No “Privilege Against Self-Incrimination” (Fifth Amendment) for Corporate Documents in a Fraud and Abuse Investigation

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In a federal grand jury investigation into illegal physician kickbacks paid by a laboratory, Circuit Court Judge Cohen, writing for the U.S. Court of Appeals for the Third Circuit, affirmed the U.S. District Court for the District of New Jersey’s order of contempt against a physician and his practice after refusing to produce documents, including patient records, from his Professional Association organized in 1973. In re In the Matter of the Grand Jury, decided May 15, 2015.

Specifically, a blood laboratory was suspected of paying kickbacks to physicians for patient referrals spanning a seven year period. A grand jury was impaneled to investigate and it issued a subpoena to the sole owned practice for certain documents that included patient records. The doctor agreed that the business was not entitled to protection, but that the implication would be he supplied the documents violating his Fifth Amendment rights.The Court noted that a custodian of records may not refuse production even if production might be incriminating, citing well established U.S. Supreme Court precedent. Noted further was that the subpoena was carefully crafted to produce only the necessary documents.  Thus, it was not overly broad in violation of the Fourth Amendment.The practice was found in civil contempt by the District Court and sanctioned in the amount of $2,000 per day for noncompliance.If you have any questions or concerns, please feel free to contact Meghan McNab at mmcnab@kdlegal.com

CMS Proposes Medicaid Managed Care Revisions

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The Centers for Medicare & Medicaid Services (“CMS”) published its proposed rule to update its standards and requirements for Medicaid managed care plans.

CMS notes that laws passed since the Medicaid managed care regulations were promulgated in 2002 have changed Medicaid to such an extent that the current regulations are no longer adequate. Accordingly, the proposed rule addresses many issues in order to bring the regulatory scheme in line with these changes, including: modernizing the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems; aligning the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through qualified Health Plans and Medicare Advantage plans; implementing statutory provisions; strengthening the actuarial soundness of payment provisions to promote the accountability of Medicaid managed care program rates; promoting the quality of care; strengthening efforts to reform delivery systems that serve Medicaid and Children’s’ Health Insurance Program (“CHIP”) beneficiaries; ensuring appropriate beneficiary protections and enhance policies related to program integrity; requiring states to establish comprehensive quality strategies for their Medicaid and CHIP programs regardless of how services are provided to beneficiaries; implementing provisions of the Children’s Health Insurance Program Reauthorization Act of 2009; and, addressing third party liability for trauma codes. See Proposed rule, 80 FR 31098, June 1, 2015, for further information.

If you have any questions or concerns, please feel free to contact Meghan McNab at mmcnab@kdlegal.com

OIG Issues Warning to Physicians

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The United States Department of Health and Human Services Office of Inspector General (“OIG”) released an alert to physicians and health care organizations related to compensation arrangements that could violate the Anti-Kickback Statute (“AKS”).  Specifically, the OIG issued guidance that compensation arrangements with physicians must be for services actually provided and not one purpose of the arrangement can be for the physician’s past or future referrals (the “Alert”).

The AKS, authorizes penalties of up to five years in jail and $25,000 in fines, for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs. However, the statute and current regulations provide safe harbors that protect certain arrangements that might otherwise implicate the AKS, from penalty.  Nevertheless, many safe harbors require compensation to represent fair market value for the services provided.

The OIG noted that it has reached settlements with 12 individual physicians who entered into questionable medical directorships and office staff arrangements.  It was alleged that the compensation paid in these arrangements was improper because such compensation took into account the volume or value of referrals and did not reflect fair market value for the services under the arrangements.  Above all, the OIG explained that the physicians were an integral part of these schemes and were subject to liability.

Knowing the OIG’s continued focus on compensation arrangements with physicians, organizations need to be aware of the potential liability issues related to such arrangements.  Organizations and physicians should ensure such arrangements are properly analyzed to ensure compliance with the AKS.

If you have any questions about this Alert or if you would like additional information, please contact Robert A. Wade at (574) 485-2002 or Alex T. Krouse at (574) 485-2003.

ACO Final Rule Released

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On June 4, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a Final Rule for the “Medicare Shared Savings Program: Accountable Care Organizations.” The Final Rule follows the December 2014 Proposed Rule and the review of more than 270 public comments. The Medicare Shared Savings Program was initially implemented under the Affordable Care Act in 2011 in order to “promote accountability for a population of Medicare beneficiaries, improve the coordination of fee-for-service items and services, encourage investment in infrastructure and redesigned care for high quality and efficient service delivery and promote higher value care.”[1] In addition to maintaining the initial purposes, the 2015 Final Rule also aims to “advance the ACO models, codify existing guidance, reduce administrative burden and improve program function and transparency in a number of program areas.”[2]The Final Rule contains the following notable revisions:

