Health Law Advisor

As much of the Southeastern U.S. continues to recover from the aftermath of Hurricanes Helene and Milton, health care providers should be aware of, and consider the extent upon which they rely upon, the flexibilities that the Centers for Medicare & Medicaid Services (CMS) extended to assist with the Public Health Emergencies (PHEs) in the affected states. As a result of Hurricanes Helene and Milton, CMS extended additional resources to Medicare providers and certain health care facilities in Florida, Georgia, North Carolina, South Carolina, and Tennessee.

As background, during a PHE, the Secretary of the U.S. Department of Health and Human Services (HHS) may temporarily waive certain HIPAA Privacy Rule requirements for hospitals.

During the recent PHE, HHS issued HIPAA-related waivers lasting up to seventy-two (72) hours to hospitals located in the declared emergency that had activated their disaster protocol, including waivers for: the distribution of HIPAA privacy notices; patient rights to request privacy restrictions and confidential communications; communications with family or friends involved in care; and, opting out of facility directories. Health Information Privacy PHE responses can be found here.

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) quietly added “Outreach Site/ Street” as an allowable place of service (POS) code for Medicare and Medicaid providers to use in claims submission for “street medicine” services provided. The “Outreach Site/ Street” POS code allows physicians to seek Medicare reimbursement of such medically necessary professional services when they are delivered in a “non-permanent location on the street or found environment, not described by any other POS code, where health professionals provide ...

Introduction

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

As explained in greater detail by our colleague Stuart M. Gerson, the Supreme Court of the United States handed down two major, and quickly decided, rulings on January 13, 2022. After hearing oral arguments only six days earlier, the Court issued two unsigned decisions per curiam. A 5-4 decision in Biden v. Missouri dissolved a preliminary injunction against enforcement of an interim final rule (“Rule”) promulgated by the Centers for Medicare & Medicaid Services (CMS), requiring recipients of federal Medicare and Medicaid funding to ensure that their employees are vaccinated against COVID-19.

Only a few days remain before the enforcement delay that the Centers for Medicare & Medicaid Services (CMS) exercised due to COVID-19 will end and the agency will require certain payors to publish a Patient Access application programming interface (“API”) and a Provider Directory API under the requirements of the CMS Interoperability and Patient Access Final Rule. Starting on July 1, 2021, all health plans that offer Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) and most Qualified Health Plans offered through the Federally-facilitated ...

On April 8, 2021, the U.S. Department of Justice (“DOJ”) announced the first charges brought in connection with alleged fraud on the Accelerated and Advance Payment Program, administered by the Centers for Medicare & Medicaid Services (“CMS”).[1]  According to the indictment, Francis Joseph, M.D., a Colorado physician, has been charged with misappropriating nearly $300,000 from three different COVID-19 relief programs: the Accelerated and Advance Payment Program, the Provider Relief Fund, and the Paycheck Protection Program.[2]

Accelerated and Advance Payment Program

The Accelerated and Advance Payment Program is intended to provide emergency funds by way of expedited payments to health care providers and suppliers when there is a disruption in claims submission or claims processing.  While CMS has historically utilized this program to provide targeted relief in response to national emergencies or natural disasters affecting certain portions of the country, the program was expanded in March 2020 to apply to a broader group of Medicare Part A providers and Part B suppliers nationwide due to the financial impact of COVID-19.[3]

According to the indictment, Dr. Joseph allegedly submitted an Advance Payment Request Form for a medical practice of which he had relinquished control, and then transferred approximately $92,000 from the medical practice’s operating account to a personal bank account (approximately $87,000 of that amount was paid by the Medicare Administrative Contractor as an advance payment the previous day).

Provider Relief Fund

The Provider Relief Fund is a $178 billion measure appropriated under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act that offers aid to providers who were financially impacted by COVID-19 and treatment and other assistance to individuals suffering from COVID-19.

The indictment marks the second time that DOJ has brought charges related to misuse of Provider Relief Fund distributions (DOJ announced the first charges in February 2021 against a home health provider).  According to the indictment, Dr. Joseph’s former medical practice met the criteria for a Provider Relief Fund distribution of $31,782, but Dr. Joseph allegedly transferred those funds from the medical practice’s operating account to a personal bank account.

The U.S. Supreme Court will consider whether the federal government can approve state programs that force Medicaid participants to work, go to school, or volunteer to get benefits. Both Arkansas and the Justice Department sought review of the issue. Epstein Becker Green attorney Clifford Barnes provides potential paths for the Biden administration to best position itself in the case.

The U.S. Supreme Court will hear oral argument in a case involving the authority of the Department of Health and Human Services to approve Medicaid work requirements programs in Arkansas and New Hampshire that were struck down by the U.S. Court of Appeals for the District of Columbia Circuit.

The high court has agreed to determine whether the HHS can allow states to impose work requirements in its Medicaid program even though all lower courts ruled against HHS’s approval of states’ Section 1115 work requirement waivers, based on the Trump administration’s refusal to consider the impact of the waivers on the core purpose of Medicaid—which is to increase health insurance coverage.

Unlike the narrow question considered by the lower courts, however, the court granted certiorari on a much broader issue. The question presented concerns the entire Section 1115 process and asks whether the HHS secretary has the power to establish additional purposes for Medicaid, beyond coverage.

Should the court rule that the HHS secretary does indeed possess this unbounded power, the entire Section 1115 landscape could shift, potentially allowing states to implement waivers like Arkansas, so long as they meet such additional purpose.

The case establishes an effective deadline for the Biden administration to take action to mitigate or eliminate the work requirements, in light of the administration’s commitment to expanding, rather than rolling back, Medicaid insurance coverage.

On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope ...

In February 2012, two years after the passage of the Affordable Care Act ("ACA"), the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule, which was subject to significant public comment, concerning reporting and returning certain Medicare overpayments ("Proposed Rule"). On February 12, 2016, four years from the issuance of the Proposed Rule (and six years after passage of the ACA), CMS issued the final rule, which becomes effective on March 14, 2016 ("A and B Final Rule").

The A and B Final Rule applies only to providers and suppliers under Medicare Parts A and B ...

Healthcare Fraud and Abuse is an ever growing problem.  The Federal government has taken several steps in its enforcement efforts to cut down on health care fraud.  It is estimated that health care fraud costs the United States about $80 billion per year.  And it continues to rise in an alarming manner, as total U.S. health care spending continues to rise, currently topping $2.7 trillion.

In the last year, spending on home health care has increased over 5 percent from previous years.  Since 2000, the senior population has increased by 15.1% versus 9.7% for the population as a whole.  According ...

Our colleagues at Epstein Becker Green have issued a client alert: "CMS Issues Final Regulations on Federal 'Sunshine' Law for Manufacturers and GPOs," by Amy K. Dow, Wendy C. Goldstein, Kim Tyrrell-Knott, Sarah K. diFrancesca, David C. Gibbons, Daniel G. Gottlieb, and Natasha F. Thoren.

Following is an excerpt:

On February 1, 2013, the Centers for Medicare & Medicaid Services issued long-awaited final regulations with a lengthy preamble relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the "Physician Payment Sunshine Act." This health ...