Health Law Advisor

On August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”)—issued a proposed rule titled “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability” (the “HTI-2 Proposed Rule”), as part of its ongoing efforts to enhance health care interoperability and data sharing. The HTI-2 Proposed Rule builds on the January 2024 “Health Data, Technology, and Interoperability” final rule (the “HTI-1 Final Rule”). Comments on the HTI-2 Proposed Rule are due October 4.

Through the proposed changes, ASTP/ONC would (1) make sweeping changes to its Health Information Technology Certification Program (“HIT Certification Program”); (2) make revisions to the information blocking regulation, including implementing two new information blocking exceptions; and (3) codify and implement the statutory provisions regarding the Trusted Exchange Framework and Common Agreement (“TEFCA”) requirements.

New and Revised HIT Certification Criteria

The proposed changes in the HTI-2 Proposed Rule would significantly expand the scope of the HIT Certification Program to introduce additional functionality and new technology for developers of HIT used by health care providers and HIT that is intended to be used by payers and for public health agencies. The certification criteria introduced in HTI-2 for payers is the first time that the health IT certification program is being extended beyond the certified electronic health record (EHR) technology developers. Some notable changes include the following:

On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA III challenged certain portions of the July 2021 No Surprises Act (“NSA”) interim final rules proposed by the U.S. Departments of Health and Human Services, Labor, and Treasury, along with the Office of Personnel Management (the “Departments”).  In a decision that significantly levels the field for providers, the District Court ruled in part ...

It is axiomatic that New York State requires every Medicaid provider to have an “effective” compliance program.  New York Social Services Law § 363-d.  In July 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) proposed extensive modifications to the regulatory requirements governing compliance programs for entities receiving “significant” Medicaid revenue (increased by these regulations from a threshold of $500,000 to $1 million).  These regulations were proposed to implement portions of the New York State 2020-2021 Budget Bill ...

On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process, created under the No Surprises Act (NSA) to provide a mechanism for payers and providers to resolve disputes as to appropriate payment amounts for certain out-of-network claims. In addition, the Departments of Health and Human Services, Labor and the Treasury launched two online portals– one to host the IDR process for providers and payers and one to host the patient-provider dispute resolution process for self-pay and uninsured patients.

This new guidance replaces earlier instruction from the agency on how the IDR process would operate and what the independent arbitrator was required to consider. The prior guidance was withdrawn after a successful legal challenge to the interim final rule implementing the No Surprises Act provisions on the IDR process, specifically with respect to the weight to be given to the Qualifying Payment Amount (QPA). The QPA is essentially the payer’s median contracted rate for similar services. The QPA is used to calculate patient cost sharing and must be considered by the independent arbitrator in resolving a payment dispute between a payer and an out-of-network provider. Initially, regulators directed arbitrators to use the QPA as a baseline, and when choosing between the parties’ proposed payment offers to choose the amount closest to the QPA unless one of the parties submitted credible information demonstrating that the appropriate payment amount was materially different from QPA.

On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued guidance terminating numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities.  The amount of blanket waivers ending is notable; while there have been terminations of waivers previously, these were usually limited to a single waiver.

CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” CMS reported that findings from onsite surveys at these facilities “revealed significant concerns with resident care that are unrelated to infection control.” Accordingly, CMS is acting to remove certain operational flexibilities not directly related to infection control.

On September 30, 2021, the federal Departments of Treasury, Labor, and Health and Human Services issued “Requirements Related to Surprise Billing; Part II,” the second in a series of interim final regulations (the “Second NSA Rules”) implementing the No Surprises Act (“NSA”). This new federal law became effective for services on or after January 1, 2022.

From our Thought Leaders in Health Law video series:  Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.

The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.

On November 12, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released final guidance confirming that hospitals can be co-located with other hospitals or healthcare providers.

CMS’ aim for the guidance is to balance flexibility in service provision for providers with ensuring patient confidence in CMS’ quality of care oversight functions.

