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Health Care

New California Medical Waste Law Impacts Out-of-State Manufacturers and Distributors with Costly Compliance Mandates

In late 2018, California passed a new law that will, in the near future, present sweeping changes to the pharmaceutical industry and certain medical device manufacturers.  The new law amends the existing California Integrated Waste Management Act and is expected to be a boom for medical waste disposal companies who stand to obtain significantly more business.  While the law was signed by the California Governor nearly two years ago, the regulations will go into effect in a few months (by January 1, 2021).  The original bill, dubbed the “California Sharps and Drug Takeback Bill”, requires a manufacturer of covered drugs or home-generated sharps waste, to offer safe disposal methods for their customers’ used and unused products.  The law has potentially sweeping affect because it encompasses all covered drugs and home generated sharps waste that are sold or offered for sale in California.

$1,040,000 HIPAA Settlement for Stolen Unencrypted Laptop Breach — Why?

The United States Department of Health and Human Services reached an agreement with Lifespan Health System Affiliated Covered Entity (Lifespan ACE) in which Lifespan agreed to pay $1,040,000 and adopt a corrective action plan in the wake of its data breach that exposed over 20,431 patients’ protected health information. The breach occurred when an employee’s unencrypted laptop was stolen which contained electronic protected health information (ePHI) including: patients’ names, medical record numbers, demographic information, and medication information.

OSHA Fines Healthcare Facilities for Improper Use of N95 Respirators

Employers beware, particularly those in healthcare sectors.  If you provide a NIOSH-approved N95 “respirator” to protect employees from COVID-19, there are a number of OSHA respiratory protection standards that must be followed in a comprehensive Respiratory Protection Program.  The Department of Labor OSHA’s July 21, 2020, national press release makes clear that OSHA will seek the maximum possible penalties for serious violations against companies that do not fully satisfy the respiratory protection standards.

Re-Opening Medical Practices Following COVID-19 Outbreak

Over the last couple of weeks, a great deal has been written about the steps hospitals should take as they begin to provide elective procedures again as the COVID-19 outbreak slowly subsides in some parts of the US.  Lurking in the shadow of this issue is the question of what steps medical practices and outpatient clinics (“Medical Practices”) should take as they begin the process of returning to normal operations.

Retroactive Change in Distribution Methodology for Provider Relief Funds May Trigger Refunds

As I am sure you know, the U.S. Department of Health and Human Services (HHS) began distributing approximately $50 billion in Provider Relief Funds provided under the CARES Act between April 10 and April 17.  The initial distribution of Provider Relief Funds (consisting of approximately $30 billion) was distributed among healthcare providers based on their “proportionate share of Medicare fee-for-service reimbursement for 2019”.  For example, a provider with $15 million of Medicare FFS revenue in 2019 and $22 million in net patient revenue for 2018 would have received approximately $930,000 of Provider Relief Funds in the initial distribution:  ($15,000,000/$484,000,000,000 (Total Medicare FFS Revenue for 2019) x $30,000,000,000).

Summary of CISA Guidance on Essential Critical Infrastructure Workforce 3.0

On April 17, 2020, the Cybersecurity and Infrastructure Security Agency (CISA) released version 3.0 of its guidance to help state and local jurisdictions, decision makers in communities and jurisdictions and the private sector across the country to manage and identify their essential workforce while responding to COVID-19. Original guidance was released on March 19, 2020 and version 2.0 was subsequently released on March 28, 2020. The reason for publishing Version 3.0 of the CISA guidance was to assist local decision makers in balancing public health and safety with the need to maintain critical infrastructure in their communities.

Is Your Hospital Ready to Re-Open for Elective Medical Services?

On April 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) provided its initial guidance to hospitals and other healthcare facilities (collectively, “Hospitals”) as they begin to consider the timing for re-commencing normal operations as the COVID-19 outbreak begins to subside in some parts of the United States (the “Re-Opening Recommendations”).[1]  In a sense, the Re-Opening Recommendations are the bookend to the guidance CMS provided on March 18, 2020 recommending that Hospitals discontinue the provision of non-emergent and elective medical services and treatments during the COVID-19 outbreak.[2]  In each case, the guidance provided by CMS is neither legally mandated nor enforceable.  Instead, the guidance merely provides a framework or frame of reference for use by Hospitals as they consider these decisions.

Public Health and Social Services Emergency Fund Payments

Many healthcare providers received an unanticipated cash infusion on or around April 10, 2020 (“Emergency Fund Payment”).  Accompanying the payments was a list of terms and conditions attached to the funds.  The U.S. Department of Health and Human Services (HHS) has stated that forms and additional information will be forthcoming; but in the meantime, the only available guidance is a letter to providers and the list of terms and conditions.

State Disaster Management Plans Impact Hospital Response to COVID-19 Outbreak

One of the most heavily-debated legal and ethical issues to arise during the current COVID-19 outbreak is what methodology a hospital should use to allocate ventilators when the number of patients who need a ventilator exceeds the hospital’s supply of ventilators.  Even more heavily discussed is whether a hospital should disconnect a patient from a ventilator against the wishes of the patient and his/her family in order to use that ventilator for another patient with a statistically greater chance of survival.

