Precision medicine has become fashionable. President Obama explained its significance in his State of the Union Address in January, and followed up by including a $215 million initiative to collect genetic information from 1 million Americans as part of the budget he sent to Congress. But even before his speech, precision medicine was receiving a great deal of attention, particularly in oncology.

This exciting new approach to medical diagnosis and decision making is a hot topic for good reason. Very few healthcare initiatives in our lifetime have evolved as quickly and shown as much promise, especially relating to the way we treat patients with cancer. But like all new ideas or technologies, rapidly occurring changes present both opportunities and challenges for everyone involved, including government, patients, payers and physicians.

It’s hard to argue with the benefits of precision medicine. Oncologists dream about treating cancer with more exact therapies that improve outcomes and reduce side effects. However, we must acknowledge and find ways to overcome some of the challenges that will arise along with such rapid and sweeping change.

The first challenge oncologists struggle with is ordering the appropriate tests for their patients. A proliferation of diagnostic companies offer molecular tests, but only limited guidance on which tests are clinically appropriate and, also important, which tests insurance companies will cover. Although genetic tests are becoming more affordable, some are still quite expensive. Payers wrestle with decisions on what types of tests to pay for and under what circumstances, often leaving the patient stuck in the middle. More evidence on the clinical utility of molecular panels is required to solve this problem.

Another challenge oncologists face is how to use the results of increasingly large molecular panels. The results of a panel may suggest a clinical trial the physician doesn’t have access to, a drug that is off label, or simply an ambiguous result. As new, more-specific information about each variation within a cancer type is unveiled, oncologists will face a substantial increase in the amount of information they must review to stay up-to-date and provide the highest quality of care. This is especially true for many community oncologists who practice as generalists, treating patients with all types of cancer.

Results that lead to expensive off-pathway therapies are particularly difficult for physicians, patients, and payers. An oncologist and his or her staff may have to spend hours on the phone trying to get a treatment authorized, and payers must struggle with the decision of whether to authorize a treatment with limited evidence of efficacy. Once prescribed, the outcomes of these treatments are not systematically recorded, resulting in the loss of potentially valuable data.

The vast amount of information and knowledge required for precision medicine underscores the value of participating in a network that offers access to shared best practices and continually updated evidence-based pathways. These pathways will become increasingly nuanced as we expand our understanding of how different mutations impact treatment decisions. Oncology-specific healthcare information technology with real-time updates on the latest pathways, drugs, and clinical trials will be required for oncologists to practice effectively in the future.

The rapidly growing world of precision medicine also creates an unprecedented need for clinical research. Driver mutations must be identified and then studied to determine if related targeted therapy really makes a difference. Already, more efficient trials are being designed to test multiple drugs against multiple targets. We need to continue to push to have these trials in the community-based setting, where oncologists deliver a majority of the cancer care. In addition, we know that a great amount of valuable retrospective data is generated every time an oncologist prescribes a treatment for a patient and documents it in an electronic health record. When everyone in the oncology community has started linking patients, cancer mutations, and treatments, and begins tracking outcomes, we will truly be driving cancer care forward.

Cancer is smart and hard to treat. Precision medicine may give us the advantage we need to more directly target a specific disease, reduce toxicity, and avoid older treatments that have unpredictable results.

Whether or not the proposed initiative is approved in this year’s budget, I expect genetic testing to continue to become more prevalent and to have an unprecedented impact on our healthcare system. In the coming years, we’re going to gain even more clarity regarding which gene mutations matter and see tremendous progress in the development of new treatment options. And as we do, precision medicine will help us improve cancer survivorship and ultimately reduce the costs of care.

Marcus Neubauer is medical director of oncology services at McKesson Specialty Health and The US Oncology Network.

Articles

Like all new ideas or technologies, rapidly occurring changes present both opportunities and challenges for everyone involved, including government, patients, payers and physicians.

Physician Quandary: Data Shortage, Surfeit Impinge on Precision Medicine

The rise of high-deductible health plans (HDHP) has been accelerated by the Affordable Care Act, yet for many oncology practices this trend adds to the administrative workload and creates deep uncertainty on the accounts receivable side. Our cover story this month takes a look at how HDHPs make it difficult for patients to utilize their insurance plans and how this makes it tougher for doctors to get paid. Practices now spend more time working with patients whose deductibles cost thousands of dollars and who must pay those up front before treatment can begin.

“We have more people working in our office now— not that we’re getting paid to pay them&mdash;to counsel patients, saying this is what it’s going to cost to get this treatment, this is what your coinsurance is going to be, you have to meet this deductible,” Kenneth Adler, MD, vice chair of the American Society of Hematology’s Committee on Practice, told 

The rising administrative burden is also addressed in a story this month on ASCO’s 

. ASCO has highlighted many positive and negative trends in oncology care and suggested a host of potential solutions, but it emphasizes the heavy workload all practices are facing, and sounds a note of concern about the high incidence of burnout among physicians. Roughly 50% of oncologists report having experienced overload syndrome.

The good news, ASCO Chief Medical Officer Richard Schilsky, MD, said in an interview, is that over 80% of oncologists surveyed said they would choose this profession all over again, despite the headaches, the long hours, and the growing complexity. There is something highly rewarding about this branch of medicine that keeps them involved and enthusiastic.

