/jamainternmed.2019.2248
Editorial: JAMA Internal Medicine 2019; DOI: 10.1001/jamainternmed.2019.2244
Study Highlights: Explanation of Findings
Koutoukidis and colleagues looked at the relationship of weight loss interventions with relevant biomarkers among 2,588 participants with NAFLD across 22 RCTs. Compared with little or no weight loss interventions, they found statistically and clinically significant improvements in biomarkers of liver disease in people with NAFLD in the short term. However, there was no change in histologic liver fibrosis after 6 months.
In keeping with European guidelines, the 2018 Practice Guidance of the American Association for the Study of Liver Diseases (AASLD) did not offer specific recommendations to refer to or provide formal weight loss programs for treating NAFLD. Hepatologists often advised participants to lose 5% to 10% of excess weight, but referral to a formal weight loss program was uncommon, according to the researchers. They noted that the mean weight loss difference in the current study was equivalent to weight loss of more than 4 kg in one year reported for patients offered access to typical weight loss programs, compared with a 1 kg loss after one year for patients who were only given advice to lose weight from a physician.
In an invited commentary, Elizabeth Adler, MD, and Danielle Brandman, MD, both of the University of California San Francisco, commended the authors on their clear summary of existing evidence that weight loss is an effective treatment for NAFLD.
The editorialists also commented on the finding that steatosis improved with behavioral weight loss programs, but not with pharmacotherapy-centered weight loss programs (including orlistat, sibutramine, and liraglutide). Evidence on the impact of many pharmacotherapeutic options for NAFLD were inconclusive.
Only patients with biopsy-proven NASH should receive pharmacotherapy, based on the AASLD guidelines. But there was no evidence for metformin and statins — therapies that form part of the treatment for metabolic syndrome (commonly seen in NAFLD patients) — as sole treatments of NAFLD. Although several drugs were in development to target a variety of mechanisms, “cost and risk of long-term adverse effects may limit the adoption of pharmacotherapy for NAFLD,” the editorialists wrote.
Adler and Brandman provided their own possible explanations for why the authors did not see an association between weight loss interventions and changes in histologic scores for inflammation or fibrosis, such as the NAFLD fibrosis score. Few studies reported histologic outcomes and there was a lack of long-term follow-up in all but 2 RCTs. In addition, weight loss was not maintained in the 2 studies that did report long-term follow-up (6 months and 5 years).
However, other evidence from the literature showed that sustained weight loss held promise for stopping fibrosis in NAFLD and thereby improving liver-related mortality. A loss of at least 7% of body weight over 48 weeks improved liver histologic findings in patients with NASH, according to one study. Significant improvements were observed in steatosis, lobular inflammation, and ballooning — all key components of NASH.
“Overall, this study should encourage clinicians — hepatologists and primary care physicians alike — to incorporate weight loss programs into their treatment of NAFLD. In addition, large-scale support for interventions focused on maintenance of weight loss will be key in trying to curb the impending epidemic of advanced liver disease due to NAFLD,” they concluded.
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College
Primary Source
JAMA Internal Medicine
Secondary Source
JAMA Internal Medicine
Additional Source
MedPage Today
CMS prohibits forced arbitration for nursing home patients
The Trump administration on Tuesday released a final rule banning nursing homes from requiring residents to sign binding arbitration agreements as a condition for admission.
The final decision was a long time coming and a reversal of the agency’s initial proposal, which sought to rescind an Obama-era regulation in response to immense pushback from nursing home stakeholders, including the American Health Care Association.
In the final rule, the CMS said it will allow nursing homes to use binding arbitration agreements, but the facilities must inform patients they aren’t required to sign them in order to receive care. That must also be explicitly stated in the agreements themselves.
In addition, the CMS mandated that nursing homes explain the agreement to the resident “in a form and manner that he or she understands.”
Nursing homes will also be prohibited from preventing residents or their families from communicating with state surveyors.
“This protects the resident and his or her representative from any undue influence by the long-term care facility to not discuss the circumstances surrounding a concern, complaint or grievance,” the CMS said in a news release.
Finally, nursing homes must retain copies of signed binding arbitration for five years after the resolution of any dispute and those documents must be available for inspection upon request by the CMS, accrediting organizations or state surveyors.
“This will ensure that CMS will be able to obtain information on how the arbitration process is being used by long-term care facilities, and on the outcomes of the arbitrations for residents,” the agency said.
The AHCA is concerned about the CMS “adding any conditions or administrative requirements when Congress has spoken on this topic, Parkinson said.
There were some proposals the agency didn’t finalize. In addition to removing the use of “plain language” in arbitration agreements from the final rule, nursing homes will no longer have to post notices describing their arbitration policies for patients and families.
“We believe these proposed requirements are unnecessary due to other requirements finalized in this rule,” the agency said.
Trump administration eases access to chronic disease treatment
The IRS on Wednesday issued guidance that makes it easier for patients enrolled in high-deductible health plans to get coverage for medications and drugs to treat chronic illnesses, including asthma, congestive heart failure and diabetes.
Under the guidance, chronically ill patients will be able to access coverage for certain services before they spend enough money out of pocket to meet the high deductible. Previously, those plans covered only low-cost preventive-care services prior to the deductible being met.
