Regulatory Developments

Following closely after the clarifying independent dispute resolution process Final Rule, the four executive branch entities tasked with implementing the provisions of the No Surprises Act, the Office of Personnel Management, the Centers for Medicare & Medicaid Services (CMS), Employee Benefits Security Administration and the Internal Revenue Service have issued a request for information to help the agencies craft the next stage of regulations for the surprise billing law.

The request is the latest effort by agencies to seek stakeholder input on the contours of the regulations implementing the No Surprises Act, this time with a focus on the requirements in the law for providers to issue a good faith estimate (GFE) to plans for services that their covered patients will submit for reimbursement and for insurers to issue an advanced explanation of benefits (AEOB) to their plan participants based on estimated charges relayed to them by providers.

Specifically, the entities are looking for information and recommendations on the process of transferring data from providers and facilities to plans, issuers and carriers to facilitate the GFE and AEOB processes, as well as the economic impacts of implementing these requirements. The notice was added to the Federal Register on Friday, Sept. 16 and comments are due to the agencies by November 15.

Continue Reading Agencies Look for Input on No Surprises Act Good Faith Estimate Rules

On June 29, 2022, the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) issued two pieces of guidance clarifying the applicability of the Health Insurance Portability and Accountability Act (“HIPAA”) related to privacy of information connected to an individual’s reproductive health. 

Through this guidance, HIPAA addresses both protected health information (“PHI”), which is subject to HIPAA’s rules, as well as general, personal information that is not directly protected by HIPAA.

Continue Reading New Guidance by OCR addresses HIPAA and Disclosures of Information relating to Reproductive Health

The Centers for Medicare and Medicaid Services has published a final rule that governed the way that Medicare Advantage and Medicare Part D plans interact with third-party marketing organizations. The rule, which goes into effect on June 28, 2022, will have a wide ranging impact on the insurers who run these plans.

Scot Hasselman

CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits.

The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below. They provide additional guidance regarding topics such as archived reporting years, salaries paid to covered recipients, reporting of device identifiers, valuing long-term device loans, debt forgiveness, and the definition of Nurse Practitioner.

Additionally, the following FAQs have been removed from the FAQ document “due to being no longer applicable, redundant with another FAQ, or of low utility” (according to CMS):
Continue Reading CMS Issues Updated Open Payments FAQs

On February 23, 2022, a federal district court judge in Texas agreed with the Texas Medical Association that some provisions of the interim final rules implementing the No Surprises Act were promulgated in violation of the provisions of the Administrative Procedures Act (“APA”). As a remedy, the court ordered those provisions vacated and remanded the affected rules back to the federal agencies for further consideration.

In a memorandum issued February 28, the Centers for Medicare & Medicaid Services, one of the federal agencies that promulgated the rule (along with the Employee Benefits Security Administration and the Internal Revenue Service) indicated that it was still reviewing the court’s decision and considering next steps, which could include an appeal to the U.S. Court of Appeals for the Fifth Circuit. Additionally, CMS said that it was withdrawing any guidance documents based on the invalidated sections and will launch revised guidance and training for certified independent dispute resolution (“IDR”) entities and parties subject to the process. Those guidance documents will be edited to conform to the court’s decision and republished. Important to providers, CMS emphasized that the court’s order does not affect its other rulemaking related to the No Surprises Act.
Continue Reading Portion of No Surprises Act IDR rule procedures set aside by federal district court

The Department of Health and Human Services’ Office of Inspector General (OIG) will be lifting its long-standing refusal to accept requests for advisory opinions if the request describes a course of action that is “the same or substantially the same” as a course of action that is either under investigation by OIG, or is the subject of a proceeding involving a governmental agency. As of February 10, 2022, a new final rule issued by the OIG will do away with that restriction and allow entities to request an advisory opinion, even if the requested course of action is the same or substantially the same as one under investigation or is the subject of a proceeding involving a governmental agency. Previously, the OIG’s policy deliberately left unsettled many fraud-and-abuse issues implicated by pending investigations or litigation.

