Month: December 2020

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Proposed Changes to HIPAA Privacy Rule

HHS has proposed several important changes to the HIPAA Privacy Rule to bring it in line with HHS’s Sprint Toward Coordinated Care initiative. These proposed changes are not yet final. Comments on the proposed rules are due within 60 days of their publication in the Federal Register.

  • Reducing the time that covered entities have to respond to a patient’s request to access his or her medical records to 15 calendar days (with the possibility of a 15 day extension);
  • Allowing an individual to take notes, videos, and photographs, and use other personal resources to capture Protected Health Information (“PHI”) in a designated record set when accessing PHI in person;
  • Changing the fee structure applicable to requests for access to PHI and adding a requirement that covered entities provide advance notice of approximate fees for copies of PHI;
  • Modifying the definition of “health care operations” to clarify that the term encompasses both individual-level and population-based care coordination and case management activities by health plans and covered health care providers;
  • Adding an exception to the minimum necessary standard for disclosures to, or requests by, a health plan or covered health care provider for care coordination and case management for an individual;
  • Expressly allowing covered entities to disclose PHI to social services agencies, community based organizations, home and community based service providers, and other similar third parties that provide health-related services to specific individuals for individual-level care coordination and case management;
  • Replacing the “professional judgment standard” with a “good faith standard” for certain disclosures of PHI allowed in the Privacy Rule;
  • Eliminating the requirement for a direct treatment provider to obtain written acknowledgment of receipt of the Notice of Privacy Practices (“NPP”) and adding an individual right to discuss the NPP with a person designated by the covered entity;
  • Expressly allowing covered entities and their business associates to disclose PHI to telecommunications relay service communications assistants; and
  • Expanding the current Armed Forces exception for covered entities to use and disclose PHI for mission requirements and veteran eligibility to all uniformed services personnel.

Source: Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement

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CMS Provides Additional Expansion Opportunities for High Medicaid Physician-Owned Hospitals

Under the Affordable Care Act’s amendments to the Stark Law, a Physician Owned Hospital (POH) cannot expand the aggregate number of operating rooms, procedure rooms or licensed beds beyond the number for which the hospital was licensed on March 23, 2010.

The Secretary of Health and Human Services may grant an exception to this prohibition to POHs qualifying as either an “applicable hospital” or a “high Medicaid facility” (as those terms are defined in the regulations).

POHs meeting one of these two exceptions were nonetheless still limited in that they could only request an expansion once every two years and the expansion was limited to no more that 200% of the rooms or beds that existed as of March 23, 2010.

These new rules relax these expansion limitations for “high Medicaid facilities,” but not “applicable hospitals”.

Though there are other requirements, a “high Medicaid facility” POH is one that for the three (3) most recent 12-month periods for which data is available, has an annual percentage of total Medicaid inpatient admissions that is estimated to be greater than the percent of such admissions for any other hospital located in the same county in which the POH is located (as determined by the data sources approved by CMS.

The new Final Rule, removes the limitation on the number of times a high Medicaid facility can request an expansion so long as the POH only has one request under review at any given time.

CMS also removed the 200% capacity limitation that previously existed for high Medicaid facilities seeking expansion.

High Medicaid facility POHs can now expand off of their main campus, but must continue to comply with Medicare rules and regulations regarding distance limitations relative to off-campus facilities and provider-based departments.

Source: CMS Provides Additional Expansion Opportunities for High Medicaid Physician-Owned Hospitals

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Texas Hospice Owner Sentenced for Fraud Scheme

A jury found Rodney Mesquias guilty last week on charges of: conspiracy to commit healthcare fraud, conspiracy to commit money laundering, conspiracy to obstruct justice, conspiracy to pay and receive kickbacks, and six counts of healthcare fraud.

Mesquias owned and operated Merida Group, a healthcare company with dozens of locations in Texas. The Department of Justice says Mesquias conspired with the company’s CEO and medical director to mislead thousands of people with long-term, but not fatal, illnesses into believing they had only six months to live. This led to their enrollment in Merida’s “expensive and unnecessary” group homes, nursing homes, and housing projects.

This story has been widely reported and is one of the more egregious examples of intentional fraud I’ve seen. It has everything – false medical records, kickbacks, medically unnecessary services. To make matters worse, there were allegations that those involved were lying to patients telling them they had fatal illnesses, going so far as to send “chaplains” to lie to patients and give them last rites.

 

Given the complexities of the fraud and abuse laws, there are occasions when providers unintentionally run afoul of the rules. This is not one of those instances. The jury clearly thought this was intentional deceit.

