Making A Move To The Hamptons

luxury home for sale

Live Like A Celebrity And Move To The Hamptons

Given that it is such a brief travel from New York or even New Jersey, the unbelievable amount of natural beauty that exists here in East Hampton is extremely astonishing. If you haven’t been here, there are these long stretches of blue Coast lines that are flowing with golden sands. In addition, the natural landscapes that exist, there are also plenty of city parks that unite to form one of the most relaxing and breathtaking destinations along the upper East Coast. If you live near here and you have money, then you know about the Hamptons! There are mega movie stars and musicians that own beautiful property here, which as a result has attracted fantastic restaurants and dining establishments for those that like the finer things in life. There are posh boutiques popping up all over town, and despite its prevalence, however, East Hampton has worked tirelessly to keep its village-like charm, something you will quickly if you visit on vacation or decide to move to the Hamptons. There are few moving companies we trust in New York and New Jersey to move families into the Hamptons, but the team at Bluebell Moving And Storage has proven time and time again that they are the East Coasts premier moving agency for the upper class on the East Coast

As A New Resident Prepare To Shop And Surf The Hamptons

Due to its astonishing landscape, perfect location, and natural abundance of awesomeness, East Hampton has a lot of activities for you to get into once you move to the Hamptons. Main Beach is the biggest attraction for a lot of East Hampton locals and visitors. Believe it or not, it is among some of the best-ranked shorelines in the country, but it is more than just a place to relax on the beach and soak in some sun rays. Main Beach hosts many of the college’s water sports competitions, there is surfing, biking, paddle boarding, body surfing, and boogie boarding. Those of you that prefer spending money on fashion, you will love what Main Street has to offer, with its fashionable posh boutiques, they cater to the upper class that has money to spend on the nicer things in life. If that is not you, don’t bother moving here because poor people don’t fit in.

Embrace The Lavish Culture Of The Hamptons

If you can tear yourself away from the shore, the city of East Hampton has lots of family-friendly attractions to check out during the day and in the evenings. One of the true gems of Long Island is LongHouse Reserve. The beautifully maintained garden stretches 16 acres across the Hamptons and is filled with amazing eye-catching stone sculptures. The Pollock-Krasner House (once home to the artists Jackson Pollock and Lee Krasner) is just another location that civilization aficionados will not want to miss out on checking out, true history at it’s finest. Folks of all ages will love the fascinating tour, and children will love making their very own Pollock-style drip paintings. Living in the Hamptons offers so many great things to enjoy, and those are just a few. Becoming culturally aware of art and the area will be necessary if you are going to fit in here.

If You Are Lucky Enough To Buy Shorefront Property

If you are lucky enough to buy shorefront property you better soak it up! Most families that buy into this luxury area don’t give up their property that easy. move to the hamptons - family home in east hamptonHouses and land are passed down through the generations over the years and children and grandchildren are often left with vacation homes they rather not sell. The experience living on the shore is unforgettable. Even though the months of June through August are the nicest, September is also a fantastic time to enjoy some good sun and good times. If you are not a sun worshiper, late spring is also an amazing time of year. Temperatures are somewhat milder, but East Hampton nonetheless retains its magical, village-like vibe. For those that want to move to the Hamptson this vibe is priceless, for visitors making a vacation of the Hamptons, they often times do not want to leave!

If You Make The Move To The Hamptons Enjoy The Parks

When you move here you may find that there is an overwhelming amount of things to do at first. Moving in, unpacking, finding your way around and all that fun stuff. But after you get settled, you need to check out the Hampton Parks. East Hampton is home to no less than 8 country parks and two county parks, with Cedar Point County Park being the most popular destination among local residents and out of town visitors. It encompasses over 600 acres of coastal beauty and is famous for its magnificent views of Gardiner’s Bay. There is an abundance of things to do such as fishing, hiking, biking, and playing in the park. Additionally, It plays host to a rich ecosystem of wildlife together with everything from deer to ducks. There are also designated dog areas for the dog lovers of the Hamptons. The rich love their poodles and purse dogs, there is no shortage of those dogs here in our parks. Locals take pride in their parks and we ask that if you move to the Hamptons that you bring your dog out to enjoy the natural beauty with you that you clean up after your animal if they poop in the park grass.

READ: New Jersey Proposes New Limits……

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Why You Need Orthodontic Insurance Coverage

Why You Need Orthodontic Insurance Coverage

Insurance insures help patients when they want financial aid to obtain the needed service and have a difficulty. Such policies are used by them as a threat coverage tool, and one main policy folks take, is orthodontic insurance if they have been aware about their oral health. Correcting abnormalities and dental issues like misaligned or damaged teeth can improve grin and an individual’s facial features. Sadly, the prices can bite difficult in the lack of quality insurance. Dental treatment from Sky Orthodontist Oklahoma City changes among individuals so, the adolescents; therefore, many parents are under pressure in the adolescents who need to wear good looking braces.

Things become a lot simpler as the cover protects all processes and gear when you’ve got insurance insuring an orthodontist’s treatment. Check whether the policy contains coverage of treatment if you’ve got an existing dental insurance. Should it not have, then contemplate purchasing a supplementary form especially for this to cover your treatment prices. It’ll save you big time if you’ve got family members that want braces or treatment.

Just like your dental or insurance coverage that is routine, you’ll need to pay a monthly or annual premium. More than a few companies pay as much as fifty percent of the overall care expenses. So, if treatment is required by some of your nearest and dearest at once, your financial weight can ease significantly.

A bulk of the expenses come from the price of gear used in the restoration procedure like other additional dental products, braces, and retainers. The price of dental x rays, allowances that are needed, and monthly visits influence the amount being spent on treatment making it higher as opposed to dental care services that are routine. Averagely, the supplier to cater up to a specific quantity of dental care per year after which the maximum annual sum for all the dental prices become your company was just wanted by the typical dental cover.