Other interesting factoids from this year’s ASCO report include the rising number of women oncologists: Women now number more than 30% of oncologists, with a median age of 46. In fact, in oncology fellowship programs women amount to 48%, which surpasses the 46% figure for women in medical training programs overall. Statistics like these show the changing face of oncology practice in the US, which also has more doctors over the age of 64—and heading for retirement&mdash; than under 40.

The need to recruit younger doctors to join the profession also is a strong theme in the ASCO report, which indicates that rural areas are especially in need of staff as physicians tend to prefer working in urban environments.

Professional employment is looked at through a different lens in an 

 this month on hematologists and their desire to gain more recognition and influence in the increasingly corporatized world of oncology and hematology. A diminished emphasis on nonmalignant hematology in academic training programs and a trend toward more bloodwork being done by non-hematology specialists has contributed to an “undervaluing” of the expertise hematologists have to offer, the American Society of Hematology says in a report issued last month.

ASH is calling for creation of “systems-based” hematology positions that would allow them greater roles in targeted medicine, for example, or have them do early troubleshooting for diseases like thrombotic thrombocytopenic purpura (TTP), which can constitute a huge drain on plasma supplies if not managed well, ASH says in the report.

This month’s issue includes new elements that will appear on a regular basis. 

 by New Jersey- New York law firm Moses & Singer offers guidance on what the courts will require you to disclose in the event you conduct an internal investigation into the handling of Medicare and Medicaid funds; and in a column on practice management, Marcus Neubauer, MD, writes about making the most of precision medicine, from ordering the appropriate tests to using the results of those tests effectively.

Lastly, in a section on Capitol Hill developments, we look at the status of the Sustainable Growth Rate formula and an early holiday present ASCO would like to see in the next US fiscal budget: more money for the National Institutes of Health and the National Cancer Institute to spend on clinical research.

The rise of high-deductible health plans has been accelerated by the Affordable Care Act, yet for many oncology practices this trend adds to the administrative workload and creates deep uncertainty
on the accounts receivable side.

Practices Hammered by Rising Uncertainty

The new Value-Based Payment Modifier program from the Centers for Medicare & Medicaid Services (CMS) may not be high on the list of concerns for the average oncologist, but with immediate payment reductions of up to 1% for large practices that don’t meet cost and quality benchmarks, its impact could be huge.

Much larger adjustments for all practices are just a few years away.

Those who practice oncology aren’t always the ones following the business end of it, and as a result, there any many practitioners who likely don’t know about the value modifier program at all, Bruce Gould, MD, president and medical director of the Northwest Georgia Oncology Centers in Marietta, Georgia, told Oncology Business Management. Gould is also president of the Community Oncology Alliance, a nonprofit organization focused on community oncology.

“I have not heard a lot about it from other oncologists; there’s been more press about it than feedback from physicians about it,” says Gould.

As one way to try to contain the spiraling costs of the US healthcare system, CMS began implementing the value modifier program this year. The program will determine payment for care of Medicare patients based on cost and quality ratings from prior years, instead of reimbursing all physicians equally as in the past. Improving the overall quality of care is also a goal.

The program, mandated as section 3007 of the Affordable Care Act, will gradually affect all physicians over the next two years and non-physician practitioners by 2018.

As of January of this year, oncologists who are part of group practices with more than 100 eligible providers (EPs) who all bill for services under a single tax ID must maintain standards established by CMS to qualify for full payment. Payment incentives were established in prior years to encourage practices to begin using quality measures and reporting tools.

Beginning in 2016, the value modifier will apply to physician payments under the Medicare Physician Fee Schedule for groups with 10 or more eligible professionals.

The value modifier can also result in no payment change at all or a payment increase, based on whether standards are met or exceeded, but “The program is budget-neutral, and downward and upward payments will balance each other,” CMS said in a statement.

Payment adjustments will become more dramatic as the program continues.

Under the 2017 value modifier (which will be based on 2015 performance criteria), the maximum downward adjustment for groups of 10 or more EPs will be —4% and the maximum upward adjustment will be based on a formula that takes into account the budget for physician reimbursement, CMS said.

Also in 2017, for groups of 2 to 9 and solo practitioners, the downward adjustment will be a maximum of —2%.

The quality measures are designed to ensure that patients get the right care at the right time. Providers must quantify how often they are meeting particular quality metrics. Feedback reports provided by CMS help practices to measure their performance against others’.

Healthcare providers who qualify as EPs under the value modifier program include doctors of medicine, osteopathy, podiatric medicine, optometry, oral surgery, dental medicine and chiropractic, as well as physician assistants, nurse practitioners, registered dieticians, and clinical psychologists.

It’s a program, however, that some in the oncology field feel harms them and that may negatively affect cancer care. “Over time, physicians will become more aware of the program’s existence,” Gould says. Because the majority of practices consist of fewer than 100 providers, he believes it’s likely that the program just hasn’t affected most practitioners yet.

Gould says that while he appreciates the concept of paying physicians based on the value of services they provide, the value modifier program isn’t a meaningful measure of oncology quality. “The way this program goes about it is unfair,” he says.

