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Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco
Patterson Belknap Webb & Tyler LLP, December 2019

In two decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP) and provided certainty to biopharma patent owners.  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc...

Directors to Get Better Protection From Fraud
Shoosmiths LLP, January 2019

The UK government has announced changes to legislation to reduce the risk of fraud, violence or intimidation faced by company directors as a result of having their residential addresses on the public record. For a number of years, directors have been able to keep their residential address details private by making use of a separate service address, often the company's registered office...

Recent Changes to EPA Coal Ash Regulations - Regulatory and Insurance Coverage Implications
Haynes and Boone, LLP, January 2019

A new rule promulgated by the U.S. Environmental Protection Agency (“EPA”) governing the disposal of coal combustion residuals, also known as CCR or coal ash, raises the risk for civil claims and the need for insurance to cover them.1 The rule, which takes effect Aug. 29, 2018, revises regulations issued in 2015 and has the stated intent of providing utilities and states “more flexibility in how CCR is managed...

The Advocate: Risks to the Energy Sector Posted by Climate Change Litigation
Haynes and Boone, LLP, January 2019

Fossil fuels are under attack in the legislative, regulatory, and judicial arenas, and in the market place—driven by environmental concerns, especially global warming and associated climate change. The Sierra Club, for example, has launched a “Beyond Dirty Fuels Initiative,” seeking to “push back against the construction of dirty fossil fuel infrastructure that would lock America into decades more of climate-polluting oil and gas production...

Pathways to Success ACO Model
Dykema, January 2019

The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality...

Securing Indemnification and Additional Insurance Coverage Requires Careful Drafting
Lowenstein Sandler LLP, January 2019

Insurance plays a prominent role in all real estate transactions. Stakeholders generally understand that insurance policies must be secured for the leasehold to address property damage and liability claims. However, stakeholders often do not pay attention to the precise contract language used to establish the insurance requirements and address how the waterfall of available insurance coverage will flow...

Medicare Coverage for Ambulance Services – Physician Certification Will Not Be Enough
Dykema, January 2019

A physician certification for Medicare coverage for ambulance services is not the final word. An ambulance service also must demonstrate the beneficiary’s condition and establish medical necessity when transporting the Medicare beneficiary...

Bona Fide Prescriber-Patient Relationship Requirement for Controlled Substance Prescribing Effective January 4, 2019
Dykema, January 2019

Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”)...

U.S. Department of Labor Issues Proposed Rule on Association Health Plans
Morris, Manning & Martin, LLP, January 2019

On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1]  The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule...

If You Have Suggestions for Improving the HIPAA Privacy or Security Rule, Now Is the Time to Speak Up
Dykema, January 2019

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310...

Best Practices For Sellers in The Evolving DSO Marketplace
Dykema, January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices...

It's Still Gray: The 2018 Farm Bill and the Legality of CBD Under Federal Law
Haynes and Boone, LLP, January 2019

President Trump recently signed the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) and the cannabis industry quickly and widely celebrated passage as clearing the way to sell products containing cannabidiol (better known as CBD). But is it really? As one might expect, this lawyer’s answer is that “it depends.” CBD has become known for its purported health benefits in relation to a wide range of conditions...

The Healthcare Industry: A Look Back. A Look Ahead.
Waller, January 2019

While buzzwords like consolidation and price transparency continue to dominate headlines, major players throughout the healthcare ecosystem are working tirelessly behind the scenes to deploy creative and complex service methods that leverage a smarter, more holistic approach to care. The goal? Control escalating costs and deliver tangible value to patients – all while maintaining a healthy balance sheet...

Year in Review: Top Insurance Cases of 2018
Hunton Andrews Kurth LLP, January 2019

2018 was a busy year for courts deciding insurance coverage disputes. Many of those decisions will shape the coverage landscape for years to come. Policyholders enjoyed their fair share of the wins, including substantial victories in areas involving social engineering to disgorgement of corporate gain. We take this opportunity to reflect on some of the year’s most notable coverage decisions...

Michigan Changes Medical Marihuana Licensing Process to Facilitate Investment, Provide Path for Publicly Traded Companies
Dykema, December 2018

As one of the final acts of its 99th Legislative Session, the Michigan Legislature passed amendments to the Medical Marihuana Facilities Licensing Act (MMFLA), as well as changes to the Marihuana Tracking Act. These amendments were signed by outgoing Governor Rick Snyder on December 28, 2018, with the MMFLA amendments effective January 1. The Tracking Act amendments took effect immediately...

Unlicensed Michigan Medical Marihuana Facilities Must Close December 31
Dykema, December 2018

CLOSE OR BE DENIED! In a major year-end development, the Michigan Court of Claims today dismissed the last of the cases that allowed unlicensed Michigan medical marihuana facilities to operate...

