• ubiquitous (present, appearing, or found everywhere, omnipresent, ever-present, everywhere, universal, pervasive, worldwide, global),
• convenient,
• on-demand network access

to a shared pool of configurable computing resources (for example, networks, servers, storage, applications and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.

Click here to read the full article.

Drafting, negotiating and interpreting indemnity provisions is not to be taken lightly. In general, it is extremely difficult to negotiate an indemnity clause for any agreement. Admittedly, it is even more challenging when negotiating an indemnification provision for information technology (“IT” or “technology”) or technology-enabled agreements.  

Click here for more information

Disclaimer: The information in this blog post (“Post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Faulk & Associates, LLC or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this Post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.

Click here for more information

Some considerations for a Pharma Company when presented with a request to enter a BAA or sub-BAA with a technology vendor:

• Is the Pharma Company directly implicated under HIPAA?  If so, how?
• How might a Pharma Company become subject to HIPAA?
• Has the Pharma Company with an HCP (or other CE) conceded such authority? If yes, then it must enter a BAA and/or sub-BAAs.

Disclaimer: The information in this blog post (“Post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Faulk & Associates, LLC or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this Post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.

References:

• CMS Information Security and Privacy Overview
• CMS Manual System

Click here for more information

Disclaimer: The information in this blog post (“Post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Faulk & Associates, LLC or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this Post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.

One example of a conflict of interest might be where a physician’s decision-making process is biased toward a particular drug and he/she engages in or encourages inappropriate prescribing, thus potentially causing harm to the very same patient the physician has a duty to provide safe and ethical medical care.  In addition to the risk of harm to patients from inappropriate prescribing, the practice also drives up health care costs and undermines the independence and rigor of clinical research. Therefore, in an effort to promote transparency through disclosure of the types of financial relationships many physicians have with drug and device manufacturers, the Physician Payments Sunshine Act (the “Sunshine Act” or the “Act”) was birthed.

The Sunshine Act was initially introduced in Congress in 2007 as a bipartisan bill.  The Act was enacted in 2010 as part of the Patient Protection and Affordable Care Act. Section 6002 of the Patient Protection and Affordable Care Act (Public Law No. 116-148), as amended by the Health Care and Reconciliation Act of 2010 (Public Law No. 111-152), provides for a federally-run program that collects information about financial relationships physicians have with drug and device manufacturers.  The purpose of the Act is to make public all payments or other transfers of value made directly or through a third party to physicians and teaching hospitals from manufacturers of drugs, medical devices, and biological, and medical supplies covered (collectively referred to herein as “Covered Products”) by Medicare, Medicaid and the State Children’s Health Insurance Program. The database is searchable using identifying information of the physician, teaching hospital or manufacturer. 

Aggregate Spend Compliance 

The Sunshine Act requires manufacturers to report identifying information about licensed physicians practicing in the United States to whom payments are made to, including their name, business address, specialty; the amount and date of the payment; and the form and the nature of the payment.  Additionally, where applicable, the name of the manufacturer’s product(s) related to the payment or transfer will also be reported.  The nature of the payments are identified as one of 14 categories, including, among others cash, speaker’s honoraria, consulting fees, travel expenses, meals (unless provided at a conference, readily available to everyone and not directed at one individual physician), entertainment, gifts, participation on a paid advisory board, royalties, licenses and charitable contributions or writing manuscripts.  Reporting exceptions include gifts under $10 or an aggregate of less than $100 in a year, product samples intended for use by patients, educational materials for use by or with patients, such as anatomical models (e.g., human skeletal set) and payment to speakers and faculty at certain accredited Continuing Medical Education (“CME”) events.

Final Provisions     

The final provisions for implementation of the Sunshine Act were approved in 2013. Data collection for reporting began August 1, 2013, and included the last five months (July to December) of 2013.  The first round of data was made available in September 2014 on the Centers for Medicare and Medicaid Services (“CMS”) Open Payment Program website.  Thereafter, June is when data will be published and will include a full 12 months (January 1, 2014 to December 31, 2014).  The current review period began on April 6, 2015, and the second round of data will be published in June 2015.  The Act also requires that manufacturers collect the requested data on an annual basis and then report it to CMS by the 90th day of each subsequent year.  Once CMS has the data, physicians have 45 days to review and file disputes with the manufacturer.  If the dispute is not resolved within 45 days, CMS will publish the data noting the dispute.

In 2014, four changes were made to the Sunshine Act, effective in 2016. These changes include deletion of the exemption regarding payment to speakers at accredited CME events; deletion of the definition of “covered device;” required reporting of the marketed name and therapeutic area or product category of the related covered drugs, devices or medical supplies and required reporting of stocks, stock options, or any other ownership interest as distinct categories.    

