January 2016 – Senate Finance Request for Comments on Chronic Care & Other Issues

LEGISLATIVE UPDATE

Senate Finance Committee Releases Document for Comment  

In December 2015, the Senate Finance Committee’s Bipartisan Chronic Care Working Group released a Policy Options Document.  The following is an excerpt from a 12/18/15 Press Release by Senate Finance Committee announcing the document’s release: (available at: http://www.finance.senate.gov/release/hatch-wyden-isakson-warner-release-chronic-care-options-paper):

The “Finance Committee Chronic Care Working Group, today released an options paper […] outlining policies being considered as a part of the committee’s effort to improve how Medicare treats beneficiaries with multiple, complex chronic illnesses.

The paper organizes policies into several key areas under consideration:

  • Providing high-quality health care in the home
  • Improving access to interdisciplinary, team-based health care
  • Expanding innovation in benefit design and access to technology
  • Identifying ways to improve payments and quality for the chronically ill population
  • Empowering patients and caregivers in care delivery

Policies in the options paper include allowing Medicare Advantage (MA) plans to tailor benefits specifically for chronically ill enrollees, adding additional tools for Accountable Care Organizations (ACO), making permanent the Independence at Home (IAH) demonstration program that helps primary care providers give high-quality care in the home, and giving greater flexibility to MA and ACOs to deliver non-health services that are pivotal for beneficiaries with multiple, complex chronic illnesses. […]

The paper comes as a part of a 7-month long process to explore and develop legislation to address the challenges facing beneficiaries with chronic conditions enrolled in Medicare. The committee launched the Chronic Care Working Group in May 2015 following the committee’s second hearing on chronic care, and proceeded to solicit comments on potential policy changes. The working group received 530 comments and conducted 80 stakeholder meetings to discuss ideas that improve the way care is delivered to Medicare beneficiaries with chronic diseases.”

Medicare Appeals Bill Introduced in Senate 

As discussed during previous Alliance calls, the Senate Finance Committee marked up a bipartisan bill entitled the Audit & Appeal Fairness, Integrity, and Reforms in Medicare Act of 2015 (AFIRM) on June 3, 2015.  The AFIRM Act is meant to address both Medicare’s hiring of contractors to conduct audits of claims submitted to the program that have led to the dramatic increase in Medicare administrative appeals filed and the resulting backlog of cases.  Several of the provisions, however, discussed below, propose to alter the Medicare appeals system in a manner that raises concerns for beneficiary advocates.  The bill was approved by voice vote at the June 2015 mark up, but legislative language had not yet been drafted.

On December 8, 2015, the Audit & Appeal Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015 (S.2368) was introduced in the Senate.  Neither the full Senate, nor the House, have voted on the bill to date.

The Center’s December 10, 2015 Weekly Alert (available at: http://www.medicareadvocacy.org/proposed-appeals-legislation-leaves-unanswered-questions/) provided the following analysis of the bill.

The Act, intended to improve the Medicare audit and appeals process, would not, in fact, improve the appeals process for beneficiaries and leaves key beneficiary concerns unaddressed.

The Bill does not address the overwhelming denial rates at the first two levels of appeal or eliminate one of these burdensome, and largely useless, steps. Further, people with cases valued at less than $1,500 would no longer have access to an Administrative Law Judge hearing.  The ALJ Hearing level is currently the third and fairest level of appeal.  It is the first chance for most beneficiaries to actually make a case for, and obtain, coverage. Instead, these cases would be heard by a new class of adjudicators known as Medicare Magistrates.  How these Magistrates will perform is unknown.  While the law includes a provision confirming the decisional independence of Magistrates and ALJs, it also includes many more provisions that encourage adherence to Medicare policies, and those policies have historically been more restrictive than the law and regulations.

Ironically, the real reason for the tremendous backlog of cases pending ALJ hearings – CMS’ hospital “outpatient” Observation Status – remains unresolved. While the law would adjust the auditing process, and study the auditor payment systems, the overwhelming use of Observation Status would continue.