Source: Texas Hospice Owner Sentenced for Fraud Scheme

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Texas Heart Hospital and Subsidiary Management Company to Pay $48 Million to Settle False Claims Act Allegations Related to Alleged Kickbacks

Huge qui tam settlement where the qui tam plaintiffs will recover $13.9 million. The underlying action involves allegations that the Heart Hospital violated the Stark Law and the Anti-Kickback Statute by requiring physician owners to satisfy the Heart Hospital’s yearly 48 patient-contact requirement in order to maintain ownership in the hospital.

This settlement arises from a lawsuit filed by former Heart Hospital physician owners Mitchell Magee, M.D. and Todd Dewey, M.D. pursuant to the whistleblower or qui tam provisions of the False Claims Act, which permit private persons to bring a lawsuit on behalf of the government and to share in the proceeds.

Dr. Dewey and Dr. Magee will collectively receive $13,920,000 as their share of the recovery.

Source: Texas Heart Hospital and Wholly-Owned Subsidiary THHBP Management Company LLC to Pay $48 Million to Settle False Claims Act Allegations Related to Alleged Kickbacks

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Federal Regulatory Compliance Issues Can Arise in State Court Matters

An interesting read regarding the use of federal regulatory compliance issues (e.g impermissible healthcare kickbacks) to support a state court tort claim.

The plaintiffs sued the manufacturer of a immunoglobulin infusion product alleging that the manufacturer improperly induced a physician to misdiagnose their condition by paying the physician impermissible kickbacks through bonuses and commissions. The plaintiffs did not assert Anti-kickback or Stark claims directly. Such claims must be brought as qui tam actions.

Instead, they alleged that the fact that the federal statutes prohibit such conduct illustrates that patient harm is a foreseeable consequence of the payment of kickbacks.

The gist is that these regulatory issues could find their way into your state court litigation case.

Source: Memorandum Order Denying Defendants’ Motion to Strike, Post v. AmerisourceBergen Corp., Northern District of West Virginia

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Two area home health agency owners charged in health care fraud and illegal kickback scheme

A federal grand jury indicted two home health agency on allegations that they fraudulently billed Medicare more than $10 million.

The indictment alleges that Tataw and Anglea Bisong, co-owners of SierCam Healthcare Services LLC, billed Medicare for home health services that were not medically necessary or not actually provided as billed.

Under the alleged scheme, the Bisongs paid SierCam patients to sign up for medically unnecessary home health services and provided free transportation and covered the copayments and other fees at doctor’s office visits to facilitate their health care fraud scheme.

It is also alleged that they created created false medical records to make it appear the services met Medicare’s criteria for reimbursement.

They were charged with six counts of health care fraud and conspiracy to commit health care fraud.

Source: Two area home health agency owners charged in health care fraud and illegal kickback scheme

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HHS Proposes Modifications to the HIPAA Privacy Rule to Empower Patients, Improve Coordinated Care, and Reduce Regulatory Burdens

The proposed changes to the HIPAA Privacy Rule include strengthening individuals’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or threatening circumstances, such as the Opioid and COVID-19 public health emergencies; and reducing administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals’ health information privacy interests.

Source: HHS Proposes Modifications to the HIPAA Privacy Rule to Empower Patients, Improve Coordinated Care, and Reduce Regulatory Burdens

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Former Owner of Health Care Staffing Company Indicted for Wage Fixing

A federal grand jury returned an indictment charging Neeraj Jindal, the former owner of a therapist staffing company, for participating in a conspiracy to fix prices by lowering the rates paid to physical therapists and physical therapist assistants in north Texas, including the Dallas-Fort Worth metropolitan area, the Department of Justice announced today.  The indictment also charges Jindal with obstruction of the Federal Trade Commission’s separate investigation into this conduct.

Price fixing is per se illegal under Section 2 of the Sherman Act. This appears to be an alleged horizontal price-fixing claim. One element in this type of charge is that the conduct must “unreasonably” restraint trade. That inquiry depends on the degree of the restraint’s adverse effect on competition and on the degree of any pro-competitive effects from restrain.

Source: Former Owner of Health Care Staffing Company Indicted for Wage Fixing | Department of Justice

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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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Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D

[T]he Final Rule will modify the federal health care program’s Anti-Kickback Statute (“AKS”) safe harbors in three key ways:

First, it will remove safe harbor protection under the AKS for rebates that a pharmaceutical manufacturer provides to Medicare Part D plan sponsors (either directly or indirectly through the PBMs with which they contract). In apparent recognition of how disruptive this change will be to current business models, the Final Rule postpones the effective date for this change until January 1, 2022.

Second, it will create a new safe harbor to protect certain price reductions given by pharmaceutical manufacturers that are passed through to beneficiaries at the point-of-sale. This new safe harbor will become available on January 29, 2021.

Third, it will create a new safe harbor, also effective as of January 29, 2021, that protects certain fixed fees paid by manufacturers to PBMs for PBM services.

Source: Cutting Out the “Middleman”? HHS Resurrects Anti-Rebate Rule for Medicare Part D