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Pharmaceutical Disposal – A Work in Progress

Posted: July 8th, 2015

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The disposal of pharmaceuticals is a growing area of concern in our over-medicated society. According to Citizens Campaign for the Environment, nearly 4 billion prescriptions are filled in the U.S. each year, of which about one third, or 200,000 pounds, are unused. Trace amounts of these drugs enter our surface and ground waters from various sources, including landfill leachate, animal feedlots, aquaculture, land application of organic materials, pharmaceutical manufacturing facilities, and deliberate flushing. Most ubiquitous of all, the pharmaceuticals pass through our bodies and are secreted, ending up in cesspools and sewage treatment plants, neither of which are equipped to filter or treat them. Studies relating to the impacts of these substances and of personal care products are still few and far between. However, according to Douglas Feldman, Chief of the Office of Water Resources of the Suffolk County Health Department, some of these compounds are known to mimic naturally occurring hormones and affect normal hormone activity. A limited number of studies have reported disruptions of the endocrine system in animals and the “feminization” of fish.

At this time, there are no mandatory regulations requiring any particular method of pharmaceutical disposal by members of the public. The New York State Department of Environmental Conservation (DEC) has focused its efforts on a public awareness program advising people not to flush their unused or expired medications. Instead, the public is urged to return them to collection events, where available, or mix them with something such as coffee grounds, cat litter or dirt, seal them in containers, and put them in the garbage. In fact, pursuant to New York’s Drug Management and Disposal Act of 2009, pharmacies, retail businesses that sell drugs, and veterinary offices are required to conspicuously display a poster to this effect. In addition, people can bring their unused medications and deposit them in drop boxes installed in police stations statewide or to municipal collection events. The current process for getting approval for a household pharmaceutical collection event is somewhat cumbersome. The DEC requires an applicant to fill out three forms identifying the location, date and time of the event, the law enforcement presence, a chain of custody from collection through destruction and pre-approval for destruction via a witnessed burn at a permitted medical solid waste combustion facility in New York State. The program requires the further approval of the New York State Department of Health, Bureau of Narcotic Enforcement (BNE) and notice to the U.S. Department of Justice Drug Enforcement Administration (DEA). After the event, the organizer must submit to DEC a chain of custody report and another form which reports the weight of pharmaceuticals collected. See 6 NYCRR 373-4 et seq. ; http://www.dec.ny.gov/chemical/68554.html. The DEC is considering new regulations to streamline this process.

A new option for Long Island residents is to bring the drugs to 11 local King Kullen pharmacies, which accept everything, except for narcotics (use this link to find participating police and supermarket locations: http://www.citizenscampaign.org/campaigns/pharmaceutical-disposal/nassau-suffolk-locations.asp). About half a million pills were collected in the first five months of the King Kullen program and sent to a hazardous waste incinerator in Texas. A recent grant will enable the store to continue the program for the next three years.

Pharmacies and hospitals usually send back their unused or expired medications to reverse distributors. However, if the drugs have the characteristics of hazardous substances (e.g. warfarin, nicotine, alcohol, mercury, acids) and are classified as waste, then the State hazardous waste regulations apply to their disposal (6 NYCRR Parts 364, 370-373). Last year, the DEC created an audit program for pharmacies, allowing them 12 to 18 months to come into compliance and deferring inspections and enforcement. See http://www.dec.ny.gov/docs/remediation_hudson_pdf/rcraaudits12182014.pdf. In addition, new hazardous waste regulations from the U.S. Environmental Protection Agency are expected to be issued in this month.

