Federal judge says HHS overstepped authority in cutting 340B payments

https://www.fiercehealthcare.com/hospitals-health-systems/federal-judge-says-hhs-overstepped-authority-cutting-340b-payments?mkt_tok=eyJpIjoiTnpBNE1HTmtObUl3WVRkayIsInQiOiJFOU1xMDRPMGtzMCtnWXU4MExUVFAzZ3Jrdm5cL2s3S1dMRkVldTRWS2QyNmJZU255UWRIWW14QmtXVkJ2T2VTeGpYTVBvQXZWWW1JVnB0S0crTXV3aFhDS0wrY3NzTmtEYmJEMHdvSG03bGkxS2ZlREdiaWZydFZkbkdlXC9tTHE1In0%3D&mrkid=959610&utm_medium=nl&utm_source=internal

Drug prices

A federal judge has sided with hospitals in the ongoing battle over cuts to 340B drug discount payments, saying the Department of Health and Human Services’ rule slashing money to the program overstepped the agency’s authority.

District Judge Rudolph Contreras from the District of Columbia has issued an injunction (PDF) on the final rule, as requested by the American Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals.

Contreras also denied HHS’ request for the hospital groups’ ongoing litigation against the 340B payment cuts to be dismissed.

The Centers for Medicare & Medicaid Services finalized the payment changes late last year, cutting the rate in 340B from up to 6% more than the average sales price for a drug to 22.5% less than the average sales price of a drug, slashing $1.6 billion in payments.

Hospital groups have warned that the cuts could substantially hurt their bottom lines, especially for providers with large populations of low-income patients. Higher cost for drugs in 340B could also lead to access problems for these patients.

Contreras said in his opinion (PDF) that the payment changes overstepped HHS’ authority.

Because the payment changes affect many drugs—any in the 340B program—and the payment cuts are a significant decrease, the agency bypassed Congress’ power to set those reimbursement rates with the rule, Contreras said.

But simply siding with the hospital groups could prove disruptive, he said, as retroactively adjusting payments and reimbursing hospitals for lost money over the past year would impact budget neutrality, requiring cuts elsewhere to offset the payments. So both parties will have to reconvene to determine the best way forward, Contreras said.

The AHA, AAMC and AEH issued a joint statement praising the ruling.

“America’s 340B hospitals are immeasurably pleased with the ruling that the Department of Health and Human Services unlawfully cut 2018 payment rates for certain outpatient drugs,” the groups said.

“The court’s carefully reasoned decision will allow hospitals and health systems in the 340B Drug Pricing Program to serve their vulnerable patients and communities without being hampered by deep cuts to the program.”

The case marks the groups’ second attempt at a legal challenge of the 340B cuts. A federal court rejected their initial appeal in July. 

An HHS spokesperson said in a statement emailed to FierceHealthcare that the agency is “disappointed” in Contreras’ ruling, but said it looks forward to addressing the judge’s concerns about potential disruption to payments.

“As the court correctly recognized, its judgment has the potential to wreak havoc on the system,” the agency said. “Importantly, it could have the effect of reducing payments for other important services and increasing beneficiary cost-sharing.”

Chip Kahn, president of the Federation of American Hospitals, said Contreras’ ruling puts lowered drug costs, that benefit all hospitals, at risk.

“The DC Federal District Court’s ruling to stop reforms to Medicare payment for drugs acquired under the 340B drug discount program is unfortunate because it undermines HHS efforts to cut drug costs and promote fairer payments,” Kahn said in a statement.

 

 

 

 

Pennsylvania health system, CEO will pay $12.5M to resolve billing probe

https://www.beckershospitalreview.com/legal-regulatory-issues/pennsylvania-health-system-ceo-will-pay-12-5m-to-resolve-billing-probe.html?origin=cfoe&utm_source=cfoe

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Allentown, Pa.-based Coordinated Health and its founder and CEO Emil DiIorio, MD, have entered into an agreement with the federal government to settle False Claims Act allegations, according to the Department of Justice.