The reports being used as a basis for measuring quality—Quality Resource and Use Reports (QRURs)&mdash;have been used in prior years, Gould says, but the measures have nothing to do with cancer care: for instance, whether a patient with diabetes had an annual eye exam, or whether a patient with lung disease was being properly treated for asthma. “I’m being judged based not on the work I do, but on the work my colleagues do. There’s no measure for how well I give chemotherapy or whether I give it for appropriate purposes, or if patients have ready access to me if they get ill.”

He added that the system was designed to have physicians hold one another to task so that quality and cost can improve. “But that’s very hard to do when you’re taking care of your own patients,” he said. “We don’t have time to be our brother’s keeper.”

Barbara McAnemy, MD, CEO of the New Mexico Cancer Center, a practice with 78 medical oncologists, and the chair of the board of trustees of the American Medical Association, agreed that most physicians aren’t aware of the value modifier program yet. “It’s a strangely constructed program, by which what you do in 2015 will affect how you are reimbursed in the future.” she said. It’s also very difficult to comply with all the regulations, she added, and that for a program to have meaningful use, it requires 100 percent compliance. “There’s a huge number of things outside our control.”

She pointed out that one measurement is to show what percentage of patients use a medical practice’s Internet portal to be aware of different aspects of their medical care. “I can set it up and tell them about it, but I can’t make them use it,” she said. “How do I make that happen? Similarly, if I want to really comply with the regulations for transition-of-care visits, I need to send medical records to an HIPAA-compliant electronic health records system. But if I can’t send it to you electronically, am I going to clog up your fax machine with 70 pages of duplicated records? Getting bogged down in huge quantities of information may hinder a practice’s ability to find the information needed to continue to care for Medicare patients.”

Such efforts could lead to more cost-cutting measures. “Half of our patients have Medicare, so we’ve had to get lean,” she added. “I think this is why we see so many practices closing satellites, consolidating or selling practices, or begging hospitals to buy them.”

Oncology is a complex specialty and should be assessed as such. Ted Okon, executive director for the Community Oncology Alliance, said in an interview that he believes the value modifier will “drastically harm cancer care.”

There are approximately 900,000 physicians in the United States, only about 5000 of whom are oncologists who will be affected by this program— those who work with Medicare patients not primarily through hospitals. “They are being penalized for something not in their control, and this is a program not ready for prime time,” said Okon. “It is virtually meaningless for oncologists.”

Instead, said Okon, the answer to spiraling healthcare costs is meaningful payment reform, “so you have quality and costs that are really attributable to that cancer patient being measured.”

Members of Congress, led by Representative Cathy McMorris Rogers (R-WA), have a bill in draft form that will specifically address oncology payment reform, said Okon. “We’ve been working with the energy commerce committee and taking the lead in helping to develop the oncology medical home model.” This model includes oncology-specific reforms such as episode-based payment, emphasis on practice transformation, and multi-payer design. “These kinds of things are a step in the right direction—not these stopgap measures” like the value modifier, he said.

The new Value-Based Payment Modifier program from the Centers for Medicare & Medicaid Services may not be high on the list of concerns for the average oncologist, but its impact could be huge.

CMS Starts Cutting Pay for Doctors Who Don't Measure Up

Over the course of the past few years, the Department of Justice has stepped up its enforcement of the False Claims Act

 (“FCA”) against health care providers at all levels. In an effort to comply with FCA, Stark

 and other self-reporting laws and regulations,

providers have enhanced their compliance efforts and instituted various levels of self-audits and internal investigations to help identify areas for improvement. Guided in part by the Office of Inspector General’s policies encouraging self-evaluation, health care providers have operated under the assumption that self-disclosure will demonstrate mitigation efforts should violations or potential violations be identified.

Given a handful of recent cases, and a recent update to the CMS Voluntary Self-Referral Disclosure Protocol, it appears that the federal government may be using the existence of these audits as a means for demonstrating that the provider “knew or should have known” that fraud occurred.

In New York, Education Law §6527(3) confers, in the context of self-critical analyses, confidentiality on proceedings and records prepared by or for a wide variety of medical institutions, including hospitals, in connection with the performance of medical or quality assurance review functions. This includes immunity from document discovery and from disclosure during depositions. The statute specifically provides protection for documents prepared and submitted to the state as part of a statutory or regulatory compliance program. “The thrust of section 6527(3) is to promote the quality of care through self-review without fear of legal reprisal."

 The privilege is not exclusive to healthcare matters, but is sometimes invoked in lawsuits involving hospitals or other health care organizations.

Until the late 1990s, the self-critical analysis privilege was also alive and well in New Jersey, thanks to a Superior Court decision in 

 involved a public utilities employee who had been injured in an automobile accident while on the job. Shortly after the accident, the utility company conducted an internal investigation to evaluate its policies and procedures to determine whether future employee injuries could be reduced or prevented. The employee sought discovery of this internal self-analysis, but the court shielded the documents, relying on the self-critical analysis privilege.

 decision, New Jersey courts began to reject a blanket privilege, and instead began advocating the use of a “balancing test.” In 

 the plaintiff in a wrongful death suit sought to compel disclosure of certain hospital internal-review documents. These internal reviews included an Executive Committee report completed by the Board of Medical Examiners, which detailed the treatment of the decedent, as well as testimony and findings by the Board’s internal expert witness.