A separate effort is being made for the collection of unused medications from long-term care facilities, such as nursing homes. For a long time, the preferred method of disposal was flushing. In fact, it is still approved for controlled substances by BNE. This is because BNE imposes restrictions on the movement of narcotics, and nursing homes may not return them to the pharmacies that issued them or dispose of them as solid waste, but rather, are required to render them totally “unrecoverable and beyond reclamation” (10 NYCRR Part 80). In recent years, there has been an effort to curtail the practice of flushing. The DEA used to conduct national collection events for controlled substances, ie. narcotics. Unfortunately, these have recently been discontinued. The DEC has picked up where the DEA left off, organizing special collection events. The first such event on Long Island took place in February 2015, yielding 52 boxes of waste medications collected for proper disposal by DEC’s Region 1 environmental enforcement personnel. A more permanent solution is expected to come soon when BNE issues regulations implementing the October 2014 rules of the DEA. These rules expand disposal options for ultimate users, such as long term care facilities, by allowing them to participate in mail back programs or use collection receptacles by DEA approved pharmacies for the return of unused drugs.

The Suffolk County Department of Health Services (SCDHS), which collects water samples from public and private wells and from groundwater monitoring wells, currently analyzes for about 30 pharmaceuticals and personal care products. To date, 25 of these have been detected in very small concentrations (less than 1 microgram per liter), with the most detections being in private wells. At this time, there is no regulatory standard for these compounds, so the standard applied is the catch-all 50 parts per billion for unregulated contaminants. According to Amanda Comando of the Suffolk County Water Authority (SCWA), the SCWA, which operates 550 wells, currently tests for 26 pharmaceutical compounds of concern and hopes to expand the list to 47 by the middle of this year.

Several legislative initiatives in Suffolk County have begun to address the issue of waste pharmaceuticals. Resolution No. 181-2011 requires hospitals, nursing homes, and long term-care facilities to file a written plan with the SCDHS for the disposal of unused or expired medications in a safe manner. Resolution No. 762-2008 established a program which allows residents to deposit unused/expired medications County police precincts 24 hours a day, 7 days a week. A companion program uses a ¼% sales tax to support the collection of unused medications for the five East End towns.

A lot of questions still remain. What are the cumulative impacts on animals, fish and humans of trace levels of pharmaceuticals in our surface waters and in drinking water? Should there be specific standards? What about compounds for which there is no current testing? How can the efforts of individual groups and municipalities be combined for greater efficiency and impact? What is the proper balance between ensuring that narcotic drugs do not get into the wrong hands and convenient disposal alternatives that are also safe for the environment? What filters or treatment methods are being developed to purify the water for human use? Hopefully, some of these questions will be answered as more public attention is focused on this emerging health and environmental issue.

The information contained in this article is provided for informational purposes only and is not and should not be construed as legal advice on any subject matter. The firm provides legal advice and other services only to persons or entities with which it has established an attorney-client relationship.

It’s Time to Stop Complaining and Get Back to Work. Who’s with Me?

Posted: July 8th, 2015

By: Joe Campolo, Esq. email

Published In: HIA-LI Reporter

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Lately, when I attend local business meetings, I hear complaints about the economy, or trouble attracting high-paying customers, or a lack of skilled workers, or workers who are not pulling their weight, or taxes as reasons for that person’s business not doing well. It’s time for Long Island business leaders to realize that we – not the government or anyone else – are responsible for the future of work and life on Long Island. We must take action to cherish and protect the amazing ecosystem of resources available to the business community here on Long Island, instead of merely complaining and wishing for something to change – what my friend Rich Isaac calls “smoking the Hopeum Pipe.” As my grandmother would have said: “It’s time to spit out the pacifier and get back to work.”

My grandmother grew up during the depression. She raised my father on her own by working long days as a seamstress, where she was paid pennies for each garment she sewed. She didn’t watch the clock, instead she knew it was time to stop working when her fingers were raw and bleeding from being struck by the sewing needle. She never complained or blamed anyone else. Eventually she earned enough money to purchase a Brooklyn brownstone. Some people say that it’s more difficult today. I don’t think that my grandmother would agree – I don’t either.

It’s absolutely true that we have been through a terrible economic period and many industries are still trying to recover. We have also suffered from big storms and a long winter. And it’s also true that new industries and technologies have disrupted older industries. But that’s the story of Long Island and Long Island businesses. It was built by responding to challenges with new ideas. In fact, “Built on Long Island” should become a badge of honor and a goal, not an afterthought.

