March 22, 2021
Typically, when a person is seeking medical care, he or she will select a provider who is in-network. This is because a provider will discount its list prices (or charges) in order to be included in an insurance plan’s network.1 Hence, a patient will often seek in-network providers because of this lower negotiated rate.2 But in practice, a patient does not always have this…
March 2, 2021
Many of you are aware of “I’m sorry” laws that have been passed in many states which allow doctors and other healthcare providers to express sympathy and regret about an adverse event without it being used against them in a later civil suit. These laws are intended to provide freedom for the practitioner to communicate with a patient on a personal basis without worry over legal consequences of…
December 18, 2020
The Federal Anti-Kickback Statute (“AKS”) is a criminal statute that prohibits transactions intended to induce or reward referrals for items and services reimbursed by federal health care programs (such as, Tricare, Medicare, and Medicaid). On November 20, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule that amends…
December 14, 2020
On November 20th, 2020, the Centers for Medicare & Medicaid Services (CMS) made sweeping changes to the Stark Law through the issuance of a new “Final Rule,” which is an essential mile-marker in the government’s Sprint to Coordinated Care. Many industry stakeholders have been eagerly awaiting the Final Rule’s issuance, hoping that it would provide more flexibility and clarity to this complex…
December 11, 2020
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposed updates aim to give patients more access to their health information and improve coordinated care, while also ensuring that patients are afforded privacy and security…
December 7, 2020
Gov. Jared Polis entered Executive Order D 2020 249 to clarify the order of operations for the increasing hospital capacity in the State of Colorado. Hospitals were directed to increase their capacity internally by utilizing unused space and supplementing their staffing. If further capacity is needed, the hospitals were directed to decrease the number of elective procedures being performed at the…
November 30, 2020
Three separate price transparency rules have been published or go into effect soon. Hospitals and insurers need to prepare for compliance and all of the legal issues that will arise during implementation of the rules.
Beginning January 1, 2021, the Hospital Price Transparency Rule (“Hospital Transparency Rule”) goes into effect, requiring all hospitals, as…
November 23, 2020
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited final rules on November 20, 2020. The final rules revise the Medicare Physician Self-Referral law (Stark law), the Federal Anti-kickback statute, and the Civil Monetary Penalties Rules.1 Each agency has issued a Fact Sheet highlighting the…
November 19, 2020
The Office of the National Coordinator extended compliance deadlines to its 21st Century Cures Act: Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”). This extension postpones compliance requirements for the Information Blocking provisions that were set to go into effect November 2, 2020 until April 5, 2021. Clearly this provides…
November 19, 2020
On November 16, 2020, the HHS Office of Inspector General (“OIG”) issued a special fraud alert regarding “the offer, payment, solicitation, or receipt of remuneration” relating to speaker programs for pharmaceutical and medical device companies.
The targeted speaking engagements involve programs presented by physicians or other healthcare provider, who are not employed by the company, and the…
November 3, 2020
Litigants and litigators face unique challenges to effectively prosecute or defend ongoing or anticipated civil actions amid the pandemic. Now, more than seven months since the declaration of a national emergency in the U.S. and with new COVID-19 cases continuing to rise in many regions, flexibility and creativity remain critical to adapt to the evolving nature of one’s “day in court” during…
October 14, 2020
A recent decision from the District of Columbia’s Court of Appeals has paved the way for the United States Department of Health and Human Services (“HHS”) to continue its policy of Medicare Part B reimbursement reductions for 340B covered entities.
Congress created the 340B drug pricing program in 1992, requiring certain pharmaceutical manufacturers to sell outpatient drugs at discounted…
March 22, 2021
Typically, when a person is seeking medical care, he or she will select a provider who is in-network. This is because a provider will discount its list prices (or charges) in order to be included in an insurance plan’s network.1 Hence, a patient will often seek in-network providers because of this lower negotiated rate.2 But in practice, a patient does not always have this…
March 2, 2021
Many of you are aware of “I’m sorry” laws that have been passed in many states which allow doctors and other healthcare providers to express sympathy and regret about an adverse event without it being used against them in a later civil suit. These laws are intended to provide freedom for the practitioner to communicate with a patient on a personal basis without worry over legal consequences of…
December 18, 2020
The Federal Anti-Kickback Statute (“AKS”) is a criminal statute that prohibits transactions intended to induce or reward referrals for items and services reimbursed by federal health care programs (such as, Tricare, Medicare, and Medicaid). On November 20, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule that amends…
December 14, 2020
On November 20th, 2020, the Centers for Medicare & Medicaid Services (CMS) made sweeping changes to the Stark Law through the issuance of a new “Final Rule,” which is an essential mile-marker in the government’s Sprint to Coordinated Care. Many industry stakeholders have been eagerly awaiting the Final Rule’s issuance, hoping that it would provide more flexibility and clarity to this complex…
December 11, 2020
On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposed updates aim to give patients more access to their health information and improve coordinated care, while also ensuring that patients are afforded privacy and security…
December 7, 2020
Gov. Jared Polis entered Executive Order D 2020 249 to clarify the order of operations for the increasing hospital capacity in the State of Colorado. Hospitals were directed to increase their capacity internally by utilizing unused space and supplementing their staffing. If further capacity is needed, the hospitals were directed to decrease the number of elective procedures being performed at the…
November 30, 2020
Three separate price transparency rules have been published or go into effect soon. Hospitals and insurers need to prepare for compliance and all of the legal issues that will arise during implementation of the rules.
Beginning January 1, 2021, the Hospital Price Transparency Rule (“Hospital Transparency Rule”) goes into effect, requiring all hospitals, as…
November 23, 2020
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited final rules on November 20, 2020. The final rules revise the Medicare Physician Self-Referral law (Stark law), the Federal Anti-kickback statute, and the Civil Monetary Penalties Rules.1 Each agency has issued a Fact Sheet highlighting the…
November 19, 2020
The Office of the National Coordinator extended compliance deadlines to its 21st Century Cures Act: Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”). This extension postpones compliance requirements for the Information Blocking provisions that were set to go into effect November 2, 2020 until April 5, 2021. Clearly this provides…
November 19, 2020
On November 16, 2020, the HHS Office of Inspector General (“OIG”) issued a special fraud alert regarding “the offer, payment, solicitation, or receipt of remuneration” relating to speaker programs for pharmaceutical and medical device companies.
The targeted speaking engagements involve programs presented by physicians or other healthcare provider, who are not employed by the company, and the…
November 3, 2020
Litigants and litigators face unique challenges to effectively prosecute or defend ongoing or anticipated civil actions amid the pandemic. Now, more than seven months since the declaration of a national emergency in the U.S. and with new COVID-19 cases continuing to rise in many regions, flexibility and creativity remain critical to adapt to the evolving nature of one’s “day in court” during…
October 14, 2020
A recent decision from the District of Columbia’s Court of Appeals has paved the way for the United States Department of Health and Human Services (“HHS”) to continue its policy of Medicare Part B reimbursement reductions for 340B covered entities.
Congress created the 340B drug pricing program in 1992, requiring certain pharmaceutical manufacturers to sell outpatient drugs at discounted…