While the Court acknowledged the existence of the self-critical analysis privilege in 

, it also recognized that the personal injury suit in 

 was fundamentally different from a wrongful death suit against a hospital. 

 case could proceed without the information in the internal audit documents it requested, whereas 

 case relied heavily on the fact that the hospital knew there were problems and it failed to act to fix them.

The court found that it was in the interest of public policy to allow “disclosure of the materials involved in an internal investigation into health-care services….”

 court advocated using a balancing approach to determine whether internal audit documents could be subject to discovery. The balancing test is intended to weigh the need for maintaining confidentiality against the need for the plaintiff to have those documents to prove its case.

The Court dealt a final blow to the blanket application of the self-critical analysis privilege in 

, the plaintiff asked the defense to turn over documents related to an internal investigation into her complaints of sexual harassment. Instead of advocating an absolute privilege for all cases in which a defendant had conducted some form of internal self-critical investigation, the Court held that the issue of disclosure of such materials should be addressed through a balancing test similar to that set forth in 

 “Self-critical analysis, although deserving of substantial consideration when a court balances a party's need to know against another party's need for confidentiality, is not qualitatively different from other confidential information, and thus does not require the protection of a broad privilege as opposed to a balancing of interests.”

, it became clear that the self-critical analysis privilege should no longer be assumed to apply, and hospitals and other corporations would have to show a truly compelling reason to keep internal audit documents from the plaintiff.

It is also important to note that New Jersey subsequently amended its statutory Rules of Evidence to create a privilege for “information and data secured by and in the possession of utilization review committees (“URCs”) of certified hospitals or extended care facilities.”

 However, at least one court has limited this privilege to URCs that are established as conditions of participation in Medicare and Medicaid, and should not be extended to include URCs created outside that scope.

 That being said, while documents and investigations prepared by the URC may be protected under the self-critical analysis privilege, it is unclear whether courts will afford the same protection to other internal hospital or medical practice reviews.

 “Whether or not a self-critical analysis privilege may exist as a matter of state law, neither the United States Supreme Court nor the Second Circuit have recognized such a privilege.”

 In fact, the doctrine is unsettled and various circuits interpret in a variety of ways.

 Notwithstanding the absence of a federal privilege, the Department of Justice has in many instances considered internal audits, which were conducted in a good faith effort to comply with regulations, as a mitigating factor in assigning penalties for self-reported misconduct.

Yet the mere existence of a compliance program, without robust implementation, is not in and of itself a defense to corporate noncompliance with Medicare and Medicaid False Claims Act violations.

According to the DOJ Attorney’s Manual, the “Department encourages such corporate self-policing, including voluntary disclosures to the government of any problems that a corporation discovers on its own. However, the existence of a compliance program is not sufficient, in and of itself, to justify not charging a corporation for criminal misconduct.”

 The manual outlines several specific factors to consider when considering mitigation, including “timely and voluntary disclosure of wrongdoing,” cooperation with the investigation, the existence and effectiveness of a corporate compliance program, and the corporation’s efforts to implement or improve an effective corporate compliance program.

The DOJ also considers whether, once wrongdoing is identified in the organization, it replaces irresponsible management, disciplines or fires wrongdoers, makes restitution, and cooperates with government agency reviews.

 It has been made clear, both from the DOJ manual and in the Federal Regulations, that “even the most sincere and thorough effort to cooperate cannot necessarily absolve a corporation that has, for example, engaged in an egregious, orchestrated, and widespread fraud. Cooperation is a relevant potential mitigating factor, but it alone is not dispositive.”

Furthermore, “OIG encourages health care providers to promptly self-disclose conduct that violates Federal health care program requirements and provides them a self-disclosure protocol and guidance.”

 What becomes problematic in this self-reporting and self-auditing scenario is that once the audit uncovers the possibility of fraudulent activity—whether accidental or deliberate&mdash;according to the knowledge standard under the FCA, the results of the audit may establish “there is evidence that the defendant knew, or should have known, that his or her conduct was prohibited.”

When a provider complies with the mandate to self report an actual or suspected FCA, Stark or Anti-kickback violation, that provider must “provide a summary of any auditing activity undertaken and a summary of the documents the disclosing party has relied upon relating to the actual or potential violation(s) disclosed.”

 According to the Voluntary Self Reporting protocol, it appears that CMS reserves the right to review those same documents that providers might otherwise try to protect under the self-critical analysis privilege.

Internal audits may also be used as evidence of Medicare and Medicaid fraud when those audits uncover past problems.

If the organization does not look back far enough, or do more than acknowledge that errors were made and make repayments, courts may be willing to allow any inaction to serve as grounds for a False Claims suit to proceed. For example, In 

United States ex rel Keltner v. Lakeshore Med. Clinic

 an employee of a medical clinic filed a qui tam suit in which she alleged Lakeshore Medical knowingly filed fraudulent Medicare claims because it “ignored audits disclosing a high rate of upcoding and ultimately eliminated audits altogether.”

 The plaintiff alleged that an annual internal audit of 25 claims per physician demonstrated that two physicians had each upcoded more than 10% of his claims.

Although the medical group returned all overpayments related to those specific claims, the group did not review any additional claims by those physicians, and the plaintiff alleged that the organization thereafter stopped reviewing billing codes altogether, in effect allowing all providers to upcode claims without being detected.

 In its ruling, the court equated defendant’s failure to take direct action as equivalent to “ignoring” the results of the audit.

