OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released its 2017 Work Plan.  Published annually and updated throughout the year, the Work Plan identifies the OIG’s key areas of focus as it carries out its mission of protecting the integrity of programs within DHHS.  The OIG is charged with ensuring the integrity of more than 100 programs administered by DHHS, including those within the Centers for Medicare and Medicaid Services, Center for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Health. The OIG Work Plan summarizes the OIG’s current activities – comprised of both new and revised activities — along with information regarding previously identified activities that have been completed, postponed, or cancelled.

The Work Plan highlights new and continuing priorities applicable to various provider types, including hospitals, nursing homes, hospices, home health, clinical laboratories, physicians and other health professionals, medical equipment suppliers and manufacturers, pharmaceutical manufacturers and other providers and suppliers.

The 2017 Work Plan is available here.

The following is a sampling of some of the new and ongoing efforts highlighted in the Work Plan:

Read More

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

More Posts - Website

Share This Article Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page

Two New Exceptions to Stark to Become Effective in the New Year

Starting January 1, 2016, physicians and certain health care organizations will be able to take advantage of two new exceptions to the physician self-referral law (commonly referred to as the “Stark Law”).  Stark contains two broad restrictions.  First, it prohibits physicians from making referrals of certain designated health services (“DHS”) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless an exception applies.  Second, Stark prohibits those entities from billing for the referred services.

The two new Stark exceptions, when satisfied, will permit (1) remuneration from a hospital, federally-qualified health center (“FQHC”) or rural health clinic (“RHC”) to a physician to assist the physician to compensate certain non-physician practitioners (“NPPs”) who will provide primary care or mental health services in the geographic area served by the hospital, FQHC or RHC (the “NPP Recruitment Exception”) and (2) arrangements in which physicians (or physician organizations) and hospitals may use one another’s space, equipment, personnel, items, supplies or services to provide services on a time-sharing basis (the “Timeshare Arrangements Exception”).

In announcing the new exceptions, CMS recognized several important policy considerations, many of which relate to increasing access to care.  CMS noted NPPs’ increased role in health care delivery in light of health coverage expansion under the Affordable Care Act and the looming shortage of primary care physicians.  Also, in a victory for mental health providers, CMS was persuaded to include clinical psychologists and clinical social workers within the definition of NPP and to add mental health care services to the scope of permissible services that may be provided by NPPs engaged under the NPP Recruitment Exception.  (The exception, as initially proposed by CMS, included only physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives and restricted their services to primary care.)  The Timeshare Arrangements Exception reflects a similar acknowledgment that time-sharing may increase access to specialists in rural areas that cannot support a specialist on a full-time basis.

Both the NPP Recruitment Exception and the Timeshare Arrangements Exception include several elements that must be strictly satisfied in order for the arrangement to qualify for protection.  Health care organizations and physicians interested in learning more about the new exceptions, or whether arrangements they are considering might qualify, should feel free to contact Parker Poe.

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

More Posts - Website

Share This Article Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page

Proposed Exclusive Arrangement Between Lab and Physician Practices May Violate Federal Law

A laboratory proposing to enter into an exclusive relationship with physician practices has been advised that the arrangement may violate federal law.  The laboratory sought advice from the Office of Inspector General (“OIG”) of the Department of Health and Human Services on an arrangement in which the laboratory would contract with physician practices to provide all laboratory services to the practices’ patients, without regard to the patients’ health insurance coverage.  The requesting laboratory would not bill those patients whose health plans — so-called “exclusive plans” — require them to use other laboratories (nor would the lab bill the practices themselves).  In its Advisory Opinion posted on March 25, 2015, the OIG concluded that the arrangement may violate the Anti-Kickback Statute and subject the laboratory to administrative sanctions, including exclusion from federal health care programs (e.g., Medicare and Medicaid).
Read More

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

More Posts - Website

Share This Article Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page

OIG Releases Health Reform Oversight Plan

Last week, while many of us were digging out from one snowstorm and bracing for another, the United States Department of Health and Human Services (“HHS”) was keeping busy. HHS lawyers were preparing to defend a key regulation under the Affordable Care Act (“ACA”) before the U.S. Supreme Court, and HHS’ Office of Inspector General (“OIG”) released its Health Reform Oversight Plan (“the Oversight Plan”) for the 2015 fiscal year. The OIG is charged with protecting the integrity of HHS programs and the welfare of program beneficiaries. It carries out this mission through a variety of initiatives, including audits, investigations, evaluations and enforcement activities.

