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See What’s Next with McDermott+Consulting’s 340B Ligitation Tracking Tool

The 340B program landscape is constantly shifting. Wednesday’s US Supreme Court American Hospital Association v. Becerra decision is of critical importance to hospitals that participate in the 340B program. The Court held that the US Department of Health and Human Services (HHS) improperly imposed a payment cut of almost 30% on 340B drugs paid by Medicare. Yet, while this decision is significant, it is not the end of the litigation surrounding the payment cut. The case has been remanded for further deliberation, which will include a determination of the remedies.

McDermott+Consulting has launched the 340B Litigation Tracking Tool, an up-to-date resource following the 30+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for updates on important case developments. This tracker, available 24/7 and routinely monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape.

View the 340B litigation tracking tool here.




Safe Harbor Issued for Reporting Healthcare Prices Under Transparency Rules

The US Departments of Labor, Health and Human Services, and the Treasury recently released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting provisions of the Affordable Care Act (ACA). The FAQs were released to provide clarity on the required drug price disclosures identified in the Transparency in Coverage final rule (the Rule) issued on October 29, 2020. As described in this SHRM article, employers are responsible for making sure that these disclosures are ready and available.

Read more here.




Four Discrimination Questions Employers Have About COVID-19

As the world enters the third year of the COVID-19 pandemic, employers have gained a greater understanding about the virus’ relationship with US anti-discrimination laws. With the inevitable rise of future variants and long-haul COVID-19 cases, however, businesses are still navigating murky waters. In this Law360 article, McDermott Partner Lindsay Ditlow offers perspective about worker accommodation requests and what they mean for employers.

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Agencies Clarify How Employers Can Charge COVID-19 Vaccine Premium Incentives

US employers have grown increasingly interested in identifying incentives that increase COVID-19 vaccination among employees. The US Departments of Labor, Treasury and Human and Human Services recently issued guidance regarding the application of the Health Insurance Portability and Accountability Act (HIPPA) wellness rules to vaccine-related premium surcharges and discounts, clarifying that employers may charge vaccine premium incentives if they adhere to the requirements of activity-only health-contingent programs. In this Employee Benefit Plan Review article, McDermott Partner Judith Wethall and McDermott Associate Sarah G. Raaii outline what this HIPPA guidance means for employers.

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Saga and Legal Challenges Continue Despite Vaccine Requirement for Healthcare Workers

The US Supreme Court’s January ruling allowing the Centers for Medicare & Medicaid Services to enforce its COVID-19 mandate is likely to continue to face challenges. Nevertheless, in this article published by the Health Care Compliance Association, McDermott Partner Sandra DiVarco said that the Supreme Court’s decision wasn’t a surprise.

“Many of [the CMS] providers may have slow-walked their compliance and now in theory need to be fully compliant,” DiVarco noted.

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Are Out-of-Pocket Costs on Their Way Out? At-Home COVID-19 Testing and Expanded Preventative Healthcare for Women and Children

In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.

In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.

COVID-19 AT-HOME TESTING COVERAGE

On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.

Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.

The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.

Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).

HRSA UPDATES ACA PREVENTIVE HEALTHCARE GUIDELINES

On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.

HRSA accepted the updates recommended by the Women’s Preventative [...]

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Update to Fraud Self-Disclosure Rules for Regulated Healthcare Entities

On November 8, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an update to the Health Care Fraud Self-Disclosure Protocol (SDP). This update revises and renames the Provider Self-Disclosure Protocol last updated by OIG in 2013. The changes are mostly procedural in nature and update the SDP based on legislative adjustments to penalty amounts.

Read more here.




Hospitals Push Back Against HHS Slashing of Reimbursement Rates

Hospitals are pushing back after the US Department of Health and Human Services (HHS) cut Medicaid reimbursement rates to participating hospitals under the 340B drug discount program.

According to this article published in The Well News, 340B program supporters have filed a petition with the Supreme Court, arguing that HHS failed to collect sufficient data and that the department overstepped its authority with the cuts. McDermott Partner Emily Jane Cook said that the cuts will mean rural hospitals are “deprived of an important source of support for the services that they provide to their communities.”

Read more here.




Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court announced in July that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely watched, given its potentially far-reaching impacts on reimbursements to most hospitals that participate in the Medicare program, not just those that participate in the 340B Program.

Read more here.




Requirements Related to Surprise Billing: Policy Update

The US Departments of Health and Human Services, Treasury and Labor, and the Office of Personnel Management issued an Interim Final Rule with comment implementing portions of the No Surprises Act, legislation enacted in December 2020 that bars surprise billing beginning January 1, 2022. Under the law, payers and providers (including hospitals, facilities, individual practitioners and air ambulance providers) are prohibited from billing patients more than in-network cost-sharing amounts in emergency and non-emergency circumstances. This IFR establishes regulations defining the payment methodology. The regulation proposes the methodology payers must use to determine cost sharing; the information payers must share with out-of-network providers; the process for submitting and receiving consumer complaints; and the format and details of the notice and consent requirements.

Read more here.




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