Long Island business leaders have access to better resources than almost anywhere else in the country. We have an educated, world-class workforce and access to dozens of universities, four-year colleges, community colleges and technical institutions. We have great natural resources. We enjoy both a sound and an ocean to provide year-round access to public beaches and beautiful views. We have the busiest commuter railroad in North America, multiple public and private airports and we are connected by bridge and tunnel to the center of commerce for most of the world. We have the ability to take our own ideas and monetize them with access to capital and other resources that other people only dream about. All we have to do, as Long Island business leaders, is accept responsibility and take action to grow our businesses and train our employees. Here are two starting points:

First, align yourself and your business with other growth-oriented business leaders. That means seeking out like-minded business leaders here on Long Island who have the same dreams and aspirations as we do for changing the cult of negativity into a positive force for business transformation. It might be difficult, you may need to stop doing business with the naysayers and complainers. My grandmother would have said, “Stop hanging around with those boys, they’re nothing but trouble” and she would have been correct. Instead look for business groups and organizations who have a vested interest in seeing all of their members become strong leaders. They are there, I promise, if you just look.

Second, keep in mind something that Napoleon Hill wrote in his book Think and Grow Rich, about how to accomplish any goal: “The starting point of all achievement is desire. Keep this constantly in mind. Weak desire brings weak results, just as a small fire makes a small amount of heat.” If you want to change the future for Long Island, you can’t stand by and be meek about it. We are the keys to Long Island’s future and it is time to stop complaining and get back to work, smarter and harder, to build our future.

Who’s with me?

Joe Campolo is a Long Island Business leader. He is managing partner of Campolo, Middleton & McCormick and Chairman of Protegrity Advisors, LLC. He is a proud former U.S. Marine and sits on the board of directors for HIA-LI, The Long Island Red Cross and other local non-profit organizations.

CMM Represents RSI Equipment, Inc. in Sale

Posted: June 29th, 2015

Campolo, Middleton & McCormick represented RSI Equipment, Inc., a New York based medical equipment distributor, in their sale to Claflin Medical Equipment, a Rhode Island-based medical equipment distributor, effective May 29, 2015.

Claflin will expand their business with RSI Equipment, a family-run business specializing in small and large renovations and new construction for hospitals and healthcare facilities in the New York Metro area.

The deal, closed by the Campolo, Middleton & McCormick legal team of Alan Weinberg, Arthur Yermash, and Lauren Kanter-Lawrence is the latest in the growing trend of significant acquisition work handled by CMM in the healthcare space. “The key to this transaction was understanding the unique needs of our client and then leveraging our expertise across a number of practice areas,” said Weinberg, whose practice covers mergers & acquisitions, corporate matters, and real estate work.

CMM’s mergers and acquisitions team advises corporations, private equity funds, emerging companies, and venture-funded startups on a full range of transactions from both the buyer and seller perspective.

Six Leadership Lessons I Learned in the Marine Corps

Posted: June 26th, 2015

By: Joe Campolo, Esq. email

Published In: Long Island Business News

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Joe Campolo: Six leadership lessons I learned in the Marine Corps

In a recent opinion article I challenged the Long Island business community to be leaders instead of complainers. The response was overwhelming, with many people asking for some guidance; they wanted to know if I had any rules that I could share. The best rules I know I learned as a Marine.

The U.S. Marine Corps is all about mission, discipline and dedication – principles Long Island business leaders can use to grow their business. Here are six of those lessons:

1. Lead by example. Before you expect your employees to demonstrate personal and professional integrity in their work, you must demonstrate it yourself. Are you the hardest-working person in the company? Taking professional advancement courses? It’s hard to expect it from others if your answer is no.

2. Know your troops. The Marines stress that a leader must know how the people under their command will respond or react during different situations. Whether they require supervision or training or they are ready to take on new challenges on their own, you need to know the difference and provide your employees with the individual support, training and tools that each person requires.