  • More efficient data sharing to allow Accountable Care Organizations (“ACOs”) improved access to Medicare beneficiary claims data, while leaving the option for beneficiaries to deny sharing of the data intact.
  • The addition of Track 3, a third performance-based risk option that offers a higher sharing rate than Tracks 1 and 2, as well as a waiver for the three-day Skilled Nursing Facility Rule, beginning in 2017.
  • Modifications to Track 2 that provide ACOs with additional choices for setting their minimum savings and loss rates, including the option of a symmetric threshold for savings and losses under the performance based risk tracks.
  • The option to renew Track 1 Participation Agreements for an additional three-year agreement period.  This option is available to ACOs that have met the quality performance standard in at least one of the first two years of their initial Track 1 agreement period and maintain good standing with the program.
  • Increased significance on primary care services in the beneficiary assignment methodology by removing “specialist physicians” from step two of the methodology and adding primary care services provided by nurse practitioners, clinical nurse specialists and physician assistants to step one of the methodology.
  • Modification to the financial benchmark resetting methodology by allocating equal weight to the historical benchmark years of the ACO, as well as applying savings produced by the ACO in its prior agreement years.
  • Updated eligibility standards, including the expansion of the requirements for agreements between ACOs and Medicare-enrolled entities, updated governing body and leadership qualifications and a requirement for the ACO to detail how they will encourage the use of “enabling technologies” to improve care coordination.[3]
All revisions in the Final Rule become effective on August 3, 2015, with the exception of three amendments. The data sharing amendment that modifies how beneficiaries may deny the sharing of claims and the amendment revising the requirements for notification of participation in a shared savings program both go into effect on November 1, 2015.  Additionally, the amendment modifying the methods ACOs may use to request beneficiary identifiable data will go into effect on January 1, 2016. With more than 400 participating organizations in the shared savings program, the Final Rule will affect a large number of health care entities throughout the country.

If you have any questions or concerns, please feel free to contact Brian Heaton at bheaton@kdlegal.com or Meghan McNab at mmcnab@kdlegal.com.

[1] Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, 80 Fed. Reg. 32692, 32694 (June 9, 2015)(amending 42 C.F.R. pt. 425).
[2] Id.
[3] Finalized Changes to the Medicare Shared Savings Program Regulations, CMS, June 4, 2015 http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-06-04.html (last visited June 16, 2015).

Changes to Advanced Practice Nurse and Physician Assistant Laws

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Utilization of advanced practice nurses, such as nurse practitioners, and physician assistants has been increasing over the past few years.  Laws with respect to these health care providers have also changed, both on a Federal and State level.  On May 4th, Governor Mike Pence signed into Indiana law House Bill 1183 which included changes for both advanced practice nurses and physician assistants.  Further, on April 16th President Barack Obama signed into federal law H.R. 2 which included various changes for nurse practitioners.  These changes are outlined below.

Physician Assistant

Physicians assistants engage in a dependent practice with physicians in which the physician delegates authority to the physician assistant.  Nevertheless, House Bill 1183 substantially changes many requirements related to physician supervision.  These changes include that a supervising physician no longer is required to name each drug or drug classification in which the physician assistant has been delegated authority to prescribe, a supervising physician does not need to cosign any prescriptions ordered by a physician assistant, and patient encounters between a patient and a physician assistant should be reviewed by the supervising physician within ten (10) days as opposed to seventy-two (72) hours.  Another large change relates to chart reviews.  Previously a supervising physician had to review at least 25% of the physician assistant’s patient charts.  Now, this is required only in the first year of employment and thereafter the physician can determine a specific number of charts that needs to be reviewed.  Finally, a supervising physician can now supervise a maximum of four (4) physician assistants at any time as opposed to two (2).

Advanced Practice Nurses/Nurse Practitioners

An advanced practice nurse includes a nurse practitioner, nurse midwife, a clinical nurse specialist, or a certified registered nurse anesthetist.  Advanced practice nurses are independent members of the health care team that make independent decisions related to the health care of patients.  For advanced practice nurses that seek prescriptive authority, a collaborative agreement is required with a physician.  House Bill 1183 had one change that is applicable to both advanced practice nurses and physician assistants.  Both are now able to prescribe and treat patients with a Schedule III and Schedule IV controlled substance for the purpose of weight reduction or to control obesity.  Although advanced practice nurses have been able to prescribe Schedule II through IV controlled substances, they now can offer treatment for weight loss.  H.R. 2 now authorizes nurse practitioners to document the face-to-face encounter required for durable medical equipment orders.  Previously, a physician needed to be involved to document such an order.


These changes may have a significant impact on how your organization utilizes these healthcare professionals.  If you have any questions or concerns related to these recent changes in laws, or the utilization of these providers in your organization, please contact Alex T. Krouse at (574) 485-2003.

