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New Stark and Anti-Kickback Statute Comparisons
/in Anti-Kickback, StarkBy Kim Stanger, J. Malcolm DeVoy, and Amber Ellis
On November 20, 2020, CMS and the OIG published their much anticipated amendments to the federal Stark and Anti-Kickback laws. As summarized in our recent client alert, the changes open the door to value-based contracting with potential referral sources. They also modify existing regulations and create new safe harbors applicable to provider relationships.
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HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth
/in COVID-19, TelehealthOn December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19. The Holland & Hart Healthcare Group shares this important update from HHS for your information:
Read the HHS Update
We will continue to monitor this news and will provide more in-depth insights on the impacts of this amendment.
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Final Rules for Stark and Anti-Kickback Reforms Issued by CMS and OIG
/in Anti-Kickback, StarkBy Amber Ellis and J. Malcolm DeVoy
On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician Self-Referral regulations (the Stark Law, or Stark) and the Anti-Kickback Statute (AKS) safe harbor regulations. These new final rules generally take effect on January 19, 2021.
The prior Stark and AKS regulations were developed in a volume-based health care delivery and payment system. Over time, and with the rise of data that could be used by providers and payers to better anticipate patient needs and payment for them, concern arose that the existing regulations and policies would potentially inhibit the innovation necessary for moving toward a value-based system of care and payment. These new final rules aim to alleviate those concerns and advance the transition to value-based care and encourage the coordination of care among providers, while continuing to provide important safeguards to protect against fraud, abuse, and overutilization. Read more
wRVU Compensation Formulas: Time to Review
/in Contracts & TransactionsBy Kim Stanger
Many hospitals, physician groups, or other providers compensate employed or contracted practitioners based on the work relative value units (“wRVUs”) they generate, e.g., a physician may be paid $x per wRVU performed. Depending on the contract terms, those wRVU values may soon be affected by the 2021 Medicare Physician Fee Schedule. If you have not already done so, you should review your wRVU compensation formula for the following issues:
1. Changes to RVU Values. The 2021 Medicare Physician Fee Schedule will increase the CMS-assigned wRVUs for several codes, including common E/M codes. (See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched). If your wRVU compensation formula is based on the then-current CMS wRVU values or automatically incorporates the 2021 changes, you may soon owe your physicians more pay than you otherwise anticipated. You may want to adjust your contractual wRVU conversion factor to account for unanticipated and unwarranted increases in practitioner compensation. If your contract does not allow for unilateral adjustments, you may need to obtain the practitioner’s agreement to the change or, alternatively, invoke contract termination provisions. Going forward, you may want to tie the wRVUs to the CMS values that existed at the time the contract was executed rather than the operative CMS values, thereby avoiding the need to monitor or update CMS changes to wRVUs. Read more
HIPAA Enforcement: Lessons from the OCR’s Recent Settlements
/in HIPAABy Kim Stanger
The OCR has announced a surprising number of HIPAA settlements in the past few months with penalties ranging from $10,000 to $6.5 million. Here are some of the key takeaways for healthcare providers:
1. Protect against cyberattacks. Healthcare entities remain a prime target for healthcare entities with disastrous effects for victims, including providers and patients whose information is compromised or destroyed. The HIPAA security rule is intended to ensure that healthcare entities maintain the integrity, availability and confidentiality of electronic protected heath information; successful cyberattacks often expose security rule violations. Premera Blue Cross agreed to pay $6.85 million after a phishing scam deployed malware that affected the information of 10.4 million persons. Another entity agreed to pay $2.3 million after a hacker accessed records of 6.1 million persons. Per the OCR, “The health care industry is a known target for hackers and cyberthieves. The failure to implement the security protections required by HIPAA Rules …. is inexcusable.” https://www.hhs.gov/about/news/2020/09/23/hipaa-business-associate-pays-2.3-million-settle-breach.html. Cybersecurity is a major focus for HHS. In December 2018, the federal government published a guide to help healthcare providers of all sizes protect against cyberthreats, Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients, available at https://www.phe.gov/Preparedness/planning/405d/Pages/hic-practices.aspx. In July 2020, HHS launched its Health Sector Cybersecurity Coordination Center (“HC3”) website, https://www.hhs.gov/about/agencies/asa/ocio/hc3/index.html, to offer additional support for healthcare providers. Cybersecurity is vital not only for regulatory compliance; it is essential to protect patients and ensure continued operation of the provider. Read more