 The case was ultimately dismissed on unrelated grounds,

 is that providers must not only conduct compliance audits, but must address problematic audit findings in a timely and comprehensive manner in order to show they did not ignore the results and possibly risk incurring additional liability.

Despite the concern that self-critical analyses may no longer protect health care providers from False Claims Act actions, self-disclosure is still the best practice. Continue fostering an environment of compliance, and continue to conduct your internal audits as required by law.

These recent developments should serve as a wake-up call that once irregularities are discovered, your organization will be deemed to have knowledge that there may be a deeper, farther reaching problem that needs to be investigated. The government will now consider not only your plans for preventing repeat occurrences in the future, they will look to see what you have done to uncover additional problems from the past, and that you have investigated your organization’s operations adequately enough to uncover any systematic failures, patterns, or even foreseeable individual events. Keep in mind that the more cooperative your organization is, and the more evidence it can provide to show its internal investigation was thorough and findings were acted upon, the better results you will likely have.

Linda A. Malek is a partner at Moses & Singer LLP and chair of the Healthcare and Privacy and Cybersecurity departments. She concentrates on regulatory, technological and business matters in the healthcare industry.

Lauren Mack is a partner at Moses & Singer LLP and member of the Healthcare Practice group, focusing on compliance, fraud and abuse. She is also a member of the White Collar Criminal Defense and Government Investigations Litigation groups.

Allyson M. Beach, Law Clerk, a third-year law student at Hofstra University School of Law, is a Dean’s Honor Scholar and member of Hofstra Law Review. She spent several years as a legislative liaison representing healthcare organizations.

			False Claims Act (FCA), 31 U.S.C. §§ 3729-3733 (2013).

			42 U.S.C. §1395nn (2013). The Stark Law established limitations on certain physician self-referrals. 

			42 U.S.C. § 1320a-7b (2013). The Anti-kickback Statute (“AKB”) prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business. 

 Patient Protection and Affordable Care Act (“ACA”) § 6409 (2010). Section 6409 establishes “a Medicare self-referral disclosure protocol ("SRDP") that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute.” 

, CMS (Oct. 21, 2013), http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Self_Referral_Disclosure_Protocol.html.

			Katherine F. ex rel. Perez v. State, 94 N.Y.2d 200, 205 (1999). 

 Wilson-Gunther ex. rel. Wilson v. Crouse Health System, Inc., 32 Misc. 3d 435 (Sup. Ct. Onon. Co. 2011). 

 Sonsini v. Memorial Hosp., 262 A.D.2d 185 (1st Dep't 1999) (finding reports of an independent review organization were privileged).

. Seaman v. Wyckoff Heights Medical Center, Inc., 25 A.D.3d 596, 597 (2d Dep't 2006) (refusing to admit testimony and documents under the §6527(3) privilege in a labor law action).

. at 1275. It is important to acknowledge that the court noted “the [internal] investigation was neither pursued in anticipation of litigation, nor connected with an investigation conducted by the Claims or Legal Departments” of the utility company. This distinction may prove to be a factor in determining whether, as part of the “balancing test” (see 

 ) favored by current NJ courts, certain documents may be discoverable while others may not.

. at 999. “As the considerations justifying confidentiality become less relevant, a party asserting a need for the materials will have a lesser burden in showing justification. If the reasons for maintaining confidentiality do not apply at all in a given situation, or apply only to an insignificant degree, the party seeking disclosure should not be required to demonstrate a compelling need.”

			Payton v. New Jersey Tpk. Auth., 148 N.J. 524 (1997)

			Todd v. S. Jersey Hosp. Sys., 152 F.R.D. 676, 682 (D.N.J. 1993) (holding “[t]he specific and special protection the Legislature has afforded utilization review committees by 

. 2A:84A—22.8 should not be broadened to include other committees and thus frustrate our discovery rules,”)(internal citations omitted).

 court also held that the only documents afforded this protection are, “notes, audits, recommendations and reports that are the product of the utilization review committee.” 

. at 682. This appears to indicate that documents prepared for presentation to the committee, such as outside or expert testimony and analyses, would not be afforded the same privilege.

			Zikianda v. Cnty. of Albany, No. 1:12-CV-1194 TJM/RFT, 2013 WL 936446, at *3 (N.D.N.Y. Mar. 8, 2013) (internal citations omitted).

			For an analysis of the status of the self-critical analysis doctrine across circuits, see generally Elisabeth M. McOmber, 

Self-Critical Analysis Privilege: Does It Protect Manufacturers Seeking to Review and Improve Internal Practices and Procedures?

 http://apps.americanbar.org/litigation/committees/products/articles/summer2014-0714-self-critical-analysis-privilege.html.

			U.S. DEP’T OF JUSTICE, UNITED STATES ATTORNEYS’ MANUAL 9-28.800 (hereinafter “DOJ MANUAL”), 

 http://www.justice.gov/usao/eousa/foia_reading_room/usam/.

			HHS OIG Work Plan, FY2015, CMS-Related Legal and Investigative Activities, 43,

https://oig.hhs.gov/reports-and-publications/archives/workplan/2015/WP15-5%20CMS%20Legal%20Investigative.pdf.

			Self-Reporting Protocol update Dec. 22, 2014 OMB CONTROL NUMBER:0938-1106 1CMS Voluntary Self-Referral Disclosure Protocol at 6, 

http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/6409_SRDP_Protocol.pdf.

