A.G. Schneiderman Announces National Settlement With Anthem To Discontinue Pre-Authorization For Opioid Addiction Treatment Drugs

Following Agreement With Cigna, Anthem Is Second Settlement Attorney General Schneiderman Has Reached To Remove Barriers and Expand Access To Life-Saving Treatment For Opioid Use Disorder

Empire BlueCross BlueShield Will Also Launch Initiative In New York To Expand Access To Opioid Addiction Treatment Drugs

   Attorney General Eric T. Schneiderman today announced that Anthem, the second largest health insurer in the country, will end its policy of requiring prior authorization for medication-assisted treatment (“MAT”) for opioid use disorder. The agreement includes Empire BlueCross BlueShield (BCBS), which insures over 4 million New Yorkers, and resolves Attorney General Schneiderman’s investigation of prior authorization practices and network adequacy for MAT treatment. The agreement comes several months after Attorney General Schneiderman announced a similar agreement with Cigna.

MAT, when prescribed and monitored properly, has proved effective in helping patients recover from opioid use disorder, and is both safe and cost-effective to reduce the risk of overdose. This policy change will apply not only to most Anthem members in New York, but nationally as well. 

“We’re facing an opioid crisis in New York and around the country – and we should be doing whatever we can to make lifesaving treatments accessible to those suffering from addiction,” said Attorney General Schneiderman. “I am pleased that this is the second national settlement my office has reached with major insurers to remove hurdles to opioid addiction treatment. While we’ve made progress, there are too many still suffering. We’re committed to continue working with health insurers across the country to eliminate barriers to lifesaving opioid addiction treatments.”

Anthem required providers to submit a prior approval form for MAT coverage requests, which required the providers -- who had already received specific training regarding MAT and federal authorization to prescribe these drugs -- to answer numerous questions about the patient’s current treatment and medication history. The Attorney General’s investigation revealed that Empire BCBS denied nearly 8% of the overall requests for coverage of MAT in 2015 and the first half of 2016. This subsequently caused significant delays in patients obtaining treatment for addiction – or patients never obtaining the treatment at all.

In contrast to its policy for drugs to treat opioid use disorder, Empire BCBS does not require prior authorization for the majority of drugs it covers for medical conditions. In particular, Empire BCBS does not require prior authorization for powerful opioids, including fentanyl, morphine, tramadol, and oxycodone, when prescribed for pain. These disparities are not consistent with the New York and federal mental health parity laws, which require health plans to cover mental health and substance use disorder treatment the same way they cover treatment for physical conditions.

Under the agreement, Empire BCBS will also launch an initiative to expand access to MAT for members in its New York service area. Empire BCBS will conduct provider outreach and education regarding the benefits of MAT, informing qualified health care providers how they can obtain certification from the Substance Abuse and Mental Health Services Administration (“SAMHSA”) to prescribe buprenorphine and buprenorphine/naloxone as part of MAT for opioid dependence. Empire BCBS will provide the Attorney General with a list of MAT providers who have joined its network as a result of this initiative.

Unlike methadone treatment, which must be administered in a highly structured clinic, MAT medications, usually containing buprenorphine and naloxone, may be prescribed or dispensed in physicians’ offices to treat opioid use disorder, provided the treating physician has obtained the appropriate certification and has been issued a special DEA license. In addition to the medication component, psychosocial therapy and management of medical issues are also recommended components of MAT to treat opioid use disorder.

Buprenorphine is an opioid partial agonist, meaning that it has lesser euphoric effects than full opioid agonists such as heroin. At low doses, buprenorphine produces sufficient agonist effects to enable opioid-addicted individuals to discontinue the misuse of opioids without experiencing withdrawal symptoms. Buprenorphine carries a lower risk of abuse, addiction, and side effects when compared with full opioid agonists. Naloxone is an opioid antagonist that can be added to buprenorphine that will decrease the likelihood of diversion and misuse of the combination drug product. If the combination drug product is crushed and injected the naloxone and can bring on opioid withdrawal, which serves as a deterrent to diversion and misuse.

The Centers for Disease Control and Prevention considers MAT a proven, effective treatment for individuals with an opioid use disorder. MAT has been shown to increase treatment retention and to reduce opioid use. One study showed that for half the patients treated with buprenorphine/naloxone for addiction to prescription opioids, they were abstinent from the drugs 18 months after starting MAT, and after three and a half years, 61% of the patients reported abstinence from illicit opioids. MAT is supported and endorsed by the CDC, the Substance Abuse and Mental Health Services Administration (SAMHSA), the American Society of Addiction Medicine (ASAM), the New York State Office of Alcoholism and Substance Abuse Services (OASAS) and the New York City Department of Health and Mental Hygiene (NYCDOHMH) as a treatment for opioid addiction.