As the final rule points out, however, seeking clarity during a pending investigation or litigation will carry risk: the mere fact that a course of action is the subject of a qui tam case or under investigation “will weigh against the issuance of a favorable advisory opinion because such circumstances generally indicate that the arrangement does not present a sufficiently low risk of fraud and abuse.”

This warning seems to assume that all investigations and litigation have equal merit, which is certainly not the case with matters initiated by self-appointed whistle-blowers under the False Claims Act, who often bring cases with very little merit. Nevertheless, the new rule provides flexibility, and provides opportunities for the OIG to provide guidance to health care companies seeking to develop business opportunities that, for example, a long-pending and/or declined qui tam case may have stymied.

Continue Reading Pending investigations/cases no longer prevent OIG advisory opinions

In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing the costs to consumers for prescription drugs and directing the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) to implement those policy objectives, HHS-OIG issued a Final Rule to amend certain provisions in the safe harbor regulations under the Federal Anti-Kickback Statute (“AKS”). The Final Rule included three key provisions:

  1. Elimination of discount safe harbor protection for manufacturer rebates paid directly, or indirectly through a pharmacy benefit manager (“PBM”) to Medicare Part D or Medicare Advantage plans (the “Rebate Rule”);
  2. Creation of a new safe harbor to protect point-of-sale (“POS”) price reductions paid by manufacturers to Medicare Part D plans, Medicare Advantage plans, and Medicaid managed care organizations (“MCOs”); and
  3. Creation of a new safe harbor to protect fair-market-value (FMV) service fees paid to PBMs by manufacturers.

The Final Rule imposed a January 1, 2022, effective date for the Rebate Rule. However, in January 2021, two months after issuance of the Final Rule and in connection to a lawsuit brought by the Pharmaceutical Care Management Association challenging the Rebate Rule, the Biden Administration agreed to delay the Rebate Rule’s effective date to January 1, 2023, as reflected in an Order by the United States District Court for the District of Columbia.

In the intervening time though, Congress passed the Infrastructure Investment and Jobs Act (the “Infrastructure Act”). That law, signed by President Biden on November 15, 2021, further delayed implementation of the Rebate Rule to January 2026. Thus the rule, which many thought would be eliminated as part of paying for the cost of the infrastructure bill, was still alive, if only delayed until the middle of the next presidential term.

Continue Reading Future of discount safe harbor for prescription drugs remains uncertain

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act.

The final rule, which takes effect January 3, 2022, comes nearly three years after the FDA first proposed it and, notably, sets forth the procedures and criteria for a manufacturer’s voluntary submission and withdrawal of a De Novo request.  Additionally, the rule clarifies how agency staff intends to accept and review the requests, as well as how FDA staff will determine whether to grant or decline the requests.  Finally, the rule also provides a way for combination products to use the De Novo pathway.

Useful for novel, low risk medical devices

The implementation of the De Novo classification process is especially significant for manufacturers of novel, low-risk medical devices.  Prior to the De Novo program, which was created in 1997, any device that lacked a predicate automatically became designated as a Class III device and, therefore, required premarket approval to legally reach the market.  Because this premarket pathway is designed to regulate the riskiest category of devices, manufacturers typically had to endure longer than anticipated wait times for approval of their low-risk devices.

Continue Reading FDA codifies requirements for the medical device De Novo classification process

Effective January 1, 2022, common prohibitions against “balance billing” under hospital professional service contracts will likely become moot due to certain superseding federal prohibitions under the federal No Surprises Act enacted December 27, 2020.  As detailed below, certain hospital-based physicians, including radiologists, anesthesiologists, and pathologists, should keep these new federal billing prohibitions in mind when entering into new hospital professional services agreements (“PSAs”) and revisit their existing agreements to determine whether any changes are appropriate.

“No Surprises Act” Background.