Unfortunately, it seems most of the incentives for AFIRM, and many of its provisions, are intended to provide a manageable provider audit system, not to improve the appeals process for older and disabled Medicare beneficiaries.

ADMINISTRATIVE UPDATE

CMS Issues Final Rule on Durable Medical Equipment (DME)

Effective February 20, 2016, CMS has created a prior authorization process for certain identified Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) before they can be approved for Medicare payment. Items subject to prior authorization will be identified on a Master List. According to CMS, there will be no new documentation requirements, but prior authorization will help ensure that applicable coverage, payment, and coding rules are met before equipment or supplies are issued. Data released from CMS, however, raises concerns that this rule creates impediments to beneficiary access to reasonable and necessary DMEPOS.

In supporting prior authorization in the new rule, CMS relies on a prior authorization demonstration program in which monthly expenditures decreased over a three-year time period from $12 million to $3 million in the program’s original seven states, and from $10 million to $2 million in the program’s twelve additional expansion states.

Those are payment decreases of 70% to 80%. CMS indicates that those substantial decreases were possible because prior authorization stops payment for equipment and supplies that are “frequently subject to unnecessary utilization.” Is it possible that a 70% to 80% decrease in payments (translate to a decrease in approval for equipment and supplies) correlates to a similar amount of fraud in the program? If so, that would be a win-win for Medicare and for beneficiaries as CMS should address fraud and only pay legitimate claims. Unfortunately, the rate of fraud is closer to 8% than 80%. According to the Federal Register, “for the 2014 reporting period, 92 percent of the DMEPOS improper payment rate is attributed to insufficient documentation.”  Insufficient documentation is often a simple mistake in the process of documenting the need for the equipment or supply: a doctor leaves off a date, or a therapist doesn’t complete a field. These are clerical errors, not fraud. This distortion of the facts by CMS, and the reports issued by the Office of the Inspector General (OIG) and the Government Accountability Office (GAO), concern beneficiary advocates when it comes to implementation of the prior authorization program.

Advice to Beneficiaries:

  • Understand which items will be subject to prior authorization. A subset of the Master List will include items that require prior authorization. Other items on the list, “may” be subject to prior authorization. The initial items are yet to be published.
  • Sufficient documentation is key. Legitimate prior authorization requests will only result in obtaining equipment and supplies when the paperwork is error-free, legible, and complete. Whenever possible have the prior authorization reviewed by multiple people before submitting it.
  • Monitor the maximum prior authorization timeframes established by the rule. 10 business days for initial review, 20 business days for re-submissions. There are unlimited re-submissions, but, unfortunately, no appeal rights.
  • Know that there is a process for an expedited request for prior authorization. Documentation must be submitted with the request that indicates how the life or health of the beneficiary will be seriously jeopardized without an expedited review. How CMS will define “seriously jeopardized” remains to be seen.

Possible Pros and Cons of the Prior Authorization Rule

Pro

Con

There are specified review timeframes. Beneficiaries may see delays in access.
A beneficiary may have greater confidence of coverage before the item is ordered. The time to review may be doubled for re-review – even for a simple clerical error. There is no appeals process.
Questionable billing practices may be prevented. Beneficiaries may be dependent upon providers and suppliers to ensure the paperwork is correct.
The system may ultimately be made more efficient for all by encouraging careful and correct legitimate requests for coverage. What exactly is subject to prior authorization, and what is not, is currently unclear.

CMS plans to issue specific Prior Authorization guidance through sub-regulatory communications. The Center for Medicare Advocacy will monitor these communications and the Prior Authorization program’s implementation.

In the event beneficiaries encounter any challenges or difficulties with the Prior Authorization process, the Center for Medicare Advocacy appreciates being apprised. Please email your comments to DMEPOS@MedicareAdvocacy.org.