In several cases, such processes are seen by individuals as being just decorative thus resulting in just several insurance companies providing cover for such a treatment services.

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Is It Necessary To See A Dentist Frequently?

Is It Necessary To See A Dentist Frequently?

The prevention of periodontal disease, cavities, and bad breath is reached with oral direction techniques which are powerful and affordable, easy to perform on a daily basis. A professional should be consulted or more often depending on significant care attempts and dental demands. Dentist OKC offers complete oral health care services to patients to help in the care of a cavity grin that is free. Personal wellness techniques and advanced oral technology are supplied according to individual conditions.

The oral evaluation can discover changes and tooth issues in tissues indicative of major ailments including cancers and diabetes. Some of the most significant measures that people can take to maintain the healthy state of teeth would be to see with the dental offices frequently. A routine checkup contains the detection of tartar, plaque and cavities in charge of gum disease and tooth decay. The formation of a failure and bacteria can improve discoloration, oral deterioration and decay. A failure to correct oral issues including little cavities may lead to important destruction of tissue and enamel including tooth loss and acute pain.

A dentist will counsel patients on easy and affordable suggestions for health care care that is individual to grow strong teeth and gums. This can be a simple and affordable method shield the state of oral tissues and to prevent cavities. Specialized tools are integrated at the practice to supply a professional clean and accomplish places that cannot be reached with flossing and brushing. It shields against spots and decay that undermine the healthy state of pearly whites. A dental practice provides complete oral care helping in treating gum and tooth ailments. Meeting an oral professional often and following day-to-day hygiene measures can best protect and improve the state of your grin.

It is important to get it assessed time to time and to take good care of your dental health and stay healthy. Google “oral health”  if you want to learn more about the oral health.

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Things To Look For In An Attorney Before Hiring Them

Things To Look For In An Attorney Before Hiring Them

Permit me to start by saying that do it yourself has its limitations. Certainly, contracts can be drafted by you by yourself, it is possible to survive discussions that are grotesque with your company customers, a married dispute can be settled by you but you should get an attorney when the demand to come to court appears. Expenses will be incurred, professional fees must be paid and the normally drawn-out procedure must be born. The prices of solving a difficulty are much greater in relation to the prices of preventing the issue. However, hiring a Sugar Land criminal defense attorney can eliminate the complexity, who knows what needs to be done.

When locating a lawyer so, search for a “competent” attorney. Before you start to share your innermost secrets together it’s absolutely ethical to require a lawyer permit. Generally though, their certifications would hang. He may be a professional in any among the following types of law: taxation law, labor law, civil law, international law, litigation, or criminal law. These are the important types. Therefore, you may learn of an immigration lawyer or a litigation attorney. Note however, that attorneys’ specialties are “obtained” through expertise, not only because they believe they have been excellent at it.

This can be one facet of being a lawyer where a youthful, inexperienced attorney can in fact get ahead of a seasoned one. Young attorneys usually are sympathetic, encouraging and lively. They have a tendency to treat their customers like their infants. They take care of every small detail, even the ones that are unimportant. But this just is paying customers desire to be treated. Customers often believe that they’re getting their money’s worth with the type of focus they can be becoming.

The personal qualities to try to find in a New Hampshire personal injury attorney depend significantly on the type of customer you might be. Should you be the no nonsense sort, you may choose to hire an old attorney who is about to retire. These kinds of attorney are interested in what you will need to say. Occasionally, they’re not thinking about what they must say. But their expertise is impeccable. The credibility of an attorney may be viewed in several circumstances. It can be built on charm coupled with referrals from previous satisfied customers. To be sure, no attorney can get customers if he’s not trustworthy and believable.

So at this point you have a credible, skilled and competent injury attorney having the individual qualities you try to find. Another matter to contemplate is whether that attorney can be acquired to attend to your own issue. Your attorney will say he is capable, willing and happy to help you. He said the identical thing to last week, and several others this morning, and the week. The point is, an attorney can only just do so much. He can not all be attending hearings all. He’d likely resort to rescheduling or cancelling hearings and assemblies that are significant to make ends meet. If your preferred attorney has a law firm, there will surely be other attorneys who can attend in case he is unavailable to you personally. You’ll find this satisfactory but not until your case continues to be reassigned to another from one hand.

The representation starts when you meet with your customer. This, nevertheless, isn’t what defines professionalism. So don’t be misled by the attorney-appear alone. It’d be amazing if your attorney can pull it away with the professionalism that is authentic and the attorney appearance though.

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Operation Warp Speed and the Standard for Review of the COVID-19 Vaccines

Operation Warp Speed and the Standard for Review of the COVID-19 Vaccines

By Mark I. Schwartz

On August 7th, FDA Commissioner Dr. Stephen Hahn, CBER Center Director Dr. Peter Marks, and FDA Deputy Commissioner Dr. Anand Shah published an article in the Journal of the American Medical Association (JAMA) outlining what the review standards would be for the COVID-19 vaccines currently under development.

There are currently dozens of COVID-19 vaccine candidates in development, however, only five of those have been selected by FDA as the most likely to produce a vaccine for COVID-19 under Operation Warp Speed:

  • The two messenger RNA vaccines from Moderna and BioNTech/Fosun Pharma/Pfizer, both of which have recently begun phase 3 clinical trials;
  • Merck’s recombinant vesicular stomatitis virus vector vaccine;
  • Johnson & Johnson/Janssen Pharmaceuticals replication-defective human adenovirus 26 vector vaccine; and
  • AstraZeneca/University of Oxford’s replication defective simian adenovirus vector vaccine.

It is worth noting that all of these vaccine candidates are aimed at inducing antibodies directed against the receptor-binding domain of the surface spike protein of the virus.

