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California: Five Things You Need to Know About AB 3129

The California legislature recently passed a bill targeting private equity and hedge fund transactions with health care providers. If signed into law, AB 3129 will require a private equity group or hedge fund to notify and...more

California: Health Care Transactions “Material Change” Regulations are Finalized

In late December, the California Office of Health Care Affordability (OHCA) issued final regulations for the new material change transactions filing process, which goes into effect this year. (22 Cal. Code of Regs. §§...more

California: Proposed Regulations Impacting the M&A Market in California

Below we outline what you need to know from the recently proposed regulations if you are a health care entity evaluating a transaction in California that is expected to close on or after April 1, 2024. Since the...more

Reproductive Health: Over the Counter Birth Control Pill Supported by FDA Advisory Committees

At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more

California: Health Care M&A Market Heats up as New Regulator Takes a Closer Look

California health care entities can expect increased scrutiny of future mergers, acquisitions, and other transactions following the passage of the California Health Care Quality and Affordability Act (HCQAA). Effective April...more

Compliance Considerations For Telehealth Abortion Services

In light of the U.S. Supreme Court's recent decision in Dobbs v. Jackson Women's Health Organization, which returned the right to enact laws regarding reproductive health care to the states, many health care providers are...more

A Post Roe World: California’s response to Dobbs v. Jackson Women’s Health

In the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health, California has taken significant steps to ensure continued ability to access abortion care in the state, and making additional funds available to...more

Three Considerations for Health Care Providers After the Dobbs Decision

Last week, the Supreme Court issued a decision in Dobbs v. Jackson Women’s Health, holding that the Constitution does not confer a right to abortion, and overruling precedent established by Roe v. Wade, 410 U.S. 113,and...more

Compliance Issues in Hospital and Health System Sports Sponsorships

Many hospital, health systems and other health care providers have seen benefits in sponsoring sports teams, stadiums and athletic tournaments. Considerations include general branding in the community, recruitment of staff or...more

CMS Requires COVID-19 Vaccination for Health Care Facility Staff

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule that requires most Medicare and Medicaid certified providers and suppliers to vaccinate staff members within 60 days. The...more

Nevada is Latest State to Enhance Oversight of Health Care Transactions

On October 1, 2021, Nevada will join a handful of states that are actively seeking to monitor the growth and impact of health care transactions in their states, and will also designate specific contracting practices viewed as...more

California Expands Use of Telehealth to Involuntary Commitment Evaluations

California recently passed legislation that allows evaluations and assessments for involuntary psychiatric holds to be conducted using telehealth technology. California’s Lanterman-Petris-Short Act authorizes the involuntary...more

FQHCs: Practical Impacts of Governance Requirements

This is the fourth article in our series addressing important topics for federally qualified health centers (FQHCs) and the providers who work with them. The first post in the series offered five tips for contracting with...more

Proposed Changes to Part 2 Rules Ease Substance-Use Disorder Record Sharing

Recently proposed changes to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) would all but eliminate the most significant and intractable barrier to sharing protected...more

Changes to California’s Knox-Keene Act Potentially Impact California Health Care Providers

On July 1, a new regulation from California’s Department of Managed Health Care (DMHC) will go into effect, and will require health care providers that engage in global risk arrangements to apply for a license or exemption...more

Health Care Information Exchanges and Price Transparency Initiatives: CMS Requests Input from Providers

On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule introducing changes to the Medicare physician fee schedule, and soliciting comments from providers on CMS data sharing initiatives....more

DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal...more

Update on California’s End of Life Option Act

In June 2016, California became the fifth state to enact an aid-in-dying law. California’s End of Life Option Act (the “Act”) authorizes an adult who is suffering from a terminal disease and meets other qualifications to...more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

California’s End of Life Option Act: Key Requirements and Considerations

On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect. The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that...more

Is My Telehealth App Subject to HIPAA?

Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and...more

OIG Releases Compliance Guidance for Health Care Governing Boards

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on...more

CMS Intends to Modify EHR "Meaningful Use" Program Requirements

The Centers for Medicare & Medicaid Services (CMS) recently announced its intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (commonly referred to as the...more

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