Friday, October 13, 2017

A 21st-Century-Cures Compliant LCD (Detailed Rationale)

21st Century Cures Act required LCD to have an evaluation of evidence submitted and a rationale for the decision.

In the LCD clipped below, released on October 13, 2017, the NGS MAC has taken this guidance seriously and released a detailed evidence evaluation in its LCD decision.  This decision compiles two reconsideration requests into one revised LCD.

The LCD mimics the "objective/subjective" sequential format used in modern NCDs, where the "evidence" is listed and described first, and then a summary and executive conclusion that a decision can be made on the evidence, and what it is.

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https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35080&ContrId=310&ver=30&ContrVer=1&CntrctrSelected=310*1&Cntrctr=310&name=&DocType=Future&s=24&LCntrctr=180*1&bc=AggAAAQAAAAAAA%3d%3d& 

L35080 NGS MAC
Released 10/16/2017, effective 12/1/2017

Coverage Indications, Limitations, and/or Medical Necessity

Indications:
EsophyX™ is a device for performing transoral incisionless fundoplication surgery (TIF) for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevents acid reflux.
Benefits are not available for endoluminal treatment for Gastroesophageal Reflux Disease (GERD) using the Stretta® procedure, the Bard EndoCinch™ Suturing System, Plicator™, Enteryx® or similar treatments as these procedures are not considered reasonable and necessary for the diagnosis or treatment of an injury or disease. Benefits are not available for LINX® Reflux Management System, which is not a true endoluminal treatment but is also not considered reasonable and necessary for the diagnosis or treatment of an injury or disease.

Currently, these procedures other than TIF are considered non-covered due to the fact that current peer-reviewed literature does not support the long-term efficacy and long-term safety of the services. Claims will be denied as "not proven effective."
Limitations:
For TIF, Coverage is not extended to:
  1. any patient who has recurrent symptoms or other evidence of failure following a prior TIF. These procedures (repeat TIF) would be considered investigational at this time.
  2. any patient in which a staged procedure is being done, as described as a laparoscopic esophageal or paraesophageal diaphragmatic hernia / opening closure followed by a TIF endoscopically.
  3. any patient who has a preoperative hiatal hernia greater than 2 cm (this is because the FDA label for this device is for GERD associated with hiatal hernia of equal or less than 2 cm. Use in patients who have preoperative larger hiatal hernias is not appropriate without a change in the FDA approval/label.)
  4. any GERD patients with BMI > 35, esophagitis LA grade >B, Barrett’s esophagus > 2 cm, and presence of achalasia or esophageal ulcer or has not been on an appropriate trial of proton pump inhibitors.