The publication of this JAMA article by FDA officials is largely in response to concerns expressed that political pressure to get a vaccine approved will result in less robust vetting of the biological product by CBER than under normal circumstances.  To the contrary, the authors emphasize that the candidate vaccines “…will be reviewed according to the established legal and regulatory standards for medical products…[T]here is a line separating the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes, which are rooted in federal statute and established FDA regulations…”

Apart from the concern over political pressure to license a COVID-19 vaccine that might not have been fully vetted, there are inherent risks in shortening the timeline of vaccine development from over a decade to less than a year.  Having spent many years at FDA, including several years as a deputy office director at CBER, it goes without saying that shortening timeframes by an order of magnitude is not easily achieved without creating unintended adverse consequences, particularly when a bureaucracy is involved.

In addition there is concern that the technologies being used for the vaccine candidates referenced above are largely novel in that only one of the five candidates uses a technology that has previously been employed for licensure of a vaccine intended for humans, namely, Merck’s recombinant vesicular stomatitis virus vector platform, which was most recently used for last year’s licensure of Ervebo, against Ebolavirus.  Indeed, there are no licensed messenger RNA vaccines, and because the RNA is so susceptible to degradation in vivo, its effectiveness depends in part on the novel lipid delivery system that would transport the RNA to the site of action.

To that end, the article states that the agency is committed to ensuring that all such vaccines are manufactured in accordance with FDA’s quality standards and that their safety and efficacy are verified before being authorized or licensed, adding that recommending a baseline for performance is necessary to provide confidence to the public that broad distribution of a potential vaccine could offer immunity to the majority of the population:

FDA has specifically recommended in its guidance to vaccine developers that the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval (CI) around the primary efficacy endpoint point estimate is >30%.

Next, the authors state that to achieve population-wide immunity these vaccines would need to be widely disseminated in clinical trials, including with sufficient representation of racial and ethnic minorities, older adults, and individuals with medical comorbidities.

Finally, the article states that the vaccines could be reviewed under either the traditional Biologics License Application (BLA) framework or under the Emergency Use Authorization (EUA) program, and that issuance of an EUA for a COVID-19 vaccine could either occur once a sponsor’s studies have demonstrated safety and efficacy of the vaccine but before submission of the BLA or, alternatively, during the review of the BLA.

We are certainly hoping that FDA’s objectives are borne out when the application reviews take place in the coming months, and that the vaccines are legitimately determined to be safe, pure, and potent prior to widespread use.

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GAO Report on Over-the-Counter Drugs

GAO Report on Over-the-Counter Drugs

By Deborah L. Livornese & Riëtte van Laack

Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs.  In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020.  The report focuses on factors that affect FDA’s ability to regulate OTC drugs, how FDA identifies and handles safety issues, and the status of FDA’s implementation of the SIA.  Due to the enactment of the CARES Act in March 2020, which includes OTC monograph reform legislation which extensively overhauls the OTC program and was intended to address some of these very issues (see our blog post here), the value of the report has diminished.

The report provides a summary of the reasons often cited for the need for monograph reform and of the major relevant provisions of the CARES Act.  GAO was informed by FDA officials that the OTC monograph system limited the Agency’s responsiveness. Due to the requirement for rulemaking and insufficient resources, the Agency was hindered in updating and amending a monograph in response to safety concerns.  However, this all changed in March 2020.  As we described in our memo (an updated version of which can be found here), the new legislation reforms the monograph system to one of administrative orders.  Instead of rulemaking which would take six or more years, FDA expects that the administrative orders process can be completed in less than two years.  Moreover, the legislation established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug’s labeling to mitigate a significant or unreasonable risk of a serious adverse event.

With respect to the requirements under the SIA, GAO notes that FDA had implemented most of the required activities within the mandated time frames, except that FDA did not meet the deadline of November 2019 for a final monograph for OTC sunscreen products.  However, this requirement was eliminated under monograph reform.  That said, the comments to the proposed rule will need to be considered in FDA’s future administrative order for OTC sunscreen drug products.  As of June 2020, FDA officials told GAO that the agency had not yet completed its review of the provisions in the CARES Act that affect FDA’s regulation of OTC drugs, and, therefore, officials could not comment on the specific requirements that will be included in the newly deemed administrative order. FDA officials said the Agency did not yet have a plan or time frame for publishing the deemed administrative order for sunscreen.  GAO also included a brief description of the 15,000 comments FDA received on the proposed sunscreen rule.  FDA informed GAO that 1,100 of the comments were unique comments and more than 100 comments included extensive attachments, such as studies or technical comments.

GAO also reports that FDA officials said it will take time before FDA is able to fully realize any benefits that might result from changes in the CARES Act. For example, it generally takes two years for any newly hired FDA staff to complete training and to acquire the knowledge and experience needed to be fully effective in reviewing scientific information related to the regulation of OTC drugs.

The new monograph user fee system is intended to provide FDA with much needed resources.  However, FDA may only collect user fees in the amount provided in an appropriation act.  As of the end of July 2020, legislation providing for an appropriation for the OTC user fees has not been enacted.

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California Dreaming Part 3: It’s No Longer Just a Dream

California Dreaming Part 3: It’s No Longer Just a Dream

By Sara W. Koblitz

When California first passed its Pay for Delay bill, AB 824: Preserving Access to Affordable Drugs, we questioned whether the law could withstand a constitutional challenge, and indeed, the Association for Accessible Medicines (“AAM”) brought such a challenge in November 2019.  For those of you who need a refresher, AB 824 Business: Preserving Access to Affordable Drugs presumes an anticompetitive effect if, as part of a Paragraph IV litigation settlement, an ANDA sponsor receives anything of value in exchange to limiting or foregoing entry of a generic drug product.  “Anything of value” includes an exclusive license or promise that the brand company will not launch an authorized generic version of the RLD, but the term “value” is not specifically defined, leaving room for interpretation (though there are several provisions explaining what the term does not include).  Essentially, AB 824 shifts the burden from the government to demonstrate that a settlement is anticompetitive to the parties to show that it is not anticompetitive, making it significantly easier for the government to challenge these settlements—regardless of whether the parties do business in California.

