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Health Law Daily

January 17, 2017

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TOP STORY

TOP STORY—Attorney adjudicators and precedential decisions added to address backlog

By Harold Bishop, J.D.

HHS is implementing rules that will expand the pool of available Office of Medicare Hearings and Appeals (OMHA) adjudicators and improve the efficiency of the appeals process by streamlining the processes so less time is spent by adjudicators and parties on repetitive issues and procedural matters. The rules are designed to reduce a backlog of appeals and will be achieved through two major changes: (1) the Chair of the Department Appeals Board (DAB) will be granted the authority to designate a final decision issued by the Medicare Appeals Council (Council) as precedential; and (2) providing authority for attorney adjudicators to issue decisions (Final rule, 82 FR 4974, January 17, 2017).

The appeals backlog. In recent years, the Medicare appeals process has experienced an unprecedented and sustained increase in the number of appeals, with request for administrative law judge (ALJ) hearings increasing 1,222 percent from fiscal year (FY) 2009 to FY 2014. Despite significant gains in OMHA ALJ productivity, and initiatives by CMS and OMHA to address the increasing number of appeals, the number of requests for an ALJ hearing and request for reviews of qualified independent contractor (QIC) and independent review entity (IRE) dismissals continue to exceed OMHA’s capacity to adjudicate the requests. For example, as of September 30, 2016, OMHA had over 650,000 pending appeals, while OMHA's adjudication capacity is approximately 92,000 appeals per year.

In response to this appeals backlog, on July 5, 2016, HHS proposed the implementation of rules that would allow the designation of precedential final decisions and the use of attorney adjudicators (see Administrative decisions granted new precedential authority, adjudicators, June 29, 2016).

Precedential final decisions. The Final rule introduces precedential authority to the Medicare claim and entitlement appeals process for: (1) Medicare fee-for-service (Part A and Part B) appeals; (2) appeals of organization determinations issued by Medicare Advantage (MA) and other competitive health plans (Part C appeals); (3) appeals of Part D prescription drug coverage determinations; and (4) certain quality improvement organization (QIO) determinations.

Under the rule, the Chair of the DAB has the authority to designate a final decision of the Secretary issued by the Medicare Appeals Council (Council) as precedential. HHS believes this will provide appellants with a consistent body of final decisions of the Secretary upon which they could determine whether to seek appeals. It will also assist appeal adjudicators at all levels of appeal by providing clear direction on repetitive legal and policy questions, and in limited circumstances, factual questions.

Under the rule, in the limited circumstances in which a precedential decision would apply to a factual question, the decision would be binding where the relevant facts are the same and evidence is presented that the underlying factual circumstances have not changed since the Council issued the precedential final decision.

The rule also provides that in selecting a Council decision as precedential, the DAB Chair may consider decisions that address, resolve, or clarify recurring legal issues, rules or policies, or that may have broad application or impact, or involve issues of public interest.

Attorney adjudicators. The Final rule provides authority for attorney adjudicators to: (1) issue decisions when a decision can be issued without an ALJ conducting a hearing under the regulations; (2) dismiss appeals when an appellant withdraws his or her request for an ALJ hearing; (3) remand appeals for information that can only be provided by CMS or its contractors or at the direction of the Council; and (4) conduct reviews of QIC and IRE dismissals.

Under the rule, an attorney adjudicator in is defined as a licensed attorney employed by OMHA with knowledge of Medicare coverage and payment laws and guidance.

The rule also revises the regulations to make clear that decisions and dismissals issued by attorney adjudicators may be reopened or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. The rule further provides that the rights associated with an appeal adjudicated by an ALJ would extend to any appeal adjudicated by an attorney adjudicator, including any applicable adjudication time frame, escalation option, or right of appeal to the Council.

Applicability of Part 405 rules to other parts. Current MA regulations at 42 C.F.R. 422.562(d) state that unless its rules regarding grievances, organization determinations and appeals under the MA program provide otherwise, the regulations found in 42 C.F.R. part 405 will apply only to the extent appropriate. In addition, the regulations at 42 C.F.R. 478.40(c) indicate that the part 405 regulations apply to hearings and appeals under subpart B of part 478 regarding QIO reconsiderations and appeals, unless they are inconsistent with specific provisions in subpart B.