			United States v. Lakeshore Med. Clinic, Ltd., No. 11-CV-00892, 2013 WL 1307013 (E.D. Wis. Mar. 28, 2013).

			Defendant's Memorandum in Support of Motion to Dismiss First Amended Complaint at *11-*14, United States ex rel. Elizabeth Keltner v. Lakeshore Medical Clinic, Ltd., 2012 WL 10095450 (E.D.Wis.).

			Order Dismissing Case with Prejudice as to Relator Elizabeth Keltner and Without Prejudice as to the United States and the State of Wisconsin, No. 11-CV-00892, (E.D. Wis. Sept 30, 2013) ECF No. 50.

Given a handful of recent cases, and a recent update to the CMS Voluntary Self-Referral Disclosure Protocol, it appears that the federal government may be using the existence of these audits as a means for demonstrating that the provider "knew or should have known" that fraud occurred.


Internal Investigations May be Open to Court and Government Agency Scrutiny

The American Society of Hematology (ASH) is calling for the creation of a new clinical hematology specialty that would be based in a medical center or health system and would focus primarily on patients with benign blood disorders while also helping to manage genomic testing and pathways-centered care.

The need for a “systems-based clinical hematologist” is driven by a variety of forces including changing practice models such as accountable care organizations (ACOs) that have shifted treatment of patients with nonmalignant conditions from primary care doctors to consultations with medical oncologists and other specialists, according to a report in Blood.

 Meanwhile, the FDA has approved at least a dozen new drugs for nonmalignant blood disorders in the past three years.

“What drove this paper was not workforce imbalance so much as looking at what are novel opportunities given ACO systems, given the current referral pattern, given the new explosion in genetics and genomics, and given new drugs such as novel anticoagulants. It’s not one single thing. There’s a whole bunch of different roles that hematologists could fill for a healthcare system and have a very important contribution to the health of the community,” Janis L. Abkowitz, MD, a former ASH president and senior author on the paper, said in an interview.

ASH has been collecting case studies and conducting interviews with hematology specialists in order to help “foster work force innovation to ensure sustainable professional roles for hematologists,” according to the report.

“Hematology over the years has been more difficult financially because there’s a huge amount of intellectual energy that goes into it,” noted Abkowitz, who is chief of the Division of Hematology at the University of Washington School of Medicine in Seattle. “That’s what makes it wonderful, but it hasn’t fit the prior billing schemes, and I think that’s what has driven it in a different direction as a practice.”

The market forces affecting the profession have been compounded by changes in hematology training programs, Abkowitz and colleagues reported. Most hematology academic training programs have merged with oncology fellowships, with a resulting diminished focus on nonmalignant hematology as a separate, sustainable discipline.

Further, many training programs no longer conform to the traditional one-third nonmalignant hematology, one-third malignant hematology, onethird solid tumor oncology model, according to the report. The Accreditation Council for Graduate Medical Education no longer mandates the number of months of nonmalignant hematology training that is required for a hematology-oncology fellowship program to be certified, the report says.

As many “classic” hematologists trained in prior decades reach the age of retirement, many newly minted physicians focus elsewhere for a principal specialty; consequently, the time is appropriate to identify career pathways that attract and enable physicians to practice nonmalignant hematology in a sustainable manner, according to the ASH report.

Indeed, current staffing trends “should be a wake-up call for the training programs to assure that they cover the benign or nonmalignant part of hematology, not just the cancer part of hematology/oncology, because of this need for this expertise that’s missing,” Abkowitz said.

Currently, there are approximately 14,000 medical oncology and hematology specialists certified to practice in the United States, according to a recent American Society of Clinical Oncology report.

Hematology care is provided through several practice settings 

“Nonmalignant hematologists vary in how much hematological malignancy they see as practitioners,” said Abkowitz. “Some will see low-grade processes such as chronic lymphocytic leukemia; others will see all malignant hematology as well as nonmalignant hematology, but not solid tumors, such as breast cancer.”

Looking forward, Abkowitz and colleagues envision the position of systems-based clinical hematologist as a dynamic element of patient care.

“Based on our observations, there is not a single role description for a systems-based clinical hematologist. Rather, the key theme is flexible adaptation to combine individual expertise and interest with larger health system needs,” the authors wrote.

The ASH report identified four specific areas uniquely suited to the expertise and management skills of a systems-based hematologist, but noted that there are many other possibilities. These areas are:

—Implementation of care pathways could reduce unnecessary exposure to heparin and direct thrombin inhibitors, and better utilize laboratory testing for suspected HIT.

Thrombotic thrombocytopenic purpura (TTP)

—Improved utilization of the metalloproteinase ADAMTS13 assay as part of a clinical analysis to diagnose TTP in order to better identify patients who need plasma replacement.

Medical director for hemostasis/thrombosis

—Hematologist-led stewardship programs could broadly and systematically address coagulation-related disorders within a medical center or delivery network. This includes handling of cancer-associated thrombosis, which is common in pancreatic and other solid tumors.

Nonmalignant hematology consultation in an ACO environmen

t—A designated hematologist specializing in nonmalignant conditions could better evaluate and manage the demand for hematology consultations, which is expected to grow as incentives for primary care physicians to handle these patients continue to decline.