AAM sued the state of California in November 2019 seeking an injunction staying the implementation of AB 824 on January 1, 2020, primarily alleging that AB 824 violates the Dormant Commerce Clause because it applies to parties outside of California.  Other arguments posed included federal preemption, violation of the Eight Amendment to the U.S. Constitution (Excessive Fines Clause), and breach of procedural due process rights.  On December 31, 2019, the Eastern District of California denied AAM’s request for a preliminary injunction on ripeness grounds “due to the nature of Plaintiff’s pre-enforcement attack on AB 824.”  The Court was sympathetic to AAM’s arguments, explaining that AB 824 as applied may very well violate the Dormant Commerce Clause, but denied the injunction because it was, at the time, too speculative.

AAM didn’t take that setback lying down:  in January 2020, AAM filed an interlocutory appeal, challenging the denial of its motion for preliminary injunction in the Ninth Circuit.  On July 24, 2020, the Ninth Circuit denied the interlocutory appeal on the basis of standing.  In a short and quick Memorandum Opinion, the Ninth Circuit dismissed AAM’s appeal because it has not shown a “substantial risk” that AB 824 will cause any member to suffer an injury in fact.  Though the lower court made its decision based on ripeness, the Ninth Circuit focused on standing.  The Court acknowledged its departure from the lower court and explained that standing and ripeness basically “boil down to the same question.”  Given this, the Court analyzed the case under the Article 3 standing criteria.

The Ninth Circuit explained that, under the Supreme Court’s standing analysis, AAM was required to show that it (1) suffered a concrete, particularized, and actual or imminent injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.  In this instance, the Court explained, where the injury in fact is the enforcement of an allegedly unconstitutional statute, the plaintiff satisfies the injury-in-fact requirement by alleging an intent to engage in a course of conduct under which a credible threat of prosecution exists.  AAM, the Court determined, failed to show that AAM members intent to enter into settlements “of the sort prohibited by AB 824.”  As such, the Court noted, “AAM has not shown that there is a ‘substantial risk’ that AB 824 will cause any of its members to suffer injury that is concrete, particularized, and imminent.”  Next, the Court explained that AAM members have not established economic injury due to complying with AB 824, which would require foregoing pay-for-delay settlements or litigating patent-infringement suits to judgment.  The possible future injury is not enough to establish a substantial risk of harm.

As we (and the Eastern District of California) explained previously, AAM still has plenty of ammunition for an “as-applied” challenge.  Once AB 824 has been applied to an AAM member (or other putative plaintiff), the constitutionality of the law can be challenged again.  But this means that parties looking to settle have to worry about proving the settlement is not anticompetitive, providing confidential commercial information to a government in which the parties may not even do business, and potentially litigating the findings with California before a settlement can be finalized.  Regardless of the actual content of the settlement, this is inherently burdensome on industry and has the potential delay settlements and eventual market access.  This is what California wanted: the bill was intended to discourage certain patent infringement settlements.  But it does more because the burden it puts on industry actually discourages most, if not all, patent infringement settlements between sponsors and generics.  With any luck, the state of California will see the District Court’s original decision as a “how not to” guide to enforcing the law, but for now, we wait until California actually tries to enforce (or a settlement is actually delayed because of the law) to see what happens.

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House Approves Amendment Shielding State-Authorized Cannabis Activities

House Approves Amendment Shielding State-Authorized Cannabis Activities

By Larry K. Houck

Last week, in what has become an annual ritual, the House of Representatives voted 254-163 (222 of 228 Democrats, 31 of 188 Republicans) to approve an amendment prohibiting the Department of Justice (“DOJ”) from using appropriated funds to enforce federal laws against authorized marijuana activities that are legal under state, territorial or tribal law.  Representative Earl Blumenauer (D-Oregon), founder and co-chair of the Congressional Cannabis Caucus, co-sponsored the amendment to H.R. 7617, the Department of Defense Appropriations Act of 2021, with Representatives Tom McClintock (R-California), Eleanor Holmes Norton (D-District of Columbia) and Barbara Lee (D-California).  Blumenauer explained “[a]s we work to ultimately end the senseless prohibition of cannabis and the failed war on drugs, these amendments will help ensure the protection of legal state, territory and tribal cannabis programs.”  Press Release, Offs. of Rep. Earl Blumenauer, House Approves Blumenauer Amendment to Protect Cannabis Programs (July 30, 2020).

The Blumenauer Amendment prohibits DOJ, which includes the Drug Enforcement Administration and other agencies, from using any funds “to prevent any … [state, territory or Indian tribe] from implementing their own laws that authorize the use, distribution, possession, or cultivation of marijuana.”  H.R. Rep. 116-461, at 51.

In recent years, a majority of states, the District of Columbia, Puerto Rico, Guam and the U.S. Virgin Islands have approved medical cannabis programs and over a dozen states have legalized adult use of cannabis.  But marijuana remains a schedule I controlled substance federally.  21 U.S.C. § 812(c)(10).  Schedule I substances under the federal Controlled Substances Act (“CSA”) have a high potential for abuse, have no currently accepted medical use in treatment in the U.S. and lack accepted safety under medical supervision.  21 U.S.C. § 812(b)(1).  Idaho, Kansas, Nebraska, and South Dakota have no approved medical cannabis programs nor do they allow recreational cannabis use.  The Blumenauer Amendment therefore does not cover cannabis activities in those states and would not cover any cannabis activities that those states may authorize.