As a result, the Final rule specifies the provisions of part 405, subpart I contained in the Final rule that are not applicable to MA program appeals or appeals of QIO reconsidered determinations under part 478, subpart B. These provisions include:

·        time frames for making a redetermination;

·        time frame for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level;

·        time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council;

·        the option to request that an appeal be escalated from the OMHA level to the Council and the time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council;

·        request for escalation to federal court; and

·        any other references to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.

OMHA references. To provide clarity to the public on the role of OMHA in administering the ALJ hearing program, and to clearly identify where requests and other filings should be directed, the Final rule defines OMHA as the Office of Medicare Hearings and Appeals within the U.S. Department of Health and Human Services, which administers the ALJ hearing process. The rule also amends regulations to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic.

Medicare Appeals Council references. The Council is currently referred to as the "MAC" throughout the appeals regulations. This reference has caused confusion in recent years with the transition from fiscal intermediaries and carriers, to Medicare administrative contractors (for which the acronym "MAC" is also commonly used) to process claims and make initial determinations and redeterminations in the Medicare Part A and Part B programs. In addition, current MA regulations reference the Medicare Appeals Council but use "Board"' as the shortened reference, and other regulations reference the DAB as the reviewing entity for appeals of ALJ decisions and dismissals, despite the fact that the Council is the entity that conducts reviews of ALJ decisions and dismissals, and issues final decisions of the Secretary for Medicare appeals.

To address this confusion, the Final rule amends the regulations to replace "MAC" or "Board" with "Council." In addition, to align references to the Council as the reviewing entity for appeals of ALJ decisions and dismissals, the rule replaces "Department Appeals Board" and "DAB" in the regulations with "Medicare Appeals Council" and "Council."

The regulations are effective March 20, 2017.

MainStory: TopStory FinalRules ClaimsAppealsNews CMSNews MedicareContractorNews PaymentNews PartANews PartBNews PartCNews PartDNews

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CASES

MEDICAID—E.D.N.C.: Court’s halt of Medicaid expansion request may span presidential administration change

By Bryant Storm, J.D.

North Carolina’s request to expand its Medicaid program under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) may now be decided by incoming Trump Administration officials, after a federal district court granted a temporary restraining order (TRO) preventing HHS from acting on the request for 14 days or until the court takes further action. The temporary halt was initiated by a complaint filed by state Senate Leader Phil Berger (R) and state House Speaker Tim Moore (R) (Berger v. Burwell, January 14, 2017, Flanagan, L.).

Complaint. The complaint alleges the incoming North Carolina administration, led by Governor Roy Cooper (D), unlawfully worked together with the outgoing Obama Administration to expand the state’s Medicaid program. In addition to violating state law requiring general assembly approval of Medicaid expansion, the complaint alleges, the Medicaid expansion request would "saddle North Carolinians with hundreds of millions of dollars of annual Medicaid expenses." The lawsuit, which does not name Cooper as a defendant, asserts that he has exceeded his executive authority.

Next steps. Before the court are HHS’ motion to vacate the TRO and the North Carolina lawmakers’ motion for preliminary and permanent injunctive relief. The court will hear the additional motions on Friday, January 20, 2017.

The case is No. 5:17-cv-25-FL.

Attorneys: Nicole Jo Moss (Cooper & Kirk PLLC) for Phil Berger. Joel L. McElvain, U.S. Department of Justice, for Sylvia Burwell, Secretary, U.S. Department of Health and Human Services.

Companies: U.S. Department of Health and Human Services; Centers for Medicare and Medicaid Services; North Carolina Department of Health and Human Services

Cases: CaseDecisions CMSNews HealthReformNews MedicaidNews EligibilityNews MedicaidPaymentNews TrumpAdministrationNews NorthCarolinaNews

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FEDERAL REGISTER ISSUANCES

GENERIC DRUGS—FDA GUIDANCE NOTES: ANDA applicants see some clarity with RLDs

By Anthony H. Nguyen, J.D.

