Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more
1/22/2025
/ Acquisition Agreements ,
Artificial Intelligence ,
Biotechnology ,
Capital Markets ,
Data Protection ,
Healthcare ,
Investment ,
Life Sciences ,
Merger Agreements ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Telehealth
Pennsylvania’s new Fair Contracting for Health Care Practitioners Act limits the use of certain restrictive covenants between employers and health care workers and imposes heightened patient notice obligations on applicable...more
The Federal Trade Commission (FTC) continues to enforce and update its Health Breach Notification Rule (HBNR) amidst a fast-changing regulatory environment. A new rule, which took effect this week, expands the scope of the...more
8/2/2024
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personally Identifiable Information ,
PHI
A new federal antitrust task force will focus on investigations in health care markets, and, where warranted, civil and criminal enforcement, the Department of Justice announced....more
A final federal rule raising minimum staffing requirements for long-term care (LTC) facilities that receive Medicare or Medicaid funding becomes effective June 21, starting a staggered timeline for LTCs to create and...more
Newly effective regulations governing confidentiality of Substance Use Disorder (SUD) records now more closely mirror regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other...more
Private equity is squarely in the cross hairs of regulators; the Department of Justice Antitrust Division, the Federal Trade Commission, and the U.S. Department of Health and Human Services recently announced the launch of a...more
3/8/2024
/ Acquisition Agreements ,
Antitrust Division ,
Antitrust Provisions ,
Competition ,
Corporate Sales Transactions ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Hart-Scott-Rodino Act ,
Healthcare ,
Hospital Mergers ,
Private Equity ,
Section 5 ,
Section 7 ,
Sherman Act ,
The Clayton Act
Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more
1/22/2024
/ Acquisitions ,
Antitrust Provisions ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Initial Public Offering (IPO) ,
Life Sciences ,
Medicare ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Private Equity
Summary -
The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule that, if finalized, will provide new minimum staffing level requirements for all long-term care facilities reimbursed by...more
Summary -
On June 1, 2023, the Supreme Court issued a landmark decision in False Claims Act cases. In United States ex rel. Schutte v. SuperValu Inc., it unanimously held that liability under the False Claims Act depends...more
6/20/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Reimbursements ,
Safeco Insurance Co of America v Burr ,
SCOTUS ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
In this episode, we discuss the current trend in the health care industry regarding the development of micro-hospitals, especially in certain rural areas. We explain what a micro-hospital is (and is not), the drivers behind...more
In this episode, we discuss the Centers for Medicare and Medicaid Services’ proposed changes to the Medicare Advantage risk adjustment payment model, which will take effect in 2024 if finalized. We’re joined by special guest...more
Summary -
The Department of Health and Human Services Office of Inspector General (HHS OIG) has announced its intention to comprehensively review nursing home citations issued by the Centers for Medicare and Medicaid...more
3/1/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Citations ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Nursing Homes ,
OIG ,
Prescription Drugs ,
Skilled Nursing Facility
Summary -
The Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) intended to require additional disclosures related to the ownership and management of nursing facilities that accept...more
On January 30, 2023, CMS posted for inspection a final rule describing its Risk Adjustment Data Validation audit methodology (the Final RADV Rule). As we have discussed in prior alerts, the finalization of the RADV Rule,...more
Summary -
CMS has announced it is engaging in a new series of audits intended to address the agency’s concern that nursing homes could be miscoding schizophrenia to reduce their reported rates of antipsychotic use, and...more
On January 14, 2023, the state Department of Human Services published a final rule, 53 Pa.B. 376, to amend the Pennsylvania Human Services Code (Code) by removing obstacles that made it harder for providers to share costs....more
Summary -
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published notice that it will postpone for another three months the finalization of a methodology to audit Medicare Advantage (MA)...more