On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

The new proposed rule reflects a significant policy change.  Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.
Continue Reading CMS Proposes to Reverse Course and Repeal Its Final Rule Expediting Medicare Coverage of Breakthrough Devices and Defining the Medicare “Reasonable and Necessary” Coverage Standard

The New Jersey Department of Health (the “Department”) recently finalized regulations initially proposed in April 2020 that will now require all telehealth organizations providing telemedicine services to patients located in New Jersey to register their business with the Department before October 15, 2021, and annually thereafter.  In addition to annual registrations, telehealth companies will also be required to submit annual reports on activity and encounter data.
Continue Reading Navigating New Jersey’s Telemedicine Business Registry

On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”).  The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on July 1, 2021.  FLDOH has announced a 90 day enforcement moratorium to allow counselors time to become appropriately licensed in the State.  Florida now joins a growing number of states that regulate the work of genetic counselors.

Continue Reading Florida Joins a Growing Number of States Requiring Licensure of Genetic Counselors

On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.[1]

Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.”[2]  The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation.  “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others.
Continue Reading U.S. Department of Justice Announces Interagency Task Force to Combat COVID-19 Relief Fraud

Epstein Becker Green (“EBG”) has released Value-Based Payments: A Comprehensive State Survey.

EBG has researched, compiled, and analyzed state-specific content about the regulatory requirements involved in providers moving away from fee for service reimbursement (such as discounted fees and per diems) and towards value-based payment arrangements involving “downside” risk or insurance risk-sharing with insurers, HMOs,

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation

On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.

The COVID-19 pandemic’s impact on the regulatory landscape of telehealth was the topic of a June 17, 2020 hearing before the Senate Health, Education, Labor & Pensions Committee.  As Chairman Lamar Alexander acknowledged during his opening statement, the health care sector and government “have been forced to cram 10 years’ worth of telehealth experience into just the past three months.” Indeed, this “cramming” has resulted in thirty-one temporary changes to telehealth policy at the federal level. Of these temporary changes, Chairman Alexander included the OCR enforcement discretion / HIPAA waiver as one of the three changes he considers most important. However, of the three changes the Chairman views as most important, he declined to include the enforcement discretion in the temporary changes he believes should be made permanent, and instead called upon his colleagues to consider whether to extend the HIPAA waiver.[1]


Continue Reading Every HIPAA Waiver Has Its Thorn

To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[1], Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.[2]

As of May 7, 2020, HHS identified $50 billion for general distribution to Medicare providers. HHS distributed to Medicare providers the Relief Fund’s initial $45 billion tranche in April 2020, and is distributing the Relief Fund’s second $20 billion tranche. Also, HHS allocated Relief Funds to: hospitals in COVID-19 high impact areas ($10 billion); rural providers ($10 billion); Indian Health Services ($400 million), and skilled nursing facilities, dentists, and providers that take solely Medicaid (unidentified amounts).[3]


Continue Reading Appropriate Use of CARES Act Provider Relief Funds

Congress is working to advance a strong emergency funding supplemental package, estimated to be between $2.5 billion and $8.5 billion, to fully address the scale and seriousness of the coronavirus (COVID-19) public health crisis. Working against a timeline to pass a funding package prior to the March 13, 2020, Congressional recess, the supplemental funding for the coronavirus emergency will result in new government contracts, grants, GSA schedule awards, as well as contract modifications. Because of the public health crisis, the government may also issue letter contracts under FAR Part 16.603, et seq., which allows the government to immediately contract for services or supplies with contract definitization at a later date.

Continue Reading Billions for Coronavirus (COVID-19): New Government Contracts and Grants on the Horizon