3. Keep everyone in the loop. Want to know what makes for the quickest confusion and poor morale? Lack of information. You can’t expect everyone on your team to know what to do and why they are doing it if you haven’t communicated the situation and made sure everyone knows his or her role. You must be the chief visionary officer and communicate that vision on a regular basis.

4. Make sure everyone understands the goal. Do you know what you’re doing today to build your business? Do your employees know the same thing? Attending a trade show? Does everyone manning the booth know their tactics and objectives? You must be clear and concise when directing your employees and what you expect them to accomplish.

5. Be decisive. Making decisions is tough. When you can’t or won’t or hesitate for a long time to make a business decision, it sends a poor message to your team. It’s your job to get the information you need, make a decision and stick with it. This builds confidence with your team and helps them learn to make decisions on their own, as well.

6. Troops eat first. Too often, business leaders decide how to reward their employees by paying just enough so they won’t leave. That is not a recipe for success; you must build a culture where your employees are rewarded first and fairly. This will be respected and appreciated, and will directly increase morale as well as your bottom line.

The Marine Corps has a list of 11 leadership principles. Last among them says, as leaders, we are ultimately responsible for the decisions and consequences of the people under our command. Take the time to take that seriously. Who’s with me?

http://libn.com/2015/06/25/joe-campolo-six-leadership-lessons-i-learned-in-the-marine-corps/

The information contained in this article is provided for informational purposes only and is not and should not be construed as legal advice on any subject matter. The firm provides legal advice and other services only to persons or entities with which it has established an attorney-client relationship.

Best Practices for Internal Investigations

Posted: June 22nd, 2015

Published In: IMA Newsletter

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On May 19, 2015, Assistant Attorney General Leslie Caldwell, the leader of the Department of Justice’s (“DOJ”) Criminal Division, gave a speech offering companies “best practices” guidance for corporate internal investigations.

Presently, the DOJ is guided by the nine factors outlined in Deputy Attorney General Mark Filip’s 2008 memo entitled “Principles of Federal Prosecution of Business Organizations.”  These are collectively known as the “Filip Factors.”   Factor 5 states that the charging decision depends in part on “the existence and effectiveness of the corporation’s pre-existing compliance program.”  U.S. Attorneys Manual (“USAM”) 9-28.300.  Caldwell emphasized that a company will get credit from the DOJ only if its compliance program is “effective.”

To develop an effective compliance program, Caldwell recommends that companies go beyond the traditional risk-based approach to compliance and examine all of their lines of business, including those not subject to regulation.  Competent internal investigations also comprise an important element of any compliance program.

The best practices Caldwell highlighted for compliance and investigations include:

  • Policies and procedures unique to a company’s risk areas, clearly written to ensure easy understanding by all employees
  • Clear communication of the company’s policies and procedures; DOJ will look at emails, memos, letters, and other recorded means of communicating its compliance policies and procedures to its personnel
  • Adequate resources and funding devoted to implementing investigatory goals and developing useful evidence against identified wrongdoers

To deter resistance to developing corporate compliance as an important arm of its business, Caldwell offered the example of Alstom S.A., the French power company, which pleaded guilty in December 2014 to violating the Foreign Corrupt Practices Act.  It also agreed to pay a penalty of over $722 million.

When the DOJ discovered wrongdoing by Alstom, it considered Alstom’s compliance program before deciding whether to prosecute.  Ultimately, it determined that Alstom’s compliance program was not effective and lacking in many respects, leading to the criminal charges.

A company does not have an obligation to disclose violations of the law to the government or to cooperate beyond lawful process when the DOJ is conducting an investigation.  However, if a company chooses to cooperate with an investigation, particularly at an early stage, it can receive significant credit when DOJ considers what action to take.

In offering cooperation, the DOJ values facts over corporate spin, and it wants to see relevant factual findings encompassing a full accounting of all the known facts under review as well as an unfettered identification of responsible individuals, regardless of who they are.