Transparency/Disclosure

Payment posting requirements is not a new concept. For example, certain Corporate Integrity Agreements (“CIAs”) require companies to track and post on company websites information about payments made by the companies to healthcare professionals (“HCPs”).  The representations of companies with these CIA requirements generally agree that payment posting requirements are expensive and time consuming to implement.  While laws have been passed in at least five states and District of Columbia with similar reporting requirements and various professional bodies, academic institutions and medical journals have implemented conflict-of-interest policies aimed at mitigating industry influence on medical education and research, the data is scattered among various agencies, resulting in a lack of access and unification of information.

Though most agree that there is great value in transparency, it is still too early to determine the true value of the data that will be collected under the Sunshine Act. However, the Act offers a centralized repository for housing the information where anyone can have access to it and evaluate the data to draw their own conclusions. Yet, it remains to be seen whether the transparency the Sunshine Act seeks to provide actually creates an opportunity to reveal to the world if payments, including those omitted from conflict-of-interest forms affect the medical decision-making of physicians who have financial arrangements with drug and medical device manufacturers.  The general consensus, however, is that having an opportunity to further scrutinize the nexus between such payments and physician behavior, is desirable. In the end, how we use the data will be determined by what it reveals. 

Compliance departments will play a pivotal role in implementing the operational aspects of the Sunshine Act, identifying inappropriate relationships and recommending appropriate corrective action, when necessary.  However, a rush to judgment should be avoided. Rather, a thorough evaluation based on fact-based outcomes and not possibilities should be the driving force when reviewing the data and drawing conclusions.

Implementation of the Sunshine Act

Practically speaking, the key to success in capturing, reporting and monitoring payments made by drug and device manufacturers to physicians is organizing the resources required to do the work. In this regard, companies should determine an operational model that is most suitable for their company.  A model approach should include global resources (i.e. budget, technology/IT systems and infrastructure, processes, master data management, analytics and ownership), country-specific milestones and timelines, and undoubtedly an ongoing monitoring component.  Many companies have housed their physician payments transparency goals within their compliance departments, which makes sense as long as the necessary resources will be added to compliance department budgets to do the work necessary to manage the process, achieve the reporting goals and act accordingly on the information the reports yield. 

Sources:

78 Fed. Reg., 9458 (February 13, 2013) (codified at 42 C.F.R. pts. 402 and 403)

Federal Sunshine Act/ Open Payments Program

The Physician Payments Sunshine Act

Open Payments

Physician Payments Sunshine Act - Open Payments Program

What Do You Know About The Sunshine Act?

What the Physician Payment Sunshine Act & Open Payments Database Mean in Practice

In 1980, Congress passed legislation that made Medicare the secondary payer for certain primary plans and required private health insurance coverage to pay medical expenses. Pursuant to 42 U.S.C. 1395y(b)(2(B)(ii)/Section 1862(b)(2)(B)(ii) of the Act) and 42 C.F.R. 411.24(e) & (g), CMS may recover from a primary plan or any entity, including a beneficiary, provider, supplier, physician, attorney, State agency or private insurer that has received a primary payment. Under CMS’ Medicare Secondary Payer (CMS), Medicare is subrogated to any right of an individual or entity to recover payments from an insurer for medical bills. 42 USC § 1395y(b)(2)(B)(iv). Federal law allows Medicare to place a lien on property to collect the money that is owed directly from another payer.  The MSP recovery claim (under its direct right of recovery as well as its subrogation right) is commonly referred to as a Medicare “lien”, but the proper term is Medicare or MSP “recovery claim.”

• A lien allows a person/company/government entity to legally take someone else’s property if an outstanding obligation (debt) is not discharged. The lien holder (e.g., Medicare) retains an interest in the property that lasts until the property owner’s outstanding debt is satisfied or released. 

A Medicare lien is managed by the federal government through CMS’ Benefits Coordination & Recovery Center. Medicare liens are typically placed on personal injury awards when the plaintiff’s treatment was paid by Medicare. A lien will be placed on the beneficiary’s property, including estate in the event that she received money in a settlement, verdict or other payment for medical bills that were paid by Medicare.

Medicare Lien vs. Medicaid Lien

Medicaid is a financial assistance program for low-income people.  Under New Jersey State law, the Division of Medical Assistance and Health Services can place a lien against real or personal property of a recipient of Medicaid. A lien is recorded against property to ensure the Medicaid recipient’s estate pays any outstanding Medicaid debts owed.  The lien protects Medicaid’s interest and its right to recover debts owed prior to the conveyance of real property. There are two types of New Jersey Medicaid liens: Pre-death (also referred to as TEFRA) and post-death (estate recovery) liens.