Summary of Evidence
Summary of evidence for TIF: 
As noted above, transoral incisionless fundoplication surgery is a method for treating gastroesophageal reflux disease. This procedure reconstructs the valve at the top of the stomach that helps prevents acid reflux. 
  1. Anti-Reflux Surgery Supplement to Endogastric Solutions TIF ESOPHYX Reconsideration Request NGS MAC, April 2017.  This is not a peer-reviewed publication but a summary of what the procedure is and a summary of selective publications.   Thus this is not a peer-reviewed publication indexed in the U.S. National Library of Medicine of the National Institutes of Health and thus not valid as supportive literature.
  2. Hakansson B., Montgomery M., Cadiere G, et al. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Alimentary Pharmacology and Therapeutics. 2015 John Wiley & Sons Ltd.  This publication is indexed in the U.S. National Library of Medicine of the National Institutes.   The study was blinded and divided equally into TIF and sham procedures.  While the follow up period was only six (6) months, the time (average days) in remission offered by the TIF procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. Likewise, the secondary outcome measures were all in of the TIF2 procedure. No safety issues were raised. 
  3. Stefanidis G, Viazis N, Kotsikoros N, Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastroesophageal reflux disease responsive to medical therapy.  Diseases of the Esophagus (2017) 30, 1–8.  This publication is indexed in the U.S. National Library of Medicine of the National Institutes of Health.  The study initially had 45 patients who had the TIF procedure and were followed for a mean of 59 months (range 36–75). Only one patient had a complication during surgery and thus was excluded.   The 44 patients all had follow-up upper endoscopy at 6 months, 1 year, and 3–5 years postoperatively.  (72.7%) that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (none PPI usage). Six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), while six more patients (four with heartburn, one with regurgitation, and one with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). This paper supports the procedure.
  4. Technology Coverage Statement on Minimally Invasive Surgical Options for Gastroesophageal Reflux Disease April 2016.  This is a position paper from the American Gastrological Association based on its reviews of TIF publications.  It is strongly supportive.
  5. Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease (GERD)sages.org/publications/guidelines/endoluminal-treatments-for-gastroesophageal-reflux-disease-gerd.  This is a statement from the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Mar 2017.  Its recommendation is: Based on existing evidence, TIF can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure. (Per SAGES, this is level of evidence +++, strong recommendation)
  6. Vaezi M, Bril J, Mills M, et al.  An Episode Payment Framework for Gastroesophageal Reflux Disease.  Gastroenterology 2016;150:1019–1025.  This is an economic and coding paper and not a clinical paper.  It is not supportive. 
  7. Hunter JG, Kahrilas PJ, Bell RCW, et al. Gastroenterology. 2015 Feb;148(2):324-333.  The largest RCT with the lowest risk of bias is an industry-sponsored double-blind sham controlled multicenter study (RESPECT) that evaluated transoral fundoplication in patients whose symptoms were not well-controlled on proton pump inhibitors (PPIs).10 Out of 696 patients screened, 129 met inclusion and exclusion criteria and were randomized in a 2:1 ratio; 87 patients received transoral fundoplication combined with six months of placebo and 42 patients received sham surgery with six months of daily PPI therapy (sham/PPI).  Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). This is supportive.
  8. Bell RCW, Barnes WE, Carter BJ, et al. Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. AM Surg. 2014 Nov;80(11);1093-1105.  This 24-month follow-up has been reported from a prospective multicenter registry of patients with chronic GERD who received transoral fundoplication using the EsophyX2 system with SerosaFuse fasteners. For the 100 consecutive patients who were treated in this community-based study, the median GERD symptom duration was nine years (range, one to 35 years), the median duration of PPI use was seven years (range, one to 20 years), and 92 percent of patients had incomplete symptom control despite maximal medical therapy.  This three-year study provides evidence to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication.  This is supportive. 
Summary of evidence for Stretta®:
The Stretta® procedure is an endoluminal treatment for GERD in which radiofrequency energy is delivered to smooth muscle of the lower esophageal sphincter (LES). A flexible catheter equipped with special needle electrodes for precise energy delivery is placed by mouth into the esophagus and carefully controlled radiofrequency energy is then delivered to the LES and gastric cardia, creating thermal lesions. The manufacturer maintains that the changes that occur immediately, and over time, result in a "tighter" LES and a less compliant gastric cardia. Additionally, the interruption of nerve pathways in the LES area is believed to reduce the incidence of inappropriate LES "relaxations," leading to an improvement in GERD symptoms. Substantial peer-reviewed evidence to fully support these assumptions needs to be published.
Summary of evidence for EndoCinch™ Suturing System and the Plicator™:
The Bard EndoCinch™ Suturing System and the Plicator™ are intended for use in endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for treatment of symptomatic gastroesophageal reflux disease. Substantial peer-reviewed evidence to fully support these assumptions needs to be published.
Summary of evidence for Enteryx®:
