Monday, January 19, 2015

DOJ Alleges Copay Waivers Led to Medically Unnecessary Procedures


Reprinted from REPORT ON MEDICARE COMPLIANCE, the nation's leading source of news and strategic information on Medicare compliance, Stark and other big-dollar issues of concern to health care compliance officers.

By Nina Youngstrom, Managing Editor

January 12, 2015Volume 24Issue 1

In a false claims complaint based partly on copay waivers, the Department of Justice alleges they led to medically unnecessary tests and procedures at a Florida cardiology practice. According to the complaint, which was announced on Jan. 5, interventional cardiologist Asad Qamar, M.D., routinely waived Medicare copayments, which allegedly encouraged some patients to submit to vascular interventions and other services they didn’t need.

Qamar and his medical group, the Institute for Cardiovascular Excellence (ICE), are accused of defrauding Medicare of millions of dollars from 2008 to 2011. Some of the reimbursement allegedly was received while Qamar was on prepayment review by the Medicare administrative contractor (MAC) for six CPT codes for cardiac catheterization procedures, which means his claims were reviewed before being paid. In 2012, Medicare paid Qamar $18 million, more than any other cardiologist. “His billings for 2012 put him second on the list of all doctors, nationwide,” the complaint contends.

The false claims lawsuit was initially filed by Holly Taylor, former director of client services at Partners in Practice (PIP), which provided practice management services for Qamar and ICE. The Department of Justice has now revealed it will take over the case.

In a YouTube video, Qamar says the allegations are “baseless” and “fiction.” He notes that ICE serves 24,000 patients in northern central Florida, and there have been zero deaths in connection with the 20,000 invasive procedures it has performed. The $18 million billed to Medicare has been taken out of context, a spokesman says, because it represents services provided in six ICE locations by 10 physicians.

The complaint alleges that Qamar told patients they did not have to pay the 20% Medicare copays, and that insurance payments would cover their bills even if they weren’t in financial distress. Unaware of his assurances, PIP billed patients for copays, who called to complain that Qamar had told them they were off the hook.

There are two problems with copay waivers, the complaint said. First, they inflate the amount Medicare pays for services. As the HHS Office of Inspector General said in a 1994 fraud alert, “if a supplier claims that its charge for a piece of equipment is $100, but routinely waives the copayment, the actual charge is $80. Medicare should be paying 80 percent of $80 (or $64), rather than 80 percent of $100 (or $80). As a result of the supplier’s misrepresentation, the Medicare program is paying $16 more than it should for this item.” Second, patients are less likely to think twice about the value of a service. “Copayments are intended to eliminate the moral hazard created when a third party (here, American taxpayers) pays for treatment,” the complaint alleges.

Complaint Alleges Documentation Games

Copay waivers were one reason for the medically unnecessary services, the complaint alleges. Patients allegedly did not question the high cost of the procedures because they didn’t have to pay their share.

For example, Qamar and ICE billed for “an unrealistically high percentage of expensive interventional procedures; in particular, peripheral vascular interventions and diagnostic imaging of the renal arteries,” the complaint alleges. In the general population, about 5% of people over age 50 have peripheral vascular disease and the same is true for 20% over age 70, yet only a small number of them need intervention. However, almost all patients under Qamar’s care who received peripheral vascular ultrasound diagnostic scans underwent the interventions, the complaint alleged.

Also, patients scheduled for a catheterization often had additional, unplanned diagnostic imaging, the complaint alleged. “Dr. Qamar would sometimes explain he had done so because he was ‘already in there,’” the complaint alleged. “For example, patients would be scheduled for a diagnostic heart cath and end up having diagnostic imaging done on multiple vascular beds.”

Documentation wasn’t up to par, the complaint alleged, which perpetuated medical necessity problems. Qamar didn’t chart his procedures or approve the scribes’ documentation of his procedures.