In a recently issued report, the Centers for Disease Control (CDC) reports that more than 33,000 people nationally died from opioid overdoses. In New York in 2015, there were almost 2,800 overdose deaths, with overdose deaths from synthetic opioids (such as fentanyl) increasing by 135% from 2014, and heroin overdose deaths increasing by 29% from 2014.

Addressing access barriers to MAT is just the latest step that Attorney General Eric T. Schneiderman has taken to address the opioid addiction crisis. In June of 2011, Attorney General Schneiderman introduced state legislation for I-STOP, an online Prescription Monitoring Program or a “PMP,” that enables doctors and pharmacists to report and track controlled narcotics in real time. I-STOP became effective in August of 2013, making New York State one of the first states to establish such a PMP, and has reduced “doctor-shopping” by 75%. The OAG has also aggressively enforced laws that require parity in health plan coverage of mental health and addiction treatment, reaching agreements with six companies, including Anthem, MVP Healthcare, EmblemHealth, Excellus, Beacon Health Options, and HealthNow. Most recently, in October 2016, the Attorney General announced a national agreement with Cigna, which agreed to remove prior authorization requirements for MAT. The Attorney General’s Office has prosecuted many individuals who have engaged in the illegal distribution and sale of narcotics as well as health care providers who illegally prescribed and diverted opioids. The OAG’s Community Overdose Prevention (COP) Program, which equips New York law enforcement agencies with a life-saving heroin overdose antidote, has saved more than 100 lives. The OAG has also reached agreements with Purdue Pharma and Endo Pharmaceuticals Inc., to ensure that these opioid makers engage in responsible and legal marketing. 

Anthem’s policy change follows efforts by both New York State and the federal government to increase access to MAT for opioid use disorder. New York State recently enacted legislation prohibiting insurers from requiring prior authorization for emergency supplies of MAT medications and also removed prior authorization for Medicaid members seeking MAT for opioid use disorder, while the federal government increased the maximum number of patients that MAT-certified providers can treat at one time from 100 to 275 and now permits qualified nurse practitioners and physician assistants to prescribe MAT drugs.

“ASAM welcomes Attorney General Schneiderman’s agreement with Anthem to discontinue the requirement of prior authorization requirements to cover buprenorphine containing medications.  We also applaud the agreement for Empire BCBS to actively work to improve access to effective opioid treatment with MAT for their network members and to provide evidence for that improved access. We hope to see other payers following the lead of Cigna and Anthem on this critical issue,” said Kelly J. Clark, President Elect of the American Society of Addiction Medicine.

“We applaud Attorney General Schneiderman for continuing to challenge discriminatory barriers to drug treatment.  Preauthorization requirements for addiction medication are not only discriminatory, but cost lives.  It is critical that all health insurers offer the full range of medications to treat substance use disorders, without imposing illegal barriers to these life-saving treatments,” said Sally Friedman, Legal Director, Legal Action Center.

“My son, Michael, was denied treatment he desperately needed,” said Avi Israel, President and Founder of Save the Michaels of the World. “This settlement removes the prior authorization obstacle for MAT that too many families have faced for too long. I thank Attorney General Schneiderman for his hard work.”

“Many individuals with mental illness also have a co-occurring addiction disorder. A significant impediment to getting medication—assisted treatment (MAT) for opioid use disorder in the pre authorization challenges that many individuals face. We applaud Attorney General Schneiderman and his staff for advocating strongly for individuals with behavioral health needs, by both working to highlight and eliminate these pre-authorization practices,” said Glenn Liebman, CEO, Mental Health Association in New York State.

Richard D. Blondell, MD, Professor and Vice Chair for Addiction Medicine in the Department of Family Medicine, University at Buffalo said, “this practice created a huge burden on the staff of medical offices and was associated with a delay in the treatment of patients. When a person who has an opioid use disorder decides to seek help, there is typically a small window of opportunity to engage that individual in effective treatment; waiting for days to treat this condition represents an unnecessary risk that can be deadly for some.”

Kevin Jones, the Executive Director of the Heroin Epidemic Action League (HEAL) of Auburn said, “this agreement with the Attorney General is a great step forward in the battle against opioid abuse. When an addict finally reaches the point where they are ready to do something about their problem, there is only a short window of time to get them treatment. Without immediate medical assistance, many return back to the streets, and it may never cross their mind again to seek help. People die every day from using drugs, while waiting for help. That was the case with my step daughter. This agreement will save thousands of lives.