Enteryx® is an endoscopic, minimally-invasive procedure in which an ethylene vinyl alcohol polymer solution is injected into one's lower esophageal sphincter muscle using a small needle. This product was recalled by the FDA in September 2005 due to adverse patient events. 
Summary of evidence for LINX® Reflux Management System:
LINX® Reflux Management System - a sphincter augmentation device designed to prevent reflux due to abnormal opening of the lower esophageal sphincter (LES). The system is comprised of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus without compressing the esophageal wall. Unlike the other procedures mentioned, this is extraluminal, not intraluminal.
  1. Saino et al. (2015) reported five-year results on the 44 implant procedures of the magnetic sphincter augmentation (MAS) first performed in the world. Safety and efficacy were evaluated in a prospective, multicenter study with patients serving as their own controls. Thirty-three of the 44 patients (75%) were followed-up at five years. Enrolled patients had an abnormal esophageal pH on ambulatory monitoring, typical GERD symptoms, had been taking daily PPIs, and were between 18 and 75 years of age. Patients were excluded if they had a large hiatal hernia (> 3 cm), Grade B or higher esophagitis (Los Angeles scale), a body mass index (BMI) > 35 kg/m2, Barrett’s esophagus, motility disorders, gross esophageal anatomic abnormalities, or an allergy to titanium, stainless steel, nickel, or ferrous materials. Mean total of time the esophageal pH was < 4 was 11.9% at baseline and 4.6% at five years (P<.001), with 85% (28) of patients achieving a normal pH or a 50% reduction. Mean total GERD-HRQL scores improved from 25.7 to 2.9 (P<.001). Complete discontinuation of PPIs was achieved by 87.8% of patients. Most patients (90.9%) were satisfied with their condition at five years versus none at baseline. Side effects such as gas bloat and difficulty swallowing were no worse after the procedure. There were no long-term complications but there were three of the 44 patients (86.8%) that had a serious adverse event which resolved. Three devices were removed. Limitations of the study were noted as lack of a comparison group, loss of patients during the five-year follow-up, and lack of pH monitoring at all sites after the first year.
  2. Ganz et al. (2015) (in press) performed a prospective study of MAS safety and efficacy in the 100 adults who had GERD for six months or more, were partially responsive to daily proton pump inhibitors (PPIs), and had evidence of pathologic esophageal acid exposure. Exclusion criteria included a hiatal hernia > 3 cm, grade C or D esophagitis (Los Angeles scale), BMI > 35, Barrett’s esophagus, or motility disorder. Eight-five patients in 14 centers in the United States and The Netherlands were followed for five years serving as their own controls. The GERD-HRQL questionnaire was performed at baseline on and off PPIs and after the placement of the device. A 50% or great reduction occurred in 83% at five years and a 50% or more reduction of PPI use occurred in 89.4%. Daily use of PPIs was 100% at baseline and 15.3% at five years with 75.3% reporting no use. All patients reported the ability to belch and vomit with no change in dysphagia. Symptoms of bloating/gas decreased from 52% to 8.3%. No device erosions occurred; seven percent (7%) were removed. Limitations of the study were stated as lack of esophageal pH testing and manometry beyond one year and no comparison group.
  3. Warren et al. (2015) performed a retrospective cohort study of patients with GERD undergoing placement of the MAS or a Nissen fundoplication (NF) at three high-volume esopohageal centers. Inclusion criteria included age of 18 – 85 years, a documented history of GERD at least partially responsive to PPIs, and positive pH testing. Excluded were those with a prior history of gastric or esophageal surgery, a hiatal hernia > 3cm, esophageal dysmotility and/or distal esophageal amplitude of < 35 mm Hg, and the visible presence of Barrett’s or esophageal stricture. There were a total of 415 patients (201 MSA and 214 NF) compared at one year post-procedure. Although the patients were similar in age and gender, the NF patients had higher BMIs (40 vs. 32), dysphagia (39 vs. 27) DeMeester scores (39 vs. 34), microscopic Barrett’s (31% vs 18%) and hiatal hernia (69% vs. 55%). At a one-year follow-up 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores. MSA patients had a greater ability to belch and vomit with less gas bloat. Propensity matched cases (144) showed similar GERD-HRQL scores. The differences in ability to belch or vomit and gas bloat persisted in favor of MSA but mild dysphagia was higher for MSA as was resumption of daily PPIs (24 vs. 12, p = 0.02) Satisfaction rates were similar. There were no deaths and no significant differences in postoperative minor and major morbidities. Two patients had the MSA device removed and two had an NF revision. Study limitations included its retrospective nature and being performed in high-volume esophageal centers may limit its application to other centers.
  4. Reynolds et al. (2015) retrospectively compared charges, complications, and outcomes at one year for 119 patients undergoing MSA (54) or NF (67). Follow-up data were available for 48/52 (92%) of the MSA patients and 59/67 (88%) of the NF patients. There were no significant differences between charges, mean GERD-HRQL, or freedom from PPIs. MSA patients had a shorter operating room time and length of stay, reported less gas bloat symptoms and inability to belch or vomit. Two 30-day complications occurred in the NF group but were resolved. Noted limitations were that the study was not powered to detect a difference in PPI use and charges versus costs were compared. It was concluded that MSA might be an alternative for “gap” patients who are those having residual symptoms on PPIs but not having complicated GERD or complete lower esophageal sphincter (LES) failure.