1. Pre-Death Medicaid Lien

   A pre-death Medicaid lien is the only type of lien that can be placed on real or personal property prior to the death of a Medicaid recipient. This type of lien only applies to permanently institutionalized recipients, such as an inpatient of a nursing facility, or an intermediate care facility for the mentally impaired or other medical institution. The pre-death lien must be dissolved if the recipient returns home.  A pre-death lien cannot be placed against real property if any of the following relatives live in the home:

   1. A spouse, child under the age of 21, or a blind or permanently disabled child of any age.
   2. A sibling who has equity interest in the home and has lawfully resided in the home for at least one year before the Medicaid recipient’s admission to a medical institution.
      
      

   Estate recovery does not begin until the Medicaid recipient dies.

2. Post-Death Medicaid Lien
   A post-death Medicaid lien is placed against the estate of the deceased Medicaid recipient. New Jersey law permits Medicaid to file a lien against a recipient’s real or personal property if he/she was permanently institutionalized or received Medicaid services after age 55. 

How to Protect their Assets from Medicare & Medicaid Liens

The estate heir must pay Medicare’s or Medicaid’s lien obligation to keep the estate’s property.

A Medicaid lien can be repaid by obtaining a loan or mortgage, or selling the home to pay off the lien.  A Medicaid recipient may also use a trust to protect their home from a Medicaid lien. Once transferred into the trust, the Medicaid recipient is no longer the owner. The house legally belongs to the trust. Consult with an elder law or other competent professional for more information.

Sources

http://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Coordination-of-Benefits-and-Recovery-Overview/Reimbursing-Medicare/Reimbursing-Medicare-.html

https://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Attorney-Services/Attorney-Services.html

http://www.medicare.gov/sign-up-change-plans/decide-how-to-get-medicare/whats-medicare/what-is-medicare.html

https://www.medicare.gov/Pubs/pdf/11306.pdf

http://aspe.hhs.gov/daltcp/reports/liens.htm

http://www.state.nj.us/humanservices/dmahs/clients/The_NJ_Medicaid_Program_and_Estate_Recovery_What_You_Should_Know.pdf

http://www.cms.gov/Medicare/Coordination-of-Benefits-and-Recovery/Coordination-of-Benefits-and-Recovery-Overview/Medicare-Secondary-Payer/Medicare-Secondary-Payer.html

Under the ACA mandate, employers are considered large if they employ 100 or more people.  These companies must now provide a reasonable health care package to at least 70% of their full-time employees and dependents this year.  In 2016, the requirement will extend to 95% of full-time employees.  Some argue the change is redundant as most large companies already offer competitive healthcare packages.  According to a survey by Kaiser/HRET, 94% of larger firms affected this year already offer health benefits to their employees.  However, the mandate also changes the definition of “full-time.”  Anyone working more than 30 hours per week must now be fully-covered. The definition of “full-time” employee is now in flux since the Republican-controlled House of Representatives vote passed to change the definition back to 40 hours per week and such measure is likely to pass in the now Republican-controlled Senate.

Another important change was a new standard of acceptable care. Health coverage plans must be both affordable and comprehensive.  To be affordable, coverage cannot cost the employer more than 9.56% of his/her income.  To be comprehensive, the package must provide at least 60% of the cost of benefits.  Missing the mark in either category could result in severe penalties for these larger companies.  Human resource employees will have to work harder in 2015 to document their compliance with these rules.  Employers must report whether they offer these minimum health benefits and their share of the total cost of benefits for full-time employees.

Penalties for a violation come in two forms.  The first is penalty “a” and results in a $2000 per full-time employee in excess of 30.  This fine will be assessed if any full-time employee receives a federal subsidy for insurance through a health exchange.  If even one employee qualifies for that subsidy due to an inadequacy in coverage (as defined above) the fines are much worse.  Under penalty “b”, the IRS will assess the lesser of a $2000 fine per full-time employee in excess of 30 or a $3000 fine per employee who receives the subsidy.  In other words, the IRS will assess stricter fines for companies that do not comply with the affordable and comprehensive aspects of the plan.  To make the transition a little smoother for larger companies, the 30-employee bar has been changed to an 80-employee bar for 2015 only.  Starting in 2016, the full letter of the law will apply. 

In 2016, a company defined as mid-sized, employing 50-99 employees, must comply with the regulation.  But only 2% of American companies are defined as large, and only 2% more are considered mid-sized.  Companies with less than 50 employees, the bulk of American employers, will never be affected by the legislation.  This means roughly 96% of American companies do not have to offer health benefits, which makes the mandate counterintuitive to some.

Nonetheless, the regulation requires larger companies to make changes to healthcare plans to avoid penalties.  They must now adhere to stricter reporting requirements and adjust to the challenging redefinition of a “full-time” employee.  This could be financially difficult for companies that employ a large number of part-time or seasonal workers who add up to full-time equivalents under the new rule.