“The Long Island Council on Alcoholism and Drug Dependence (LICADD) wishes to convey our debt of gratitude to NYS Attorney General Eric Schneiderman who continues to advocate for the rights of substance users to access evidence-based treatment modalities void of stigma and inequities often displayed in the excluding policies of insurance companies. In times of great crisis, there emerges individuals with a great sense of duty and responsibility. AG Schneiderman has demonstrated his willingness to engage in effective action in challenging these inequities demonstrated by insurance companies to insure all New Yorkers, and their families, afflicted with the disease of substance use disorders have equal access to the quality care and treatment afforded to individuals living with other diseases and conditions.  On behalf of the thousands of individuals and families we serve at LICADD, thank you Mr. Attorney General,” said Steve Chassman, LCSW, CASAC- LICADD Executive Director.

“Medication-assisted treatment can provide a path to recovery for those struggling with addiction,” said Jennifer Faringer, M.S.Ed., CPP, Director of the National Council on Alcoholism and Drug Dependence-Rochester Area (NCADD-RA). “The Monroe County Opioid Task Force is focused on eliminating barriers to treatment, and Attorney General Schneiderman’s continued push to end prior authorizations for MAT is crucial to this effort.”

Consumers with questions or concerns about this settlement or other health care matters may call the Attorney General’s Health Care Bureau Helpline at 1-800-428-9071.

Read the agreement with Anthem.

A.G. Schneiderman Leads Coalition To Defend EPA Rule Protecting States From Upwind Smog Pollution

Six A.G’s File Motion To Defend EPA’s Cross-State Air Pollution Update Rule Against Challenge By Fossil Fuel Industry And Upwind States In The South And West 

A.G.s’ Action A Critical Safeguard Against Any Attempts By Incoming Trump Administration To Undermine Federal Environmental Protections And States’ Responsibility To Prevent Air Pollution From Spreading To Their Neighbors 

   Attorney General Eric T. Schneiderman today filed a motion in D.C. District Court seeking to intervene in support of the Environmental Protection Agency’s Cross-State Air Pollution Update Rule, which requires power plants in 22 states to significantly reduce smog pollution that blows into downwind states like New York and threatens public health.

New York joins five other states – Maryland, Massachusetts, New Hampshire, Rhode Island, and Vermont – in the motion to defend the EPA measure, which has been challenged by fourteen energy corporations and upwind states seeking to overturn the rule.

“Smog pollution blowing in from other states threatens the health of millions of New Yorkers, particularly seniors and children,” said Attorney General Schneiderman. “New York has already put in place some of the most effective air quality protections in the country, but we have no control over dirty air that pours in from other states.  The Trump administration has signaled its desire to roll back federal environmental protections, including those that protect states from out-of-state polluters.  This is why defending this sensible, fair, and crucial rule is so important.”

The importance of the rule, and the coalition’s defense of it, is underscored by President-elect Trump’s nomination of Oklahoma A.G. Scott Pruitt as Administrator of the EPA. As stated in a January 17, 2017 letter to the U.S. Senate signed by A.G. Schneiderman and eight state attorneys general, Pruitt has “sought to tear apart the very notion of cooperative federalism that forms the foundation of our federal environmental laws.” Cooperative federalism – where national, state, and local governments act collectively to solve common problems – is critical to avoiding a situation where states with inadequate pollution control measures pass this pollution and its public health and environmental impacts to neighboring states. 

The federal Clean Air Act confers dual responsibility on the EPA and the states to improve and maintain air quality both in-state and in downwind states. When states' efforts to address interstate air pollution are inadequate, the Act specifically requires EPA to address the interstate transport of air pollution.

The Cross-State Air Pollution Update Rule requires power plants in 22 states to participate in a regional allowance trading program beginning in May 2017 that will reduce emissions of nitrous oxide (which contributes to the formation of ground-level ozone, or “smog”) in time to assist downwind states with meeting the national ozone standards established by EPA in 2008.

Attorney General Schneiderman has made clear that he stands ready to use the full power of his office to compel enforcement of our nation’s environmental laws. In addition to opposing A.G. Pruitt’s nomination to lead the EPA, Schneiderman has led a coalition of 19 states and localities calling on President-elect Trump to continue the federal government’s defense of the Clean Power Plan and reject the “misguided” advice to discard the plan.

SCAFFOLDING CORP. PRESIDENT PLEADS GUILTY TO $1M TAX FRAUD; WILL PAY $2M IN BACK TAXES AND FEES, SERVE JAIL TIME

Three-Year Investigation By Bronx DA’s Office and NYC Department of Finance 

  Bronx District Attorney Darcel D. Clark today announced that the president of two scaffolding corporations has pleaded guilty to Criminal Tax Fraud and will pay over $2 million in taxes and penalties and serve 16 weekends in jail for underreporting millions of dollars in income of his Bronx-based businesses. 

