Billions in ‘transfers of value’ to physicians, hospitals by industry get DOJ attention

In calendar year (CY) 2015, over $7.5 billion in “transfers of value” were made by pharmaceutical companies to physicians and hospitals through the federal Open Payments program, which in turn has caused the Department of Justice (DOJ) to focus on this area while investigating fraud in the health care system. In an HCCA sponsored seminar titled “Sunshine, Open Payments, and Potential Conflicts of Interest,” Senior Compliance Executive C.J. Wolf, M.D., of Healthicity, noted that under the Open Payments program, CMS has now accumulated over 28 million records of transfer of value. Within this vast repository of data, CMS uses it to uncover outliers in payments, and as a result, industry and providers, alike, are very interested in how the open payment system affects their operations.

Open Payments

Under Section 6002 of the Affordable Care Act (ACA), manufacturers must disclose to CMS payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations must also report ownership and investment interests held by physicians. The HHS Office of Inspector General (OIG) included these aspects into its list of priorities in its 2017 Work Plan, with Medicare and Medicaid payments high on the list (see Focus remains on Medicare, Medicaid payments in 2017 OIG Work Plan, Health Law Daily, November 10, 2016).

The 2017 Work Plan also stressed that the OIG will also determine how much Medicare paid for drugs and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) ordered by physicians who had financial relationships with manufacturers and group purchasing organizations.

Wolf noted the DOJ has taken a keen interest in this area of open payments, as evidenced by actions such as Teva Pharmaceuticals USA, Inc., and its subsidiary IVAX, LLC, agreeing to pay a total of $27.6 million to the federal government and the State of Illinois in a settlement regarding allegations of false billing practices under the False Claims Act (see Teva Pharmaceutical to pay federal and state government $27.6 million to resolve false billing allegations, Health Law Daily, March 11, 2014).

Conflicts of interest

There are 11 payment “categories” that must be reported under the Open Payments program: (1) consulting fees, (2) honoraria, (3) gift, (4) entertainment, (5) food and beverage, (6) travel and lodging, (7) education, (8) charitable contribution, (9) royalty or license, (10) grant, and (11) research.

As part of the transparency initiatives under the ACA, the dollars that physicians receive from industry is reported and documented. Physicians and providers should be aware that these categories touch upon even compensation for serving as faculty or as a speaker for a non-accredited and noncertified continuing education program.

Because the Open Payments program also includes ownership interests that physicians or their immediate family members have in various companies and the data is then made available to the public each year, reporting often is paramount.

Specialists, former government officials augment litigation and health practices

Global and national law firms bolstered their presence in litigation, health, and intellectual property practices with additions from both the public and private sectors.

Jenner & Block

Former Acting U.S. Solicitor General Ian Heath Gershengorn will join the firm as a partner in its Washington, D.C. office, effective September 1, 2017. Gershengorn will serve as chair of the firm’s Appellate and Supreme Court Practice and will also be a member of its Complex Commercial Litigation Practice, where he will use his experience in regulatory matters to assist clients across multiple industry sectors.

Gershengorn was named Acting Solicitor General of the United States on June 2, 2016, an appointment he held until the end of the Obama administration in January 2017. Prior to that, he was the Principal Deputy Solicitor General. He also supervised the government’s briefing in a range of high-profile cases, including those involving the Affordable Care Act (ACA), Dodd-Frank, election law and redistricting, immigration reform, the Fair Housing Act, Title VII, the Religious Freedom Restoration Act, and same-sex marriage.

WilmerHale

 Brian Boynton has returned to the firm as a partner following his service in the U.S. Department of Justice as counselor to former Attorney General Loretta Lynch. He was involved in coordinating the DoJ’s Civil Division’s defense of high-profile and significant matters before the department, including challenges to the ACA, agency guidance relating to gender identity discrimination and other administrative agency actions.

Boynton will be a member of the firm’s Government and Regulatory Litigation Group and will be based in Washington DC.

Polsinelli

Polsinelli added three new members to the firm’s Intellectual Property Department with focus on biotech and life sciences. Dr. David W. Clough joined as shareholder in Polsinelli’s Chicago office, along with patent attorneys Christopher Cabral, shareholder, and John W. Campbell, associate.

Clough brings more than 25 years of experience to the firm and counsels many sectors of the biotechnology, medical, and pharmaceutical industries. His practice focuses on acquiring and enforcing key intellectual property rights globally. Cabral is experienced with biotech and life science patent prosecution and counseling to clients around the world. Campbell offers an extensive background in bioinformatics, biotechnology, and microbiology research.

Goodwin 

Roger Cohenjoined the firm’s Life Sciences and Private Equity practices as a partner at its New York office. Cohen specializes in representing health care, life sciences and health care IT clients, and investors in such companies, in a wide array of regulatory matters. He has particular expertise in health care fraud and abuse, HIPAA and related privacy and data security issues, Medicare and Medicaid rules and regulations, reimbursement matters, telemedicine, and government investigations and enforcement actions, including litigation under the False Claims Act.

