Tag: 2016 News

Dr. Michael Roger Chiarottino, age 68, of San Rafael, was indicted by a federal Grand Jury on September 14, 2014. He was charged with fifteen counts of distribution of controlled substances in violation of Title 21, United States Code, Section 841(a)(1).

Chiarottino pleaded guilty on March 8, 2016, to one count of distributing oxycodone, a Schedule II controlled substance, outside the usual course of professional practice and without a legitimate medical purpose.

According to his plea agreement, Chiarottino admitted that he prescribed large quantities of controlled substances (including oxycodone, oxymorphone, hydromorphone, methadone, and hydrocodone) to undercover DEA agents posing as patients in exchange for cash. On each occasion, Chiarottino failed to conduct an appropriate medical examination of, or obtain a sufficient patient medical history from, the undercover agent to support a prescription for such a large quantity of narcotics. In total, Dr. Chiarottino prescribed 46.8 grams of oxycodone (numbering 1,530 thirty-milligram pills) and admitted doing so with the intent to act outside the usual course of professional practice and without a legitimate medical purpose.

In his plea agreement, Chiarottino also admitted that he met with patients and wrote prescriptions for controlled substances at North Bay Pain Management Services and therefore maintained a premises for the distribution of controlled substances. Chiarottino also admitted that, as a licensed physician and DEA registrant, he abused a position of trust and used a special skill to intentionally prescribe controlled substances without a legitimate medical purpose.

Chiarottino was sentenced this July to three years in prison for illegally prescribing oxycodone and other controlled substances.

The sentence was handed down by The Honorable Jeffrey S. White, U.S. District Court Judge. Judge White also sentenced the defendant to a five-year period of supervised release. During this period of supervised release, Chiarottino is barred from providing medical treatment or examining any patient in the course of any employment or professional practice. Chiarottino is also forbidden from prescribing medication or controlled substances to any person and may not supervise any medical practitioner in treating any medical patient or prescribing any medication. Finally, as a condition of his supervised release, Chiarottino is required to cooperate with and not contest any administrative action to revoke or suspend his license to practice medicine or prescribe controlled substances by the Medical Board of California and the Drug Enforcement Administration. Chiarottino’s medical license is currently suspended.

The defendant will begin serving the sentence on October 20, 2016.

The prosecution is the result of an investigation by the Drug Enforcement Administration, the Livermore Police Department, the Pleasanton Police Department, and the Medical Board of California. This case is the product of an extensive investigation by the Organized Crime Drug Enforcement Task Force, a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state and local law enforcement agencies.

Opioid abuse has come to the forefront as a serious public health issue. In fact, drug overdoses are now the leading cause of death in the United States, ahead of motor vehicle accidents and firearms. A number of federal legislative proposals have recently been introduced to address this crisis.

In near-apocalyptic terms, U.S. Sen. John Cornyn described the rising tide of American opioid abuse at a Senate Judiciary Committee hearing earlier this year. “Opioid prescription drug and heroin addiction is ripping away at the fiber of our homes and our communities in our nation,” Texas’ senior senator said. “It’s destroying families, increasing crime, making our communities less safe, hurting our economy, and robbing millions of Americans of their future.”

The National Law Review reports that while the U.S. House passed several bills on the issue, the U.S. Senate passed its own measure, S.524, the Comprehensive Addiction and Recovery Act of 2016 (CARA Act). In a bipartisan effort, both the House and Senate appointed conferees to hammer out differences. Those appointed to the Conference included 35 House members (made up of 21 Republicans and 14 Democrats) including Representatives from -key Committees including the House Energy and Commerce Committee and the House Ways and Means Committee. The Senate had seven conferees. While addressing opioid abuse is bipartisan in nature, there was disagreement on process and content throughout the legislative process. One area of debate was funding for the bill.

The Act passed in the Senate by 90-2 after Democrats followed their colleagues in the House of Representatives and dropped calls for the legislation to include additional funding. Senate Majority Leader Mitch McConnell, called for Senate Democrats to pass the measure, citing support for the legislation by the National Association of Counties, the National League of Cities, the Fraternal Order of Police and more than 200 other groups.

CARA includes several provisions concerning the need for expansion of prevention and education on the misuse of prescription pain killers and heroin. Law enforcement agencies and first responders are permitted to distribute naloxone for the reversal of overdose. Evidence-based treatment and intervention programs for incarcerated individuals and those across the country will be implemented. There will be safe disposal sites for prescription medications to diminish the opportunity for ill use. The Act creates a medication assisted treatment program for pain management and expands states’ drug monitoring programs to eliminate doctor shopping.

Now that CARA has passed and has been signed into law by the President, stakeholders will be watching closely for implementing rules, regulations, changes to incentive-based patient surveys, as well as any grant opportunities.

Further discussion of funding may arise as Congress discusses budgetary options in 2017and beyond.