Congress has attached similar riders to appropriations bills since 2014 shielding medical cannabis activities that are legal under state law from DOJ enforcement of the federal CSA.  Then-Attorney General Jeff Sessions urged congressional leaders not to renew the amendment in 2017.  Letter from Jeff Sessions, Att’y Gen., to Mitch McConnell, Sen.; Charles Schumer, Sen.; Paul Ryan, Rep.; and Nancy Pelosi, Rep. (May 1, 2017).  We are not aware if Attorney General William Barr has taken a position on the amendment.  We note that the current amendment would expand protection of medical cannabis programs to also include recreational cannabis operations.

The Blumenauer Amendment continues efforts to provide some comfort to those in the industry that federal law enforcement will not take enforcement action against them if their activities are authorized and legal under state law.  However, because the amendment now includes recreational cannabis operations, that comfort may be short-lived or abbreviated as the Defense Appropriations bill moves to the Senate and may itself be amended in whole or in part.

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CMS Cuts in Drug Payment to Hospitals for 340B Drugs – Post Script

CMS Cuts in Drug Payment to Hospitals for 340B Drugs – Post Script

By Alan M. Kirschenbaum

Our post was a day too early.  Yesterday, we posted an article on a D.C. Circuit decision upholding CMS’s payment cuts to hospitals for drugs purchased under the 340B Drug Discount Program.  We wrote in that post that CMS was expected very soon to issue its proposed rule on the Hospital Outpatient Prospective Payment System (HOPPS) for 2021, and that the Court’s decision opened two options for CMS: continuing to implement its current ASP minus 22.5% rate for 340B drugs in 2021; or basing payment rates to hospitals for 340B drugs on CMS’s recent survey data on drug acquisition costs, which could result in even larger cuts.  CMS did indeed issue its HOPPS proposed rule very soon – today –  and somewhat surprisingly, CMS did not choose between these options but instead proposed them as two alternatives.

As predicted, CMS used its acquisition cost data gathered in a survey of 1,422 340B hospitals in April and May of this year to arrive at an average acquisition cost of ASP minus 34.7%.  To this amount CMS proposes to add a 6% add-on for handling, storage, and other overhead (similar to the add-on for non-340B drugs under Medicare Part B), for a net payment rate of ASP minus 28.7%.  However, referring to its win in the D.C. Circuit last Friday, CMS argues, as it did successfully to the Court, that its current ASP minus 22.5% payment rate also represents a reasonable interpretation of the statute.  The result is that the two payment rates, ASP minus 28.7% and ASP minus 22.5%, are proposed as alternatives.  The likelihood of an ASP+6% rate for 340B drugs (i.e., zero cuts) has faded as a result of CMS’s use of survey data, which would be authorized under the statute even if the hospitals requested reconsideration by the D.C. Circuit and won.

Excluded from the payment cuts would be children’s hospitals, PPS-exempt cancer hospitals, and rural sole community hospitals, which would preserve their payment rate of ASP+6% for 340B drugs and other separately paid drugs.  See pp. 296-323 of the preamble.  The deadline for comments on the HOPPS proposed rule is October 5, 2020.

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D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B Hospitals

D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B Hospitals

By Alan M. Kirschenbaum

In December 2018, we reported on a decision of the Federal District Court for the District of Columbia enjoining CMS from implementing a 28.5% cut in Medicare Part B drug payments to hospitals that purchase drugs under the 340B Drug Discount Program.  On Friday, July 31, the D.C. Circuit reversed that decision.  Both courts applied the Chevron analysis for evaluating the lawfulness of an agency’s interpretation of the statute it administers, but they came to opposite conclusions.  Whereas the lower court had held that the extent of the cuts exceeded CMS’s authority under 42 U.S.C. § 1395l(t)(14)(A)(iii)(II) (“Clause II”) to “adjust” average prices in setting payment rates, the D.C. Circuit concluded that CMS’s interpretation of Clause (II) was not directly foreclosed by the statute and was therefore entitled to deference if reasonable.  The court found that CMS’s interpretation was reasonable, since there was no limit on “adjustments” that may be made under Clause (II), CMS adopted the cuts pursuant to notice and comment rulemaking, and the hospitals did not dispute that the 28.5% reduction (from average sales price (ASP) plus 6% to ASP minus 22.5%) would bring payment rates in line with actual drug acquisition costs under the 340B program.  The court rejected the hospitals’ argument that, under Clause (II), CMS could make only minor adjustments for overhead costs, and could not target 340B hospitals for cuts but not other hospitals.  It is possible that the hospitals will request reconsideration or reconsideration en banc, which must be done within 45 days.

This decision comes at a time when CMS is expected very soon to issue its proposed regulation on the Part B hospital outpatient prospective payment system (“HOPPS”) for 2021, which raises speculation about what action CMS will now take regarding hospital payment for 340B drugs.  CMS had issued the 28.5% cuts in 2018 and 2019, but the 2018 cuts were enjoined by the lower court decision in December 2018, and that court extended its injunction to the 2019 cuts in an opinion issued in May 2019.  Despite the lower court decision, CMS doubled down and maintained the cuts in the 2020 HOPPS rule while the government pursued its appeal.  CMS explained in the preamble to that rule that the lower court decision prohibited CMS from implementing the cuts as an “adjustment” to average prices under Clause II, but CMS was still permitted to reduce rates based on acquisition costs obtained through survey data under 42 U.S.C. 1395l(t)(14)(A)(iii)(I) (“Clause I”).  Accordingly, CMS explained that, if the government lost on appeal, CMS would either use hospital survey data to estimate acquisition costs under Clause I, or rely on solicited public comments to fashion a different remedy for the rates found unlawful under Clause II.  See 84 Fed. Reg. 61142, 61322 (Nov. 12, 2019).  In the meantime, hedging its bets, CMS conducted a survey of hospital acquisition costs for 340B drugs in April-May 2020 with an eye toward a Clause I rate setting.

