Finally, More Certainty and Fewer Surprises – Final Rules Issued Under the No Surprises Act

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

The Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued final rules related to the No Surprises Act on August 26, 2022, to be effective October 25, 2022 (Final Rules).  These Final Rules come after months of uncertainty and legal battles regarding the Federal Independent Dispute Resolution (IDR) process, as we have discussed in recent blogs.

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Florida Medicaid Providers: Action is Required by October 1, 2022

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, Physicians

Check your mailboxes.  AHCA is sending out postcards to existing Florida Medicaid providers (Providers) alerting them to upcoming changes in the Florida Medicaid program.  These changes require Providers to pay certain of their employees a minimum wage of at least $15.00 per hour.  Governor Ron DeSantis’s “Freedom First Budget for Fiscal Year 2022-2023” includes funding for AHCA to increase reimbursement rates and capitation rates in order to ameliorate the cost increases to Providers and Plans.  AHCA has released guidance to assist Providers in complying with this new obligation.

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More Turbulence for the No Surprises Act Thanks to Air Ambulance Providers

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

Given the trajectory, it is no longer surprising that the No Surprises Act (the Act) continues its turbulent path through implementation. The U.S. District Court for the Eastern District of Texas, on July 26, 2022, again vacated provisions of the Federal Independent Dispute Resolution (IDR) process, this time relating to air ambulance payment disputes. (LifeNet, Inc. v. United States Department of Health and Human Services, et al., No. 6:22-cv-00162-JDK, slip op. (E.D. Tex. July 26, 2022).

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Don’t Just Phone It In – Avoiding Fraud in Telehealth Contracts

Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Healthcare Reform Legislation, Medical Devices & Equipment, Medicare & Medicaid, Physicians, Technology

To facilitate the provision of care during the pandemic, the federal government and many state governments enacted changes that encouraged physicians and other nonphysician practitioners (collectively, Practitioners) to use telehealth services. While this new flexibility increased access to care, it also increased opportunities for fraud. On July 20, 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Fraud Alert cautioning Practitioners about potential fraudulent telemedicine contracts (Fraud Alert).

The Fraud Alert is derived from the lessons learned during the OIG’s coordinated enforcement action with the Department of Justice (DOJ) and other agencies that resulted in criminal charges against 36 defendants involving more than $1.2 billion in fraudulent telemarketing services identified as telehealth. The Fraud Alert highlights these common themes in telehealth arrangements that raised red flags to the OIG and DOJ investigators:

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Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Chapter 2022-60, Laws of Florida (http://laws.flrules.org/2022/60), that went into effect July 1, 2022, allows registered pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.”  These pharmacy technicians will be allowed to administer all of the vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel, as well as any vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor. This is a big jump compared to the 2007 legislative session when the legislation first allowing pharmacists themselves to administer only the flu vaccine was enacted, and only after a hard-fought legislative battle when most other states already allowed pharmacists to administer vaccines.  Fast forward to 2022 and pharmacy technicians are allowed to administer not just the flu vaccine, but nearly all the vaccines that a pharmacist can.  The law still reserves to pharmacists the authority to vaccinate children 7 years of age and older.

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Healthcare Providers: Add OCR’s Latest Right of Access Settlements to Your Summer Reading List

Posted in Electronic Health Records & Medical Records, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Physicians

The Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced on July 15, 2022, that it has resolved 11 investigations conducted under the Health Insurance Portability and Accountability Act (“HIPAA”) Right of Access Initiative. These settlements remind providers that, as OCR Director Lisa J. Pino stated, “OCR is serious about upholding the law and peoples’ fundamental right to timely access to their medical records.” With these latest settlements, OCR has resolved 38 enforcement actions in its Right of Access Initiative, which continues to have momentum.

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ALERT! Your COVID-19 Policies and Procedures Need a BOOSTER!

Posted in Healthcare Law, HIPAA, Privacy, and Data Security, Labor Relations & Employment Law

Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employ­ment Opportunity Commission (“EEOC”) has issued new guidance limiting the former and has penalized a healthcare practice recently for doing the latter.

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Healthcare Cyber Insurance? Fortify Your Defenses

Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

Healthcare breaches, including ransomware attacks, continue to increase. As a result, many healthcare organizations seeking cyber coverage to help defray the costs associated with a ransomware attack or other data incident may find that carriers have increased premiums, reduced coverage, and tightened underwriting requirements. Healthcare organization leaders should understand that implementing reasonable administrative, technical, and physical safeguards to protect the organization’s information and operational systems is not only required by laws such as HIPAA, but is increasingly required to obtain cyber coverage.

A recent report by Sophos, a technology security company, confirms this new reality. Sophos reported that one of the reasons for the growing demand for cyber insurance by healthcare organizations is the rampant growth in ransomware (Sophos Report). According to the Sophos Report, ransomware has led to more payouts and less profit for insurers, making cyber insurance coverage difficult and expensive to obtain, even driving some insurers out of the market. Continue Reading

OCR Releases Guidance on HIPAA Compliance When Providing Audio-Only Telehealth

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth services and clarify for health care providers and health plans how they can provide such services while complying with the HIPAA Privacy, Security, and Breach Notification Rules (the “HIPAA Rules”).  The Guidance is the strongest signal yet from OCR that it intends to resume imposing penalties against covered entities that do not comply with the HIPAA Rules when providing telehealth.  Healthcare providers and health plans should ensure that they can continue to provide telehealth while safeguarding the privacy and security of individuals’ protected health information (PHI).

OCR recognizes that, despite the explosive growth of telehealth during the COVID-19 pandemic, there are still individuals in the U.S. that, for a variety of factors such as lack of sufficient broadband or cell coverage, financial resources, internet access, disability, or limited English proficiency, have difficulty accessing audio-visual telehealth and must rely on audio-only telehealth.  Continue Reading

SCOTUS May Resolve Circuit Split on the Specificity Required of False Claims Act Claims: Relief or More FCA Grief for Providers?

Posted in Fraud & Abuse & False Claims Act

Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals regarding the level of specificity when relators (whistleblowers) plead FCA violations.  The FCA imposes civil liability on any person requesting government funds or property who “knowingly presents . . . a false or fraudulent claim for payment or approval.” 31 U.S.C. § 3729(a)(1)(A).  A pleading, “alleging fraud or mistake . . . must state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b) (emphasis added).  And the Circuits of the U.S. Courts of Appeals are split on what information is required in a relator’s FCA complaint under Rule 9(b) to avoid a dismissal of the complaint. The U.S. Supreme Court may resolve the difference in the standards if it grants certiorari in Johnson, et al. v. Bethany Hospice & Palliative Care of Ga., LLC. Continue Reading

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