“This is a historic moment, the first time in decades that Congress has passed comprehensive addiction legislation, and the first time Congress has ever supported long-term addiction recovery,” said Sen. Rob Portman, a chief author of the legislation. “This is also the first time that we’ve treated addiction like the disease that it is, which will help put an end to the stigma that has surrounded addiction for too long.”

The U.S. Department of Justice and attorneys general from multiple states and the District of Columbia filed litigation to block Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana, alleging that the transactions would increase concentration and harm competition across the country, reducing from five to three the number of large, national health insurers in the nation.

The department and state attorneys general filed these two merger challenges in the U.S. District Court for the District of Columbia; The complaints allege that the two mergers – valued at $54 billion and $37 billion – would harm seniors, working families and individuals, employers and doctors and other healthcare providers by limiting price competition, reducing benefits, decreasing incentives to provide innovative wellness programs and lowering the quality of care.

Eleven states – California, Colorado, Connecticut, Georgia, Iowa, Maine, Maryland, New Hampshire, New York, Tennessee and Virginia – and the District of Columbia joined the department’s challenge of Anthem’s $54 billion acquisition of Cigna; Eight states – Delaware, Florida, Georgia, Iowa, Illinois, Ohio, Pennsylvania and Virginia – and the District of Columbia joined the department’s challenge of Aetna’s $37 billion acquisition of Humana.

The suit against Anthem and Cigna alleges that their merger would substantially reduce competition for millions of consumers who receive commercial health insurance coverage from national employers throughout the United States; from large-group employers in at least 35 metropolitan areas, including New York, Los Angeles, San Francisco, Denver and Indianapolis; and from public exchanges created by the Affordable Care Act in St. Louis and Denver. The complaint also alleges that the elimination of Cigna threatens competition among commercial insurers for the purchase of healthcare services from hospitals, physicians and other healthcare providers. The merger would eliminate substantial head-to-head competition in all these markets, and it would remove the independent competitive force of Cigna, which has been a leader in the industry’s transition to value-based care.

The lawsuit against Aetna and Humana alleges that their merger would substantially reduce Medicare Advantage competition in more than 350 counties in 21 states, affecting more than 1.5 million Medicare Advantage customers in those counties. Before seeking to acquire Humana, Aetna had pursued aggressive expansion in Medicare Advantage. Aetna, the nation’s fourth-largest Medicare Advantage insurer by membership, has nearly doubled its Medicare Advantage footprint over the past four years. Humana is the nation’s second-largest Medicare Advantage insurer by membership. The lawsuit also alleges that Aetna’s purchase of Humana would substantially reduce competition to sell commercial health insurance to individuals and families on the public exchanges in 17 counties in Florida, Georgia and Missouri, affecting more than 700,000 people in those counties. The lawsuit alleges that by buying Humana, Aetna would eliminate one of its strongest and most capable competitors in these markets.

Anthem, Inc. is headquartered in Indianapolis, Indiana. It is the nation’s second-largest health insurer and the largest member of the Blue Cross and Blue Shield Association. It holds the Blue Cross license in 14 states and provides health insurance to 39 million people. In 2015, Anthem reported over $79 billion in revenues.

Cigna Corp. is headquartered in Hartford, Connecticut. It is the nation’s fourth-largest health insurer. It operates in every state and the District of Columbia and provides health insurance to 15 million people. In 2015, Cigna reported $38 billion in revenues.

Aetna Inc. is headquartered in Hartford, Connecticut. It is the nation’s third-largest health insurer. It operates in every state and the District of Columbia and provides health insurance to 23 million people. In 2015, Aetna reported $60 billion in revenues.

Humana Inc. is headquartered in Louisville, Kentucky. It is the nation’s fifth-largest health insurer, operates in every state and the District of Columbia and provides health insurance to 14 million people. In 2015, Humana reported $54 billion in revenues.

Packaging medical records and moving them over to a PTP, or UR or IMR or the WCAB within the time constraints imposed by law is an incessant, repetitive, and time consuming task for claim administrators.

Yet many health industry experts say patients should not be finding data-sharing a challenge in 2015. In the era of such user-friendly Internet services as Facebook and Google, it is shocking to some that pertinent and sensitive medical information should still live in PDF files attached to emails, or be delivered by fax machine.

Calls for the digitization of health information, with a goal of lowering costs and delivering higher quality care, date back to the Clinton era. Former President George W. Bush also chose the issue as a personal passion project, noting in his 2004 State of the Union address that doctors could save more lives when armed with modern technology.

It was not until 2009, however, that President Obama signed a law that attempted to speed the transition from paper records to electronic records by offering doctors and hospitals incentive payments through Medicare and Medicaid if they used electronic medical records. The law, called the Health Information Technology for Economic and Clinical Health Act, or “HITECH Act,” provided roughly $30 billion over 10 years for the payments. It took effect on January 1, 2011. The law supposedly provided incentives for providers to adopt electronic medical records, and as a result hospitals have spent millions, sometimes billions, on computer systems to facilitate the purpose of the HITECH Act..