The final guidance provides direction to state surveyors in the evaluation of a hospital’s compliance with the Medicare Conditions of Participation (“CoPs”) when it is sharing space or contracted staff through service arrangements with another co-located hospital or healthcare provider.  CMS also reiterated a key tenet of co-location arrangements: that each provider must independently meet its applicable CoPs, but, overall, the final guidance is less prescriptive than the draft guidance CMS released in May 2019, and in its wake raises new questions for providers.

On April 10, 2020, the U.S. Department of Health and Human Services (“HHS”) provided additional details regarding its plan to provide billions in relief to providers in an effort to off-set healthcare-related expenses resulting from the Coronavirus (“COVID-19”) outbreak.

Passed into law on March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, also called the “CARES Act”, provided $100 billion in funding for the Public Health and Social Services Emergency Fund (the “Fund”). The Fund is a pre-existing resource overseen by the Office of Financial Planning & Analysis within HHS. The $100 billion added via the CARES Act was made available to qualifying healthcare providers to reimburse them for “health care related expenses or lost revenues that are attributable to [COVID-19]”. The CARES Act stipulated that the $100 billion would be made available to public entities, Medicare or Medicaid enrolled suppliers and providers and other entities as may be further specified in regulations or guidance, provided that any such provider must “provide diagnoses, testing or care for individuals with possible or actual cases of COVID-19”. Monies received from the Fund may not be used to cover expenses that have already been reimbursed through other sources or that other sources are obligated to reimburse. Little other detail regarding the funding or mechanism for disbursal was provided in the CARES Act itself.

In a new issuance on its website, found here, HHS provided additional details on the program. HHS noted that $30 billion out of the appropriated $100 billion will be distributed immediately via direct deposit, starting April 10, 2020. Further, HHS clarified that the money is “payment” and not a loan, and thus will not need to be repaid. The initial $30 billion tranche is being made available only to providers that received Medicare fee-for-service payments in 2019. The payments are being distributed according to the Taxpayer Identification Number (TIN) of the billing organization.

As the coronavirus spreads throughout the country, hospitals and other health care providers are finding themselves inundated with patients. Those providers who are in-network with payors have and will likely continue to experience difficulty in complying with certain provisions of their contracts. For instance, as payors are also experiencing an unexpected influx of telephone traffic, the wait time for various approvals, including, but not limited to, pre-authorizations are being delayed.

Providers are often contractually obligated to obtain pre-authorizations for certain procedures and services prior to rendering the care. Due to the increased telephone traffic and increased wait times on the payor end, these providers are now faced with a dilemma. A process that as of two weeks ago only took a matter of ten to fifteen minutes now can take up to an hour or more. This creates a serious dilemma for those providers who need to render care to their patients and comply with their contractual obligations to payors.

The Senate has spoken to this issue via the Families First Act which prohibits cost sharing and imposing prior authorizations for COVID-19 related testing under Medicare, CHIP, and individual and small/large self-funded group plans. See Division F-Health Provisions, § 6001, Coverage of Testing for COVID-19. While some payors have recognized and acknowledged the difficulties posed by COVID-19 and have made exceptions to the standard requirements, those exceptions have been limited. For example, the Blue Cross Blue Shield Association has indicated that its network of 36 BCBS companies will waive prior authorizations for diagnostic tests and covered services that are medically necessary for members diagnosed with COVID-19. Similarly, Wellmark and Anthem, Inc., have waived prior authorizations for covered services related to COVID-19. While these limited pre-authorization waivers are a start, they do not resolve the dilemma faced by those providers treating patients who are not suffering from COVID-19.

Effective June 11, 2018, all Department of Veterans Affairs (“VA”) health care providers will be able to offer the same level of care to all beneficiaries regardless of the beneficiary’s or the health care provider’s location. In its recently released final rule, the VA stated that in December 2016 Congress mandated that the agency provide veterans with a self-scheduling, online appointment system, and that the agency meet the demands for the provision of health care services to veterans, regardless of whether such care was provided in-person or using telehealth ...

