HIPAA’s Business Associate Traps for Biotech & Life Sciences

Since inception, the Health Insurance Portability and Accountability Act of 1996, et seq. (HIPAA) has required that patient health information (PHI) be kept confidential. HIPAA meets this goal primarily through its Privacy Rule, Security Rule and Breach Notification Rule. “Covered Entities” such as physicians, hospitals and insurers were initially the only entities required to comply with these Rules. The increased use of digital media for storage and transmission of PHI lead to the passage of the Health Information Technology for Economic and Clinical Health Act Continue reading →

The FDA Moves Towards a Streamlined Regulatory Process for Artificial Intelligence

A question that investors frequently ask of emerging growth life sciences companies is whether they have considered how to monetize the data they will inevitably collect in the development, marketing and sale of their service or product. Data merely existing in a compilation can have value; analytics can increase that value by orders of magnitude. Beyond compilation and analytics is the use of data to provide direct treatment or services. Using artificial intelligence (AI) (smart machines that are developed to do work normally done by Continue reading →

Data Security Now Part of Medicare Reimbursement Requirements

The Medicare Access and CHIP Reauthorization Act (MACRA) mandates the performance and maintenance of the information security risk assessment as part of Medicare reimbursement criteria. As reported in a recent article in healthdatamanagment.com, the Merit Based Incentive Payment System (MIPS) under MACRA requires group practices to update the assessment to security risks and document steps taken to mitigate those risks. The MIPS reimbursement scheme has four components.  The security risk assessment requirement falls within the Advancing Care Information (ACI) category.  The ACI category accounts for Continue reading →

What We Can Learn From HIPAA Settlements

A data breach at a business is serious enough, but when it involves a healthcare organization, there are greater ramifications. And when the sensitive nature of patient medical records are jeopardized, it can be costly. The Health and Human Services’ Office for Civil Rights (OCR) enforces HIPAA privacy and security rules, which safeguard patient medical information. A recent article in healthitsecurity.com took a look at settlements over the past two years, to share five lessons on what was overlooked and how confidential information can be Continue reading →

Fewer Than Half Nation’s Physicians Are Now Independent

For the first time, Modern Healthcare reports than less than 50% of the nation’s physicians own their own practices.[1]  According to a study released last week by the American Medical Association, the trend toward an employment model is continuing in healthcare.[2]  However, physicians are not necessarily becoming hospital employees.  While hospital systems were busy acquiring practices between 2012 and 2014, practice acquisition seems to have leveled in 2015.  Rather, the practice structure trend toward larger physician owned practices of 50 or more physicians, with fewer Continue reading →

CMS to Delay New Home Health Agency Rule

CMS is proposing a six-month delay for implementation of the new final home health agency rule.  CMS is seeking to change the effective date of the rule from July 13, 2017 to January 13, 2018. The new rule updates the conditions of participation for federal Medicare and joint federal-state Medicaid programs.  The conditions add operational requirements to enhance integration and coordination of patient care.  The regulation aims to improve the continuity of care through the agencies and the patient’s physicians.  Additional requirements include written instructions Continue reading →

Philadelphia Health Care Lawyers: New Home Care Overtime Rules Start Next Week

The US Department of Labor (DOL)’s Fair Labor Standards Act (FLSA) regulations extending overtime to home care workers will take effect on October 13. While DOL first issued the new regulations in 2013, industry groups challenged the new regulations in federal court.  The regulations were upheld on appeal. The Home Care Association of America and the national Association for Home Care and Hospice then filed an emergency petition to the US Supreme Court to delay the regulations pending a full appeal. The groups argued that Continue reading →

Philadelphia Health Care Lawyers: State and Federal Pull Away from Fee-For-Service

Health policy wonks and the quality movement have long championed the shift away from fee-for-service to payment models that ‘align incentives with outcomes.’  But alternative payment models are based on predictions rather than services rendered, and can have significant ramifications for the sustainability of any practice. Common alternative payment structures include: 1) bundled payments, where one payment covers multiple services for an episode of care (common in obstetrics); 2) capitation, such as a global payment per patient per month regardless of services rendered (think PCMH); Continue reading →

Philadelphia Health Care Lawyers: Latest Supreme Court Ruling on the Affordable Care Act

In June, 2015, the United States Supreme Court decided to uphold the Affordable Care Act (ACA) tax subsidies for both state and federal health exchanges. Six justices were in favor of the decision. The Court’s ruling should ensure the survival of the ACA until after the 2016 presidential election. The Affordable Care Act Survives Another Supreme Court Ruling The case called into question whether customers of the federal marketplaces in 34 states were eligible to receive federally funded subsidies to help pay for their insurance Continue reading →

Philadelphia Healthcare Lawyers: Medical Marijuana in Pennsylvania – Potential Issues for Employers

Marijuana laws are changing rapidly across America; right now there are 24 states permitting the use of marijuana for medical uses when prescribed by a physician (and 18 states with pending legislation to do the same), there are 14 states that have decriminalized marijuana (substituting fines for jail time) (and 17 states with pending legislation to do the same), and there are 4 states that legalize and regulate marijuana like alcohol (and 16 states with pending bills to do the same). Pennsylvania has pending bills Continue reading →