      CMS Issues Proposed Rule on Discharge Planning

As discussed during the last Alliance call, on November 3, 2015, CMS published in the Federal Register a proposed rule that would revise the discharge planning requirements that hospitals, including long-term care hospitals and inpatient rehabilitation facilities, critical access hospitals, and home health agencies, must meet in order to participate in the Medicare and Medicaid programs. According to CMS, the “proposed changes would modernize the discharge planning requirements by: bringing them into closer alignment with current practice; helping to improve patient quality of care and outcomes; and reducing avoidable complications, adverse events, and readmissions.”  The proposed rule would also implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act).  Comments were due January 4, 2016.

The Center’s December 30, 2015 Weekly Alert provided the following analysis of the proposed rule (as well as comments on other proposed CMS rules and policy), available at: http://www.medicareadvocacy.org/the-center-for-medicare-advocacy-responds-to-requests-for-comments-from-cms/.

The Center for Medicare Advocacy (the Center) appreciates the comprehensive approach taken by CMS in developing its discharge planning proposed rule. The proposed rule focuses on reducing avoidable hospital readmissions and improving patient care, with particular attention to the psychiatric and behavioral health needs of patients, including substance abuse disorders. The proposed rule recognizes the importance of the “Improving Medicare Post-Acute Care Transformation Act of 2014” (The Impact Act of 2014), Pub. L. 113-185.  The IMPACT Act should promote better coordination among HHAs, SNFs, IRFs (Inpatient Rehabilitation Facilities), and LTCHs (Long-term Care Hospitals).  See §2 of the IMPACT Act, which added new §1899B to the Social Security Act (SSA) at https://www.;govtrack.us/congress/bills/113/hr4994/text and see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html.

Point-by-Point Comments:

Design (Proposed §483.43(a))

Having input from the hospital medical staff, nursing leadership, and other pertinent services will ensure adequate input in the development of the discharge planning process. This input is critical.  Even so, a clearly defined “point person” is essential to making the design work happen.  This person should have sufficient authority and resources, including staff, to assure that the design process is completed within a specific and well-published timeframe.

Applicability (Proposed §482.43(b))

The Center is in agreement with CMS’ proposal to extend applicability of discharge planning services to certain observation patients such as persons who are undergoing same day surgeries and other outpatient same-day procedures where sedation or anesthesia is involved.   We urge CMS to require discharge planning for all patients who stay overnight in a hospital but are classified as observation status “outpatients.” Without such a discharge planning requirement, these patients are in particular jeopardy of being poorly served after hospitalization.

Discharge Planning Process (Proposed §482.43(c))

We agree with the general breadth of the proposed discharge planning process, particularly the requirement that discharge planning should begin as early in the hospital stay as possible; that the anticipated post-discharge goals, preferences, and needs of the patients are considered; and that an appropriate plan is developed consistent with a patient’s needs and requests, including any co-morbidities.  We also find the reference to the holding in the Supreme Court’s decision, Olmstead v. L.C., 527 U.S. 581 (1999) to be most appropriate. Likewise, we appreciate CMS’ direction that hospitals must continue to abide by federal civil rights laws, including Title VI of the Civil Rights Act of 1964.

Proposed combining of §482.43(b)(2) and §482.43(c)(1) into a single requirement at §482.82(c)(1)

With respect to the proposal to combine and revise the existing requirements of §482.43(b)(2) and §482.43(c)(1) into a single requirement at §482.82(c)(1). We agree that having a registered nurse, a social worker, and other professionals involved are good points. What is missing is a requirement of physician involvement (beyond certification), particularly for persons in geriatric or related specialties, depending on patient need.  Proposed §482.82(c)(2) raises the important issue of a specific time period in which discharge planning should begin.

Discharge to Home (Proposed §482.43(d))

The proposal to re-designate and revise the current requirement at §482.43(c)(5) to become §482.43(d), discharge to home represents a useful expansion. It is a recognition of the importance of care in the home, or residence, or in one’s community (when there is no home).  It also acknowledges the importance of appropriate follow-up care by one’s primary care provider (PCP) or specialist.  Extending this requirement to HHAs, hospice services, or any other type of outpatient health care service is extremely important. Similarly, assuring that proper discharge planning includes instructions about follow-up care is essential.