Abbreviated new drug application (ANDA) applicants were offered additional guidance and recommendations on the usage of reference listed drug (RLD) in applications to the FDA. In two related draft guidance documents ANDA applicants were provided information on identifying and assessing factors when seeking approval of a generic combination product and how to identify and use the known RLD.

Background. The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417), known as the Hatch-Waxman Act, allows an ANDA applicant to rely on the FDA’s previous finding that a reference listed drug (RLD) is safe and effective as long as the ANDA applicant demonstrates that the proposed generic drug and the RLD are the same with respect to active ingredients, dosage form, route of administration, strength, and certain labeling.

Combination products. The general principles apply to products submitted in ANDAs, including drug-device combination products. A generic drug-device combination product classified as therapeutically equivalent to the RLD can be expected to produce the same clinical effect and safety profile as the RLD under the conditions specified in labeling. The FDA recognized that an identical design is not always feasible and, in certain instances, differences in the design of the user interface for a generic drug-device combination product as compared to the RLD may exist without precluding approval of the generic combination drug-device product under an ANDA. The draft guidance will assist potential applicants who plan to develop and submit an ANDA to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part (Notice, 82 FR 4890, January 17, 2017).

The draft guidance document guidance provides general principles, including recommendations on threshold analyses, which are intended to assist potential applicants in the identification and the assessment of differences in the design of the user interface of a proposed generic drug-device combination product when compared to the user interface for its RLD. The FDA also provides recommendations on the design and conduct of comparative use human factors studies that may help applicants determine whether design differences identified between the proposed generic drug-device combination product and its RLD would preclude approval as an ANDA.

Approved product references. The FDA provides potential ANDA applicants guidance information on how to identify a "reference listed drug," "reference standard," and the "basis of submission" in ANDA submissions. According to the agency, a variety of factors has led to industry confusion on what these terms mean and how an ANDA applicant should use them (Notice, 82 FR 4894, January 17, 2017).

Most notably, the discontinued marketing of many approved drug products and the FDA’s identification of reference standards with the RLD symbol ("+") in the printed version, and under the "RLD" column in the electronic version, of FDA’s "Approved Drug Products with Therapeutic Equivalence Evaluations" (Orange Book). The draft guidance explains what these terms mean and clarifies the differences. In addition, the draft guidance provides recommendations on how to accurately use these terms in an ANDA, how persons can request FDA designation of an RLD, and how persons can request FDA selection of a reference standard.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews GenericDrugNews

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TOBACCO—FDA GUIDANCE NOTICES: FDA releases draft guidances for small-packaged cigars and vape shops

By Lindsey Firnbach, J.D.

In accordance with an FDA rule which extended its tobacco product authority to cigars, products made or derived from tobacco, and electronic nicotine delivery systems, the FDA issued two draft guidance notices explaining its opinion on the regulation of small-packaged cigars, labels on products made or derived from tobacco, and vape shops. The rule (81 FR 28707) made cigars and vape shops subject to the requirements of other tobacco products under the federal Food Drug, and Cosmetic Act (FDC Act) (Notice, 82 FR 4892, January 17, 2017; Notice, 82 FR 4893, January 17, 2017).

Cigars. The FDA will require cigars to display health statements in accordance with Section 906(d) of the FDC Act. These requirements will take in effect on May 10, 2018, and all cigars must contain a required warning statement. The statement must be displayed in accordance with a warning plan that is previously sent to the FDA for approval. The warnings must be in at least 12-point font and must encompass at least 30 percent of the two main display panels of the package. Although there is not an exception for cigars that have packaging too small to accommodate these requirements, there is an exception for other tobacco products. This exception allows the mandated warning statement with the font and display requirements in the act, to appear either on the outer container, or on a tag otherwise firmly and permanently affixed to the product package. The FDA stated that it does not intend to take enforcement action with respect to cigars unable to accommodate the label requirements, so long as they meet the requirements of the exception for other tobacco products.