CMS Continues to Enhance Oversight of Accrediting Organizations
Dykema, December 2018

The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331...

Michigan Passes New Industrial Hemp Law, Sets Up Statutory Conflict
Dykema, December 2018

On the last day of the legislative session, the Michigan Legislature passed House Bills 6330, 6331, and 6380 to create the Industrial Hemp Research and Development Act (IHRDA). If signed by the Governor, IHRDA will require the registration of industrial hemp growers and processors as a prerequisite to grow or sell industrial hemp. Oversight authority is given to the Michigan Department of Agriculture and Rural Development (MDARD)...

New Owner Through Foreclosure Must Perfect Title to Property Before Serving a Three-Day Notice to Quit to Tenant
Dykema, December 2018

In December of 2018, the California Supreme Court issued its ruling in Dr Leevil, LLC vs Westlake Health Care Ctr, No S241324, 2018 LEXIS 9546 that an owner acquiring title to real property under a power of sale contained in a deed of trust must perfect titlebeforeserving the three-day written notice to quit required by California Code of Civil Procedure section 1161a(b). Westlake Village Property, L.P., owned real property in Thousand Oaks...

A New Year’s Resolution for Illinois Employers: Update Policies and Procedures to Comply with New Law Requiring Broad Expense Reimbursement Duties
Dykema, December 2018

Beginning on January 1, 2019, Illinois employers will—for the first time—have to reimburse employees for “all necessary expenditures or losses incurred by the employee within the employee’s scope of employment and directly related to services performed for the employer...

Community Banks Disappointed with Federal Regulators’ Proposed Community Bank Leverage Ratio
Dykema, December 2018

One of the key provisions of the Dodd-Frank Act rollback law signed by President Trump on May 24, 2018, hasn’t met its early promise for U.S. community banks. Recently proposed rules to implement simplified capital requirements have fallen short of the industry’s expectations when the bank deregulation law was enacted in May...

Tax Planning for the End of 2018 and Beginning of 2019
Dykema, December 2018

Before 2018 comes to a close, it may be worthwhile to review the state of your tax, estate, and charitable giving plans. Along with the typical end-of-year considerations, this year it is crucial also to pay careful attention to the effects of the 2017 tax act (P.L. 115-97, signed into law on December 22, 2017, and informally called the “Tax Cuts and Jobs Act of 2017,” herein the “2017 Tax Act”) that altered many longstanding rules and assumptions...

Bringing Back Discretion: DOJ Announces Revisions to Current Policy Concerning Corporate Misconduct
Dykema, December 2018

In 2015, the Department of Justice (“DOJ”) announced a more aggressive stance requiring individual accountability in civil and criminal investigations of corporate misconduct...

Covered by the Clean Water Act and WOTUS? Maybe Not Anymore.
Schwabe, Williamson & Wyatt, December 2018

In December of 2018, the U.S. Environmental Protection Agency (EPA) and Army Corps of Engineers (Corps) released their much-anticipated draft proposed rule to re-write the definition of “waters of the United States” (WOTUS) (“2018 Rule”). The definition of WOTUS establishes the scope of agency jurisdiction over waters and wetlands under the Clean Water Act (CWA)...

Crumpets, Congress, Cannabis and Crypto: Top 10 Issues for Financial Services in 2019 – Part 2
Dykema, December 2018

Continuing froma previoiuspost, here is the second half of our “Top 10 List” of key issues U.S. financial institutions, non-banks providing financial services, and financial technology (fintech) entities should plan for and watch throughout 2019...

PBJ: The Sandwich that Bites Back
Dykema, December 2018

Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now...

Industrial Hemp - Now Legal and Unregulated in Michigan
Dykema, December 2018

On November 6, 2018, Michigan voters approved Proposal 1 and made Michigan the twelfth U.S. jurisdiction to legalize recreational marijuana. The Michigan Regulation and Taxation of Marihuana Act (MRTMA) went into effect December 6. What has been lost in all the smoke from the past several weeks is how MRTMA impacts the regulation of industrial hemp...

Michigan Legislature Amends State Minimum Wage and Paid Sick Leave Acts
Dykema, December 2018

On December 4, 2018, the Michigan Legislature pared back the minimum wage and paid sick leave laws it passed last September in an effort to preclude those issues from being on the November ballot. Had the Legislature not adopted the language of the ballot initiatives legislation, the measures would have been on the November ballot and it would have needed a vote of three-fourths of each house to amend the law if adopted by the voters...

FDA Releases Medical Device De Novo Pathway Proposed Rule
Dinsmore & Shohl LLP, December 2018

On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway.  In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway...

PBM Contracting Transparency: Pennsylvania Auditor General Releases PBM Report
Dinsmore & Shohl LLP, December 2018

On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system...