New Post-Discharge Follow-Up Process (Proposed §482.43(d)(4))

The proposed rule is designed to reduce adverse events post-discharge, with a particular emphasis on medication compliance.  We agree with the notion that information about what to look for, in terms of signs of a possible adverse event, is helpful.

Transfer of Patients to another Health Care Facility (Proposed §482.43(e))

We agree that existing requirements with respect to the discharge and transferring of patients to other facilities should continue. The requirements to transfer medical information, discharge orders, etc., are essential.  We think that in addition to patient specific information, the information to be transferred should include a standardized set of contact information, starting with how to contact the Medicare Ombudsman as well as social services agencies, including legal assistance providers and sources to assist beneficiaries in accessing necessary medications, supports and services.

Requirements for Post-Acute Care Services (Proposed §482.43(f))

We support the re-designation of §482.43(c)(6) through (8) as new §482.43(f), with the addition of IRF and LTCH PAC providers, and extending the requirements consistent with the IMPACT Act.  We also agree that the requirement that Medicare-participating hospitals provide a list of available Medicare-participating HHAs and SNFs is useful, including providing information, if known, about providers that participate in a managed care organizations’ network.

Home Health Agency Discharge Planning Proposal (new 42 CFR §484.58)

The Center is pleased that CMS is proposing to update the HHA discharge requirement by adding proposed §484.58.  This rule would address the requirements of the IMPACT.  CMS is also soliciting comments on the timeline for HHA implementation of proposed discharge planning requirements:  addressing the needs of HHA patients, including the language barrier issues, mobility needs, and visual concerns, and physical, mental, and cognitive issues.  Further, the Center is pleased that this rule will require that the physician responsible for the home health plan of care of a patient be involved in the ongoing process of establishing the discharge plan.

HHA Discharge or Transfer Summary Content (Proposed §484.58(b))

The Center agrees with the bulleted list of items to be included in the discharge patient’s demographic information, including but not limited to name, sex, date of birth, race, ethnicity, and preferred language; contact information of the physician responsible for the home health plan of care; advance directive, if applicable; course of illness/treatment; procedures; diagnoses; laboratory tests and the results of pertinent laboratory and other diagnostic testing.

Critical Access Hospital (CAH) Discharge Planning (Proposed §485.642(a))

The Center is pleased that CMS has outlined a design for CAH discharge planning.  See (Proposed §485.642(a)). As the proposal points out, there are currently no CAH discharge planning conditions of participation (CoP). The proposal notes that the current CoPs at §485.631(c)(2)(ii) provides that a CAH must arrange for, or refer patients to, needed services that cannot be furnished at the CAH.  The Center agrees that there is benefit in improving the transfer and discharge requirements from an inpatient acute care facility, such as CAHs and hospitals.

Applicability (Proposed §485.642(b)

The Center is pleased that CAHs, under the CMS proposal, will be required to have a discharge planning process that is designed to identify the discharge planning needs of each patient and to develop an appropriate discharge plan; that physicians must be involved and certify that the individual is about to be discharged or transferred to a hospital within 96 hours after admission to the CAH. We find, however, that a 96 hour wait before discharge planning commences is far too long; that discharge planning should begin at the beginning of hospitalization, whether the patient is in a CAH or in any other hospital setting.

Discharge Planning Process (Proposed §485.642(c))

We agree with the scope of services to be included in the proposed discharge planning process for CAHs, including identifying the anticipated post-discharge goals, preferences, and discharge planning needs of the patients.  We also agree that a registered nurse, social worker, or other personnel qualified in accordance with the CAH’s discharge planning policies must coordinate the discharge needs evaluation and development of the discharge plan.  We recommend that the process begin at admission as opposed to a 24 hour delay.

Discharge to Home (Proposed §485.642(d)(1) through (3))

The Center is pleased with the establishment of a new “discharge to home” standard.  This requirement focuses on caregiver support, including caregiver instruction, medication management, and patient understanding of written discharge instructions.  These important additions should enhance patient well-being and provide concrete steps to evaluate the success of discharge planning efforts.