Electronic nicotine delivery systems. The rule also extended the FDA’s tobacco product authority to electronic nicotine delivery systems and other products now deemed as tobacco products. The FDC Act requires that tobacco products must demonstrate on their label the percentage of foreign and domestic grown tobacco contained in the product, and the FDA stated that this would also extend to products derived from or made from tobacco. However, the FDA affirmed that it does not intend to enforce this against products made or derived from tobacco that do not contain tobacco, such as tobacco-derived liquid nicotine.

Vape shops. Although the FDA will not enforce this part of the FDC Act, it will enforce the other provisions of the Act regarding vape shops. Tobacco product manufactures and vape shops that are engaged in the preparation, manufacturing, compounding or processing of tobacco products are subject to the requirements of ingredient listing, reporting of harmful or potentially harmful constituents, tobacco health document submission, and premarket authorization requirements for modification of products. The FDA demonstrated that it would not enforce compliance only in limited circumstances, and explained some instances in which it does not intend to enforce compliance. One such instance is if the original manufacturer provided specifications for the tobacco product, but a vape shop modifies a product without having an authorization order. The FDA does not believe that these modifications will alter the performance of the tobacco product and therefore does not plan to enforce the requirements against the vape shop. Another instance where the FDA does not plan to enforce is when a vape shop does not make any additional modifications that are outside the marketing authorization order, or that are not consistent with the original manufacturer’s specifications, to the device or e-liquid before, after, or during a refill of an open ENDS. Finally, the FDA stated that it does not plan to enforce if the vape shop does not modify the product, such as replacing original coils with the same replacement coils. The guidance demonstrated that only in limited circumstances would the FDA decline to enforcement the requirements.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews AdvertisingNews DrugBiologicNews LabelingNews TobaccoNews

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REPORTS AND LETTERS

ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—OTHER AGENCY DOCUMENTS: Continuous glucose monitors are DME, covered under Medicare Part B

By Paige Arnold, J.D.

Therapeutic continuous glucose monitoring systems used independently, and not to complement glucose monitors, are classified as durable medical equipment (DME) under Medicare Part B, the CMS Administrator determined. Therapeutic CGMs are covered under Medicare as DME because they are used directly in making diabetic treatment decisions, the system as a whole replaces glucose monitors, and the receiver component as an essential component makes the system durable (CMS Ruling, CMS-1682-R, January 12, 2017).

Background: The CMS Administrator addressed the classification of CGMs as DME in an administrative ruling. CMS rulings are binding on all components of CMS, and all components HHS and Social Security Administration adjudications of CMS matters. DME is a benefit category and is defined, in part, under Medicare Plan B, by Section 1861(n) of the Social Security Act (SSA). While blood glucose monitors have been covered as DME under the Medicare program, CMS policy on coverage of CGMs were articulated in this ruling.

The CGMs are multicomponent Class III medical devices that continuously monitor a patient’s glucose level. CGMs require premarket approval by the FDA. This ruling distinguished between two categories of CGMs and addressed whether nontherapeutic and therapeutic CMGs fall within the definition of DME. For the purpose of this ruling, nontherapeutic CMGs work in conjunction with glucose monitors and therapeutic CMGs work independent of glucose monitors and provide information that help the diabetic make treatment decisions.

Nontherapeutic CMGs. Medicare does not cover CMGs used as adjunctive devices to complement, not replace, information in glucose monitors. The Administrator ruled that because adjunctive CGMs do not decide treatment for the diabetic patient and are not durable, they are not covered under Medicare. Specifically, the Administrator considered that these devices do not replace the information from glucose monitors, and that the short lifespan of the sensors of the devices make the system as a whole not considered durable equipment.

Therapeutic CMGs. In determining that therapeutic CGMs are covered, the Administrator looked to the regulation, 42 C.F.R. Sec. 414.202. There are five components required for DME, including that it: (1) can withstand repeated use; (2)has life of at least three years; (3) is used primarily for a medical purpose; (4) is only useful to persons with illness or injury; and (5) is appropriate for use at home.