Allegations of copay waivers are unusual and hard to rebut because they are illegal on their face, unless providers obtain documentation of the patient’s financial struggles, says attorney Ed Gaines, chief compliance officer of Zotec Partners in Greensboro, N.C., who is not involved in this case. “It puts a new twist on a classic issue,” he says. “It will be interesting.”

OIG warned against copay waivers on the same day the false claims case was announced — perhaps not coincidentally — in the first advisory opinion issued this year (14-11). There is always the potential for civil monetary penalties and exclusion if beneficiaries are given remuneration that could influence their selection of a provider or supplier, although in this case OIG said it would not sanction a charity for helping financially needy patients who have Crohn’s disease or ulcerative colitis with copayment obligations.

Compliance monitoring often focuses on providers whose billing falls off a bell curve. Billing far outside the norm, as alleged in the complaint, is a good way to get on the government’s bad side, although it doesn’t necessarily equate to noncompliance, Gaines says. Compliance officers in practices and hospitals that employ physicians should identify physicians who are coding outliers as a first step. “You can go to the MAC and get comparative billing reports,” he says. Ask for CBRs by tax identification numbers, and compare the physicians’ billing and coding to see if anything jumps out. But there could be a good reason for an outlier. Maybe a physician who bills a lot of level five evaluation and management (E/M) services works in a trauma center. Or a sudden shift from mostly level threes to level fives reflects a change in work schedule from a rural to an urban emergency room, Gaines says.

Read the press release at www.justice.gov and the OIG advisory opinion at http://tinyurl.com/q7va2dd. Watch the YouTube video at http://youtu.be/NSWC6TsuPg8.

http://aishealth.com/archive/rmc011215-04?utm_source=Real%20Magnet&utm_medium=Email&utm_campaign=63546371

Today's Datapoint


90% of health care and medical apps have been hacked, and, of those, 22% are FDA-approved. Also, 97% of the top 100 paid Android and 87% of the top 100 paid Apple apps have been breached, according to a mid-November report from Arxan Technologies.

Quote of the Day


"Traditionally, we could count on generics to help save and decrease costs. For the first time in recent history, generic pricing inflation is now trending on-par with branded medication inflation. This is a significant issue considering [that] today around 84% of prescriptions dispensed are generics."



— Sumit Dutta, M.D., senior vice president and chief medical officer at Catamaran Corp., told AIS's Drug Benefit News.

Friday, January 16, 2015

New Hep C Drugs Land Exclusive Spots On Express Scripts, CVS Formularies


Reprinted from DRUG BENEFIT NEWS, biweekly news and proven cost management strategies for health plans, PBMs, pharma companies and employers. Sign up for an $86 two-month trial subscription today.

By Lauren Flynn Kelly, Editor

January 9, 2015Volume 16Issue 1

Following last month’s approval of AbbVie Inc.’s hepatitis C therapy Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets), both Express Scripts Holding Co. and CVS Health’s CVS/caremark PBM made bold but expected moves that are setting a new paradigm in formulary management of specialty drugs.

Express Scripts on Dec. 22 unveiled what Chief Medical Officer Steve Miller, M.D., calls a “game-changing agreement” through which Viekira Pak will be the exclusive genotype 1 hepatitis C treatment option for members that are on the National Preferred Formulary at a “significant discount” to clients.

And after conducting a “comprehensive clinical review” of Viekira Pak and Gilead Sciences, Inc.’s Harvoni (ledipasvir and sofosbuvir), CVS/caremark chose the latter as the preferred agent for its 2015 standard formulary, CVS Health explained in a Jan. 5 fact sheet outlining its hepatitis C therapy strategy for clients and consultants.

Viekira Pak on Dec. 19 became the fourth oral agent in the hepatitis C class to receive FDA approval since November 2013. The new agent can be used with or without ribavirin, and is approved to treat patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis. It is not recommended for patients with decompensated liver disease. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni in October 2014 (DBN 10/24/14, p. 1).