The guidance, effective immediately, follows President Donald Trump’s June 24 executive order that directed the U.S. Treasury Department to find ways to expand the use of health savings accounts paired with high-deductible health plans to pay for “medical care that helps maintain health status for individuals with chronic conditions.”
The IRS, with the Treasury Department and HHS, re-classified certain medical services to treat chronic care as preventive for someone with that chronic condition. The list of 13 services that can now be covered without a deductible include insulin and glucometers for diabetes, inhalers for asthma, blood pressure monitors for hypertension, and SSRIs for depression.
In determining what services would be included on the list, the trio of agencies chose care that was low cost and likely to prevent the chronic illness from getting worse or the patient from developing a secondary condition that required higher cost treatments. The agencies will review and add or subtract from the list periodically, according to the guidance.
Several groups that have been pursuing HSA expansion for years cheered the guidance.
“Pre-existing, chronic conditions are debilitating for millions of Americans. These conditions also represent an enormous drain on the economy through high health costs and reduced employee productivity. Modernizing HSAs to address chronic disease prevention is important to help tackle this problem,” James Klein, president of the American Benefits Council, said in a statement.
In 2017 about 19% of workers with job-based health insurance were enrolled in high-deductible health plans eligible for a health savings account, according to the latest data from the Centers for Disease Control and Prevention. That was up from 4.2% in 2007.
While some advocates have touted high-deductible plans as way to tamp down healthcare spending by giving employees’ more “skin in the game,” others have argued that the plans discourage patients from getting needed care for fear of racking up a big medical bill.
Experts have said that allowing patients to access care for chronic illnesses would alleviate some of that issue and lead to lower healthcare spending in the long run.
“As more and more Americans are facing high deductibles, they are struggling to pay for their essential medical care,” Dr. Mark Fendrick, director of the University of Michigan’s Center for Value-Based Insurance Design, said in a statement. “Our research has shown that this policy has the potential to lower out-of-pocket costs, reduce federal health care spending, and ultimately improve the health of millions diagnosed with chronic medical conditions.”
Alector Phase 1b Data Demonstrates Progranulin Deficit Reversal in Dementia
– AL001 was seen to be generally safe and well-tolerated based on the results of the Phase 1 portion of the INFRONT clinical study
– AL001 elicited an increase in the level of progranulin to normal range in the plasma and CSF of frontotemporal dementia patients carrying a granulin mutation in the Phase 1b portion of the INFRONT clinical study
Cortexyme’s Approach to Key Underlying Cause of Alzheimer’s Detailed at AAIC
Cortexyme, Inc. (Nasdaq: CRTX) today announced the presentation of clinical data that supports its ongoing work to pioneer a novel, disease-modifying therapeutic approach to treating a key underlying cause of Alzheimer’s and other degenerative diseases. In a poster presentation at the Alzheimer’s Association International Conference® 2019 (AAIC®), researchers highlighted the Phase 1b clinical development experience of COR388, the company’s lead investigational gingipain inhibitor, and provided an overview of the design for the GAIN trial, the company’s large, international Phase 2/3 trial in patients with mild to moderate Alzheimer’s disease (AD). AAIC is the largest international meeting dedicated to advancing dementia science and is being held this week in Los Angeles.
“In Phase 1a/b testing, COR388 was well tolerated and associated with encouraging signs of early clinical activity, providing a solid rationale for the GAIN trial, our ongoing Phase 2/3 study that seeks to enroll approximately 570 patients with mild to moderate Alzheimer’s disease,” said Michael Detke, M.D., Ph.D., Cortexyme’s chief medical officer. “The response from the Alzheimer’s investigator and patient communities has been strong, and we look forward to enrolling the study and fully evaluating COR388’s utility as a potential treatment for Alzheimer’s.”
GAIN Trial’s Scientific Foundation and Clinical Trial Design Detailed
In a Developing Topics poster (P4-663), researchers detailed the rationale for and design of the GAIN trial, which began enrolling subjects in the United States in April 2019. The trial represents the first large, randomized late-stage clinical study evaluating the gingipain hypothesis, which is based upon growing evidence that the bacterium most commonly associated with chronic periodontal disease, Porphyromonas gingivalis, plays a key role in the development of AD, given its identification in the brains of AD patients and ability to cause neurodegeneration, inflammation, and other pathology associated with Alzheimer’s in animal models. In these models, the pathological effects were blocked by COR388, which targets the gingipains, or toxic proteases, released by P. gingivalis as it colonizes tissue.
The GAIN trial is based on Phase 1b data demonstrating benefits on both biomarkers and cognitive endpoints. After a 10-day multiple ascending dose study in 24 older healthy volunteers showed an encouraging tolerability and safety profile, a 28-day study of nine subjects with mild to moderate AD between the ages of 55 and 85 was conducted. Participants showed a trend to improvement on several measures of cognition, including the Mini-Mental State Exam (MMSE) and Cambridge Neuropsychological Test Automated Battery (CANTAB) memory composite of cognitive function score, measures commonly used to assess cognitive impairment in Alzheimer’s patients. Researchers also reported a statistically significant improvement for COR388 versus placebo on multiple measures of the Winterlight Cognitive Assessment, a new speech-based testing platform intended to identify cognitive impairment associated with dementia. Across the Phase 1b study, as well as single and multiple ascending dose studies in healthy volunteers, COR388 twice daily was found to be well tolerated and brain penetrant.
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