Caldwell also emphasized that DOJ would continue its policy promoting parallel proceedings, in which civil and criminal investigative authorities and regulators will continue to share information about targets.  Many targets have bemoaned this “piling on” practice, which can drain a company’s finances and resources.  Caldwell defended the practice, stating that different government agencies have different interests and goals.  While she promised to carefully consider the impact created by parallel investigations, she offered no specific safeguards against “piling on.”  As always, prevention is a company’s best medicine.

For further guidance, Caldwell also recommended thorough review of Non Prosecution Agreements (“NPAs”) and Deferred Prosecution Agreements (“DPAs”) publicly available on the DOJ website in order to measure and compare corporate compliance policies against them.

Companies should take Caldwell’s remarks as a call to examine their compliance programs and the policies and procedures for implementing internal corporate investigations, as well as the resources devoted for such tasks.  Compliance programs should be thoroughly reviewed and held up to NPAs and DPAs to measure the effectiveness of such programs and to identify areas requiring improvement.  Competent white collar defense counsel may offer guidance here, and companies should definitely consider retaining outside counsel to conduct necessary internal investigations to help maintain independence and to protect the results of any investigation under attorney-client privilege.

The information contained in this article is provided for informational purposes only and is not and should not be construed as legal advice on any subject matter. The firm provides legal advice and other services only to persons or entities with which it has established an attorney-client relationship.

The Towns Must Step Up Environmental Review of Commercial Solar Projects in Suffolk County Because They Can’t Rely on LIPA to Do It

Posted: June 22nd, 2015

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LIPA apparently believes, contrary to all evidence, that it need not comply with the State Environmental Quality Review Act (“SEQRA”)[1] before it approves 20-year, fixed rated Power Purchase Agreements for commercial solar electrical generating facilities.  One reason may be that it believes the State exempted it from environmental review in 2011 when the State enacted the Power New York Law of 2011.[2]  If so, LIPA is wrong.

The Power New York Law of 2011 amended and reenacted Chapter 10 of the Public Service Law, which addresses the siting of major electrical generating facilities.  The former version of Article 10 lapsed on January 1, 2003.  The earlier version of Article 10 applied to the siting of any electrical generating facility with a rated output of 80 MW or more.  The goal was to provide a single procedure to gain approval for the site of major power plants without having to deal with myriad and conflicting local laws, and SEQRA.  Few if any base load power plants, intended to operate 24-hours a day to provide a steady source of power for the system, were approved once Article 10 lapsed.

The Power New York Law of 2011 is also designed to provide a single administrative proceeding for the siting of major facilities.  The number of major facilities subject to Article 10 expanded, however, because the threshold for “major facilities” was reduced from 80 MW to 25 MW.[3]  At the same time, the Legislature added a new Section 173 to the Public Service Law.  Section 173 makes clear that Article 10 fully applies to all “major electric generating facilities which any such authority [including LIPA] builds or causes to be built.”  However, “[f]or generating facilities which are not major electric generating facilities, none of the above named authori­ties shall be permitted to serve as lead agency for purposes of environ­mental review pursuant to the provisions of the environmental conserva­tion law.”

Why would the Legislature bar LIPA from serving as lead SEQRA agency for actions involving non-major electrical power facilities (i.e., those with a rated output of less than 25 MW)?  The reason becomes clear when the Assembly Debates are reviewed.  Concern was expressed about the way LIPA handled electrical power facilities that were not major (less than 80 MW) under the old Article 10.  Numerous peaking facilities (i.e., facilities designed to be turned on only when the power is needed during peak hours) were rated at 79.5 MW to avoid going through the very public review process under Article 10.  Although the LIPA approvals were subject to SEQRA, LIPA repeatedly declared itself to be lead SEQRA agency, and inevitably adopted a negative declaration so that a Draft Environmental Impact Statement would not have to be prepared.  The result was that peaker plants went wherever LIPA found them to be convenient, without regard for environmental impacts.[4] Assemblyman Losquadro described the problem thusly (Assembly Debate June 22, 2011 p. 83 – 84):

The previous threshold of 80 megawatts led to a proliferation of 79 megawatt peakers all over the place and it was just a mish-mash.