Crumpets, Congress, Cannabis and Crypto: Top 10 Issues for Financial Services in 2019 (Part 1 of 2)
Dykema, December 2018

As an eventful 2018 comes to a close, we look ahead to 2019 and our “Top 10 List” of key issues U.S. financial institutions, non-banks providing financial services, and financial technology (fintech) entities should plan for and watch throughout the upcoming year. The first five items on the list are discussed below, and the remainder of our list will follow shortly in another post...

Illinois’ BIPA’s Rollercoaster Ride to the Illinois Supreme Court
Dykema, December 2018

Over the last several years, the emphasis on privacy and data protection has grown significantly. With the amount of data collected by companies and technology skyrocketing, the need to protect personal information has been at the forefront of states’ legislative agendas. While all 50 states now have breach notification statutes, states are now taking a closer look at issues such as tracking online behavior and the use of biometric data...

Where Does the Money Go?
Dykema, December 2018

Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars...

Are You at Risk of Having Electronic Data Seized When Traveling Abroad?
Dykema, December 2018

Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time...

OIG Puts SNF Involuntary Discharges and Transfers Under the Microscope
Dykema, December 2018

Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures...

Executive Session Privilege: There is No Such Thing
Dinsmore & Shohl LLP, December 2018

Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee...

Supreme Court Ruling on Critical Habitat in Dusky Gopher Frog Case
Schwabe, Williamson & Wyatt, December 2018

The Supreme Court has handed down one of the most anticipated Endangered Species Act (ESA) rulings in recent years. In Weyerhaeuser Co. v. U.S. Fish and Wildlife Serv., the Supreme Court unanimously overruled the Fifth Circuit Court of Appeals, holding that the Fish and Wildlife Service can only designate property that is “habitat” as critical habitat under the ESA...

New California Employment Laws to Take Effect in January 2019 and Beyond
Dykema, December 2018

As in previous years, the California legislature kept busy in 2018. As a result, a number of new and noteworthy employment laws will go into effect on January 1, 2019, and beyond. Much of the legislation stems from the #MeToo movement by strengthening harassment and discrimination protection, imposing broader anti-harassment training obligations, updating lactation accommodations and mandating female presence on boards of public companies...

SEC Takes Aim at Cybersecurity Disclosures
Dykema, December 2018

In February of this year, the Securities Exchange Commission issued its updated Statement and Guidance on Public Company Cybersecurity Disclosures. In April, the SEC issued an Order that, among other things, levied a $35 million fine against Yahoo! Inc. for failing to properly report a 2014 data breach. These actions support the view that the SEC is consciously committing attention and resources to cybersecurity issues affecting public companies...

Starwood Data Breach Serves as Wakeup Call to Tennessee Bars, Hotels and Restaurants
Waller, November 2018

We suspect that thousands of Tennessee restaurants, hotels, bars and other hospitality businesses gather personal information from their customers for marketing purposes.   It’s just a birthdate, address, anniversary, spouse’s name – good stuff to know, right? That’s all fine and dandy until some hacker steals the information...

How to Prepare for the 2019 Nursing Home Compliance Program Mandate
Dinsmore & Shohl LLP, November 2018

The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid...

Department of Education Proposes New Title IX Regulations
Dinsmore & Shohl LLP, November 2018

Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017.  This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming...

What's Past is Prologue: Applying Lessons from the Financial Crisis to the Future of eMortgage and eNote Litigation
Dykema, November 2018

In the fallout from the 2008 financial crisis, courts across the United States were inundated with litigation challenging the legitimacy of mortgages, notes, and the records purporting the transfer or assign them...

CMS Announces Section 1115 Waiver Allowing Medicaid Payments for Inpatient Mental Health Treatment
Dinsmore & Shohl LLP, November 2018

In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED)...

BIS Requests Public Comment on Emerging Technologies to be Subject to Increased Export Controls
Dinsmore & Shohl LLP, November 2018

On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls...

What do Hurricanes, Tornadoes, Blizzards, Floods, Wildfires and Earthquakes all have in Common?
Dykema, November 2018

Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S...

FDA Proposes Changes to Clinical Trial Informed Consent Rules
Dinsmore & Shohl LLP, November 2018

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects...

OIG Ramping Up Enforcement Actions Against Dental Practices
Dinsmore & Shohl LLP, November 2018

In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program...

DOL Cancels 80/20 Rule for Tipped Employees
Dinsmore & Shohl LLP, November 2018

In the last quarter of 2018, the Department of Labor (DOL) issued an opinion letter ending what had become known as the “80/20 rule” for tipped employees. The new rule, which eases restrictions on an employer’s application of the tip credit, is a reissuance of a 2009 opinion letter that had been supplanted by contrary guidance since 2011...

Proposed Rule Would Require Ohio Providers to Accept Standard Authorization Form for Use and Disclosure of Protected Health Information
Dinsmore & Shohl LLP, November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information...

 

 

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