Category Archives: Quality Improvement Organizations

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly all of these changes broaden permissible arrangements for certain health care and health service providers. The OIG is seeking public comment regarding how to best balance the promotion of beneficial arrangements that enhance the efficient and effective delivery of health care and promote the best interests of patients, while simultaneously avoiding payment arrangements that risk abuse of Federal health care programs or program beneficiaries. Comments about these proposed regulations are due to the OIG no later than December 2, 2014 at 5:00 p.m. EST. The proposed regulations in their entirety are available here. Selected proposed changes are described below.

Antikickback Regulations

1.   Cost-Sharing Waiver Safe Harbors. The OIG proposes to codify as regulations AKS safe harbors for certain cost-sharing waivers determined to be low risk to Federal health care programs.

a.   Safe Harbor for Part D Cost-Sharing Waivers by Pharmacies. A pharmacy waiving Part D cost-sharing for a beneficiary would qualify for the safe harbor when:
(i) the waiver is not advertised or part of a solicitation;
(ii) the pharmacy does not routinely waive the cost sharing; and
(iii) before waiving cost-sharing, the pharmacy either determines in good faith that the beneficiary has a financial need or the pharmacy fails to collect the cost-sharing amount after making a reasonable effort to do so.
Conditions (ii) and (iii) do not apply to a subsidy-eligible individual.

b.   Safe Harbor for Cost-Sharing Waivers for Emergency Ambulance Services. Emergency ambulance providers and suppliers that are paid by Medicare fee-for-service and are owned and operated by a State, a political subdivision, or a Federally recognized Indian tribe would receive AKS safe harbor protection for arrangements when:
(i) the ambulance provider or supplier is the Medicare Part B provider or supplier of the services;                                                                                                        (ii) the waiver is offered uniformly, without regard to patient-specific factors;
(iii) the waiver is not the furnishing of free services paid for by a government entity; and
(iv) the provider or supplier bears the cost of the waiver.

2.   AKS Remuneration Exceptions. The OIG proposes to codify as regulations two recent statutory exceptions to the definition of remuneration.

a.   Medicare Coverage Gap Discount Program Exception. Applicable drugs provided at a discount to applicable beneficiaries under the Medicare Coverage Gap Discount Program would be excepted from the AKS definition of remuneration if the drug manufacturer is a compliant participant in the Medicare Coverage Gap Discount Program.

b.   Local Transportation Services Exception. Excepted from the AKS definition of remuneration would be free or discounted local (no more than 25 miles away) transportation made available by an individual or entity to established patients who are Federal health care program beneficiaries for the purpose of obtaining medically necessary items or services when:
(i) the individual or entity providing the transportation services does not primarily supply health care items and bears the cost of the transportation services;
(ii) the availability of transportation services is not determined in a manner related to the volume or value of Federal health care program business;
(iii) the transportation services are not air, luxury, or ambulance-level services; and
(iv) the transportation services are not marketed or advertised and drivers or others arranging the transportation are not paid per beneficiary transported.

Civil Monetary Penalty Regulations

1.   CMP Remuneration Exceptions. The OIG proposes to codify as regulations recent statutory exceptions to the CMP rule definition of remuneration. The proposed regulations additionally provide proposed definitions of terms intended to help interpret these exceptions. Proposed exceptions to the CMP rule definition of remuneration include:

(a)   Reductions by a hospital of the copayment amount for covered outpatient department services to no less than 20% of the Medicare outpatient department fee schedule.

(b)   Remuneration promoting access to care and posing a low risk of harm to patients and Federal health care programs.

(c)   Retailer rewards programs consisting of coupons, rebates, or other rewards from a retailer offering items or services on equal terms to all members of the public and which are not tied to the provision of other items or services reimbursed in any part by Medicare or an applicable State health care program.

(d)   The offer of certain items or services for free or at less than fair market value after making a good faith determination that the recipient is in financial need and when the items or services are not advertised.

(e)   Certain copayment waivers for the first fill of a covered Part D generic drug for beneficiaries enrolled in the Medicare Prescription Drug Plan or the Medicare Advantage Part D Plan.

2.   Gainsharing Prohibition. The OIG proposes codify the statutory gainsharing prohibition that forbids hospitals from knowingly making a payment to a physician as an inducement to reduce or limit services provided to Medicare or Medicaid beneficiaries under the care of that physician. In doing so, the OIG acknowledges that it seeks to strike a balance that interprets the prohibition broadly enough to protect Federal health care program beneficiaries, and narrowly enough to allow low risk programs that further the goal of delivering high quality health care at a lower cost. Furthermore, in the proposed regulations the OIG acknowledges that it has previously allowed certain gainsharing arrangements through its advisory opinion process and that it seeks comment regarding an interpretation of the statute that permits the implementation of low risk, beneficial gainsharing arrangements.

If you have questions about these proposed regulations, or about fraud and abuse compliance for Federal health care program participants generally, contact Heather E. Baird, or any member of the Benesch Health Care Department.

OIG Issues Report Finding Inconsistencies in Medicare Billing for Hospice Inpatient Stays

On May 3, 2013, the US Department of Health and Human Services Office of the Inspector General’s (OIG) Office of Evaluation and Inspections (OEI) issued a report (OEI-02-10-00490) entitled “Medicare Hospice:  Use of General Inpatient Care.”  The report found that while Medicare paid $1.1 billion for hospice general inpatient care (“GIP”) in 2011, there were unusual Medicare billing patterns for hospice inpatient stays, raising concerns about whether the stays were billed appropriately and whether the patients received the right level of care. Continue reading

CMS Provides Videos on Person-Centered Care

On September 14, 2012 CMS released S&C 12-44 NH  which provided information on CMS’ new series of training materials for nursing homes on person-centered care for residents with dementia.  The Hand in Hand training materials consist of an orientation guide and six one hour video modules for training of nursing assistants and other nursing caregivers.  These materials focus on prevention of abuse with the dementia population and person centered care for the residents with dementia and other memory disorders.  CMS will be mailing the training series free to all nursing homes this month.

The training materials can also be downloaded at – http://www.cms-handinhandtoolkit.info/Index.aspx

You can find a copy of S&C 12-44NH here —> CMS Letter

OIG Report – Nursing Home Assessments and Care Plans and Antipsychotic Medications

On July 6, 2012, the US Department of Health and Human Services Office of the Inspector General’s (“OIG”) Office of Evaluation and Inspections issued a report (OEI-07-08-00151) entitled “Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs.”

The new study analyzes nursing facility assessments and care plans for residents receiving atypical antipsychotic medications.  The study utilized a random sample of records derived from a previous OIG study of elderly nursing facility residents with Medicare claims for atypical antipsychotic drugs between January and June 2007 .  The study concluded that 99% of the records failed to meet the federal requirements for care plans and/or assessments.

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CMS Issues Proposed Rule on Rights of Beneficiaries to Make Complaints to Quality Improvement Organizations (QIOs)

On February 2, 2011, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule in the Federal Register, 76 FR 5755, that requires most Medicare providers and suppliers to provide written notice to beneficiaries of their right to lodge quality of care complaints with Quality Improvement Organizations (QIOs).

CMS contracts with a QIO in each state. QIOs are mostly private organizations staffed by health care professionals that CMS has trained to review the quality of medical care, help Medicare beneficiaries with complaints about care, and to implement improvements in the quality of care provided by Medicare providers and suppliers. CMS’ mission for the QIO Program is to improve the effectiveness, efficiency, economy, and quality of services delivered to Medicare beneficiaries. Continue reading