The settlement resolves allegations that Coordinated Health inflated payments from federal payers by unbundling claims for reimbursement for orthopedic surgeries, including many for total joint replacement, from 2007 through mid-2014.

Instead of stopping the illegal unbundling, Dr. DiIorio changed how he wrote operative reports to enable Coordinated Health billers to maximize improperly unbundled reimbursements, according to the Justice Department.

Two outside coding consultants identified the improper unbundling during audits in 2011 and 2013 and told top Coordinated Health executives about the problem. “Motivated by its bottom line, Coordinated Health simply ignored the consultants’ recommendations and continued abusing Modifier 59 to improperly unbundle orthopedic surgery claims until mid-2014,” states a Justice Department press release.

Coordinated Health will pay $11.25 million and Dr. DiIorio will pay $1.25 million to settle the allegations. In addition to the monetary settlement, Coordinated Health entered into a corporate integrity agreement with HHS that will require monitoring of its billing practices for five years.

Regarding the settlement, Coordinated Health released the following statement: “We are pleased to have come to a resolution with the federal government regarding allegations of our past use of a specific Medicare billing modifier, involving a complex Centers for Medicare and Medicaid Services rule, which does not relate to the quality of patient care. We have already updated our billing practice to resolve the issue in question, and have taken a number of decisive actions to reduce the potential for issues in the future. Our focus has been and always will be providing the best possible patient care in the communities we serve.”

 

Humana files suit against 37 drug makers accusing them of price fixing

https://www.healthcarefinancenews.com/news/humana-files-suit-against-37-drug-makers-accusing-them-price-fixing?mkt_tok=eyJpIjoiWlROaE56WXlNV1JrTlRRNSIsInQiOiJtQUlRODhrK2xUNW00em4rcUIyWEg0enJuVFBPXC9DUEl0VGhLTWNNUHFwcmdCMG5FTm9cLzNPbzQ4Sm5pR1hcL1wvSzBvNmU2Z0RFVGloQlBpU0Z4bnFhZmFEWnJUWXVmdHZcL3V1UEd0dzB5MFF5XC96OTNHWUpPVkpyaVRDRTRPaTYraSJ9

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The conspiracy involving secret meetings resulted in higher prices for insurers, the government and consumers, the lawsuit claims.

Humana has brought a lawsuit against 37 pharmaceutical companies including Novartis, Mylan and Teva, alleging price fixing for numerous generic drugs.

The conspiracy increased the profits of the drug makers and others working with them at the expense of consumers, the government and private payers such as Humana, the lawsuit said.

Humana wants to recover damages it said it incurred from overcharges for certain widely-used generics, according to the lawsuit filed Friday in federal court for the Eastern Division of Pennsylvania.

Humana said the conspiracy is far-reaching among the drug makers to manipulate markets and obstruct generic competition. They agreed to fix, increase, stabilize and/or maintain the price of the drugs specified, along with other drugs, the court document said.

Humana accuses the pharmaceutical companies of secret meetings and communications at public and private events such as trade association meetings held by the Generic Pharmaceutical Association and others.

Humana’s allegations are based on personal knowledge and information made public during ongoing government investigations, the insurer said.

The pricing fixing is also under investigation by federal and state authorities, the lawsuit said.

The Attorneys General of 47 states, Washington, D.C. and Puerto Rico have filed a civil enforcement action against most of the named defendants, alleging agreements to fix 15 drug prices, the lawsuit said.

The Department of Justice has convened a grand jury to investigate a number of the defendants for price increases ranging from 100 percent to 400, 2,600 and 8,000 percent, Humana said.

The price increases are consistent with Medicare Part D price increases found by the Government Accountability Office for many of the subject drugs.

