Day Pitney’s Healthcare Law Blog provides regular updates on issues affecting all aspects of the healthcare industry. In this era of ever-increasing regulation, we monitor healthcare news and developments from all federal and state agencies, as well as significant court decisions and public policy initiatives. We cut through the jargon and give our clients and other readers what they need to know in a concise, no-nonsense style to save them time while helping them stay informed.

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NJ “Surprise Bill” Restrictions Finally Become Law

Date: June 18, 2018 | Posted: Eric D. Fader | Topics: Hospitals and Institutions; Legislation and Public Policy; Private Insurers; Reimbursement Matters; State Matters

On June 1, New Jersey Governor Phil Murphy signed into law the “Out-of-network Consumer Protection, Transparency, Cost Containment and Accountability Act,” making New Jersey the latest state to restrict “surprise” medical bills. A previous attempt to do so in the state was discussed here. New York, Connecticut, Florida, California, and a handful of other states have similar laws.

FDA Releases Long-Awaited Off-Label Guidance

Date: June 13, 2018 | Posted: Susan R. Huntington | Topics: FDA; Life Sciences; Medical Devices; Pharmaceuticals

On June 12, the U.S. Food and Drug Administration (FDA) published two new guidance documents that address how companies can share off-label information with insurers and healthcare professionals about drugs and medical devices, as well as information for uses that haven’t yet been approved.

Feds Get Dinged for Subpar Health-Care Cybersecurity

Date: June 08, 2018 | Posted: Day Pitney | Topics: Electronic Health Records; Legislation and Public Policy; Privacy and Data Protection

A June 6 article in Bloomberg Law’s Health Law & Life Sciences News, "Feds Get Dinged for Subpar Health-Care Cybersecurity," discussed a letter that was recently released by members of the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. The letter asked the U.S. Department of Health and Human Services (HHS) to update its cybersecurity plans and provide guidance on how it will coordinate efforts among various agencies. Day Pitney’s Eric Fader was quoted in the article.

Yet Another Delay for 340B Drug Pricing Program Rule

Date: June 05, 2018 | Posted: Eric D. Fader | Topics: Hospitals and Institutions; Legislation and Public Policy; Medicare and Medicaid; Pharmaceuticals

On June 5, the Health Resources and Services Administration, part of the U.S. Department of Health and Human Services, published a final rule that further delays the effective date of the January 5, 2017 final rule on calculation of drug price ceilings and the imposition of civil monetary penalties for manufacturers that knowingly and intentionally overcharge covered entities under the 340B Drug Pricing Program.

NJ Adopts Individual Mandate

Date: June 04, 2018 | Posted: Eric D. Fader | Topics: Affordable Care Act; Employer/Employee Matters; Legislation and Public Policy; Private Insurers; State Matters

On May 30, New Jersey Governor Phil Murphy signed into law the Health Insurance Market Preservation Act, making New Jersey the second state to adopt an individual health insurance mandate. Massachusetts’ mandate has been in effect since 2006.

CMS Plans $25 Billion Quality Initiative

Date: May 31, 2018 | Posted: Eric D. Fader | Topics: Home Healthcare; Hospitals and Institutions; Legislation and Public Policy; Medicare and Medicaid

The Centers for Medicare & Medicaid Services (CMS) recently announced a proposed contract action for a program entitled "Network of Quality Improvement and Innovation Contractors (NQIIC)." CMS’s Request for Proposal indicates that it seeks to consolidate a number of quality improvement networks, end-stage renal disease networks, and hospital improvement innovation networks under one large “indefinite delivery/indefinite quantity” contract with a budget of up to $25 billion.

July 1 Deadline for Meaningful Use Hardship Exception Applications

Date: May 31, 2018 | Posted: Susan R. Huntington | Topics: Electronic Health Records; Hospitals and Institutions; Legislation and Public Policy; Medicare and Medicaid; Reimbursement Matters

Under the American Recovery and Reinvestment Act of 2009, payment adjustments are made to Medicare-eligible hospitals and critical access hospitals (“Eligible Hospitals”) that are not meaningful users of certified electronic health record technology under the EHR Incentive Programs (now called the Promoting Interoperability (PI) Programs). An Eligible Hospital may be exempt from this Medicare penalty if it can show that demonstrating meaningful use would result in a significant hardship. Significant hardship is defined as circumstances beyond the Eligible Hospital’s control which significantly impaired the Eligible Hospital’s ability to meet the meaningful use requirements.

Device, Pharma Recalls Reach Historic Highs in 2018 First Quarter

Date: May 28, 2018 | Posted: Antoinette M. Solomon | Topics: FDA; Life Sciences; Medical Devices; Pharmaceuticals

Medical device and pharmaceutical recalls reached historic highs in the first quarter of 2018, according to a report from Stericyle Expert Solutions.

Google and Fitbit Launch Health Records Initiative

Date: May 22, 2018 | Posted: Eric D. Fader | Topics: Electronic Health Records; Medical Devices

Google and Fitbit recently announced plans to integrate Fitbit’s user data into electronic medical records (EMRs) using Google’s Cloud Healthcare API.

Survey: Many ACOs Will Leave Program if Required to Assume Risk

Date: May 22, 2018 | Posted: Eric D. Fader | Topics: Accountable Care Organizations; Affordable Care Act; Home Healthcare; Hospitals and Institutions; Legislation and Public Policy; Medicare and Medicaid; Private Insurers; Reimbursement Matters

According to a recent survey by the National Association of Accountable Care Organizations (NAACOS), most of the ACOs that joined the Medicare Shared Savings Program (MSSP) in 2012 and 2013 in the non-risk bearing “Track 1” will leave the program if they are required to assume financial risk. Under the program’s current rules, these ACOs will be required to move to a two-sided (risk-bearing) model in their third agreement period that begins in 2019.

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