Transfer of Patients to another Health Care Facility (Proposed §485.642(e))

The Center supports adding the proposed rule governing the transfer of patients to another health care facility.  We agree with the proposed list of demographic information to be collected, in addition to date of birth, race, ethnicity and preferred language.   implantable device(s), if any; all special instructions or precautions for ongoing care; as appropriate patient’s goals and treatment preferences; and any other necessary information including a copy of the patient’s discharge instructions; the discharge summary; and any other documentation as applicable, to ensure a safe and effective transition of care that supports the post-discharge.

LITIGATION UPDATE

  • Bagnall v. Sebelius (Observation Status) No. 3:11-cv-01703 (D. Conn., filed 11/3/2011). In November 2011, the Center for Medicare Advocacy and Justice in Aging filed a class action lawsuit on behalf of individuals who have been denied Medicare Part A coverage of hospital and nursing home stays because their care in the hospital was considered “outpatient observation” rather than an inpatient admission. When hospital patients are placed on observation status, they are labeled “outpatients,” even though they are often on a regular hospital floor for many days, receiving the same care as inpatients.  Because patients must be hospitalized as inpatients for three consecutive days to receive Medicare Part A coverage of post-hospital nursing home care, people on observation status do not have nursing home coverage.  They must either privately pay the high cost of nursing care or forgo that skilled care.  The number of people placed on observation status has greatly increased in recent years.

As previously reported, on September 23, 2013, a federal judge in Connecticut granted the government’s motion to dismiss the lawsuit.  Plaintiffs appealed, but limited the appeal to the issue of the right to an effective notice and review procedure for beneficiaries placed on observation status.

On January 22, 2015, a three-judge panel of the U.S. Court of Appeals for the Second Circuit decided that Medicare patients who are placed on “Observation Status” in hospitals may have an interest, protected by the Constitution, in challenging that classification.  The panel held that the district court erred when it dismissed the plaintiffs’ due process claims, and it sent the case back to that court for further proceedings.

Update: The parties are now in discovery on the question of whether plaintiffs have a “protected property interest” in Part A coverage of their hospital stays, such that they would have due process rights. Plaintiffs have received voluminous documentation from the government. The law firm of Wilson Sonsini Goodrich & Rosati, which has helped the Center in previous litigation, is providing pro bono assistance with the discovery process.

On August 26, 2014, the Center filed a nationwide class action lawsuit in United States District Court in Connecticut: Lessler v. Burwell, No. 14-1230 (D.Conn.). The five named plaintiffs, from Connecticut, New York and Ohio, have all waited longer than the statutory 90-day limit for a decision on their Medicare appeals. The current average wait time is over five times the Congressionally-mandated time limit.  The complaint is available here: http://www.medicareadvocacy.org/wp-content/uploads/2014/08/00083998.pdf.

On January 29, 2015, defendant’s motion to dismiss was denied.  On June 10, 2015, the court granted the plaintiffs’ motion for certification of nationwide class of Medicare beneficiaries who have been or will be waiting more than 90 days for a decision on their timely-filed request for an ALJ hearing.  The parties have also conducted discovery.

UPDATE: Briefing of cross motions for summary judgment has been postponed while the parties are in settlement negotiations.