Assemblyman Cahill then commented (Assembly Debate June 22, 2011 p. 84):

[J]ust going back to your previous point that may be of interest to you as well. In this legislation, talking about those 79.5 megawatt peaker plants that were built in New York City and on Long Island, this legislation would specifically prohibit the Power Authority of the State of New York and the Long Island Power Authority from taking lead agency status in the development of a plant that they wish to develop themselves, which may be something that would have prevented those 79.5 megawatt plants from being built back then.

One comment made during the debates in the Assembly in 2011 shows how quickly expectations have changed with regard to the role solar electric generating facilities will play in helping to meet our power needs.  Assemblyman Losquadro assumed that the definition of major facilities in the Power New York Law would force all review of electric generating facilities into Article 10 of the Public Service Law:

Well, I’ll tell you one thing that I do like about this legislation is the fact that you did drop the megawatt threshold from 80 down to 25, because for any commercially-viable project, there’s really going to be nothing built less than 25 megawatts.

Within less than a year of the adoption of Public Service Law §173, LIPA issued a series of requests for proposal for renewable energy projects, all of which sought renewable energy projects under 25 MWs.  By resolution dated June 28, 2012, the Trustees established LIPA’s Clean Solar Initiative Feed-In Tariff under SC-11 for the purchase of up to 50 MW of distributed solar PV generation renewable resources for a fixed price of $0.22 per KWh under a 20-year PPA (“FIT I”).  The maximum project size that would be considered under FIT I was 10 MW.  On October 3, 2013, LIPA’s Trustees approved the FIT II program which sought to add an additional 100 MW of renewable energy, but no project could exceed 2 MW.  Then, on October 18, 2013, LIPA issued an RFP for an additional 280 MW of on-Island renewable energy.  The 280 MW RFP set a minimum size requirement of 2 MW, and a maximum of 280 MW.  Nevertheless, on December 11, 2014, when LIPA announced its selections for negotiation of Power Purchase Agreements pursuant to the 280 MW RFP, eleven commercial solar projects, totaling approximately 122.1 MW of installed capacity, were announced, the largest of which was 24.99 MW.  Thus, every renewable energy project selected by LIPA since Public Service Law §173 was enacted has been under 25 MW, thus proving that, when guaranteed a fixed price per kWh far above the cost of energy on the open market, projects less than 25 MW are indeed economically viable. It is difficult to imagine that LIPA has not intentionally kept commercial solar projects below 25 MW in order to avoid having the projects go through the Article 10 process.  Without having to deal with a Siting Board appointed by the Public Service Commission, and without having to serve as lead SEQRA agency, LIPA appears to have concluded that it can best control the timing of projects if those projects remain under 25 MW.  The problem is, LIPA is acting on a faulty premise:  because it cannot serve as lead SEQRA agency, it need not comply with SEQRA at all before it approves Power Purchase Agreements.

When Public Service Law §173 was adopted, the assumption was that if LIPA could not be lead agency on its own projects, the Towns would step up and conduct proper environmental review.  Unfortunately, with the exception of a proposed commercial solar electrical generating facility in Middle Island, where the Brookhaven Town Board adopted a positive declaration,[5] no other proposed commercial solar farm has resulted in a positive declaration requiring preparation of a DEIS.  The cumulative impacts caused by commercial solar electrical generating facilities which should be examined in a Generic Environmental Impact Statement have been addressed in earlier blogs.[6] The key is, Towns must understand that just because LIPA has approved a 20-year Power Purchase Agreement, they cannot assume that it has examined the environmental impacts of the project; it has not.

In fact, not only has LIPA not conducted environmental review before approving Power Purchase Agreements for commercial solar electric generating facilities, its approvals are in complete derogation of its SEQRA obligations.