  District Attorney Clark said, “This defendant used a check-cashing scheme to avoid paying nearly $1 million dollars in taxes on income from city, state and private contracts. Together with the New York City Department of Finance, we investigated this case and the defendant pleaded guilty to felony charges and will pay $2 million to city and state coffers. Such disregard of the law is a slap in the face of hardworking taxpayers.” 

  New York City Department of Finance Commissioner Jacques Jiha said, “This conviction is the result of our ongoing investigation into tax crimes that eventually impact the many New York City businesses that are law abiding. I want to thank our Tax Enforcement unit as well as our partners at the Bronx D.A. for their hard work and dedication, and I hope this serves as a strong deterrent to those who look for ways to skirt the law.” 

  District Attorney Clark said the defendant, Prabhjit Singh, 36, president of Rock Scaffolding Corporation and M.S.S. Sidewalk, Bridging and Scaffolding Corporation, pleaded guilty today before Bronx Supreme Court Justice John Carter to two counts of fourth-degree City Criminal Tax Fraud. As part of his plea, he will pay $2 million and will be sentenced on February 3, 2017, to serve weekends in jail for four months. 

  

  District Attorney Clark said that, according to the investigation, since 2008, the corporations avoided paying taxes by either not filing returns, or filing returns with understated income. The income was hidden by cashing checks payable to the firm at check-cashing outlets, instead of depositing them into the firms’ bank accounts where the funds would be reported. 

  The case was prosecuted by Assistant District Attorney W. Dyer Halpern, Director of the Tax and Organizational Fraud Unit, under the supervision of William Zelenka, Chief of the Economic Crimes Bureau, and under the overall supervision of Stuart Levy, Deputy Chief of the Investigations Division and Jean T. Walsh, Chief of the Investigations Division. 

   District Attorney Clark thanked Lieutenant Frankie Brumfield and former Detective Investigator Marie D’Angelo of the Bronx District Attorney’s Detective Investigators for their work on the case.

Bronx Borough President - African American History Month

FREE RAT ACADEMY: RESIDENTS TO LEARN HOW TO RID NEIGHBORHOODS OF CITY’S MOST PESKY RODENT

Senator Jeff Klein, along with Assemblyman Jeffrey Dinowitz , and Councilman Andrew Cohen, will sponsor a special city Department of Health workshop that will offer safe and effective methods for rat prevention on Thursday, January 26 at 3880 Sedgwick Avenue, Bronx from 6 p.m. to 8 p.m.

The one-of-a-kind class will offer free training for homeowners, tenants, business owners, building superintendents, community garden volunteers and others who wish to drive away the four-legged critters from their buildings and neighborhoods.

The Department of Health will raffle off twenty rodent-resistant garbage cans to workshop participants.

STATE SENATOR GUSTAVO RIVERA HOSTS A DAY OF ACTION IN RESPONSE TO THE INAUGURATION OF DONALD TRUMP

    State Senator Gustavo Rivera in partnership with Planned Parenthood of New York City, Citizen Action of New York, Saint Barnabas, Montefiore Health System, the Teen Health Center and the Committee for Hispanic Children & Families, Inc. held a Day of Action this morning at the intersection of Grand Concourse and Fordham Road. This day of action is in direct response to the inauguration of Donald Trump as the 45th President of the United States. 

    Senator Rivera used this Day of Action as a way to directly interact with his constituents and to have a honest conversation about the potential challenges facing our communities in the era of Trump. Additionally, 

participating organizations and his office's staff distributed important information about the variety of services and resources available to them to help address issues they may be facing, whether they concern women's reproductive and health rights to the criminal justice system, among many others.

 This Day of Action reaffirmed Senator Rivera's support towards all those organizations that provide vital services to his constituents and face an uncertain future due to the potential actions by the incoming administration and the Republican-led Congress. Senator Rivera took this opportunity to reassure his community that both as an elected official and as an American he is committed to protecting and defending the rights and dignity of his fellow Bronxites and Americans against any attempt by the federal government to infringe upon them. 

Bronx Community Board 7 Land Use Meeting.

  In what can be described as a usual bland short meeting attended normally by a handful of people, last night's CB 7 Land Use Meeting lasted several hours before a packed room at the Community Board 7 office.