  • Jimmo v. Sebelius (Improvement Standard) No. 11-cv-17 (D.Vt. filed 1/18/11).  As reported during previous Alliance calls, the Settlement in Jimmo was approved on January 24, 2013 during a scheduled fairness hearing.  As previously discussed, CMS has issued revisions to its Medicare Benefit Policy Manual to ensure that Medicare coverage is available for skilled maintenance services in the home health, nursing home and outpatient settings.  CMS also implemented a nationwide education campaign for all who make Medicare determinations to ensure that beneficiaries with chronic conditions are not denied coverage for critical services because their underlying conditions will not improve. Pursuant to the Settlement, counsel for the parties are meeting twice a year to discuss problems with implementation and possible solutions, and are in regular contact between meetings.
  • For more information, see the Center’s website at: http://www.medicareadvocacy.org/medicare-info/improvement-standard/
  • Hull v. Sebelius, No. 14-801 (D.Conn.) (Lower level Medicare appeals) On June 4, 2014, the Center filed a complaint in United States District Court in Connecticut against Kathleen Sebelius, Secretary of Health and Human Services (at that time), on behalf of plaintiffs who have been denied a meaningful review of their Medicare claims at the first two levels of appeal. The case was brought as a class action on behalf of Connecticut Medicare beneficiaries seeking home health care coverage, and the four named plaintiffs represent the thousands of beneficiaries who cannot get a meaningful review of their cases. Instead, Medicare beneficiaries receive almost automatic denials of coverage, which is essentially “rubber stamped” at both the Redetermination and Reconsideration levels. The problem persists throughout the country.

On December 8, 2014, the court granted the government’s motion to dismiss on the grounds that the named plaintiffs, who are dual-eligibles, lack standing because they received coverage from Medicaid.  Plaintiffs filed a motion for reconsideration.

Update: On July 6, 2015, the court reconsidered its order but adhered to its decision granting the government’s motion to dismiss because the plaintiffs lack of standing.  In its reconsideration, the court noted that the Supreme Court has granted certiorari in a case that may shed light on the standing issue at dispute. See Spokeo, Inc. v. Robins, 135 S. Ct. 1892 (2015) (granting cert on the following question presented: Whether Congress may confer Article III standing upon a plaintiff who suffers no concrete harm, and who therefore could not otherwise invoke the jurisdiction of a federal court, by authorizing a private right of action based on a bare violation of a federal statute.).  Plaintiffs appealed the case to the Second Circuit on September 17, 2015, and they plan to ask the court to hold the appeal in abeyance pending the outcome of Spokeo at the Supreme Court.

  • For more information, see the Center’s press release “Lawsuit Challenges Unjust and Inefficient Medicare Appeals Process” (June 5, 2014), available at: http://www.medicareadvocacy.org/lawsuit-challenges-unjust-and-inefficient-medicare-appeals-process/;
  • Olsen-Ecker v. Burwell, No. 15-1468 (D.Conn.) (Lower level Medicare appeals) On October 9, 2015, the Center filed a complaint in United States District Court in Connecticut against Sylvia Mathews Burwell, Secretary of Health and Human Services, on behalf of plaintiffs who have been denied a meaningful review of their Medicare claims at the first two levels of appeal. The case was brought as a class action on behalf of Medicare beneficiaries seeking home health care coverage, and the named plaintiff, like the plaintiffs in Hull, represents beneficiaries who cannot get a meaningful review of their cases. However in this “rubber stamp” case, the plaintiff was not eligible for Medicaid and thus was personally financially liable for the Medicare services under appeal.  A motion for class certification was filed on October 23, 2015. This case is still in its early stages. The Center is interested in hearing about similar problems that beneficiaries are encountering with respect to “rubber stamp” denials of home health or SNF coverage at the first two levels of appeal.  Advocates and beneficiaries are encouraged to contact Ali Bers at abers@medicareadvocacy.org
  • Ryan v. Burwell (Prior Favorable Homebound Determination) On December 19, 2014, the Center for Medicare Advocacy and Vermont Legal Aid filed a class action lawsuit against Sylvia Mathews Burwell, the Secretary of Health and Human Services, to stop Medicare’s practice of repeatedly denying coverage for home health services for beneficiaries on the basis that they are allegedly not homebound, when Medicare has previously determined them to be homebound. (Ryan v. Burwell). The lawsuit was filed in the United States District Court in Burlington, Vermont on behalf of two Vermont residents, Marcy Ryan and John Herbert, as a regional class action lawsuit covering New England and New York.

