The Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
The US Department of Justice’s (DOJ’s) Civil Division released its annual fraud statistics on February 7, covering fiscal year 2022. Settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the...more
The Centers for Medicare & Medicaid Services (CMS) delayed the publication of the final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation...more
The Inflation Reduction Act of 2022, passed by the US Senate on August 7, 2022, will dramatically affect a range of climate change, healthcare, prescription drug pricing, and tax matters. With an investment of more than $400...more
Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more
The Centers for Medicare & Medicaid Services released its CY 2022 Physician Fee Schedule final rule on November 2 reflecting the Biden-Harris administration’s goal of increasing access to and quality of care and reducing...more
11/15/2021
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Final Rules ,
Health Care Providers ,
Medicare Part B ,
MIPS ,
Payment Rates ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Telehealth ,
Telemedicine
The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for...more
DOJ recently announced a massive coordinated effort with other federal agencies to charge 345 defendants allegedly responsible for over $6 billion in fraud. DOJ, OIG, FBI, DEA, and various US Attorneys’ Offices in 51 federal...more
The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020...more
The Center for Medicare and Medicaid Services (CMS) released a far-reaching interim final rule (IFR) to address the coronavirus (COVID-19) pandemic on March 30. The IFR represents a comprehensive set of policy changes...more
On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed...more
The Centers for Medicare & Medicaid Services has expanded its payment program to provide emergency funding and increased cash flow to providers and suppliers that participate in Medicare based on historical Medicare payments...more
As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or...more
The Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25 saying that it planned in some cases to exercise enforcement discretion with respect to late or incomplete data...more
As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the...more
3/20/2020
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Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Facebook ,
FaceTime ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
OIG ,
Public Health Emergency ,
Skype ,
Telehealth ,
Waivers
CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the...more
3/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and...more
The Open Payments program established by the Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of covered drugs, medical devices, biologicals, and medical supplies (applicable manufacturers) to report...more
HB 2536 requires pharmaceutical manufacturers to disclose to the Texas Health and Human Services Commission (HHSC) when a drug’s price increases 15% or more compared to the previous year, or 40% or more over three calendar...more
In CMS’s continuing effort to take “a strategic approach to protecting taxpayer dollars and reducing regulation to put patients over paperwork,” Administrator Seema Verma recently highlighted changes to the Recovery Audit...more
Clearing the way for consideration by the US House of Representatives, the Ways and Means Committee has unanimously approved bipartisan legislation aimed at increasing drug price transparency by manufacturers and pharmacy...more
While Maryland became the first state in the nation to pass legislation creating a Prescription Drug Affordability Board, it may not be the last. Several other states are exploring similar legislation but legal challenges may...more
The newly enacted SUPPORT Act’s wide-ranging provisions take aim at the entire healthcare continuum, including providers, who will be on the front lines of change as the new law takes effect. The law includes amendments to...more
Mixing innovative change with standing policy, the proposed physician fee schedule rule for CY 2019 highlights a Medicare payment system in transition. Clinicians and groups focused solely on driving volume without devoting...more