“The government provided the funding, but private developers created the system,” said Dena Mendelsohn, a health policy analyst with Consumers Union, based in San Francisco, “and the medical providers were incentivized to purchase the system. But nowhere in the conversation was it said that these systems had to talk with each other.” There is a fancy word for this, it’s called interoperability. Mendelsohn said the inability to share health information across medical systems is slowing down the consumers’ ability to access high-quality health care. Patients who walk into a hospital are complete strangers.

But, what’s happened, experts say, is that private, competing companies sold proprietary software to hospitals that can’t talk with each other. Also, several of the largest electronic health records systems have prioritized billing and regulatory reporting over other aspects of care. And many hospitals are still wedded to “fee for service” models, which reward doctors for pricey procedures and tests, rather than patient outcomes. The medical record vendors are helping these hospitals thrive in the status quo and there is little incentive to share access to the records of those lucrative patients.

“These fee-for-service hospitals are fighting tooth and nail to retain patients – and the vendors are responding to these needs,” said Dr. Bob Kocher, one of the key architects of the Affordable Care Act, and a partner who focuses on health care with Venrock, a Palo Alto venture capital firm. “They [some hospitals] have not wanted features that make it easier to share information.”

Now the government is trying to address the interoperability problem. Through April 3, the U.S. Department of Health and Human Services was taking public comments on a new “roadmap” designed to approve more uniform technical standards for electronic records.

It’s a huge undertaking. Arien Malec, a former technology coordinator for the department, said most doctors are now using some type of electronic records, but overhauling the entire system will take time. “This is like 15 percent of the economy going from the Stone Age to the Internet age in five years,” Malec said. “It’s like going from paper ledgers to online banking in five years. Wow, that would be painful.”

The payoff of getting it right is big, experts say. Benefits of seamless electronic medical records including personalized medicine, better preventative care and accessing doctors and medical information through mobile devices such as smart phones and tablets. And for claim administrators, the movement of medical records from PTP to IMR may end up as easy as point and click.

The California Department of Insurance reached a $30 million settlement with pharmaceutical giant Bristol-Myers Squibb over allegations of drug marketing fraud and physician kickbacks. The settlement stems from charges in a whistleblower lawsuit filed by three former Bristol-Myers Squibb sales representatives. The California Department of Insurance joined the whistleblowers in the lawsuit.

This lawsuit was initially filed by former Bristol-Myers Squibb employees Michael Wilson and Lucius and Eve Allen, all of whom are represented by the law firm of Waters Kraus & Paul in Los Angeles. Lucius Allen is a former Los Angeles Lakers basketball player.

The plaintiffs alleged that Bristol-Myers Squibb violated the California Insurance Frauds Prevention Act by employing and using sales representatives for the purpose of defrauding private commercial health insurers by using kickbacks to procure patients or clients. The kickbacks were designed to increase physician prescriptions of several drugs produced by Bristol-Myers Squibb including Pravachol, used to lower cholesterol. As part of its alleged scheme, Bristol-Myers Squibb provided physicians and their families with gifts and cash to induce physicians to increase prescriptions for Bristol-Myers Squibb products.

Enticements included box suites at sporting events where physicians were provided tickets, food, drinks, and parking. Enrollment in a Lakers basketball camp for doctors and their children. Pre-paid golf outings at luxurious golf courses. Tickets for physicians and their families to see Broadway plays in California cities.Monetary incentives given to doctors responsible for prescription-drug decisions for formularies. Lavish dinners, resort hotel trips, and concert tickets, given to doctors who were large-volume prescribers, to induce more prescriptions in the future.

Insurers alleged to have been defrauded: Prudential, Cigna, Maxicare, Blue Cross/Blue Shield of California (name of entity at time lawsuit was filed), HMSA Health Plan Hawaii, Scan Health Plus, United Health Plan, CalOptima, Argus, Merck-Medco, PCS, Prosever, Express RX/Value RX/DPS, Caremark, MedImpact/MedCare, Envoy, Aetna Pharmacy Management, Pharmaceutical Care Net, Advance PCS, Rx America, Prescription Solutions, WellPoint Pharmaceutical Management, First Health, Save-Rx, PacifiCare, and Health Net.

Medications in kickback scheme included: Plavix, Pravachol, Monopril, Abilify, Glucovance, Metaglip, Glucophage, Glucophage XR, Cefzil, BuSpar, Serzone, Tequin, Pravigard, and Avapro.

In addition to the $30 million payment, the settlement agreement requires Bristol-Myers Squibb to affirm its commitment to abiding by California laws regulating its sales representatives’ interactions with doctors, including compliance with pertinent provisions of the California Health and Safety Code and the California Insurance Frauds Prevention Act. Among other requirements, Bristol-Myers Squibb is required to utilize a Comprehensive Compliance Program that is in accordance with the Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers.”

As required by the state’s insurance whistleblower law, Bristol-Myers Squibb’s settlement payment will be divided between the whistleblowers and the State of California. The state will receive $14.1 million, to be used to enhance the investigation and prevention of insurance fraud. Bristol-Myers Squibb did not admit to wrongdoing in the settlement agreement.