On March 25, 2015, the government filed a motion to dismiss on the grounds that plaintiffs lack standing, that the court lacks subject matter jurisdiction, and that plaintiffs have failed to state claim on which relief may be granted.  On July 27, 2015, the court denied the government’s motion to dismiss, finding four separate ground on which the dually eligible plaintiffs have standing. (Compare Hull, above, in which the court rejected similar standing arguments.) The court also found that it had subject matter jurisdiction and that plaintiffs had stated a claim on which relief could be granted.

UPDATE: Oral argument on the plaintiffs’ motion for certification of a regional class took place in Rutland, Vermont on September 21, 2015.  Judge Crawford has since requested additional briefing on whether certain beneficiaries should be included in the class, and whether the class should be “closed,” meaning time-limited to the point where the agency removed a Manual provision which is at issue in the case.  The supplemental briefing will be filed by November 18, 2015.

  • For more information, including a copy of the complaint, see: http://www.medicareadvocacy.org/federal-court-class-action-challenges-medicares-practice-of-repeatedly-denying-home-health-coverage-for-homebound-beneficiaries/.
  • Lodge v. Burwell (Extreme Dental) 3:15-CV-390 (D. Conn., filed 3/17/2015).  This appeal filed in federal court, District of Connecticut, presents an opportunity for the court to review whether surgical treatment to a Medicare beneficiary’s teeth damaged by radiation therapy to the head and neck was 1) properly characterized by an Administrative Law Judge as a covered physician service medically reasonable and necessary as a part of an overall plan of care for cancer or 2) improperly characterized by the government contractor as excluded dental services.  These competing interpretations depend upon how the specific treatment is characterized.

The plaintiff amended the Complaint on June 30, 2015 to add a claim under the Administrative Procedure Act (APA), stating that in 1974 the agency removed the word “routine” from the description of excluded dental services without following proper notice-and-comment procedure.   On August 13, 2015, the government answered the Complaint and attempted to file a motion to dismiss the APA claim as time-barred. The court quickly denied the government’s motion without prejudice to renew because a procedural pre-filing rule had not been followed.

UPDATE: A conference was held with the court on October 21, 2015, and the government re-filed its motion to dismiss on October 22, 2015.  The motion seeks to dismiss the APA claim as barred by the statute of limitations.  Plaintiff’s opposition to the motion to dismiss will be filed by November 16, 2015.

  • Bremby v. Burwell (per se skilled services) was filed on September 22, 2015, in the U.S. District Court for the District of Connecticut (03:15-cv-01397).  It challenges the denial of Medicare home health coverage for a beneficiary who required monthly Vitamin B-12 intramuscular injections.  Intramuscular injections are, by regulation, a per se skilled service, and the beneficiary in this case has a condition (Total Gastrectomy) for which Medicare policy expressly recognizes B-12 injections to be a medically necessary treatment.  The Center is interested in hearing about similar problems that others are encountering with respect to denials of home health or SNF coverage for per se skilled services listed at 42 C.F.R. 409.33(b).  Advocates and beneficiaries are encouraged to contact Wey-Wey Kwok at wkwok@medicareadvocacy.org.

Other examples of health care services that are defined by Medicare as skilled in either a Skilled Nursing Facility or for Home Health care include:

(1) Intravenous or intramuscular injections and intravenous feeding.

(2) Enteral feeding that comprises at least 26 per cent of daily calorie requirements and provides at least 501 milliliters of fluid per day.

(3) Nasopharyngeal and tracheostomy aspiration;

(4) Insertion and sterile irrigation and replacement of suprapubic catheters;

(5) Application of dressings involving prescription medications and aseptic techniques;

(6) Treatment of extensive decubitus ulcers or other widespread skin disorder;

(7) Heat treatments which have been specifically ordered by a physician as part of active treatment and which require observation by nurses to adequately evaluate the patient’s progress;

(8) Initial phases of a regimen involving administration of medical gases;

(9) Rehabilitation nursing procedures, including the related teaching and adaptive aspects of nursing, that are part of active treatment, e.g., the institution and supervision of bowel and bladder training programs.