Among the drugs for which GAO identified “extraordinary price increases” — defined as a price increase of 100 percent or more — between the first quarter of 2011 and the first quarter of 2015, are, according to Humana, Amitriptyline, an antidepressant; Baclofen, a muscle relaxant and anti-spastic agent; Benazepril, an ACE inhibitor to treat hypertension; Clobetasol, a steroid and anti-inflammatory agent;  Clomipramine, an antidepressant for obsessive compulsive disorder; Digoxin, used to treat heart failure and atrial fibrillation; Divalproex for seizure disorders; Doxycycline (in Hyclate form) an antibiotic; Leflunomide for rheumatoid arthritis; Levothyroxine, a thyroid drug to treat hypothyroidism; Lidocaine, an anesthetic;  Nystatin, an antifungal for skin infections; Pravastatin to lower cholesterol; Propranolol, a beta blocker to treat hypertension; Ursodiol, to decrease the amount of cholesterol produced by the liver; and Verapamil, to treat hypertension, angina and certain heart rhythm disorders.

 

AT&T, Time Warner, and the Future of Health Care

https://www.commonwealthfund.org/blog/2018/att-time-warner-and-future-health-care?omnicid=EALERT%25%25jobid%25%25&mid=%25%25emailaddr%25%25

AT&T Time Warner Merger

Policymakers and private actors should not interpret a federal court’s AT&T and Time Warner ruling as an unconditional green light for vertical integration in health care.

The need for change in the U.S. health care system is obvious, but whether vertical integration is the change we need remains to be determined.

The recent federal district court ruling allowing the merger of AT&T and Time Warner — a case of so-called vertical integration — will likely encourage similar unions throughout the U.S. economy, including in health care. Nevertheless, a close look at the court’s decision, and at the wide variety of vertical health care mergers under way, suggests that policymakers and private actors should not interpret the court’s ruling as an unconditional green light for vertical integration in health care, or any other sector.

Vertical integration typically involves the combination of entities operating on different parts of a supply chain in the production of a particular product. Manufacturers of tires, for example, are part of the supply chain that results in a finished automobile. Similarly, ambulatory physician services are sometimes seen as an input on the supply chain of more advanced hospital services. The acquisition of physician practices by hospitals is often characterized as vertical integration.

Some antitrust experts question whether the analogy between manufactured products and health care delivery is accurate. Independent physicians, for example, often work within hospitals and help to produce their “products.” Nevertheless, there are clear differences between mergers across the same types of health care organizations, like hospitals, and those between different types of providers, like physicians and hospitals.

The AT&T/Time Warner case was the first time in 40 years that the government has taken a proposed vertical integration to court, and many commentators have noted that antitrust theory with respect to vertical integration could use some updating. In the meantime, however, Judge Richard Leon’s 172-page opinion seems to have relied on traditional antitrust considerations: would the merger increase or decrease competition, and thereby increase or decrease consumer welfare? His ruling rested heavily on what he viewed as the government’s failure to supply evidence that the merger would have adverse effects. In other words, if the government had produced more convincing data, the ruling could have gone the other way.

Judge Leon’s ruling may be appealed and, if so, may not stand. But if it does, what are its implications for vertical integration in health care? Simply put, the facts matter. And unfortunately, the facts about vertical integration in health care are obscure, and likely to vary enormously according to the details of the merger and from market to market.

Evidence on the effects of horizontal health care mergers has grown considerably in recent years, and generally shows that they increase prices. But studies of vertical health care mergers are much less common. Perhaps the most relevant experience concerns long-standing integrated health systems, such as Kaiser Permanente, Intermountain, Geisinger, and a handful of similar organizations.

Widely regarded as industry leaders in quality and efficiency, these systems seem to demonstrate the benefits of vertical integration: they are able to coordinate services across different types of providers, and, when incentives encourage it, they can easily substitute less expensive services (e.g., ambulatory care) for more expensive ones (e.g., hospital care). However, whether the experiences of these integrated systems are generalizable to the current flock of mergers is unclear. Each of these venerable organizations has a unique history and culture that have shaped its performance over decades.