This is part 5 of 7 in the Medicare Secondary Payer Compliance series. All titles in this series can be viewed below. Subscribe to our blog to receive these future updates. Prior installments of this series can be accessed using the links provided.

• Medicare Secondary Payer Compliance: An Introduction (Part I)
• Medicare Secondary Payer Compliance: Conditional Payments (Part II)
• Medicare Secondary Payer Compliance: Group Health Plans (Part III)
• Medicare Secondary Payer Compliance: Non-Group Health Plans (NGHPs) (Part IV)
• Medicare Secondary Payer Compliance: Providers (Part V)

On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient ...

We recently wrote about the many failures of health insurance co-ops created under the Affordable Care Act ("ACA"), and the impact of those failures on providers and other creditors, consumers, and taxpayers.

As we described, nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers; however, low prices, lack of adequate government funding, restrictions on the use of federal loans for marketing, and low risk corridor payments from the Centers for Medicare & Medicaid Services created financial challenges for these ...

On March 31, 2015, the Supreme Court of the United States decided Armstrong v. Exceptional Child Center, Inc. The Court handed down a hodgepodge of opinions but, in the end, five Justices concurred in the judgment that the Constitution's Supremacy Clause does not confer a private right of action, and that Medicaid providers, therefore, cannot sue for an injunction requiring compliance with the reimbursement laws.  This ruling will adversely affect at least those health care companies that have contemplated suing on the basis that the reimbursement they are getting is less than what ...

Everyone is talking about Ebola, including the risk of contracting it, treatment for those who do contract it, and protection for those who treat patients who have it.  There has been very little discussion, though, about how to pay for the costs of treating Ebola patients, including whether health insurance will cover the treatment and pay the providers.

Most health insurance coverage that complies with the ACA minimum essential coverage standards will cover the costs of medically necessary hospitalization and physician services.  However, many of those policies have significant ...

Epstein Becker Green is pleased to announce that Valerie Butera, an accomplished Occupational Safety & Health (OSHA) lawyer, has joined as a Member of the Firm based in the firm's Washington, D.C., office.  Valerie is OSHA 30 certified and has substantial training and experience in process safety management (PSM). Valerie represents clients from numerous industries, including health care and life sciences and focuses on OSHA and other workplace safety and health issues.   For more information, click here.

Is Skype HIPAA-compliant? This is probably the question I get asked the most. For the sake of this post, I am using the term Skype to include Skype and similar free web-based communication platforms relying on proprietary voice over Internet technology.

As with so many things, the answer is complicated. But the question itself is misleading. Many vendors and manufacturers market their technology and products using terms such as “HIPAA compliant.”

However, products or technology cannot themselves be “HIPAA-compliant.” Hospitals, providers, and other covered entities ...

by Jason B. Caron, O. Benton Curtis III, Anjali N.C. Downs, and Jennifer K. Goodwin

Almost two years after the passage of the Patient Protection and Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule regarding overpayments to providers and suppliers, as provided for under Section 6402(a) of the ACA. To date, regulators, courts, clients, and members of the bar have interpreted the requirements of Section 6402(a) in various ways. The proposed rule provides CMS's view on this matter, and, given that CMS is proposing a ...

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the ...

As the “Three Tenors” (Chairmen Waxman, Miller and Rangel) struggle to finance the access enhancements that are central to the President’s health reform aspirations, the need for meaningful payment reform continues to challenge. This week House Speaker Nancy Pelosi urged the Chairmen to sharpen their pencils in this regard. Moreover, in a letter to the Speaker and Majority Leader Steny Hoyer, the fiscally-conservative “Blue Dog” coalition of House Democrats has now said that the current drafts fail to include sufficient structural reforms likely to succeed in ...