The federal government’s growing focus on surprise medical bills reached a new high on July 1, 2021, when the Department of Health and Human Services (“HHS“), along with the Department of Labor and Department of the Treasury, released a consumer-focused interim final rule with comment period taking aim at surprise billing and excessive cost-sharing practices.  The rule, which also cites an ineffective “patchwork” of consumer protections under existing state laws, represents the first implementing regulation under the No Surprises Act.  Both the rule and the statute become effective on or after January 1, 2022.

Balance Billing Prohibition.

This article discusses two distinct but interwoven billing procedures that deserve clarification: “surprise billing” and “balance billing.”

Continue Reading No Surprises Act: Time to revisit balance billing prohibitions in hospital-based physician professional services agreements with hospitals?

On August 2, 2021, the U.S. Food and Drug Administration (“FDA”)  published a final rule amending existing regulations (21 C.F.R. § 201.128 and 21 CFR § 801.4) that describe the types of evidence relevant to determine a drug or device’s intended use under the Food, Drug and Cosmetic Act (“FDCA”).  See 86 Fed. Reg. 41,384–85.

This final rule, which takes effect as of September 1, 2021, withdraws and replaces a final rule that FDA promulgated on January 9, 2017, but which never became effective due to an outcry concerning a problematic knowledge provision that was contrary to the statutory scheme of the FDCA and to physicians’ autonomy to use FDA-approved products in an off-label manner.

Prior to the 2021 final rule, FDA issued a proposed rule on September 23, 2020 that eliminated the 2017 rule’s knowledge provision and was much more aligned with FDCA intent and current FDA policy and practice.  FDA maintains, and we agree, that August 2021 final rule remains largely unchanged from the 2020 proposed language.

The following is a review of some important changes that FDA regulated entities should take note of as they develop and market FDA regulated products:

Continue Reading FDA clarifies evidence and knowledge requirements in intended use final rule

Just when the procedures thought they were out(patient), CMS pulls them back in(patient).

Last year, in the final CY 2021 Outpatient PPS rule, CMS announced its intention to eliminate the Inpatient Only (IPO) List by January 1, 2024. The IPO list featured more than 1,700 procedures that were surgically invasive or required more than 24 hours of post-operational recovery time. As a result, any procedure on the list would only be paid for by Medicare on an inpatient basis.

With the CY 2021 rule, those procedures would be released to outpatient providers in stages, allowing physicians to clinically determine whether inpatient admission was indicated for a particular procedure.

However, in the proposed CY 2022 Outpatient PPS rule, announced on July 19, 2021, CMS reversed that decision and announced that it will now keep the IPO List, reinstating the 298 procedures that were removed by the 2021 rule. CMS said it was responding to concerns from stakeholders about patient safety. In particular, CMS indicated that the 2021 rule removed the procedures on too steep of a timeline. The agency said it wanted to provide “greater consideration of the impact removing services from the list has on beneficiary safety and to allow providers impacted by the COVID-19 PHE additional time to prepare to furnish appropriate services safely and efficiently before continuing to remove large numbers of services from the list.”

Continue Reading CMS Gives the IPO List the Godfather 3 Treatment

Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1]  In the past year

The 2019 Novel Coronavirus pandemic (“COVID-19”) introduced several unfamiliar hardships adversely impacting the long-term care industry, especially for nursing homes.  Acknowledging these hardships, the Centers for Medicare & Medicaid Services (“CMS”) enacted several temporary emergency blanket waivers effective March 1, 2020, lending flexibility to nursing homes in their COVID-19 response efforts.  Since that time, according

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine.

The IFR governs any vaccine that

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient).
Continue Reading Patient access to health information at the forefront of government initiatives and scrutiny

On September 15, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors on how to advance value-based care (VBC) across their health care systems, with an emphasis on Medicaid populations, and how to share pathways for adoption­ of such approaches.  Within the 33-page letter, CMS highlights the merits of

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s Seniors,” directs the Secretary of Health and Human Services to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients.”  EO 13890 explicitly requests that the Secretary make coverage