Studies of vertical integration will have to take into account the type of merger under consideration. The most common type of vertical integration seems to be the acquisition of physician groups — both primary care and specialty — by hospitals. Between 2012 and 2016, the number of hospital-employed U.S. physicians increased from 95,000 to 155,000.

But health care is witnessing a variety of other types of vertical integration. Insurers are buying physician groups, as in the case of UnitedHealth Group’s acquisition of parts of DaVita’s physician network. Drug store chains are buying insurers, as in the case of CVS’s purchase of Aetna. And integrated health systems like Partners HealthCare are proposing to buy insurers like Harvard Pilgrim Health Care.

The effects of these varied mergers will depend on the types of services being combined and the markets affected. From both a societal and legal standpoint, the facts matter.

For example, it turns out that the CVS-Aetna merger includes an important horizontal union between Part D health plans owned independently by CVS and Aetna. Part D health plans provide drug coverage to Medicare beneficiaries. In recent testimony before the California Department of Insurance, economist Richard Scheffler showed that in a number of markets, the merger of these Part D plans would significantly reduce competition, and thereby, could potentially increase the prices of drug coverage for Medicare patients. Fear of consolidation among Part D plans has caused the American Medical Association to oppose CVS’s acquisition of Aetna.

Adding to the uncertainty surrounding these questions is the unique nature of the health market, in which governments are the largest purchasers and consumers often don’t know the prices or value of the products they buy. Traditional competition in local markets sometimes results in radically increasing prices and costs, as providers pile on new technologies and facilities and compete for star physicians in an effort to attract customers. And many parts of health care already have a high degree of consolidation that limits price competition.  The result is a level of dysfunction that has created an almost universal cry for radical disruption of the status quo.

Health care is a conundrum on many levels, and how and whether to regulate vertical integration among its varied components may turn out to be another one. The need for change is obvious. Whether vertical integration is the change we need, and how the courts will treat it, remain to be determined.

 

Henry Ford Allegiance ‘Reluctantly’ Settles DOJ Antitrust Suit

http://www.healthleadersmedia.com/marketing/henry-ford-allegiance-reluctantly-settles-doj-antitrust-suit?utm_source=edit&utm_medium=ENL&utm_campaign=HLM-Daily-SilverPop_02142018&spMailingID=12931448&spUserID=MTY3ODg4NTg1MzQ4S0&spJobID=1341286596&spReportId=MTM0MTI4NjU5NgS2

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The Jackson, Michigan–based health system agrees to stop coordinated anti-competitive business activities with competitors, but insists that it did nothing wrong.

Henry Ford Allegiance Health has settled its three-year antitrust fight with state and federal prosecutors, just weeks before the case was set for trial in federal court.

The Department of Justice and the Michigan Attorney General’s office filed suit in 2015, alleging that Henry Ford Allegiance Health and three other health systems in south central Michigan carved up the territory and insulated themselves from competition by agreeing to withhold outreach and marketing in each other’s respective counties.

The three other health systems, Hillsdale Community Health Center; Community Health Center of Branch County in Coldwater; and ProMedica Health System in Toledo, OH, settled their suits two years ago.

“As a result of Allegiance’s per se illegal agreement to restrict marketing of competing services in Hillsdale County, Michigan consumers were deprived of valuable services and healthcare information,” Assistant Attorney General Makan Delrahim in DOJ’s Antitrust Division said in a media release. “By prohibiting further anticompetitive conduct and educating Allegiance executives on antitrust law, this settlement will ensure that consumers receive the fruits of robust competition.”

The proposed settlement was filed Friday in U.S. District Court for the Eastern District of Michigan, where the case was scheduled to go to trial on March 6.

Allegiance said in prepared remarks that it felt compelled to settle even though it did nothing wrong.

“We reluctantly chose to settle this litigation because continuing to defend ourselves against the United States and State of Michigan became too costly,” the health system said. “This decision, regrettable but necessary, requires us to discontinue our defense of this case before the Court could rule on any of the highly contested issues raised in the litigation.”