Vanderbilt Experience Illustrates the Issues

The ASH concerns in the evolving landscape of hematology care are reflected at Vanderbilt University Medical Center, according to Kevin T. McDonagh, MD, a professor of Medicine and a hematologist/oncologist at the Vanderbilt-Ingram Cancer Center.

In his division, there are about 60 attending physicians, approximately 20 of whom are involved in hematology care. The majority of those hematologists manage patients who have malignant diagnoses such as leukemia, lymphoma, or myeloma, or who are undergoing transplants. Vanderbilt has only three faculty members who practice in both malignant and benign hematology and, until recently, had just one doctor who focused exclusively on nonmalignant hematology, said McDonagh.

That doctor has left for a position elsewhere, leaving the hospital system interviewing for not just one replacement, but two additional nonmalignant hematologists, as Vanderbilt has recognized the need for more. That won’t be easy, McDonagh says. “It is difficult to find people who have really focused in benign hematology during their training. As the report said, this is probably an area that has been somewhat deemphasized in many hematology/oncology programs as the volume of malignant diagnoses and management has increased.”

McDonagh speculated that at large institutions less money has been set aside for hematology salaries and related support staff. “The way that budgeting is done is not perceived that this is something that is as profitable or as valuable to the institution’s bottom line. I think as the report emphasized, it is not hard to take a step back and realize how critical and valuable this expertise is to institutions, particularly at a high level academic institution that does complex surgery and takes care of incredibly sick patients. You need people with this type of expertise,” he said.

In pondering the future of hematology care, Vanderbilt is considering systems-based roles for specialists in the field. “One approach that we are looking at is the impact that somebody in this position has in terms of pharmacy services, because the management of the portfolio of drugs that are used to treat, in particular, hemostasis and thrombosis disorders is very, very large. That has a huge bottom-line impact on the institution.”

He noted that Vanderbilt already has diagnosis management teams comprised of pathologists and hematologists who review coagulation testing ordered by other doctors.

“All of the coagulation testing that is done both in the inpatient as well as the ambulatory setting is reviewed by experts in hemostasis who generate a report and recommendations that flow back within our electronic record to physicians who order those studies,” said McDonagh. “And that might be a hematologist/oncologist who doesn’t have a special expertise in hemostasis/thrombosis, but it might also be a primary care physician or an obstetrician or a neurologist who has even less expertise in that area.”

“It is a very effective model,” he added.

			Wallace P, Connell N, Abkowitz J. the role of hematologists in a changing United States healthcare system [published online March 6, 2015]. 

			The American Society of Clinical Oncology. The State of Cancer Care in America: 2015. Available at: http://goo.gl/XndwW8. Published March 17, 2015. Accessed March 20, 2015.

The American Society of Hematology is calling for the creation of a new clinical hematology specialty that would be based in a medical center or health system and would focus primarily on patients with benign blood disorders, while also helping to manage genomic testing and pathways-centered care.


ASH Report Carves Out a New Role for Hematologists

The growing popularity of high-deductible health insurance plans has created a range of increasing pressures on oncologists and hematologists. According to doctors and administrators at a number of practices, more and more patients find themselves unable to afford their deductibles, payment plans are routinely extended by years, bad debt and write-offs of losses are ubiquitous, practices must hire additional financial counselors and business staff, and patients are more dependent on financial assistance programs.

High-deductible plans, which require larger out-of-pocket spending by patients, are becoming more prevalent in part because of the insurance mandate and coverage requirements of the Affordable Care Act (ACA). Both employers and people buying individual insurance on the state and federal health exchanges have responded to rising costs by choosing plans with the lowest monthly premiums, which typically come with annual deductibles of a few thousand dollars that patients pay up front before their treatment begins.

At North Shore Hematology Oncology Associates in New York, bad debt now amounts to “hundreds of thousands of dollars per year,” said Jeff Vacirca, MD, the practice’s CEO and vice president of the Community Oncology Alliance. “It’s gone up 10-fold in the past decade. I probably get a half a dozen letters a week from patients who can’t afford their care and don’t know what to do.”

“Obviously, the first thing we do is call them and say, ‘We’ll take care of it, we’re going to work something out. The last thing we want is for you not to get treated,’” said Vacirca. “But in the end it’s a tough burden to carry. Doctors are having trouble staying in business.”

High-deductible health plans, or HDHPs, were for years found mostly in the small market for individual insurance. They grew more common as rising medical costs led insurers to boost premiums in both individual and group plans, and became a new norm when the health exchange expanded the individual market. The law’s benefit requirements further pressured insurers’ bottom lines, accelerating the trend.

The number of Americans using HDHPs has risen about 15% a year since 2011, according to survey results announced last July by the insurance industry trade association America’s Health Insurance Plans.

 Of the 17.4 million people enrolled in those high-deductible plans in January 2014, 74% were in large group plans.

“I understood going into this that we were going to be dealing with a lot more patients getting high-deductible plans. But what I didn’t take into account was the fact that so many employers would be switching over to these plans, including even hospitals,” said Ricky Newton, director of financial services and operations for the Community Oncology Alliance in Washington, DC.

According to the Large Employers’ 2015 Health Plan Design Survey by the National Business Group on Health, 35% of employers are considering moving retirees and active employees to private exchanges in 2016. The lure of private exchanges is in large part the savings that can be achieved through high deductibles.