Nothing in Public Service Law § 173 suggests or implies that the Legislature intended to exempt LIPA altogether from its SEQRA obligations.  Indeed, the opposite is true.  The reason Section 173 was enacted was because the Legislature wanted to make certain LIPA would no longer act without undertaking proper environmental review of its own projects.  The Legislature could not have intended to exempt LIPA from SEQRA altogether because LIPA would then be free to approve these projects whenever it wanted without any environmental review – the very harm the Legislature sought to overcome when it barred LIPA from serving as lead SEQRA agency on its own projects.  In fact, SEQRA requires that LIPA withhold approval of any Power Purchase Agreement until the Town where the project will be located completes its SEQRA review.

While LIPA cannot serve as lead SEQRA agency, it remains an “involved agency.”[7]  As such, LIPA is obligated to provide relevant information to the lead agency.[8]  More importantly, as an involved agency, LIPA is barred from taking any action with regard to the Power Purchase Agreement until the lead agency either issues a negative declaration, or accepts a Draft Environmental Impact Statement as complete.[9]

CONCLUSION

As noted in earlier Blogs, PSEG-LI conducted a reliability study, and concluded that LIPA has sufficient energy sources to maintain reliability through 2024.  Thus, the rush to enter into 20-year Power Purchase Agreements at fixed prices 2-3 times the cost of power on the open market with commercial solar providers makes no sense.  Even if these out of State commercial giants continue to be permitted to cover property entirely with solar panels, between 5 and 6 acres of open space per MW will be lost to these projects.  Because distributed solar panels on rooftops use up no open space, and the electricity goes into the LIPA distribution system at virtually no cost to LIPA or impact on the transmission system, LIPA should be focusing its efforts on ways to maximize distributed solar power.  While at one time, LIPA expressed fear that distributed power was problematic because the owners of structures with solar panels on the rooftops were not paying LIPA for the power used, which would result in a loss of revenue, LIPA has eliminated that concern.  Earlier this year, it adopted a decoupling mechanism which allows LIPA to maintain needed revenue based on the number of customers it has, and not just on kWhs sold.  Each RFP LIPA issues puts more upward stress on the cost of open space, making affordable housing more difficult, while eliminating scenic vistas and altering the character of communities.

LIPA must stop approving Power Purchase Agreements with providers of commercial solar power before SEQRA review has been completed.  At the same time, Towns must take their responsibilities more seriously when it comes to being SEQRA lead agencies with regard to proposed commercial solar projects.  No more commercial solar electrical generating projects should be approved until a Generic Environmental Impact Statement is prepared so that the cumulative and long term impacts of these projects can be fully explored.

[1] ECL Article 8.  The DEC’s Regulations are found at 6 NYCRR Part 617.
[2] Ch. 388 of 2011, approved August 4, 2011.
[3] N.Y. Public Service Law §160(2).
[4] N.Y. Assembly Debates, June 22, 2011 Ch. 388, Power NY Act of 2011, pp. 73-76, 83-87, 109-113.
[5] Town of Brookhaven Resolution 2014-484, adopted June 24, 2014.
[6] “Tiger Salamanders and Industrial Scale Solar Facilities in Suffolk County,” May 2015.
[7] 6 NYCRR §617.2(s):  “Involved agency means an agency that has jurisdiction by law to fund, approve or directly undertake an action. If an agency will ultimately make a discretionary decision to fund, approve or undertake an action, then it is an “involved agency”, notwithstanding that it has not received an application for funding or approval at the time the SEQR process is commenced. The lead agency is also an “involved agency.”
[8] 6 NYCRR §617.3(e): “Each agency involved in a proposed action has the responsibility to provide the lead agency with information it may have that may assist the lead agency have that may assist the lead agency in making its determination of significance, to identify potentially significant adverse impacts in the scoping process, to comment in a timely manner on the EIS if it has concerns which need to be addressed and to participate, as may be needed, in any public hearing. Interested agencies are strongly encouraged to make known their views on the action, particularly with respect to their areas of expertise and jurisdiction.”
[9] See 6 NYCRR §617.3(a)  (“ No agency involved in an action may undertake, fund or approve the action until it has complied with the provisions of SEQR”) and  6 NYCRR§617.3(c)(1 and 2) (“An application for agency funding or approval of a Type I or Unlisted action will not be complete until: (1) a negative declaration has been issued; or (2) until a draft EIS has been accepted by the lead agency as satisfactory with respect to scope, content and adequacy.”