Express, CVS Cut Hep C Deals

For commercial clients that adopt the CVS/caremark standard formulary with exclusions, Viekira Pak will be considered non-formulary and available only by a medical exception or prior authorization for patients who have not yet begun therapy, explained CVS. Both Harvoni and Sovaldi are included on the second tier of that formulary, with Sovaldi designated as a preferred agent for the treatment of other genotypes. Olysio, meanwhile, is on the third tier for commercial plans and non-formulary for exchange plans that use the standard formulary. Harvoni is also recommended as a preferred agent on Medicare Part D and managed Medicaid template formulary clients, said CVS. The changes went into effect Jan. 7.

In its fact sheet, CVS pointed out once-daily treatment with Harvoni is “extremely well tolerated, facilitating the completion of a full course of therapy,” which for some patients may last only eight weeks compared to typical 12-week regimens with its competitors. The recommended dosing for Viekira Pak, which combines three distinct mechanisms that combat the hepatitis C virus at three separate stages of the disease lifecycle to keep it from reproducing, is two fixed-dose ombitasvir/paritaprevir/ritonavir tablets once a day in the morning and one dasabuvir 250 mg tablet twice daily with a meal.

Express Scripts Favors AbbVie Drug

Meanwhile, Viekira Pak was added to Express Scripts’ exclusionary formulary on Jan. 1 as the preferred, covered alternative for all clinically appropriate plan members, regardless of their disease stage. The National Preferred Formulary now excludes Sovaldi, Harvoni and Olysio, unless patients had already begun treatment regimens with those agents. Sovaldi, however, will still be covered for patients with other genotypes. Express Scripts also has preferred select antivirals and interferons that may be used with the covered agents.

“We want all hepatitis C patients to receive the best care our health care system can deliver,” Miller explains to DBN. “At the same time, we have been vocal throughout 2014 that Gilead’s price for Sovaldi and Harvoni was unsustainable for our plan sponsors, and that U.S. payers should not have to pay orphan-drug prices for non-orphan drugs.”

A 12-week course of Sovaldi is priced at $84,000, or $95,000 per patient when used with ribavirin and interferon, while the same length of treatment with Harvoni costs roughly $94,500. The AbbVie drug is set at $83,319 for the typical 12-week treatment. While most patients will qualify for the 12-week course, the recommended dosing for genotype 1a-infected patients with cirrhosis is 24 weeks with ribavirin, according to the prescribing information. The treatment is also indicated for patients who are co-infected with HIV or who have had liver transplants.

Based on data from the Viekira Pak clinical trials, Express Scripts anticipates there being very few instances where it wouldn’t be clinically appropriate for a genotype 1 patient, adds Miller. But if, for example, a patient has an allergy to one of the treatment’s ingredients, the patient would be able to receive coverage for one of the excluded products, he explains.

Moves by both of the big PBMs came as no surprise to industry analysts, given that Express Scripts had been vocal throughout 2014 about its plans to pit hepatitis C drugmakers against each other for better discounts, and an exclusive Gilead partnership seemed inevitable for CVS following the Express Scripts news.

In a Dec. 22 research note, Evercore ISI Senior Managing Director and Partner Ross Muken pointed out that Express Scripts has “historically not been afraid to take bold steps when it comes to wielding its position with the [supply] chain relative to branded drug manufacturers.” He pointed to when the PBM moved Lipitor (atorvastatin) to the third tier of its national formulary in early 2012 after the first generic version of Pfizer Inc.’s blockbuster cholesterol-lowering drug was launched.

“Ultimately, specialty trend has been and remains a major problem for customers, and decisions like this (assuming a reasonable discount with much of the rebate passed back to customers) will be increasingly necessary in order to control spend and should help to set the stage for the treatment of biosimilars in the future,” wrote Muken.

Will New Exclusions Help PBMs’ Sales?

During a Dec. 22 webinar to discuss the Express Scripts news, Evercore Managing Director Michael Cherny suggested that it may be the “one shot that could help accelerate the move to more restrictive formularies.” Cherny also asked whether the deal could enable the company to win back business it’s lost in recent years to competitors.