The Administrator determined that therapeutic CGMs met all five of these requirements. Specifically therapeutic CGMs are not useful to persons without diabetes, and therapeutic CGMs are used to replace a blood glucose monitor for use in making treatment decisions at home. As to the durability criteria, the administrator noted that for multicomponent equipment like CGMs, the component that performs the medically necessary function must be durable in order for the device to be classified as DME. The receiver component was determined to serve the necessary function of these CGMs. Although the glucose sensors are not durable because they must be replaced after six to seven days, and the transmitter has a short life of three months, because the receiver component of the CGM does have a lifespan of over three years, the system is considered durable. Furthermore, the receiver of the therapeutic CGMs also was determined to withstand repeated use by monitoring the patient’s glucose levels over a period of time, and showed the trending of the continuous glucose measurements.

Payment rules. Covered therapeutic CGMs are subject to the payment rules contained in Section 1834(a)(2) of the SSA. The 2017 statewide fee schedule amounts for purchase or rental were calculated by looking at reasonable charges of glucose monitors during a set period in addition to other factors. The schedule amounts will increase in 2018 and subsequent years accordingly.

ReportsLetters: AgencyDocuments CMSNews DMENews MDeviceNews PartBNews

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INDUSTRY NEWS

AGENCY NEWS—Medstar Ambulance settles false billing claims, agrees to CIA

By Harold Bishop, J.D.

Medstar Ambulance Inc., including four subsidiary companies and its two owners agreed to pay $12.7 million to resolve claims that, from January 1, 2011, through October 31, 2014, the Massachusetts-based ambulance company routinely billed Medicare for services that did not qualify for reimbursement. According to U.S. Department of Justice (DOJ) allegations, the company billed for transports that were not medically reasonable and necessary, for higher levels of services than were required by patients’ conditions, and for higher levels of services than were actually provided.

According to a District of Massachusetts press release, Medstar and its subsidiaries (Medstar EMS, Inc., MetroWest Emergency Medical Services, Inc., Fitchburg Emergency Medical and Pioneer Valley EMS, Inc.) provided ambulance services to municipalities, hospitals and skilled nursing facilities in central and western Massachusetts.

The allegations came to the government’s attention when a former employee in Medstar’s billing office filed a complaint in federal court alleging wrongful billing by Medstar. The government intervened in the whistleblower action, which claimed that after Medstar took its ambulance billing services in house around 2011, it began a pattern and practice of submitting false claims to Medicare for ambulance transport services.

The DOJ admits, however, that once Medstar became aware of the investigation in late 2014, it quickly put in place meaningful changes, including revamping its ambulance billing software and training its billing employees. According to the DOJ, Medstar has worked cooperatively with the government throughout the investigation, and has taken swift action to address past misconduct. In addition, Medstar agreed to a corporate integrity agreement (CIA) with HHS.

The case is captioned U.S. ex rel. Meehan v. Medstar Ambulance, Inc., No. 13-CV-12495-IT (D. Mass). The claims settled by the agreement are allegations only; there has been no determination of liability. The whistleblower will receive approximately $3.5 million of the settlement.

Companies: Medstar Ambulance Inc.; Medstar EMS, Inc.; MetroWest Emergency Medical Services, Inc.; Fitchburg Emergency Medical; Pioneer Valley EMS, Inc.

IndustryNews: NewsStory AgencyNews ReimbursementNews BillingNews CMSNews EnforcementNews FCANews FraudNews PartBNews PaymentNews QuiTamNews

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REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments

This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.

New Proposed rules. On January 12, 2017, CMS published aProposed rule that would specify: (1) the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom fabricated orthotics; (2) accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom-fabricated orthotics; (3) requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and (4) a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, this rule would remove the current exemption from accreditation and quality standards for certain practitioners and suppliers. Comments on the rule are due by March 12, 2017.

See the Regulation Tracker for details.

New Final rules. On January 9, 2017, the FDA published a Final rule describing the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the federal Food, Drug, and Cosmetic Act. The FDA expects the rule to: (1) assist investigators in determining the investigational use requirements that apply to their proposed studies; (2) provide clarity regarding the intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug, device, or combination product; and (3) help consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses. The regulations will be effective February 8, 2017.

On January 12, 2017, the HHS Office of Inspector General (OIG) published a Final rule amending the regulations relating to exclusion authorities under the authority of the HHS OIG. The rule incorporates statutory changes, early reinstatement provisions, and policy changes, and clarifies existing regulatory provisions. The regulations will be effective February 12, 2017.

