Kusserow on Compliance: New CMS proposed outpatient rules

The 2020 annual rule cycle has been active for CMS with several proposed rules in the outpatient prospective payment system (OPPS) area. Hospitals and health system executives should monitor these annual rules carefully for provisions that will affect their organizations’ operations. Among the significant regulatory rule proposals for hospital and health system executives are the following:

  1. Mandated disclosure of negotiated charges between health plans and hospitals for all items and services for about 300 “shoppable” services
  2. Proposed penalties which would be over $100,000 a year for noncompliant hospitals
  3. The addition of several ASC procedures
  4. The removal of total hip arthroplasty from the inpatient-only list for 2020, allowing the procedure to be performed on an outpatient basis
  5. Reduction of supervision level for hospital outpatient department from direct to general for hospital outpatient departments
  6. A requirement for prior authorization of certain outpatient department services.
  7. Continued payment reduction for 340B purchased drugs
  8. Increased per-day cost threshold for separate payment for certain outpatient drugs
  9. The establishment a prior authorization process for five categories of services that often may be cosmetic: blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty, and vein ablation
  10. Various updates to Hospital Outpatient Quality Reporting Program requirements

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on LinkedIn.

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Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: New OIG Work Plan items

The HHS Office of Inspector General (OIG) recently issued updates to its Active Work Plan (Work Plan). The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond. Recent additions related to Medicare/Medicaid include the following:

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies. Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug. The OIG will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

 

  1. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose. An OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017. The OIG will study: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review.

Part D plans that meet certain limitations have the discretion to include different Part D drugs and drug utilization tools in their formularies. Under the Affordable Care Act, the OIG conducts an annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

 

  1. Nursing Facility Staffing: Reported Levels and CMS Oversight. CMS uses the Payroll Based Journal auditable daily staffing data to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website. It aids the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing. The OIG will issue two reports to: (1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and (2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

 

  1. Medicare Part B Payments for Podiatry and Ancillary Services. Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. It does not cover routine foot-care services unless they are: (1) necessary and integral part of otherwise covered services; (2) for the treatment of warts on the foot; (3) in the presence of a systemic condition or conditions; or (4) for the treatment of infected toenails. The OIG will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG Work Plan update

The OIG Work Plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond. Projects included in the Work Plan span the Department and include CMS. The OIG also plans work related to issues that cut across departmental programs, including state and local governments’ use of federal funds. At the end of December, the OIG announced two new projects led by the Office of Evaluation and Inspection beginning in 2019. They are:

  1. T-MSIS Data Assessment: Usefulness of National Data to Monitor Opioid Prescribing in Medicaid. Although all States have been submitting T-MSIS data, it does not mean the data are complete and without complete data, it cannot be used as a national dataset to help Medicaid manage critical issues such as the opioid crisis. The will OIG determine whether T-MSIS contains the data necessary to identify recipients of opioid prescriptions through Medicaid who may be at risk of opioid abuse nationally.  The OIG intends to interview states to determine the challenges they face, if any, in submitting the data necessary to identify and prevent beneficiary harm from opioid misuse.

 

  1. States’ Compliance with FFS and MCO Provider Enrollment Requirements. The OIG noted that provider enrollment is a key program integrity tool to protect Medicaid from fraudulent and abusive providers. The 21st Century Cures Act requires states to enroll all Medicaid providers, both those in Medicaid fee-for-service (FFS) and managed care organizations (MCOs). This study, by the OIG, is mandated by the Cures Act and will survey state Medicaid agencies about their enrollment of FFS and managed care providers and implementation of required provider enrollment screening activities.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: CMS Preclusion list

Those on Preclusion List are prohibited from MA Plan or Part D sponsor payment

Effective April 2019, under a final rule published by CMS, Part D sponsors, or their pharmacy benefit manager must screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on the Preclusion List. Additionally, effective April 2019, MA plans must deny payment for a health care item or service furnished by an individual or entity on the list. Plans and sponsors must also notify impacted beneficiaries who received care or a prescription from a provider on the Preclusion List in the last twelve months. The list includes those who are currently revoked from Medicare; are under an active reenrollment bar, where CMS has determined that the underlying conduct is detrimental to the Medicare program; or have engaged in behavior for which CMS could have revoked the prescriber and determined the underlying conduct would have led to the revocation. Such conduct includes, but is not limited to, felony convictions and OIG exclusions. Only health care plans approved by CMS will have access to the Preclusion List. MA plans and Part D sponsors will be required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS.  The List will be updated around the first business day of each month. CMS indicated that individuals or entities appearing on the List of Excluded Individuals/Entities (LEIE) and/or the System for Award Management (SAM) list would also be placed on the Preclusion List.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.