DOJ’s settlement with Allegiance expands on the earlier settlements with the other three health systems, which means that Allegiance cannot communicate, coordinate or limit marketing or business development with competitors. The agreement ends the health system’s carve out in Hillsdale County. Allegiance must also file annual compliance reports and submit to compliance inspections, and reimburse state and federal prosecutors for the court costs.

DOJ said the deal includes several new provisions that are now included in all new consent decrees that add greater specificity and accountability.

“The proposed settlement will make it easier and more efficient for the department to enforce the decree by allowing the department to prove alleged violations by a preponderance of the evidence,” Delrahim said. “These provisions will encourage a stronger commitment to compliance and will ease the strain on the department in investigating and enforcing possible violations.”

Patricia Wagner, an antitrust attorney with Epstein Becker Green and a disinterested observer, said DOJ is applying more rigorous benchmarks for its consent decrees.

“When you do your annual report you have to document that everybody got their four hours of training and you have to provide the materials that were used in those training sessions. If DOJ asks, you’d have to provide a lot of who had what conversations, and when,” Wagner said. “Instead of just having a general ‘you will comply with this consent order and verify annually that you are doing so,’ it is giving organizations the steps that DOJ thinks they need to take in order to comply with the consent judgements.”

“If I am a CEO of a hospital maybe I am thinking about how to get ahead of this situation. Should I have someone who is responsible for antitrust compliance?” she said. “All hospitals have large compliance programs that are usually focused, as they should be, on fraud and abuse and licensure issues. It seems like a natural evolution to say ‘maybe we should be thinking about including antitrust in that larger compliance program.'”

Henry Ford Allegiance Health operates the only hospital in Jackson County, MI. The system also operates primary care, physical rehabilitation, and diagnostic facilities in several counties in south central Michigan. Allegiance joined Henry Ford Health System in 2016.

Allegiance’s statement in full reads as follows:

Allegiance Health and the Department of Justice have settled an antitrust case brought by the DOJ against Allegiance Health in 2015. The original complaint alleged that Allegiance Health entered into an agreement with Hillsdale Community Health Center to limit marketing in Hillsdale County.

We reluctantly chose to settle this litigation because continuing to defend ourselves against the United States and State of Michigan became too costly. This decision, regrettable but necessary, requires us to discontinue our defense of this case before the Court could rule on any of the highly contested issues raised in the litigation. 

We still deny unlawful conduct of any kind, and the settlement does not include any admission of liability. Despite almost three years of litigation, there was no finding of wrong doing by the Court, and, as recently as December, the Court contemplated dismissing the action in its entirety.  In addition, the Court has never ruled that the citizens of Hillsdale County were harmed by our marketing strategy.

We reaffirm our belief that we promoted competition in south central Michigan and benefitted the citizens of Hillsdale County in undeniable ways. The terms of the settlement allow us to continue our marketing strategies in order to best serve the people of south central Michigan including Hillsdale County.

 

 

Court Strikes Down Overtime Pay Rule

https://www.tlnt.com/court-strikes-down-overtime-pay-rule/?mkt_tok=eyJpIjoiWW1Wa01qQm1NalF6TlRaaiIsInQiOiJtdjRoMkRUTFB4MkU3eFNobGdCYWszVVwvanBPbnYrSW5LdVZJenZvTVNKTG4zRmxCVjdacVJ4eWI0UFlFUzlXMnJJQXhEZEJCbjBacXJrVGQ0RXVWYWRCaE1xeks3XC9CSFJYSGxyRDVERzFuNjJkcVBUNW5TWURPREVGMncxYnZnIn0%3D

The Department of Labor rule that would have compelled employers to pay overtime to millions of more workers has been struck down by a federal court in Texas.

Agreeing with business groups and the 21 states that had challenged the Obama administration rule, District Judge Amos Mazzant said the pay level in the changed rules was set too high.

