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Articles Posted in Health Law News

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“We serve patients poorly when government regulations gather dust in the attic: they become even more stale and liable to wreak havoc throughout the health care system. Administrative costs are driving up the cost of health care in America – to the tune of hundreds of billions of dollars. The Stark proposed rule is an important next step in President Trump’s health care agenda for Americans. We are updating our antiquated regulations to decrease burden for providers and helping bring down these increasingly escalating costs.”

– Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma.

The Department of Health and Human Services (HHS) announced today the release of several proposed changes to the regulations that interpret the Physician Self-Referral Law (the Stark Law), the Civil Monetary Penalty Law (CMP), and the Federal Anti-Kickback Statute (AKS). The proposed revisions are intended to provide greater clarity to health care professionals.

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By Adrienne Dresevic, Esq. and Carey Kalmowitz, Esq. of The Health Law Partners, P.C.

The Centers for Medicare & Medicaid Services (CMS) issued a final rule that strengthens the agency’s ability to stop fraud by barring unscrupulous providers out of federal health insurance programs. This rule is unlike past rules in that it stops providers before they get paid. This is a momentous step on CMS’s part to end “pay and chase” in federal health care fraud efforts and replace it with proactive measures.

The final rule, Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-FC), becomes effective November 4, 2019 and establishes novel revocation and denial authorities to buttress CMS’ efforts to stop waste, fraud and abuse. This rule is applicable to the entire provider community, including radiologists.

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An Ashland, KY addiction treatment specialist, Dr. Rose O. Uradu, and her substance abuse treatment center, Ultimate Care Medical Services, LLC d/b/a Ultimate Treatment Center, have agreed to pay $1.4 million to resolve civil allegations that they violated the Controlled Substances Act, and defrauded the Medicare and Kentucky Medicaid programs.

The settlement resolved a civil lawsuit alleging that Ultimate Treatment Center, at the direction of Dr. Uradu, sought and received payments from Medicare and Kentucky Medicaid for services that were not actually provided to patients. According to the Complaint, between January 2013 and September 2014, defendants billed these government programs for “evaluation and management” services, purportedly provided to patients who visited the clinic to receive daily methadone doses. The United States alleged that Ultimate Treatment Center did not actually perform these services when patients received their methadone doses, but falsely documented the performance of these services, in the patients’ medical records, in order to create the false appearance that the reimbursement was justified.

The United States further alleged that, during the period July 2013 and December 2014, defendants billed Medicare and Kentucky Medicaid for complex urine testing that the clinic’s equipment was incapable of performing, therefore violating the False Claims Act.

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On April 8, 2019, the American College of Physicians (“ACP”) released the clinical guideline, “Screening for Breast Cancer in Average-Risk Women: A Guidance Statement from the American College of Physicians” (the “Guideline”). The Guideline divides women into three categories based on age and offers breast cancer screening methodology guidance for each category. The Guideline offers the following guidance for women of average-risk:

  • Women aged 40-49: clinicians should discuss whether to screen for breast cancer with mammography, including a discussion on the benefits and harms of screening as well as the woman’s preference. The ACP notes that potential harms generally outweigh the benefits for most women in this category;
  • Women aged 50-74: clinicians should offer biennial screening for breast cancer with mammography;
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On July 30, 2019, a federal jury in Detroit, Michigan, found a patient recruiter guilty for his role in a scheme involving approximately $1.3 million in fraudulent Medicare claims for home health care that were procured through the payment of illegal kickbacks.

Following a six-day trial, Dominic Trumbo, 45, of Lexington, Kentucky, was found guilty of one count of conspiracy to pay and receive health care kickbacks and three counts of receipt of health care kickbacks.

According to evidence presented at trial, from 2009 to 2017, Trumbo, owner of Trumbo Consulting Agency, solicited and received kickbacks in exchange for referring Medicare beneficiaries to serve as patients at multiple home health agencies. These agencies then submitted claims to Medicare for home health services that were purportedly provided to those beneficiaries.

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This year, key information regarding the Appropriate Use Criteria (AUC) program is being released by the Centers for Medicare & Medicaid Services (CMS) via guidance documents. A Change Request was issued July 26, 2019, informing Medicare Administrative Contractors (MACs) that they are to begin accepting AUC-related modifiers and healthcare common procedure coding system (HCPCS) codes in 2020.

Under the AUC program, a practitioner must consult a qualified Clinical Decision Support Mechanism (qCDSM) at the time of an advanced diagnostic imaging service order. The qCDSM – an electronic portal through which AUC is accessed – provides a determination of whether the order adheres to AUC or if the AUC consulted was not applicable to the patient’s clinical condition.

