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HHS

Changes in Healthcare Information Regulation: Information Blocking

On November 3, 2020 new rules from the Health and Human Services Department concerning information blocking in healthcare will come into effect. The rules are an implementation of the 21st Century Cures Act (“Act”) which is the latest in the government’s effort to lower costs and allow for greater patient access to electronic health information (“EHI”). The Act aims to prevent covered healthcare providers from restricting the flow of EHI in inappropriate ways. Violations of the new Act may result in considerable civil fines.

Rural Hospitals in Crisis Receive a Boost to Value-Based Care Model from New CMS CHART Model

The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.

CARES Act Provider Relief Fund: Compliance and the Impact on Hospital Margins  

The effects of COVID-19 create numerous hospital financial management issues. One specific issue is hospitals maintaining financial stability. As the United States adjusts to the pandemic, hospitals have the burden of navigating their purpose, mission, and values while maintaining operations. The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) is a comprehensive bill that includes provisions that financially assist healthcare providers. Nevertheless, as with all federal assistance, compliance with specific conditions is required. As the pandemic continues, if hospitals accept federal help to stabilize finances, awareness, and increasing training to comply with federal guidelines is crucial.

Rule Changes, Regulatory Waivers Expand Access to Health Care Services During Pandemic

Recent regulatory waivers and rule changes by the Centers for Medicare and Medicaid Services (“CMS”) have resulted in a notable increase in patients seen remotely, according to two recent studies. The studies suggest that CMS regulatory waivers and rule changes, which included expanded access to COVID-19 testing and telehealth services in response to challenges faced by health care providers and patients during the COVID-19 pandemic, have increased remote delivery of mental health care and highly specialized clinical practices like plastic surgery.

CMS Issues New Rigid COVID-19 Requirements for Skilled Nursing Facilities

The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as  part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.

CMS Modernizing the Physician Self-Referral and Anti-Kickback Regulations

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.

CMS Issues New Rule to Tighten Provider Enrollment

On September 5, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released its final rule with comments on Program Integrity Enhancements to the Provider Enrollment Process (“ The Program Integrity Enhancements”).  The final rule gives CMS the power to revoke Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollments of providers or suppliers who have an “affiliation” with previously sanctioned entities, even if those providers and suppliers aren’t directly violating any existing rules themselves. CMS says that this new authority will help to “stop fraud before it happens.”

Rush University Medical Center’s 2019 Privacy Breach Incident

In March 2019, Rush University Medical Center (“Rush University”) sent out breach notification letters to approximately 45,000 patients. The letter advises patients that a privacy incident occurred that may have involved the patients’ personal information. The privacy incident was caused by an employee of a third-party financial services vendor. The employee released a file that contained patient information to an unauthorized person. According to the breach notification letter, law enforcement and regulatory officials were involved in the investigation of the privacy incident. Rush University sent the breach notification letter in compliance with the Health Insurance Portability and Accountability Act’s privacy and security rules.

The Years Long Process to a Revised Common Rule and Implementation

The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.

Trump Administration’s Proposal to Update Anti-Kickback Safe Harbors Gives Patients Drug Price Relief at the Pharmacy Counter

On January 31, 2019, the Trump administration proposed yet another regulation in efforts to control rising prescription costs for Americans. If the regulation becomes final, drug manufacturers and Pharmacy Benefit Managers (“PBM”) will no longer be able to harbor from Anti-Kickback violations when negotiating discounts with Medicare and Medicaid managed care programs. The Administrations, continuing the tone of transparency, will instead provide Medicare Part D beneficiaries with the ability to receive discounted prices at the pharmacy counter. The administration hopes this will allow patients to not endure high out-of-pocket costs by purchasing medications at a more affordable price necessary to sustain their health.