What the Labor Department had done was to nearly double the minimum pay — from $455 to $913 a week — for determining what workers were exempt from overtime and what workers were entitled to it.

“This significant increase would essentially make an employee’s duties, functions, or tasks irrelevant if the employee’s salary falls below the new minimum salary level,” Mazzant said in his ruling.

While that was also true of the old salary threshold, the states and business groups that challenged the DOL argued the new pay level was set so high that it would sweep in millions of workers performing managerial, administrative and professional work.

Under the Fair Labor Standards Act, workers regardless of how much they earn must be paid overtime, except if they fall under certain exemptions, which largely define them as managers and white collar workers. But over the years, the DOL has adopted a financial test setting a minimum pay as a way to simplify the classification.

Thus, those making less than $455 a week are automatically to be paid overtime. And under the duties test, even workers earning more than the $455 a week are entitled to overtime unless they are “bona fide executive, administrative, professional (or) outside sales employees.” Some types of computer jobs also are included.

The revised salary threshold was to have gone into effect December 1 last year. But just weeks before the deadline, Judge Mazzant issued an injunction which left the old pay level — first adopted in 2004 — in place. The Labor Department appealed the injunction, then reversed course after the Trump administration took office. That left the injunction in place and freed the district court to rule on the merits.

In his ruling, Mazzant said the DOL can use a salary test, but only in conjunction with a duties test.

BCBS of Michigan faces more than 30 lawsuits alleging hidden health plan fees

http://www.beckershospitalreview.com/legal-regulatory-issues/bcbs-of-michigan-faces-more-than-30-lawsuits-alleging-hidden-health-plan-fees.html

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More than 30 lawsuits filed against Detroit-based Blue Cross Blue Shield of Michigan in the past week claim the insurer charged employers unauthorized and hidden fees for their health plans, Bloomberg BNA reports.

Filed between Aug. 9 and Aug. 11 in Michigan’s federal court, the lawsuits allege BCBSM issued hidden markups to employers’ health plan assets to shore up its finances, the report states. The allegations stem from a 2014 appeals court decision finding the payer responsible for the unauthorized fees under the Employee Retirement Income Security Act. The decision also upheld a $6 million judgment against BCBSM.

More than 200 ERISA lawsuits alleging hidden health plan fees were filed against the payer since the 2014 decision, the report states. A college, an auto parts maker, a plastics manufacturer and a car dealer are among the employers suing BCBSM.

BCBSM did not respond to Bloomberg BNA‘s request for comment.

Trinity Health Settles Church Pension Suit for $75M

http://www.bna.com/trinity-health-settles-n73014445765/

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Pasadena doctor who falsely claimed patients were terminally ill is sentenced to four years for fraud

http://www.latimes.com/local/lanow/la-me-ln-pasadena-doctor-prison-20160824-snap-story.html?utm_campaign=CHL%3A+Daily+Edition&utm_source=hs_email&utm_medium=email&utm_content=33409508&_hsenc=p2ANqtz–KDKuU4PH1yztKbkXarPsY58B6-80M433Uz-u6qd86BDE6zJ4zbv5sPgwskL5rfPSDgOeUJw0jeuHlEK79jrfz4jh2Jg&_hsmi=33409508

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A Pasadena doctor convicted of falsely certifying that more than 79 patients were terminally ill as part of a scheme to bilk Medicare and Medi-Cal was sentenced by a federal judge to four years in prison.

U.S. District Judge S. James Otero also ordered Boyao Huang, 43, to pay $1,344,204 in restitution last week. In May, Huang was found guilty of four counts of healthcare fraud at the conclusion of a two-week trial that centered on a ploy to defraud the government of $8.8 million by making it pay for hospice-related services. Huang could have received up to 10 years in prison for each of the counts.

Fla. physician gets 25 years in prison for 3 overdose deaths

http://www.beckershospitalreview.com/legal-regulatory-issues/fla-physician-gets-25-years-in-prison-for-3-overdose-deaths.html

Drug Overdoses