The CARES Act and Substance Use Disorder Records: Confidentiality Updates

Section 3221 of the CARES Act, signed into law on March 27, 2020, sets the stage for HHS to make significant changes to 42 C.F.R. Part 2, governing the confidentiality of Substance Use Disorder (“SUD”) records. Under the Act, HHS has 12 months to work with appropriate Federal agencies to make revisions to 42 C.F.R. Part 2 consistent with Section 3221’s mandates.

Prohibition on Beneficiary Inducements Hinders Rural Hospital Efforts to Aid Communities During COVID-19 Outbreak

During times of national or local crisis, people often look to the pillars of their communities, local employers, charities and other publicly-supported institutions, to provide much needed resources and stability.  In many rural communities, the local hospital fits into all three categories being one of the largest (if not they largest) local employer, charity and publicly-supported institution in the community (other than the local government).  As a result, people often look to hospitals during times of crisis, not just for healthcare services but also for the other resources needed in their lives (e.g., food, housing, financial assistance, etc.).

Structuring Physician Relationships After Forest Park

If a relationship with physicians or other referral sources has been structured to carve out Medicare and Medicaid patients to avoid triggering Anti-Kickback Statute requirements, it is time to review the compliance of the relationship.

Loosened Maximum Distance Requirements for APRNs in Missouri

Effective Thursday, April 26, the Missouri Board of Registration for the Healing Arts (MBHA) and the Missouri Board of Nursing (MBN) loosened the regulatory requirements which dictate the maximum distance between the location at which an Advance Practice Registered Nurse (APRN) practices and the location at which his/her collaborating physician practices.

A Tidal Wave of Meaningful Use Audits Hits the Midwest – 5 Steps to Take Now

The Centers for Medicare and Medicaid Services (“CMS”) provided over $20 billion in Meaningful Use incentive payments to hospitals and eligible professionals who attested to compliance with the EHR Incentive Program (the “Program”).

Providers Need to Take the “Necessary Steps” for HIPAA Compliance

On February 3, 2016, the U.S. Department of Health and Human Services issued a statement and released the opinion of the Administrative Law Judge who found in favor of the Office of Civil Rights (“OCR”) determining that a home health agency, Lincare, Inc. (“Lincare”) violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule requiring Lincare, to pay $239,800 in civil money penalties. All covered entities should review the opinion and the OCR’s comments and begin taking any and all “necessary steps” to ensure HIPAA compliance and to make certain protected health information is adequately protected.

Three Key Take-Aways from CMS’ Final Rule on Reporting and Returning Overpayments

In the Centers for Medicare & Medicaid Services’ (“CMS”) Reporting and Return of Overpayments Final Rule, published February 11, 2016 (“Final Rule”), CMS has clarified some outstanding questions faced by healthcare providers and suppliers who may have received overpayments from the Medicare program.

Agencies Plug Several Holes in the ACA Dike

In the years since the 2010 enactment of the Affordable Care Act (“ACA”), the agencies charged with enforcing the ACA have worried that certain responses to the law’s requirements could negatively affect the overall health insurance system. For instance, because the ACA requires insurers to issue individual health insurance coverage without regard to health status, sponsors of self-funded employer plans may be tempted to shift their high-risk employees into the individual market. But by leaving only healthier employees in the self-funded plans, this approach could result in “adverse selection” – leading to an erosion of the individual insurance market.

Four weeks and counting for “grandfathered” HIPAA business associate agreements

The HIPAA Omnibus/Final Rule, published on January 25, 2013, changed the specifications for business associate agreements (BAAs). In general, covered entities were required to comply with the changes to the rule; however, rather than requiring covered entities to immediately enter into new BAAs with all business associates, the Final Rule grandfathered valid HIPAA business associate agreements entered into by the covered entity prior to that date through September 22, 2014. But now this grace period is quickly coming to an end. With the ultimate compliance deadline looming, covered entities that took advantage of this grace period will be required to ensure their grandfathered BAAs, and for that matter all their BAAs, are fully compliant with the Final Rule requirements.

FTC PROSCRIPTION FOR ANTITRUST ENFORCEMENT IN HEALTH CARE

On June 19, 2014, Deborah Feinstein, the current Director of the Federal Trade Commission’s Bureau of Competition, addressed the Fifth National Accountable Care Organization Summit in Washington, D.C. Her speech, entitled “Antitrust Enforcement in Health Care: Proscription, Not Prescription, advised that “there is no tension between rigorous antitrust enforcement and bona fide efforts to coordinate care, so long as those efforts do not result in the accumulation of market power.”

FTC Proscription for Antitrust Enforcement in Health Care

On June 19, 2014, Deborah Feinstein, Director of the Federal Trade Commission’s Bureau of Competition, addressed the Fifth National Accountable Care Organization Summit in Washington, D.C.  Her full comments, entitled “Antitrust Enforcement in Health Care: Proscription, not Prescription,” are available on the FTC’s website: www.ftc.gov.