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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.

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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.”

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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.

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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.

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“Because of Bostock” – Court Delays HHS Rule Re-interpreting Section 1557 Discrimination “Because of Sex”

One day before an updated rule of the US Department of Health and Human Services regarding Section 1557 of the Patient Protection and Affordable Care Act took effect, the US District Court for the Eastern District of New York ordered a stay and issued a preliminary injunction precluding the most recent final rules from becoming operative. Entities subject to Section 1557 should — at least until decisions are issued in cases pending in US district courts — be cautious in their approach to their non-discrimination compliance obligations.

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Use a Checklist to Avoid LGBTQ Discrimination in Your Benefits Programs

The US Supreme Court ruled June 15 in Bostock v. Clayton County, Ga. that the prohibition against sex discrimination in the workplace under Title VII of the Civil Rights Act covers sexual orientation and gender identity. Title VII applies to employers with 15 or more employees, including part-time and temporary workers.

Following the decision, benefits experts advise that employers review their benefits programs to ensure that lesbian, gay, bisexual, transgender and queer (LGBTQ) employees are treated equally. Employers can use a checklist to find and correct discriminatory language and practices, and thereby reduce the likelihood of being sued under Title VII or other statutes that provide employees with sexual-orientation and gender-identity protections.

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HHS Finalizes Anti-Discrimination Revisions to ACA Section 1557

On June 12, 2020, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) finalized a rule under Section 1557 of the Patient Protection and Affordable Care Act (the 2020 Final Rule) that rescinds certain protections afforded to LGBTQ individuals and persons with limited English proficiency. At the same time, the 2020 Final Rule removes burdensome disclosure requirements that may be a welcome relief for entities covered by Section 1557. On June 15, 2020, the Supreme Court of the United States ruled that workplace discrimination based on gender identity and sexual orientation is forbidden under Title VII of the Civil Rights Act of 1964. Although Title VII is not included in the precedential civil rights laws that gave rise to Section 1557, we nevertheless anticipate that the Supreme Court’s holding will lead to legal challenges in a number of areas, including healthcare and health insurance, religious exemptions and the 2020 Final Rule from HHS OCR.

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HHS Proposes Changes to 2016 Regulations for ACA Non-Discrimination Rule

On Friday, March 24, 2019, the US Department of Health and Human Services issued a proposed rule (along with a related fact sheet) under Section 1557 of the Affordable Care Act (ACA) that would make significant changes to the final regulations issued in 2016. Section 1557, in effect since the ACA was enacted in 2010, provides that an individual shall not—on the grounds prohibited under Title VII of the Civil Rights Act of 1964 (race, color, national origin), Title IX of the Education Amendments of 1972 (sex), the Age Discrimination Act of 1975 (age) or Section 504 of the Rehabilitation Act of 1973 (disability)—be excluded from participation in, be denied the benefits of or be subjected to discrimination under any health program or activity, any part of which is receiving federal financial assistance, or under any program or activity that is administered by an agency established under Title I of the ACA.

The proposed rule addresses a broad range of changes to the previously issued rule. These changes would include eliminating the non-discrimination notices and “tagline” translation notices in significant communications and revising prior guidance on sex discrimination to no longer include gender identity and termination of pregnancy, among other changes. Interested parties are invited to submit comments on the proposed rule through the period ending 60 days after publication in the Federal Register.




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Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

On July 28, 2016, US Department of Health and Human Services (HHS) issued guidance (guidance) under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and recover from ransomware attacks. Ransomware attacks can also trigger concerns under state data breach notification laws.

Ransomware is a type of malware (malicious software). It is deployed through devices and systems through spam, phishing messages, websites and email attachments, or it can be directly installed by an attacker who has hacked into a system. In many instances, when a user clicks on the malicious link or opens the attachment, it infects the user’s data. Ransomware attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker who deployed the malware. After the user’s data is encrypted, the ransomware attacker directs the user to pay a ransom in order to receive a decryption key. However, the attacker may also deploy ransomware that destroys or impermissibly transfers information from an information system to a remote location controlled by the attacker. Paying the ransom may result in the attacker providing the key necessary needed to decrypt the information, but it is not guaranteed. In 2016, at least four hospitals have reported attacks by ransomware, but additional attacks are believed to go unreported.

Read the full article here to learn about the indications of a ransomware attack, what do in the event of a ransomware attack and what circumstances constitute a HIPAA breach.




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