Category: Highlight

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OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk

Summary of article from Ankura, by Emily Petersen:

In a recent testimony, the Inspector General of the Department of Health and Human Services (HHS), highlighted issues surrounding risk adjustment in Medicare Advantage (MA) and proposed stricter rules for diagnoses used in risk adjustment calculations. She underscored the issue of rising improper payments within Medicare and Medicaid, emphasizing the need for increased oversight and enforcement. Significant vulnerabilities in the MA risk adjustment process and challenges in Medicaid Managed Care were also discussed, with a call for organizations to review their medical records and ensure the accuracy of diagnosis codes. Furthermore, systemic weaknesses such as eligibility determination errors and duplicate payments were pointed out, requiring urgent attention. Lastly, Grimm emphasized the need for increased investment in oversight and enforcement to combat fraud, waste, and abuse in healthcare programs.

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Enhanced Nursing Home Ownership Data Required by Biden HHS

From Bloomberg Law, by Tony Pugh:

  • The Biden administration finalized a rule requiring nursing homes to provide more detailed information about their ownership structure, including whether they are owned by private equity firms or real estate investment trusts (REITs). 
  • The additional data collected will be made public to allow families to make more informed choices about facilities and allow outside researchers to study the impact of different ownership models on quality of care.
  • Previous research has found that private equity ownership is associated with higher mortality rates for Medicare patients in nursing homes and increased taxpayer costs per resident. 
  • The private equity industry argues that its investments help strengthen struggling nursing homes by providing capital. 
  • The new rule implements requirements under the Affordable Care Act to increase transparency around nursing home ownership and oversight structures.
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Health care company owner to pay $1 million to settle False Claims Act case

The former owner of Providence Home Health and Providence Hospice has agreed to pay $1.05 million to settle claims she knowingly and willfully paid improper kickbacks for referrals of Medicare patients to her businesses, announced U.S. Attorney Ryan K. Patrick along with Special Agent in Charge Miranda Bennett of the Department of Health and Human Services – Office of Inspector General (DHHS-OIG).

This is a whistleblower case filed by two employees. They alleged that Teresita Alquero paid kickbacks to a medical director for Providence. The payments exceeded fair market value, so as to induce him to refer Medicare patients to Providence for home health and hospice services.

Alquero also allegedly submitted false claims under the name of a physician who was apparently incarcerated at the time. Thus, he could not have performed the services for which she was reimbursed.

Source: Health care company owner to pay $1 million to settle False Claims Act case | Woodlands Online

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CMS final 2021 physician fee schedule rule

CMS issued the final rule for the 2021 Physician Fee Schedule and doctors will see a conversion factor of $32.41, a decrease of $3.68 from the 2020 PFS conversion factor of $36.09.According to CMS, the lower conversion factor is a result of the budget neutrality adjustment, as required by law, to account for changes in RVUs, including significant increases for E/M visit codes.

The decreased conversion factor is concerning to many physician advocacy groups.

Source: CMS final 2021 physician fee schedule rule

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OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

As the title implies, this final rule clarifies and amends the discount safe harbor at 42 C.F.R. § 1001.925(h) under the federal Anti-kickback statute (AKS) such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers (PBMs) are not protected from liability under the discount safe harbor. The rule also adds a new safe harbor for point-of-sale reductions in price that are passed on directly to a buyer (a defined term under the rule) and an additional safe harbor for “legitimate” service fees paid to PBMs by drug manufacturers.

Source: OIG Finalizes Rebate Rules: Removal of Safe Harbor Protections for Rebates and Creation of New Safe Harbors for Other Discounts and Service Fees

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Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements

The finalized Radiation Oncology payment model and the Final CY 2021 Medicare Physician Fee Schedule (“MPFS”) have now been made public. Many in the industry will continue to face downward pressure on reimbursement during the coming year under the new MPFS payment rates set by Medicare which will drive overall cuts estimated to average 5.0% for all Medicare revenues.

Source: Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements

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HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

A value-based arrangement is an arrangement entered into between a value-based enterprise (VBE) and one or more of its participants, or among VBE participants in the same VBE, for the provision of one or more value-based activities for a target patient population. The final rule defines a VBE participant as an individual or entity that engages in at least one value-based activity as part of a value-based enterprise, other than a patient acting in their capacity as a patient.

For purposes of the OIG’s new safe harbors, a VBE is two or more participants that: (1) are collaborating to achieve at least one value-based purpose; (2) are each a party to a value-based arrangement with the other (or at least one other participant in the same VBE); (3) have an accountable body or person responsible for financial and operational oversight of the VBE; and (4) have a governing document describing the VBE and how its participants intend to achieve the VBE’s value-based purpose(s).

The size and structure of a VBE can vary greatly from a large network of providers and suppliers; a separate legal entity, like an Accountable Care Organization (ACO); or just two providers contracting together to form a value-based arrangement.Finally, a value-based purpose is (1) coordinating and managing the care of a target patient population; (2) improving the quality of care for a target patient population; (3) appropriately reducing the costs to, or growth in expenditures of, payors without reducing the quality of care for a target patient population; or (4) transitioning from health care delivery and payment mechanisms based on the volume of items and services provided to mechanisms based on the quality of care and control of costs of care for a target patient population.

Source: HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements | Mintz

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HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health Law Blog

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New Stark and Anti-Kickback Statute Comparisons

A great resource of the a redline versions of the regulations that highlight the changes for the new revisions to Stark and the Anti-Kickback Statute. The documents may be accessed here:

The Federal Register versions of the revised regulations and accompanying commentary may be accessed here:

Hat tip to Holland and Hart.

Source: New Stark and Anti-Kickback Statute Comparisons

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Ways your Healthcare Company is Breaking the Law — Without Realizing it

According to the U.S. Department of Health & Human Services’ Breach Portal, sometimes called the “Wall of Shame,” 418 breaches of HIPAA were reported in 2019. Some 34.9 million Americans had their protected health information (PHI) compromised. How is this still happening?

Healthcare companies and practices make the biggest mistake by believing human behavior can be perfect all the time. … [R]esulting from this assumption about human behavior, healthcare providers cheap out and refuse to pay for sufficient security measures for their network. A cheap security system may not contain proper firewalls and leave devices vulnerable, while wholly unencrypted devices can be a nightmare. Healthcare employees leave their cell phones, laptops, or iPads in their vehicles while they run out for coffee or to the grocery. And what happens next? The vehicles are broken into, and PHI is at risk.

I think there is another erroneous assumption that employers make: they assume their business model will continue to be the same.

It is so easy when putting a deal together, to come up with workflows and policies that make the deal compliant. But as time goes on, the business model shifts, even slightly, in a way that makes the previously workflow and policy no longer compliant.

As a result, as part of their ongoing Compliance Program, Covered Entities should routinely audit their HIPAA Privacy and Security standards to ensure they are evolving with their business.

Source: Ways your Healthcare Company is Breaking the Law — Without Realizing it