Medicare Releases Individual Prescriber Data

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On May 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released Medicare Part D prescription drug data that individual physicians, nurse practitioners, physician assistants, and other health care providers prescribed in 2013. This release of data follows various releases aimed at creating more transparency within the health care. For example, the Sunshine Act released payment information between drug and medical device manufacturers to physicians and teaching hospitals. Further, CMS released payment data to physicians and other health care providers on April 9, 2014. Although this data is a push for more transparency, it could represent a significant risk to health care providers.

The data released, contains individual data for each prescriber and drug.  This amounts to more than one (1) million individual health care providers who prescribed approximately $103 billion in prescription drugs under the Part D program in 2013. CMS provided the following chart highlighting the higher number of prescribers by specialty:


Average Costs and Number of Unique Drug Products for Specialties with the Highest Number of Prescribers, 2013

Specialty
Number of Prescribers
Average Total Costs
Cost per Claim
Average Number of Unique Drug Products Prescribed
Internal Medicine
130,640
$205,923
$63
65.7
Dentist
124,322
$855
$14
2.1
Family Practice
105,413
$211,977
$56
74.9
Nurse Practitioner
97,722
$67,708
$78
24.2
Physician Assistant
69,180
$47,405
$70
18.7
Emergency Medicine
43,664
$16,822
$41
9.5
Organized Health Care Education/Training Program - Student
42,307
$8,036
$67
5.6
Obstetrics/Gynecology
35,979
$15,953
$85
6.2
Psychiatry
25,906
$174,274
$104
28.3
Optometry
25,654
$17,501
$99
4.8


It should be cautioned that such data is not indicative of a specific providers prescribing patterns; however Medicare Part D equals billions per year in government reimbursements. Further, for providers or organizations that see a high proportion of Medicare patients, this data may be used in ways that could increase risk to your organization. This includes risks related to prescribing practices, forms of prescription fraud, or even technical non-compliance with prescribing documentation issues.

It is advised that providers and organizations should analyze this data carefully to ensure that any risks associated with this data being published are properly analyzed from both an operational and legal perspective.

If you have any questions or concerns related to the Medicare Part D program, or this recent release of data, please feel free to contact Robert A. Wade at (574) 485-2002 or Alex T. Krouse at (574) 485-2003.

New Guidance Issued for Health Care Boards Regarding Compliance Oversight

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Are hospital and health system boards aware of compliance within your organization?  On April 20th, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”), in collaboration with various healthcare and legal compliance organizations, published a report advising health care organizations that compliance needs to be an integral issue for health care boards.  Specifically, HHS published the report titled, Practical Guidance for Health Care Governing Boards on Compliance Oversight (the “Report”).  The Report addressed various issues relating to a board’s oversight and review of compliance program functions.

The Report states that one of the first areas boards should focus on relates to understanding the actual expectations the government has with respect to board oversight of compliance program functions.  Although the Report notes that a board must make inquiries to ensure information and reporting systems exist, the board must also confirm that the reporting system is adequate to ensure compliance issues are presented to the board.  Further, the Report explains that boards must develop a formal plan to keep informed of regulatory and compliance changes. 

One method to ensure the board is able to analyze and understand compliance related issues is to utilize the expertise of others to assist in fulfilling this duty.  Specifically, the Report advises that an expert to the board can assist the board in identification of risk areas, provide insight into best practices in governance, and provide consultations on other substantive or investigative matters.  While there is no one-size fits all standard for health care organization boards, the Report indicates that boards have a responsibility to ensure they understand compliance functions, are aware of compliance issues within the organization, and receive expert advice to ensure the board can act upon those issues.

The Report also discusses various issues of which boards should be aware.  This includes the roles and relationships between the audit, compliance, and legal functions.  With respect to each of these areas, HHS believes health care boards should be able to evaluate the adequacy and performance of such functions on a periodic basis.  Further, boards are expected to set and enforce expectations related to receiving compliance information from various functions within an organization.  One issue that is stressed within the Report is the need for regular reports from an independent perspective.  Finally, the Report addresses the need for boards to understand active monitoring of risk areas as well as encouraging accountability and compliance as an enterprise-wide responsibility.

Krieg DeVault has significant experience in this area as Partner and Health Care Practice Group Leader Bob Wade is currently the Compliance Expert to the Board of Halifax Health, a 678-bed hospital system based in Daytona Beach, Florida. In March 2014, Halifax Health signed a Corporate Integrity Agreement (“CIA”) with the OIG as part of an $85 million settlement with the U.S. Department of Justice over alleged illegal contracts with physicians, that violated the Stark Law as well submitting false Medicare claims to the federal government. This settlement is the largest Stark Law settlement involving a hospital system to date.  Under their CIA, the OIG mandated a Compliance Expert to the Board.  This Report, and Bob Wade’s recent appointment, highlight that the OIG and HHS are insisting on enterprise-wide compliance from the board level.


If you have any questions or concerns related to the health care organization board compliance, or the Report, please feel free to contact Robert A. Wade at (574) 485-2002 or Alex T. Krouse at (574) 485-2003.