Over the last two months, the U.S. Department of Health and Human Services (“HHS”) published guidance regarding the enforcement of HIPAA and its privacy and security requirements in response to the COVID-19 public health...more
5/6/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Facebook ,
Good Faith ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Public Health ,
Public Health Emergency ,
SAMHSA ,
Telehealth
On March 9, 2020, CMS released its final rule creating certain interoperability and patient access standards (CMS Final Rule). On the same day, the ONC released a rule that addressed interoperability as well (ONC Final...more
On January 31, 2020, the Department of Defense (DoD) released the latest version (Version 1.0) of its Cybersecurity Maturity Model Certification (CMMC) framework, setting forth future cybersecurity requirements for thousands...more
3/5/2020
/ Certification Requirements ,
Controlled Unclassified Information (CUI) ,
Cybersecurity ,
Cybersecurity Maturity Model Certification (CMMC) ,
Defense Contracts ,
Defense Sector ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
NIST ,
Request For Information ,
Third Party Assessment Organization (3PAO)
On February 5, 2020, CMS issued a proposed rule advancing multiple updates and changes to Medicare Advantage (MA) and Medicare prescription drug benefit (Part D) programs (Proposed Rule). Unlike in past years, CMS will not...more
2/12/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Insurance ,
Health Plan Sponsors ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Public Comment
On October 31, 2019, CMS issued a final rule (the Final Rule) that updates payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) effective for calendar year (CY) 2020 and makes...more
On October 23, 2019, the Office for Civil Rights (OCR) at HHS announced the imposition of a $2,154,000 civil monetary penalty against a Florida hospital system (Hospital System) for alleged violations of the HIPAA Security...more
On October 15, 2018, the HHS Office of Civil Rights (OCR) announced a record $16 million settlement with Anthem, Inc., to settle allegations that Anthem violated certain HIPAA requirements prior to and following a 2015...more
On July 11, 2018, CMS announced that the process for recompeting contracts with suppliers currently in effect under the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Bidding Program (CBP)...more
On June 6, 2018, a CEO and four physicians were charged in a superseding indictment as part of an investigation into a $200 million healthcare fraud scheme involving a network of pain clinics, laboratories, and other...more
On May 8, 2018, CMS released its first “Rural Health Strategy.” The Rural Health Strategy focuses on the following five objectives to achieve CMS’s vision for rural health: (i) applying a “rural lens” to CMS policies; (ii)...more
On April 20, 2018, the House Energy and Commerce Committee posted a request for information regarding the cybersecurity risk posed by the use of legacy technologies in the healthcare sector (the RFI). “Legacy” technology is...more
On February 15, 2018, CMS released a final policy decision updating the national coverage determination (NCD) governing implantable cardioverter defibrillator (ICD) implantation for Medicare fee-for-service patients. In this...more
A While House policy “wish-list,” reportedly leaked on October 19 (Policy Document), identifies what appear to be the Trump Administration’s policy goals for various government programs, including Medicaid, the 340B Drug...more
On June 2, 2017, CMS filed a motion to dismiss its appeal to the U.S. Circuit Court for the Fifth Circuit of a U.S. District Court decision blocking the agency’s ban on mandatory nursing home arbitration. CMS’s motion did...more
On April 11, 2017, the U.S. District Court for the District of Oregon granted Oregon Health and Sciences University’s (OHSU) motion to dismiss a qui tam False Claim Act (FCA) suit, holding that (1) OHSU is an “arm of the...more
On March 27, 2017, CMS posted a new set of standardized forms for disclosure of potential violations of the Stark Law under the Self-Referral Disclosure Protocol (“SRDP”). The forms instruct disclosing entities to follow...more
On March 21, 2017, the U.S. District Court for the District of Columbia ruled that a hospital lacked standing to challenge a decision of the Provider Reimbursement Review Board (the “PRRB”), since the hospital failed to...more
On February 14, 2017, the U.S. Court of Appeals for the Fourth Circuit issued a long-awaited opinion in the case U.S. ex rel. Michaels v. Agape Senior Community, Inc. et al. (case number 15-2145 and 15-2147). In this FCA...more
On January 30, 2017, the Health Resources and Services Administration (HRSA) withdrew its 340B Program Omnibus Guidelines (Guidelines) from regulatory review by the Office of Management and Budget (OMB). HRSA published the...more
On December 7, 2016, HHS OIG issued a “General Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries” (Policy Statement). In the Policy Statement, OIG announced that it is changing its...more
On November 17, 2016, CMS released three application program interfaces (APIs) that make it easier to analyze the Medicare Access and CHIP Reauthorization Act of 2015 Quality Payment Program (QPP) measures and to build...more