On January 13, 2017, CMS published a Final rule revising the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements (1) focus on the care delivered to patients by HHAs, (2) reflect an interdisciplinary view of patient care, (3) allow HHAs greater flexibility in meeting quality care standards, and (4) eliminate unnecessary procedural requirements. The changes are part of CMS’ effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers. The regulations will be effective on July 13, 2017.

On January 17, 2017, CMS published a Final rule revising the procedures that HHS follows at the administrative law judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this rule revises procedures that HHS follows at CMS and the Medicare Appeals Council levels of appeal for certain matters affecting the ALJ level. The regulations will be effective March 20, 2017.

See the Regulation Tracker for details.

IndustryNews: NewsStory ReimbursementNews ComplianceNews DrugNews MDNews CMSNews ClaimsAppealsNews CombinationNews CoPNews CopayNews DMENews EnforcementNews FDCActNews HomeNews MedicaidNews PartANews PartBNews PartCNews PartDNews QualityNews TobaccoNews

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SUPREME COURT NEWS—Biosimilar dispute headed to the Supreme Court

By Kathryn S. Beard, J.D.

Biosimilar manufacturers will soon have a definitive answer on the timing of giving notice of commercial marketing, thanks to the Supreme Court. On January 13, 2017, the Court granted and consolidated Sandoz, Inc.’s petition for writ of certiorari and Amgen, Inc.’s conditional cross-petition for writ of certiorari. The dispute appeals the Federal Circuit’s July 21, 2015 decision holding that Amgen was entitled to an additional 180-day marketing exclusivity period because of Sandoz’s late notification of its intention to market a biologic product that is biosimilar to Amgen’s Neupogen® (see Court interprets biosimilar ‘enigma’ in favor of abbreviated biologic license applicant, July 22, 2015).

The Court also granted Apotex, Inc.’s motion for leave to file a brief as amici curiae; Apotex was involved in a similar dispute with Amgen (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, July 6, 2016), though the Court denied Apotex’s petition for writ of certiorari earlier this term (see SCOTUS denies cert in biosimilar licensing dispute, December 12, 2016).

The Biologics Price Competition and Innovation Act (BPCIA), which was passed in 2010 as sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), created an abbreviated pathway for FDA approval of a "biosimilar" biologic product. Amgen originally brought suit against Sandoz in federal court asserting various violations of Amgen’s approved license for its cancer-fighting biologic Neupogen (filgrastim) and infringement of Amgen’s patent for a particular method of using filgrastim. The Court will be hearing arguments relating to Sandoz’s question regarding the 180-day notice of commercial marketing and Amgen’s cross-petition on the optionality of a process to settle patent disputes known as the "patent dance" (see Shall we dance? Biosimilars step toward new legal and regulatory future, March 31, 2016).

Makeup of the Court. Since the February 13, 2016, death of Justice Antonin Scalia, there have been eight Justices sitting on the Court. President Barack Obama’s nominee to replace Scalia, D.C. Court of Appeals Chief Judge Merrick Garland, was not considered by the Senate; President-elect Donald Trump plans to nominate a successor early into his term. In order to receive a vote in cases pending before the Court, a Justice must be seated on both the day of the oral argument and the day the written decision is released. Trump’s nominee will only be part of the decision if he or she is confirmed and duly sworn in before the oral arguments, which are not yet scheduled.

Companies: Sandoz, Inc.; Amgen Inc.; Amgen Manufacturing Limited; Apotex, Inc.

IndustryNews: NewsStory DrugNews SupremeCtNews FDCActNews DrugBiologicNews TrumpAdministrationNews

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In the News

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Amgen Inc. | Amgen Manufacturing Limited | Apotex, Inc. | Centers for Medicare and Medicaid Services | Fitchburg Emergency Medical | Medstar Ambulance Inc. | Medstar EMS, Inc. | MetroWest Emergency Medical Services, Inc. | North Carolina Department of Health and Human Services | Pioneer Valley EMS, Inc. | Sandoz, Inc. | U.S. Department of Health and Human Services

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