Challenges ahead for next generation of bundled payments

In late 2016, HHS announced the final models for the next group of mandatory episode-based payments. Researchers at the University of Pennsylvania in a Journal of the American Medical Association (JAMA) suggested that the next generation of bundled payments should align with population health by (1) extending the duration of the bundles, (2) expanding the accountable entities beyond hospitals, and (3) integrating bundled payments with global budget models within accountable care organizations (ACOs). All hospitals accepting Medicare patients in over 90 metropolitan areas will be required to accept new bundled payments, which include a fixed payment for hospital care plus services for the 90 days following discharge of patients with acute myocardial infarction and coronary artery bypass graft surgery (see Final rule puts quality at the heart of new Medicare payment models, Health Law Daily, December 21, 2016).

In the JAMA article, the authors noted that current bundled payment models have limitations. Namely, these models retain the fee-for-service incentive to do more, especially for conditions without well-defined criteria for intervention, and to select healthier patients, potentially increasing low-value care use that offsets efficiency savings. The researchers believe bundled payments would be more efficient if restricted with defined starting points that limit physician and patient discretion.

Bundle duration

According to the authors the central challenge of current bundles is their short duration. Most cover services up to 90 days after hospital discharge; extending the bundled payments to a year or more would allow for a broader set of conditions to be included. Extending the bundle duration could also mitigate undesirable effects, such as decreasing the incentive to avoid more complex patients who may be at higher risk for poor outcomes in the short term. The authors stressed that more importantly, bundles with a longer duration could encourage greater coordination of care between specialists and PCPs.

Bypassing hospital-centric procedures

Medicare ACOs have primarily generated savings by reducing avoidable hospitalizations. Bundled payments could generate savings in a similar manner, shifting care to non-hospital-centric procedures, such as allowing outpatient clinicians such as PCPs, outpatient health centers, and ambulatory surgery centers to take on financial accountability for performance.

ACO integration

The authors suggested that for next generation bundled payments, care should be coordinated along with ACO programs by aligning incentives and proactively disseminating information on shared beneficiaries. The current policy penalizes care organizations by attributing the high historical baseline payments for patients with poor outcomes within the bundle to the ACO’s global budget rather than the actual payments, which could be lower if an ACO improves efficiency.

Future

Regardless it was unclear to the authors whether bundles which build up the degree of financial risk a hospital or other health care organization bears is better than moving to global budgets in one step. Using bundle payment models to transition to global budgets may be the preferred strategy, giving clinicians several years to adapt and transform care delivery.

DOJ focus is on ‘egregious’ and ‘despicable’ health care fraud

In a speech on May 18, 2017, at the American Bar Association’s 27th Annual Institute on Health Care Fraud, Acting Assistant Attorney General Kenneth A. Blanco stressed that the Department of Justice (DOJ) would continue with keeping health care fraud a priority. The amount of loss to the American tax payer per year due to healthcare fraud is in the billions, with some estimates putting the number close to $100 billion per year.

Blanco stressed the importance of cooperation between the Medicare Strike Force, the U.S. Attorney’s Offices, and federal and state investigative agencies. He noted that the DOJ was employing an in-house data analytics team to review CMS billing data in order to focus on the most aggravated cases quickly. In turn this data is pushed to other federal and state investigative agencies.

Detailing examples of recent work by the Health Care Fraud Unit, Blanco highlighted that October 2016, Tenet Healthcare Corporation, a publicly-traded company and the third largest hospital chain in the United States, entered into a global resolution with the government, agreeing to resolve an investigation of a corporate bribery and fraud scheme at four Tenet-owned hospitals in Georgia and South Carolina. As part of that scheme, the hospitals paid over $12 million in bribes to a chain of prenatal care clinics in exchange for the referral of Medicaid patients.

Under the global resolution: (1) two Tenet subsidiaries pleaded guilty to conspiracy to defraud the United States and pay kickbacks and bribes in violation of the Anti-Kickback Statute, and forfeited over $146 million in Medicare and Medicaid funds; (2) Tenet entered into a non-prosecution agreement requiring, among other things, an independent compliance monitor for a period of three years over all entities owned, in whole or in part by Tenet; and (3) Tenet and its subsidiaries entered into a civil settlement agreement and paid $368 million to the United States, the State of Georgia and the State of South Carolina (see Corporations, beware: Tenet Healthcare to pay $513M to settle kickback charges, Health Law Daily, October 4, 2016). Subsequently two individuals have pleaded guilty and a former senior executive of Tenet was indicted for the scheme (see DOJ comes for executive in Tenet fraud case, Health Law Daily, February 2, 2017).

CMS has estimated that the total health care spending in the United States in 2015 reached $3.2 trillion, or 17.8 percent of the gross domestic product. As such, the DOJ considered health care fraud as “egregious,” and from Blanco’s viewpoint, “despicable,” because it resulted in depriving medical care for those in actual need. Blanco noted that health care fraud impacts the public’s access to medical care, even the most basic forms, because fraud increases the costs for all.