  The agenda included a length;y discussion of the old Dollar Savings Bank building by the corner of  the Grand Concourse and Fordham Road. The new owner wants to build a new entrance to the building which was built in three parts over a period of years in 1938. The ten story tower has only one entrance, and another entrance must be built to accommodate new tenants in the tower that was used by the bank as a headquarters in the past. New Congressman Espiallat has taken an office on the first floor of the old bank, and there are also plans for a day care center. The building is land marked, and any alterations to a land marked building must be approved  by the NYC Landmarks Commission. The owner came to CB 7 for a letter of support which the committee approved.

  A proposed 12 story building on Creston Avenue at the corner of West 191st Street where a current parking lot is was then discussed. The building will be built over the parking lot which is to remain on the ground floor level. There was much opposition to a 12 story building in an area where currently there are buildings no higher than six stories. 174 apartments will be built ranging from studios up to three bedroom apartments. The apartments will be half affordable half market rate priced. 

  The meeting ended with a discussion about the possible down zoning of the Mosholu Parkway area that has been promoted by many area residents. some wanted to know why it was not included in the recent approved contract to survey certain areas of the community board area for possible down zoning. After a gallant try by the residents to add more neighborhood area to the survey, they were told by the Land Use Chair Ms. Jean Hill that the current survey underway could not be increased since the agreement signed stated only a limited area. She added that the consultant would not add any more area to the previously agreed upon contract. Ms. Hill said that the board would have to wait until the next fiscal year to hire another consultant for another survey of the area requested that is not being done currently.

One of the frustrated community members.

A.G. Schneiderman Announces Settlement With Drug Manufacturer For Engaging In Anticompetitive Conduct To Prevent Competition For A Life-Saving Drug For Infants

Joint Investigation Found That Mallinckrodt Illegally Acquired Rights To Competitor Drug 

Schneiderman: We Will Vigorously Enforce The Antitrust Laws To Prevent Consumers And Taxpayers From Being Saddled With The Out-Of-Control Pricing That Can Result From Unlawful Conduct

   Attorney General Eric T. Schneiderman announced a joint settlement with four other Attorneys General and the Federal Trade Commission with Mallinckrodt plc and its U.S. subsidiary, formerly known as Questcor Pharmaceuticals (“Questcor”), a drug manufacturer. The complaint and settlement, filed jointly, alleges that Questcor unlawfully acted to prevent competition for its drug H.P. Acthar Gel, which is typically used as a last resort to treat certain life-threatening diseases, including infantile spasms and multiple sclerosis.  

“This is an egregious case of a monopolist doing a deal to eliminate potential competition and keep its power over pricing. It is abhorrent that lifesaving drugs cost New Yorkers tens of thousands of dollars.” said Attorney General Schneiderman. “This settlement will restore the competition that was prevented by Questcor’s illegal actions, and my office will continue to vigorously enforce antitrust laws to prevent consumers and taxpayers from being saddled with the out-of-control drug prices that can result from unlawful conduct.” 

In 2001, Questcor bought the rights to Acthar, known as an adrenocorticotropic hormone (ACTH)-based therapeutic drug, which are used to treat certain life-threatening diseases, and is the standard of care for infantile spasms. It is the only such drug sold in the United States. Since then, Questcor has increased the price of Acthar 85,000%, from $40 per vial to over $34,000 per vial. The complaint alleges that Questcor monopolized the market for ACTH drugs by purchasing the rights to Synacthen, which was being sold by Novartis Pharma A.G. in 2012. Synacthen is used to treat patients with the same life-threatening conditions as Acthar, but is sold in Europe and Canada at a fraction of the price.

The complaint alleges that three other companies had all conducted due diligence and submitted formal offers for Synacthen with plans to develop and launch Synacthen in the United States in direct competition with Questcor.  However, perceiving the threat to its U.S. monopoly if a rival drug company purchased the assets, Questcor stepped in to outbid the three other companies, offering Novartis $135 million in guaranteed payments with only vague plans for Synacthen and after very limited due diligence. Through the acquisition, Questcor sought to extinguish the most likely challenges to its Acthar monopoly. According to the complaint, this allowed Questcor to continue charging over $34,000 per vial for H.P. Acthar Gel. 

Under the settlement, Mallinckrodt will pay $100 million. The company will also be required to license a competitor to the rights it acquired from Novartis to commercialize and develop Synacthen in the United States, including the Synacthen trademark, along with clinical trial data and certain intellectual property related to manufacturing and formulation. Mallinckrodt is also prohibited from taking actions that would interfere with clinical trials or clinical plans for Synacthen. 

The defendants named in the antitrust action are Mallinckrodt ARD, Inc., formerly known as Questcor Pharmaceuticals, Inc., and its Ireland-based parent company Mallinckrodt plc. In addition to New York, the Attorneys General of Alaska, Maryland, Texas, and Washington entered into this settlement.