Category Archives: Compliance

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Website Accessibility: An Issue for Health Care Companies

Website accessibility under the Americans with Disabilities Act of 1990 (ADA) and Rehabilitation Act of 1973 (Rehabilitation Act) is an issue of which health care providers and other health care companies should be aware. There have been lawsuits filed that include claims for website accessibility under these Acts. A number of entities, including health care … Continue reading this entry

Revoking Controlled Substances Registrations: the DEA’s Weapon to Fight Abusive Prescribing and Dispensing

pharmacy
In response to the opioid crisis, the Drug Enforcement Administration (DEA) is cracking down on pharmacies, pharmacists, and prescribers by leveraging an old enforcement weapon: revocation of controlled substance registrations. The DEA actively revived this enforcement mechanism in February and March of 2018 when it arrested 29 people and revoked 147 controlled substance registrations throughout … Continue reading this entry

Biometric Privacy: Illinois Supreme Court Decision Allows Claims to Proceed Without Showing of Actual Harm

On January 25, 2019, the Illinois Supreme Court handed down a key ruling that will make it significantly easier for consumers and workers to sue and recover damages for mere non-compliance with the requirements of the state’s Biometric Information Privacy Act, 740 ILCS 14/1 et seq. (BIPA or Act). In its highly anticipated decision in … Continue reading this entry

A Proposed Agreement for Blockchain-Enabled Medical Staff Credentialing Process

healthcare partnerships
The medical credentialing process, whether for a hospital, a hospital system or a health plan, has emerged as a potential early target for the application of blockchain technology and administration.1 It is a process that allows a secure database to be established over time and on a cumulative basis. Medical credentialing involves verifying whether a … Continue reading this entry

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

drug testing
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research conducted or supported by participating federal departments and agencies.[1]  Compliance with the revised Common Rule is expected on January … Continue reading this entry

Health Care Policy Happenings - October 1 - 5, 2018

Public Affairs
In case you missed it, here are some key health care policy headlines from the past week. Congress Legislation and Committee Activity Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell  to President – On Wednesday, the U.S.  Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by … Continue reading this entry

Refusing to Hire Medical Marijuana User Puts Employer in Jeopardy

Nursing Home
The following is a wake-up call to all employers, especially those in the health care industry, that have adopted “zero tolerance policies.” These policies will increasingly butt up against the tidal wave of laws legalizing the medical and recreational use of marijuana.  In a just-decided case, a federal judge in Connecticut issued a ruling in … Continue reading this entry

Public Policy August Recess Health Care Newsletter  

Public Affairs
Foley’s  Bipartisan Public Policy Team is pleased to share our Public Policy August Recess Health Care Newsletter  in which we compiled the top health care policy news and legislation from this month. The House was not in session and the Senate came back mid-month to focus on passing appropriation bills and presidential nominations.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Health Care Policy Newsletter

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

Florida’s New Law Changes Physician Responsibilities for Opioid Dispensing

controlled substances
Florida’s House Bill (HB) 21, enacted to help combat opioid abuse, contains several noteworthy changes to Florida law that impact the dispensing of opioids. Effective July 1, 2018, dispensing providers must consult Florida’s Prescription Drug Monitoring Program (PDMP) prior to dispensing controlled substances to patients, and must report any controlled substances dispensed in the PDMP … Continue reading this entry

Health Care Policy Newsletter

Policy
Foley’s Bipartisan Public Policy Team  is pleased to share our “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.… Continue reading this entry

The Resurgence of the Ambulatory Surgery Center: Seven Considerations for Ownership

ambulatory
After a prolonged period of stagnant growth primarily due to a glut of capacity coupled with flat or declining revenue growth, we’re beginning to see a resurgence of Ambulatory Surgery Centers (ASCs).  In fact, experts are forecasting a significant growth spurt in the ASC industry including de novo growth.  This growth is likely precipitated by … Continue reading this entry

Medicare Enrollment for Providers No Longer Required Under Medicare Parts C and D

controlled substances
On April 2, 2018, CMS released the Contract Year 2019 Final Rules for Medicare Advantage (MA) and Part D (the MA Final Rule), incorporating changes that support CMS’ stated commitment to supporting flexibility and efficiency throughout the MA and Part D Programs.… Continue reading this entry

Lessons Learned from 2017 OCR HIPAA Enforcement Actions

So far 2017 is proving to be an active year for Health Insurance Portability and Accountability Act (HIPAA) enforcement. This comes on the heels of 2016, which saw an unprecedented level of enforcement actions, with 13 total settlements and nearly a 300 percent increase in total collected fines over 2015. To date in 2017, nine … Continue reading this entry

New Attorney General Issues Guidance on Corporate Compliance Programs

The US Department of Justice (DOJ) Fraud Section has published new guidance for corporate entities on corporate compliance programs.  The guidance, titled, “Evaluation of Corporate Compliance Programs” (Compliance Program Evaluation)  provides companies – and their compliance teams – with key insights into how government regulators will assess efforts taken to develop, implement and evaluate the … Continue reading this entry

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 covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased … Continue reading this entry

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the state of Hawai’i, beginning with January 1, 2017. The waiver was authorized pursuant to Section 1332 of the ACA, which allows … Continue reading this entry

21st Century Cures Act Provides Some Welcome Relief

The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the long-anticipated relief for Medicare “site-neutrality” policies relating to off-campus outpatient hospital departments (“OCODPs”), certain cancer hospitals, and long-term care … Continue reading this entry

OPPS Final Rule Finalizes Limits for Off Campus Departments

Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule will cause new (non-grandfathered) hospital off-campus outpatient departments to no longer be reimbursed under the Medicare Outpatient Prospective Payment System (OPPS). … Continue reading this entry

The Top 10 Things you Need to Know About Voluntary Disclosures and Government Refunds

Regulatory-Developments
In February 2016, CMS issued the highly anticipated Final Rule on reporting and returning Medicare Part A and B overpayments. The Final Rule was meant to clear up some of the confusion among providers regarding such overpayments. Summarized below is our Top 10 list of the things you need to know:… Continue reading this entry

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were finalized in October 2015, clarified in December 2016, and effective as of January 14, 2016, apply to all health IT products and services certified to the 2014 Edition … Continue reading this entry

CMS Expands Mandatory Bundled Payments to Cardiac Care

On Monday July 25, 2016, CMS proposed new models that expand mandatory participation in bundled payments and continue CMS’s initiative to shift Medicare payments from fee for service to alternative payment models.  Coming just as the Comprehensive Care for Joint Replacement (CJR) initiative gets underway, the new models are, according to CMS, intended to reward … Continue reading this entry