The D.C. Circuit’s decision now opens two options for CMS: (1) the Clause II option of continuing to implement the 28.5% cuts for 2021 and subsequent years; or (2) the Clause I option of basing payment rates for 340B drugs on the new survey data on drug acquisition costs, which could result in even larger cuts.  A third possibility depends on the November election.  A newly elected Biden Administration could order the withdrawal of the payment reductions so as to avoid further financial stress on 340B safety net hospitals during the COVID 19 pandemic.  We will update our readers in the near future when CMS issues its proposed HOPPS rule for 2021.

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DEA Publishes Proposed Rulemaking Addressing Reporting of Thefts and Significant Losses of Controlled Substances

DEA Publishes Proposed Rulemaking Addressing Reporting of Thefts and Significant Losses of Controlled Substances

By Karla L. Palmer

On July 29, 2020, DEA published a Notice of Proposed Rulemaking titled, “Reporting of Thefts or Significant Loss of Controlled Substances.”  (85 Fed. Reg. 45547 (Jul. 29, 2020)). See Federal Register notice here.  As registrants are well aware, the current DEA regulation addressing reporting to DEA of thefts and significant losses of controlled substances requires applicable registrants to submit in writing an “initial notification” of a theft or significant loss to the Field Division Office of Administration in his or her area, within one business day of discovery.  Next, the registrant must complete, and submit to the Field Division Office in his or her area, a DEA Form 106 regarding the loss or theft.  There is currently no time limitation for when the DEA Form 106 must be submitted.  Registrants regularly submit a Form 106 upon completion of their internal investigation concerning the theft or loss, and then provide updates to the DEA Field Division to the extent that the registrant learns new facts or circumstances surrounding the same.  The DEA Form 106 currently may be submitted either in writing (hard copy) or electronically.

DEA proposes to amend the rule to require the registrant to file a “complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after discovery of the theft or loss.”  (Emphasis added.) 85 Fed. Reg. at 45551.  While we indeed applaud DEA’s proposal to require electronic submissions (as DEA states 99.5 percent of all Form 106’s are already reported electronically), we are curious that DEA seems to be requiring the submission of a “complete and accurate” Form 106 within 15 days of discovery of the theft or significant loss.  While this may seem unimportant or even obvious, if the registrant cannot complete the investigation into the significant loss or theft within the 15-day period, then that submission will not, in fact, be “complete” or even “accurate.”

We assume DEA will accept supplemental Form 106’s after the initial 15-day clock has expired.  We also assume that a registrant will be permitted to supplement its initial Form 106 to correct any “inaccurate” or “incomplete” information included in the initial Form 106 submission based on the later discovery of additional facts or upon completion of an investigation.  Note that DEA is still requiring the submission of an Initial Notification of a theft or significant loss – in writing– within one business day of discovery.  DEA’s regulation on the Initial Notification remains unchanged, so a registrant may still submit it in writing to the appropriate DEA Field Division.

DEA also states in its Notice that the proposed amendment would clarify the submission process by aligning it with the current requirements of reporting losses or disappearance of listed chemicals on a DEA Form 107 and not accepting physical copies. DEA Form 107 also must only be submitted electronically, within 15 days of discovery of the circumstances requiring the report.

DEA seeks comments from industry on the following:

  • Whether the proposed collection of information is necessary for the proper performance of the functions of DEA, including whether the information will have practical utility.
  • The accuracy of DEA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
  • Recommendations to enhance the quality, utility, and clarity of the information to be collected.
  • Recommendations to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.

Registrants must submit comments to OMB (include RIN 1117-AB57/Docket No. DEA–574 on the submission) on or before September 28, 2020.

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Up, Up and But Not Away: DEA Raises Registration Fees

Up, Up and But Not Away: DEA Raises Registration Fees

By Larry K. Houck

An interesting aspect of a federal or state administrative agency seeking appropriations or raising fees is its justification for doing so and the light it sheds on the priorities for fulfilling its mission.  The Drug Enforcement Administration’s (“DEA’s”) recent increase of initial registration and renewal fees, through its Notice of Proposed Rulemaking, (Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants, 85 Fed. Reg. 14,810 (Mar. 16, 2020)) and Final Rule, (Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants, 85 Fed. Reg. 44,710 (July 24, 2020)) is no exception.  In addition to raising fees, DEA also codifies the conditions under which it will now refund registration fees.

Raising Registration Fees

DEA asserts that increasing controlled substance and chemical registrant fees is necessary to recover the full costs of the Diversion Control Program (“DCP”) “so it can continue to meet the programmatic responsibilities set forth by statute, Congress, and the President.”  Without the fee increases, DEA continues, “the DCP will be unable to continue current operations, necessitating dramatic program reductions, and possibly weakening the closed system of [controlled substance] distribution.”  Fed. Reg. 44,717.

The Controlled Substances Act (“CSA”), while authorizing DEA “to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals” also requires the agency to set fees “at a level that ensures the recovery of the full costs of operating the various aspects of” the DCP.  21 U.S.C. §§ 821, 886a(1)(C).  So, DEA must set registration fees that are not only “reasonable” but which also cover all costs of the DCP.

DEA most recently increased registration fees in March 2012 to cover the “full costs” of the DCP for Fiscal Years 2012 through 2014.  DEA has determined that it must increase its total collections by 21 percent to fund the DCP for Fiscal Years 2021 through 2023.  Fed. Reg. 44,721.