The Oversight Plan identifies the OIG’s four key strategic goals in overseeing ACA programs: (1) fighting fraud, waste and abuse; (2) promoting value, safety and quality; (3) securing the future; and (4) advancing excellence and innovation. With these goals in mind, the Oversight Plan highlights two key areas of focus for the OIG: health insurance marketplaces and other ACA-related reforms.Read More

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

More Posts - Website

Share This Article Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste.  On October 31, 2014, the OIG released its Work Plan for fiscal year 2015.  The Work Plan highlights the projects and issues that OIG intends to prioritize in 2015.

According to the Work Plan, the OIG will continue to emphasize oversight of Medicare and Medicaid payments, emerging payment models, IT systems security vulnerabilities (particularly in health insurance marketplaces), quality of care and access in Medicare and Medicaid, and public health and human services programs.  The Work Plan indicates that the OIG is also considering new work in the areas of food, drug and medical device supply chain integrity, electronic data security, health information technology and emergency preparedness and response.

Within these broad categories of focus, the Work Plan highlights many specific initiatives.  Many of these are ongoing projects, while others are new to this year’s Work Plan.

Some notable new initiatives include review of:

  • Hospital wage data used to calculate Medicare payments
  • Factors contributing to adverse and temporary harm events for Medicare beneficiaries receiving care in long-term care hospitals, determination of preventability of those events, and estimation of the costs to Medicare
  • Medicare payments to independent clinical laboratories to determine labs’ compliance with selected billing requirements, with the goal of identifying those that routinely submit improper claims and recovering overpayments
  • Medicaid beneficiary transfers from group homes and nursing facilities to hospital emergency rooms, with a particular focus on potential quality issues raised by high transfer rates
  • Managed care organization payments for services after beneficiaries’ deaths and for ineligible beneficiaries

The Work Plan also continues a number of initiatives from prior years.  These focus areas span the healthcare provider industry – including hospitals, nursing homes, physician practices and other providers, hospices, long-term care providers, home health, ambulatory surgery centers, end-stage renal disease facilities, ambulance providers and others.  The following are a few notable initiatives relevant to various industry segments:

Hospitals

  • Impact of the “two midnight” rule on inpatient and outpatient billing
  • Compliance with provider-based status criteria
  • Provider-based versus free-standing clinic payment rates
  • Reimbursement for swing-bed services at critical access hospitals, as compared to the same level of care provided at traditional skilled nursing facilities
  • Duplicate or excessive graduate medical education payments
  • Outpatient evaluation and management services billed at the new patient rate, rather than the established patient rate
  • Oversight of pharmaceutical compounding
  • Review of medical staff candidate credentialing

Nursing Homes

  • Billing for high level therapy when beneficiary characteristics remain largely unchanged
  • Questionable billing patterns for Part B services during stays not paid under Part A
  • Oversight of state agency verification of correction plans for deficiencies identified during recertification surveys
  • Hospitalization of residents for conditions manageable or preventable in the nursing home setting


Hospices

  • Review of extent of hospice services rendered to beneficiaries resident in assisted living facilities, including length of stay, levels of care and common terminal illnesses
  • Appropriateness of hospice general inpatient care

Home Health

  • Compliance with prospective payment system requirements, including documentation requirements
  • Employment of individuals with criminal convictions

Medical Equipment

  • Competitive bidding and post-award audit
  • Power Mobility Devices, including rental v. lump sum payments, medical necessity and face-to-face examination requirements
  • Lower limb prosthetic billing practices
  • Medical necessity of nebulizer machines and related drugs
  • Diabetic testing supplies, including medical necessity, frequency and other requirements

Ambulatory Surgery Centers (“ASC”)

  • Review of Medicare’s methodology for ASC payment rates
  • Review of disparity between payments to ASCs and hospital outpatient departments for similar surgical procedures

End-Stage Renal Disease Facilities

  • Medicare payments under prospective payment system

Ambulance Providers

  • Questionable billing, including medical necessity, level of transport and transports billed but not conducted
  • Analysis of Part B data to identify vulnerabilities, inefficiencies and fraud trends

Physicians and Other Providers

  • Place-of-service coding errors by physicians
  • Payments for personally performed anesthesia services (and incorrect service code modifiers)
  • Questionable billing for chiropractic services
  • Inappropriate billing by opthalmologists
  • Medical necessity of high-cost diagnostic radiology tests
  • Documentation and medical necessity of outpatient physical therapy services
  • High utilization of sleep testing procedures

The foregoing are just a few of the many initiatives outlined in the Work Plan.  Download the full Work Plan here: http://oig.hhs.gov/reports-and-publications/workplan/index.asp

Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

More Posts - Website

Share This Article Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Email this to someonePrint this page