Healthy people may ignore the fine print and simply buy the cheapest plan. Lower-premium plans can include narrow provider networks, drug exclusions, and higher deductibles, co-pays, and coinsurance requirements. Many buyers may not consider the possibility of serious illness.

“When you’re getting an insurance plan, you’re not thinking, I’m going to get cancer, or some kind of blood disorder,” said Newton, previously practice director at Cancer Specialists of Tidewater and Riverside Cancer Center in Virginia.

For a patient who assumed insurance would cover most expenses, the cost of a cancer drug regimen and their out-of-pocket obligation can come as a tremendous shock, amplified by confusion over how their policy terms dictate the payment calculation. Coming up with a $3000 copay so that a round of chemotherapy can begin, for example, is simply not in the cards for many patients, Newton said.

Yet physicians say such scenarios are common now and practices must be prepared if they are to provide the appropriate treatment and recover payment.

As a result, financial counseling has become “a big deal” in cancer practices, said Kenneth Adler, MD, vice chair of the American Society of Hematology’s Committee on Practice. Vacirca said his practice’s financial counselor went from part time to full time two years ago, while Thomas Gallo, executive director of the Virginia Cancer Institute, said each of his eight offices has a counselor.

“We have more people working in our office now—not that we’re getting paid to pay them&mdash;to counsel patients, saying this is what it’s going to cost to get this treatment, this is what your coinsurance is going to be, you have meet this deductible,” said Adler, a hematologist at Regional Cancer Care Associates in New Jersey. “Here we have somebody dealing with a leukemia or lymphoma, their head is spinning from the new diagnosis; and now, you have be a PhD to figure out what the heck it’s going to cost you.”

Counselors and business staff play crucial roles beyond helping patients understand their medical bills. For example, they take on the time-consuming task of seeking pre-authorizations from payers and appealing denials, which Vacirca and others said some insurers use as a delaying tactic, even when a patient’s treatment meets National Comprehensive Cancer Network guidelines.

To avoid creating even more work for staff and still losing out on payments, doctors need to avoid accepting exchange plans that throw up roadblocks, Vacirca said.

“I would make sure, if they’re going to look into any of the ACA plans, that they speak to someone who’s already in the plan to see what the plan’s track record is,” Vacirca said. “It’s really difficult to go at risk with a multitude of different plans. They should pick and choose the ones that they know are run the right way, so they’re not going to end up not getting paid, getting delayed, and going into debt.”

Once the insurance coverage is clear, counselors discuss the patient’s ability to pay his or her portion of the bill. A quarter of all non-elderly Americans with private insurance coverage do not have sufficient liquid assets to pay even a midrange deductible of $1200 for single coverage or $2400 for family coverage, according to a Kaiser Family Foundation study (see chart).

 More than one-third can’t afford a higher-range deductible of $2500 single/$5000 family, and among households at 100% to 250% of the poverty line, 68% lack sufficient resources.

“We do have people that have issues with paying deductibles, and we do set up a payment plan and don’t charge interest,” said George Kovach, MD, a hematologist-oncologist with Iowa Cancer Specialists and past president of the Association of Community Cancer Centers. “We give them statements monthly and ask them to try to make a payment, and sometimes it’s five bucks a month! It’ll take 20 years, but at least they’re making some effort toward it, rather than not doing anything. We certainly don’t want to deny them care.”

Practice staff must continuously monitor a long list of individual payment plans, tracking multiple streams of micro-payments and contacting patients when they fall behind. At that point, using third-party collection agencies is an option, as reflected in figures showing that medical expenses account for more than half of overdue debt on credit reports.

Newton said his former practice would send nonpaying patients collection letters to prod them to contact the office, without officially putting them in collections. Doctors said they preferred not to use third-party firms because of the risk of alienating patients, and beca use yields are extremely low and are shared with the agency.

One worrisome twist is that the ACA gives subsidized enrollees a 90-day grace period before their insurance coverage can be canceled for failure to pay the monthly premium. If it is canceled, the insurer is responsible for the first 30 days of medical costs and the provide s for the rest, retroactively eliminating coverage for 60 days of past treatment. Vacirca said the rule has created challenges in his practice, while Newton and others said it has not yet become a significant problem.

As greater financial demands are being made of patients, more of them need financial help from foundations and pharmaceutical company assistance programs, which creates even more work for counselors, practices find.

“The demand has increased over the past few years, particularly with the cost of some of the new agents out there,” Gallo said. “It’s quite often the case that our financial counselors will get aid from multiple places to cover pieces of it, and try to put together a package for the patient. On the business office side, there is a higher administrative expense to track the payments from the foundations and apply them correctly to the different individuals.”

The growing popularity of high-deductible health insurance plans has created a range of increasing pressures on oncologists and hematologists.

April 2015 | Oncology Business News®

Physician Quandary: Data Shortage, Surfeit Impinge on Precision Medicine

Practices Hammered by Rising Uncertainty

CMS Starts Cutting Pay for Doctors Who Don't Measure Up

Internal Investigations May be Open to Court and Government Agency Scrutiny

ASH Report Carves Out a New Role for Hematologists

ACA's High-Deductible Plans Cause Headaches, Hurt Patient Care