DEA cites the following activities as factors justifying the fee increase:

  • Continuing to address the nationwide opioid abuse crisis;
  • Managing and supporting the growing registrant population, expected to rise from 1.4 million in 2012 to over 2 million by 2023, through inspections, registration improvements, enhanced information technology, education and outreach;
  • Fulfilling expanded responsibilities and scope, that include promulgation, implementation and enforcement of regulations due to legislative amendments to the CSA by:
    • The Designer Anabolic Steroid Control Act of 2014 (providing for temporary and permanent scheduling of anabolic steroids);
    • The Comprehensive Addiction and Recovery Act of 2016 (expanding the type of practitioners who can dispense narcotic drugs for maintenance or detoxification treatment);
    • The Protecting Patient Access to Emergency Medications Act of 2017 (creating emergency medical service agencies as a new registration category with recordkeeping and handling requirements); and
    • The Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act (addressing the opioid epidemic in a number of ways including establishment of a centralized database for suspicious order reports and providing manufacturer and distributor access to ARCOS data);
  • Increasing scheduled regulatory inspections of various registrant types;
  • Increasing education and outreach;
  • Identifying additional sources of diversion;
  • Collaborating investigations with state and local entities;
  • Expanding the use of Tactical Diversion Squads (“TDSs”) (comprised of DEA diversion investigators and special agents, state and local law enforcement and regulatory officers conducting criminal investigations);
  • Scheduling drugs of abuse;
  • Establishing controlled substance and listed chemical quotas; and
  • Employing sufficient personnel to fulfill DEA’s regulatory and enforcement mission. Reg. 14,814-14,819.

As of the end of Fiscal Year 2019, DEA employed 86 TDSs, 87 Diversion Groups, 15 Diversion Staff employees and 16 TDS Extensions (2 DEA special agents) around the country.  DEA estimates that it will need 94 TDSs, 95 Diversion Groups, 10 Diversion Staff employees and 10 TDS Extensions by the end of Fiscal Year 2023.  Fed. Reg. 44,720.

Fee Calculation Methodology

DEA considered three methodologies for determining reasonable fees for each registrant category to cover DCP costs during Fiscal Years 2021 through Fiscal Year 2023.  DEA decided to continue using Weight-Ratio methodology that has been in use since Congress established registrant fees and because it remains “a reasonable reflection of differing costs.”  Fed. Reg. 44,725.  The Weight-Ration methodology assigns fees to the different registrant categories based on DEA’s general historical cost data expressed as weighted ratios.  The different fees are expressed in ratios: 1.0 for researchers, canine handlers, analytical labs, and narcotics treatment programs; 3.0 for registrants on three-year registration cycles including pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners; 6.25 for distributors and importers/exporters; and 12.5 for manufacturers.  Fed. Reg. 44,724-25.  Fees under the Weighted-Ratio methodology result in different fees for each registrant group in which “registrants with generally larger revenues and costs pay higher fees than registrants with lower revenues and costs.”  Fed. Reg. 44,725.

DEA considered a Flat Fee methodology that would have set the same fee for all registrants.  This methodology would not take into account the proportion of DCP costs and resources, such as cyclic inspections, that certain registrant categories require.  DEA concluded that calculating fees using this methodology is “not reasonable” as required by the CSA as the disparity among registrant would be “too great,” resulting in reduced fees for manufacturers and distributors by 90 percent and 80 percent, and increase practitioner fees by 23 percent.  Fed. Reg. 44,722-23.

DEA also considered a Past-Based methodology that would use historic DEA investigative work hour data to apportion the cost to each registrant type.  DEA determined that Past-Based methodology would disproportionately burden a small number of registrants, finding that Narcotic Treatment Program fees would increase by 856 percent, while changes for the other registrant groups would range from a 44 percent decrease to an increase of 131 percent.  DEA characterized the Past-Based methodology as “backward looking” and could not assume that the agency’s future workload would reflect past work hour data.  Fed. Reg. 44,723-44,725.

The New Fees

DEA’s new initial registration and renewal fees for each three-year and annual registration cycle registrant category is as follows:

Current and New Fees for Three-Year Cycle Registrants

Registrant Category Current Three-Year Fee New Three-Year Fee Increase Per 3-Year Cycle
Pharmacy; Hospital/Clinic;

Practitioner;

Teaching Institution;

Mid-Level Practitioner

 

 

$731

 

 

$888

 

 

$157

Current and New Fees for Annual Cycle Registrants

Registrant Category Current Annual Fee New Annual Fee Increase Per Year
Manufacturer

(controlled substance and chemical)

$3,047 $3,699 $652
Distributor

(controlled substance and chemical)

$1,523 $1,850 $327
Researcher/
Canine Handler
$244 $296 $52
Analytical Lab $244 $296 $52
Importer

(controlled substance and chemical)

$1,523 $1,850 $327
Exporter

(controlled substance and chemical)

$1,523 $1,850 $327
Reverse Distributor $1,523 $1,850 $327
Narcotic Treatment Program $244 $296 $52

Fed. Reg. 44,718.

DEA received twelve comments received in response to the proposed fee increases.  Five comments were outside the scope.  Two comments supported the fee increases in part while the remaining five expressed concern.

DEA will begin collecting the increased fees for new applications and renewal applications submitted on and after October 1, 2020.  Fed. Reg. 44,710.

Fee Refunds

In addition to establishing new registration fees, DEA also amended 21 C.F.R. §§ 1301.13(e) and 1309.12(b) to “codify existing practices” for issuing controlled substance and chemical registration fee refunds.  Fed. Reg. 44,718, 44,732, 44,734.  Although registration fees are “generally . . . not refundable,” DEA recognizes the need to refund fees as they increase.  The DEA Administrator now has discretionary authority to refund fees in limited circumstances, that include: applicant error such as making duplicate payments for the same renewal, incorrect billing or transposing incorrect credit card digits, payments for incorrect business activities or payments by exempt registrants; DEA error such as incorrectly advising that a new application was needed, or to submit payment for a wrong business activity; and death of a registrant within the first year of the three-year registration cycle.  Fed. Reg. 44,718.

DEA will identify the process for obtaining refunds on the DCP website.

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FDA Finds Limited Evidence That Daily Consumption of Certain Cranberry Products Reduces The Risk of Recurrent UTIs in Healthy Women

FDA Finds Limited Evidence That Daily Consumption of Certain Cranberry Products Reduces The Risk of Recurrent UTIs in Healthy Women

By Riëtte van Laack

On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consumption of certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.