Muken suggested in a Jan. 5 note that the CVS/Gilead alignment may be perceived as “less bold” than the Express Scripts/AbbVie deal and “potentially appealing to a broader segment of the employer market” because it involves two drugs that are “more advantaged,” given the potentially shorter regimen, more convenient dosing and fewer drug-to-drug interaction issues.

“By rolling their new hepatitis C formulary exclusions into their broader National Preferred Formulary strategy, [Express Scripts] will likely get decent client uptake on this,” predicts Josh Golden, practice leader, employer consulting at Pharmaceutical Strategies Group, LLC, in an interview with DBN. “The hope is that most or all of the incentives that are created by these new exclusions would flow back to the plan sponsor — but in reality the PBM often retains some of that value. What’s less predictable is the client uptake of ESI’s new Hepatitis Cure Value Program.”

That new program, launched alongside the hepatitis C formulary update, provides additional discounts on Viekira Pak for plan sponsors that elect to treat all their genotype 1 patients (including those with early stages of the disease) and use the Express Scripts-owned Accredo Specialty Pharmacy.

“It’s basically a way for [Express Scripts] to capture more volume through exclusive Accredo distribution,” suggests Golden. “Clients that already have an exclusive Accredo arrangement will probably jump on this one. Others will likely take a more measured look before leaping.”

Golden adds that he was “not surprised” to see CVS/caremark follow up with an exclusionary strategy for the hepatitis C class. “Gilead was obviously hungry to negotiate after the [Express Scripts] decision,” he remarks. “In the long run, this will hopefully provide some competitive price relief for this class. It’s becoming a hallmark of our heavily consolidated PBM industry: cost containment through back-room deals and supply chain alliances, instead of good, old-fashioned open market price competition.”

While several health plans and PBMs recently polled by DBN say they are hopeful that increased competition in this expensive category will create opportunities for manufacturer contracting, many indicated it is too soon to make coverage determinations on Viekira Pak.

Prime Therapeutics LLC reports that it is “actively engaged” with both Gilead and AbbVie and is “working closely” with its Blue Cross and Blue Shield plan owners to finalize a hepatitis C strategy. The PBM declined to say whether it would have an exclusive arrangement to prefer one agent over others.

“We will review the newly released product, [but there is] no urgency to do so since this newer product has a pill burden compared to existing therapy and complexity of treatment regimen without any clinical advantage,” observes Mesfin Tegenu, R.Ph., president of PerformRx, which is a wholly owned subsidiary of the AmeriHealth Caritas Family of Companies. Viekira Pak will remain off the PBM’s formulary, while Harvoni, Sovaldi and pegylated interferons are covered.

When asked if Express Scripts has any concerns about the potential “pill burden,” Miller responds, “AbbVie has created a very elegant packaging solution that effectively mitigates any potential challenges posed by Viekira’s twice-a-day dosing regimen.” Moreover, clinical trial data shows “very high medication compliance” and cure rates of up to 100%.

Contact Golden at jgolden@psgconsults.com, Miller via David Whitrap at dwhitrap@express-scripts.com, Tegenu via Cynthia Arnold at carnold@performrx.com, and Cherny and Muken at rossandmichael@evercoreisi.com.


 

Today's Datapoint


$392 is the new cap for 2015 on non-cash gifts that hospitals can provide to each physician annually, and medical staff incidental benefits are now capped at $33, under CMS's exceptions to the Stark self-referral law.

Quote of the Day


2015 "will be the year the jumbo (10,000+ employee) employer market, driven by a desire to reduce compliance/administrative burden, moves beyond 'tire-kicking' and starts to actively migrate all, or as pilots portions of, their covered population to private exchanges."



— Jay Savan, a partner at Mercer LLC, a unit of Marsh & McLennan Companies, told AIS's Health Plan Week.

Thursday, January 15, 2015

Today's Datapoint


22% of new Medicare beneficiaries chose Medicare Advantage plans in 2011, accounting for 48% of new MA enrollees that year, according to a study published in the Jan. 5 Health Affairs.