Sources

http://www.click2houston.com/news/money/obamacare-is-finally-hitting-employers/30502054

http://www.washingtontimes.com/news/2014/dec/31/obamacare-employer-insurance-mandate-kicks-in-jan-/http://www.lexology.com/library/detail.aspx?g=081f1b8f-7cbb-4bf7-83d9-7e320f825d15

http://www.forbes.com/sites/michaelcannon/2015/01/07/nine-questions-on-the-house-vote-to-tweak-obamacares-employer-mandate/

http://www.irs.gov/Affordable-Care-Act/Employers/Questions-and-Answers-on-Employer-Shared-Responsibility-Provisions-Under-the-Affordable-Care-Act

The 10^th Amendment

The government has more power than you think. Under the 10^th Amendment, state governments have the power to quarantine or restrain an individual to prevent the spread of a disease.  Many states are exercising their power through mandatory quarantines of healthcare professionals and others returning from West Africa.  This is done despite a lack of proof that an individual is infected with the disease.  Some politicians have even requested an air travel ban on anyone returning from the region.  But this is far beyond what the Obama Administration is willing to do.  At the moment, a health crisis has not been declared in the United States.  The only federal response has been the implementation medical checkpoints in a select number of airports.  The goal is solely to screen for individuals showing signs of disease.

Response of State Politicians

In New Jersey, Governor Chris Christie imposed a 21-day quarantine on healthcare worker Kaci Hickox who had been working with Ebola victims in West Africa.  Although Hickox showed no symptoms of the disease, she was sent to an isolation tent outside a New Jersey hospital. She was only allowed to return home after seeking legal support.  But Governor Paul LaPage continued to seek quarantine for Hickox, asking her to remain in her home for the full 21-day period.  The governors were acting within their legal rights.  But what about Hickox’s rights?  And what about the recommendation of the Obama administration and the CDC?  The CDC only requires self-monitoring for those returning or arriving from West Africa.  The CDC has also reported quarantine to be unnecessary unless symptoms of disease are present. 

Civil Liberties at Stake

While the Constitution gives the government power to quarantine, it cannot decide whether an individual poses an actual threat.  That is left up to the interpretation of politicians who often cater to the public’s fears.  What’s worse, these politicians are also acting against scientific fact.  There is no evidence to suggest Ebola can be transmitted by someone who is asymptomatic.  The Obama Administration and the CDC hold up this belief.  But the actions of local politicians are reactionary.  In striving for “safety,” they have created uncertainty about our civil rights. You can’t tip the scales in one direction without a drop on the other side.

Some Americans believe lawmakers like Christie are acting in our best interest.  They believe they are doing everything they can to protect the American people.  But the time-sensitive nature of disease control is a danger in and of itself.  With the suspension of due process, individual liberties are tossed aside.  For a nation that prides itself on freedom, this is no small concern.  When criminals receive better treatment than philanthropic aid workers, there is clear ground for a legal debate.

Sources

http://fas.org/sgp/crs/misc/ebola.pdf

http://www.usatoday.com/story/news/nation/2014/10/29/ebola-legal-issues-in-maine/18123443/

https://verdict.justia.com/2014/10/31/travel-bans-mandatory-quarantines

http://www.cnn.com/2014/10/06/justice/callan-law-on-quarantine/

The 2014 physician payment rates increase payments for many medical specialties with some of the greatest increases going to providers of mental health services including psychiatry, clinical psychologists and clinical social workers. The final rule also includes several provisions regarding physician quality programs and the Physician Value-Based Payment Modifier (Value Modifier).  The Centers for Medicare and Medicaid Services (CMS) is also finalizing several related proposals to the Physician Quality Reporting System (PQRS) for 2014, including a new option for individual eligible professionals to report quality measures through qualified clinical data registries.

In 2014, quality measures will be aligned across quality reporting programs so that physicians and other eligible professionals may report a measure once to receive credit in all quality reporting programs in which that measure is used. Additionally, CMS is better aligning PQRS measures with the National Quality Strategy and meaningful use requirements, and transitioning away from process measures in favor of performance and outcome measures.  Requiring health care providers to focus attention to cost and quality is widely viewed as crucial to the United States reining in its healthcare spending and maintaining Medicare solvency.  

Significantly, the finalized physician payment rates and policies for 2014 include a major proposal to support care management outside the routine in-office interaction.  While the move to compensate physicians for care coordination services is a milestone that the CMS is applauded for in recognizing the significance of care that occurs outside of the traditional face-to-face encounters, the administrative burden issue remains a concern for many primary care physicians.

Beginning in 2015, CMS will offer separate payments for the management of a patient’s care outside of the face-to-face visit for those practices demonstrating the ability to provide such services. 

More to follow on this subject.

Sources:

http://cms.gov/Newsroom/MediaReleaseDatabase/Press-Releases/2013