Currently running as a voluntary program, CMS has announced an Education and Operations Testing Period to begin January 1, 2020 and running the full calendar year to give practitioners appropriate time to adjust to the system. During this period, “claims will not be denied for failing to include AUC-related information or for misreporting AUC information.” However, CMS also writes that they expect ordering professionals to begin consulting qCDSMs and providing the relevant information to the furnishing providers during the test period “as it is important for CMS to track this information.”

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On July 10, 2019, United States Attorney Matthew Schneider announced the indictment of Dr. Vasso Godiali of Bay City, charged with health care fraud in the amount of $60 million, and money laundering for financial transactions involving approximately $49 million in proceeds derived from the scheme.

According to the indictment, Dr. Godiali submitted false and fraudulent claims for the placement of stents in dialysis patients and for the treatment of arterial blood clots; exploited medical billing software to improperly maximize payments from Medicare, Medicaid, and Blue Cross Blue Shield of Michigan; submitted false and fraudulent claims to Medicaid, Medicare, and Blue Cross for services not rendered; and “unbundled” claims by exploiting modifier-59 to falsely claim he was performing many separate and distinct procedures, when in fact he was entitled to a single reimbursement for a single procedure. The indictment further alleges that Dr. Godiali utilized six corporations through which he laundered approximately $49 million, which he ultimately used to fund investment accounts at multiple financial institutions, and that he engaged in money laundering by using proceeds from his scheme to pay property taxes on a Houghton Lake, Michigan, residence.

The United States Attorney’s Office also filed a related civil lawsuit seeking the forfeiture of approximately $39.9 million seized from accounts controlled by Dr. Godiali and/or related to four separate real estate transactions.

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Anyone practicing midwifery in the State of Michigan will be required to be licensed in midwifery beginning August 1, 2019.  The Department of Licensing and Regulatory Affairs (LARA) began accepting applications on May 6, 2019.

Under Public Act 417, which established Part 171 in the Public Health Code, an individual may not engage in the practice of midwifery unless licensed or otherwise authorized by article 15 of the Public Health Code. Those who are not licensed as of August 1, 2019, may be in violation of the public health code (there are statutory exemptions from licensure which can be found in MCL 333.17105(3)) and subject to significant penalties.

For additional information on the above matter or any matter related to healthcare professional licensing in Michigan, please contact Robert S. Iwrey, Esq. at 248-996-8510 or riwrey@thehlp.com.

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The Michigan Department of Licensing and Regulatory Affairs (LARA) recently launched a new licensing platform for physicians (MDs and DOs) and 10 other licensed professions called the Michigan Professional Licensing User System (MiPLUS). The new system is intended to provide an improved interface for licensees and consumers and reduce mailing delays. All professional licensees will be required to apply for a new license or renew their current license by using the new online platform. Under the new system, license expirations dates will correspond with the licensee’s date of initial licensure and will be for the full length of the license cycle.

Some of the MiPLUS features are:

  • Individuals can apply online, track the status of their application, and renew their license.
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IMPORTANT NEWS FOR HOME HEALTH AGENCIES – In a fact sheet released July 11, 2019, the Centers for Medicare & Medicaid Services (CMS) detailed its annual update to the Medicare rate, as well as its plan for the implementation of the Patient-Driven Groupings Model (PDGM) and other proposals for calendar year (CY) 2020, which can be downloaded here. Despite the pushback in recent months from lawmakers, home health stakeholders, and organizations such as the National Association for Home Care & Hospice, CMS indicates their intentions of moving forward with many of the provisions included in PDGM.

Perhaps chief among Thursday’s proposed rule is CMS’s plan to phase out pre-payments for home health agencies (HHAs). This would eliminate the ability of HHAs to submit a Request for Anticipated Payment (RAP) in order to obtain 50-60% of the anticipated payment at the beginning of a patient’s care episode. According to CMS, the plan for the elimination of RAPs was brought on by “a marked increase in RAP fraud schemes perpetrated by existing home health agencies that receive significant upfront payments, never submit final claims and then close for business.” CMS is proposing that RAP payments for existing providers will be phased out over the next year, with full elimination occurring by 2021.

However, CMS’s proposed rule also includes a 1.3% – or $250 million – projected increase to the Medicare payments made to HHAs. This rate increase reflects a 1.5% home health payment update as well as a 0.2% decrease due to reductions made by the new rural add-on policy.

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