A health claim characterizes the relationship between a substance and a disease or health-related condition. Under the law, FDA may authorize health claims provided that there is significant scientific agreement (SSA) that the claim is supported. In 2017, a Petition submitted on behalf of Ocean Spray Cranberries, Inc. requested that FDA authorize a health claim regarding the relationship between the consumption of cranberry products and a reduced risk of recurrent UTI in healthy women.  FDA determined that the evidence supporting the claim did not meet the SSA standard for an authorized health claim, and, early in 2018, the Petitioner agreed to have the Petition treated as a qualified health claim petition.

As described in FDA’s letter of enforcement discretion, FDA will not object to claims regarding the consumption of cranberry juice beverages containing at least 27 percent cranberry juice, provided that claims include a qualifier that there is limited in inconsistent evidence showing that daily consumption of 8 fl ounce of a cranberry juice beverage reduces the risk of recurrent UTI in healthy women.

For cranberry dietary supplements, FDA will also exercise enforcement discretion for a claim about the relationship between the consumption of cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and the reduced risk of recurrent UTIs in healthy women provided the claim specifies that the claim is supported by limited scientific evidence.

The letter of enforcement discretion is effective immediately, i.e., the qualified health claims may be used immediately in the labeling of eligible products.

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Donald Trump Issues Executive Orders to Control Prescription Drug Prices

Donald Trump Issues Executive Orders to Control Prescription Drug Prices

By Alan M. Kirschenbaum

On Friday, July 24, Donald Trump signed three Executive Orders addressing the high prices of prescription drugs, and threatened to sign a fourth if drug manufacturers do not put forward acceptable proposals for reducing prices.  For the most part, these Orders recycle proposals previously issued by the Department of Health and Human Services (HHS), and their implementation will require rulemaking by that agency.  Nevertheless, it is significant that Trump has now very publicly thrown his weight behind these approaches, all of which are likely to carry momentum regardless of the results of the November election.  The three executive orders and the possible fourth are described below.

Executive Order on Importation of Drugs

One Executive Order directs HHS to complete its rulemaking process to permit the importation of certain drugs from Canada – something that HHS is doing anyway.  HHS issued a proposed rule in December 2019 that would implement Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act) to allow FDA-authorized entities to import certain prescription drugs from Canada.  We reported on this proposed rule here.  HHS’s regulatory agenda identifies December 2020 as the expected time of finalization.

The Executive Order also directs HHS to grant waivers of the prohibition on importation of prescription drugs for the personal use of individuals, provided that the importation poses no additional risks to public safety and results in lower costs to American patients.  This is merely a reiteration of FDC Act section 804(j)(2), which authorizes such waivers with the same provisos.  HHS has never yet certified that waivers under Section 804(j)(2) pose no additional risks to public safety and result in lower costs to American patients.  In fact, when HHS issued the proposed rule described above in December 2019, it specifically declined to implement Section 804(j), citing problems with rogue on-line Canadian pharmacies.  It is unclear whether HHS is prepared to change its outlook now.  If it is, HHS would presumably issue another proposed regulation to implement Section 804(j) and set forth the procedures for obtaining waivers.

Finally, this Executive Order authorizes HHS to permit the re-importation of insulin under FDC Act Section 801(d) upon a finding by HHS that it is required for emergency medical care.  Once again this merely reiterates FDC Act Section 801(d), which has provided HHS with such authority since 1997.

Executive Order on PBM Rebates

On February 6, 2019, the Office of the Inspector General (OIG) of HHS published a proposed rule designed to eliminate the current antikickback law safe harbor protection for rebates paid by drug manufacturers to pharmacy benefit managers (PBMs), and replace it with a new safe harbor protecting manufacturer discounts provided to federal program beneficiaries at the point of sale.  We reported on that proposal here.  HHS withdrew this proposed regulation on July 10, 2019 following a May report by the Congressional Budget Office (CBO) that the rule, if finalized, would increase federal spending by about $177 billion over a ten-year period while increasing premiums for Medicare Part D enrollees.

This Executive Order directs HHS to revive and complete the rulemaking process, but only after confirming “that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.”  In light of the CBO’s findings in May 2019, it appears doubtful whether such confirmation is possible.

Executive Order on Dispensing of Insulin and Epinephrine by FQHCs

The third Executive Order provides that Federally Qualified Health Centers (FQHCs) must provide insulin and self-injectable epinephrine to low income individuals at discounted prices.  FQHCs, which are community-based health care providers that receive funds from HHS to provide primary care services in underserved areas, currently purchase these drugs (among many others) at a statutory discount under the 340B Drug Discount Program.  However, FQHCs are not currently required to provide these drugs to patients at the discounted price.  The Executive Order directs HHS to ensure that FQHCs make these drugs available to their patients at their cost plus a minimal administration fee.

Possible Executive Order on International Reference Pricing

The fourth Executive Order will peg drug payment by Medicare (and perhaps other payors) to prices in foreign countries.  This Order once again recycles a previous HHS proposal – this time, an October 30, 2018 Advance Notice of Proposed Rulemaking (ANPRM), which we reported on here.  The 2018 ANPRM would provide for drug payment rates under Medicare Part B to be based on an international pricing index derived from prices in 14 foreign countries.  To date, the ANPRM has not reached the proposed regulation stage.  A similar international reference price approach is included in H.R. 3, the drug pricing bill passed by the House on December 12, 2019.

The details of this Executive Order are not known, because Donald Trump did not actually sign and issue it.  Instead, he threatened to sign it on August 24 at noon (“not 12:01”) unless drug manufacturers put forward proposals to significantly reduce drug prices before then.  In his remarks, Trump said he will be meeting with the heads of the major drug manufacturers on Tuesday, July 28, to discuss pricing.

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