 

 

The information contained in this article is provided for informational purposes only and is not and should not be construed as legal advice on any subject matter. The firm provides legal advice and other services only to persons or entities with which it has established an attorney-client relationship.

Court Strikes Down CMS Prohibition on ‘Per-click’ Equipment Rentals, Upholds ‘Under-Arrangements’ Prohibitions, Under Stark Law

Posted: June 22nd, 2015

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Freddy Kreuger from Nightmare on Elm Street, Jason from Friday the 13th, and The Exorcist.  This triumvirate struck fear in me as a kid and caused many sleepless nights.  Fast forward to present, and the Stark Law invokes similar fears, with its strict liability and draconian punishments for even inadvertent violations.  The Stark Law prohibits a physician from billing any federal healthcare program for items or services provided by another entity with whom the physician has a financial relationship, unless the arrangement falls within a statutory exception.  See generally, 42 U.S.C. 1395nn.

The Secretary for Health and Human Services has enacted three major regulatory declarations interpreting and refining implementation of the Stark Law.  These have been collectively referred to as Stark I, Stark II, and Stark III.

On June 12, 2015, the United States Circuit Court for the District of Columbia took a step forward in clarifying an issue that has flummoxed medical practitioners since the “Stark III” update in 2007.  See Council for Urological Interests v. Burwell, 2015 WL 3634632 (June 12, 2015).  Medical practices often lease equipment to hospitals, such as radiological equipment, and charge the hospital for the use of the equipment on a per-use, or “per-click” basis.  In 2007, Stark III changed CMS’s interpretation of the equipment rental exception and specifically prohibited such per-click leasing arrangements if the medical practice leasing the equipment to a hospital also referred patients to that hospital for services provided using the leased equipment. See 42 C.F.R. 411.357(b)(4)(ii)(B).  These per-click arrangements were permitted under Stark II pursuant to the statutory exception for equipment rentals. 42 U.S.C. 1395nn(e)(1)(B)(iv).

In response, the Council for Urological Interests, an association of physicians representing those who lease equipment to hospitals and then refer their patients to those hospitals to perform procedures using the leased equipment, filed a challenge to Stark III’s prohibition of such per-click arrangements.

The argument advanced by the Council of Urological Interests stated that the Stark III rule exceeded the Secretary’s authority under the Administrative Procedure Act (“APA”) and violated the procedural requirements of the Regulatory Flexibility Act (“RFA”).

The D.C. Circuit Court evaluated the challenge in the context of the equipment rental exception under 42 U.S.C. 1395nn(e)(1)(B)(iv).  Under that section, a medical provider may lease equipment to a hospital and refer patients to have procedures performed on that equipment so long as “rental charges over the term of the lease are set in advance, are consistent with fair market value, and are not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.”

Citing legislative history, the D.C. Circuit ultimately remanded 42 C.F.R. 411.357(b)(4)(ii)(B) to the district court with instructions to remand to the Secretary of HHS for further proceedings.  Specifically, the D.C. Circuit held that the Secretary should reconsider whether a per-click ban on equipment leases is consistent with a 1993 Conference Report published at the time Congress passed the Stark Law.

This D.C. Circuit decision is important to health care providers who rent equipment to a hospital and then treat their Medicare patients using the equipment they rent to the hospital.  The 2008 prohibition of this practice may begin to crumble, and providers should monitor its progress and take advantage of the ability to once again enter into such per-click arrangements if the current ban is reversed.

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