Analysis of Evidence


(Rationale for Determination)



Gastroesophageal reflux disease (GERD) is mostly treated by medical management. As outlined in the ACG Practice Guidelines (updated in 2005) many patients are treated by empirical therapy, without the use of endoscopy. However some patients require additional diagnostic studies and interventions. The Practice Guidelines discusses the historical controversy of medical vs. surgical intervention but did establish the following two treatment guidelines: 
  • Antireflux surgery, performed by an experienced surgeon, is a maintenance option for the patient with well-documented GERD.
  • Endoscopic therapy controls symptoms in selected patients with well-documented GERD. 
These guidelines note anti-reflux surgery, performed by an experienced surgeon, is a maintenance option for the patient with well documented GERD. In these guidelines endoscopic therapy for GERD was discussed, pointing out there are three broad categories of endoscopic therapy: ‘radiofrequency application to the LES area, techniques designed to decrease reflux using endoscopic sewing devices, and techniques using an injection into the LES region.’ The guidelines also raised remaining issues, including: long-term durability, efficacy in atypical presentation of GERD patients, and efficacy of these procedures performed outside of clinical trials.  
Transoral Incisionless Fundoplication (TIF):
Since these guidelines were updated in 2005, a newer endoscopic suturing technique has emerged in the literature. Transoral Incisionless Fundoplication (TIF) is an endoscopic technique.  At present, the only such device currently on the market is the ExophyXTM. The FDA cleared this device. The FDA clearance is for those patients with chronic GERD, with continued responsiveness to PPIs, and a small hiatal hernia of less or equal to 2 cm. The TIF procedure is described as: 
During transoral fundoplication, a General Surgeon constructs an anterior partial fundoplication of 270-300 degrees by attaching the fundus to the anterior and left lateral wall of the distal esophagus slightly above the esophagogastric junction through full thickness placation using multiple fasteners around the gastroesophageal junction.  The TIF procedure has had different versions (TIF 1.0 vs. 2.0) depending on the circumferential amount of reestablishment of the valve, i.e. 220 degrees vs. 240 degrees.  
As noted above, the evidence supports limited coverage for Transoral Incisionless Fundoplication (TIF). 
Stretta® procedure: 
At this time, open-label studies or patient registries with short term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remain equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective. 
Thus the evidence is not sufficient and/or robust to support any change in coverage.
Enteryx® Procedure: 
Based on the evidence and FDA recall of this product, change in coverage is not warranted. 
LINX® Reflux Management system:  
LINX® Reflux Management system and/or similar treatments are promising for treatment of patients in whom proton pump inhibitor therapy fails. Clinical data from various studies are emerging. At this time, open-label studies or patient registries with short term follow-ups are the dominant source of data. The overwhelming preponderance of reviewers remain equivocal in their support and have called for randomized controlled trials with long-term follow-ups. In the absence of evidence from such studies, and in the absence of wide acceptance, endoscopic treatments for GERD are not proven effective. 
NGS finds the MAS literature to have small numbers of patients with only short follow-up periods with the exception of Saino et al. and Ganz with 44 and 100 patients respectively, noting data were available for 33/44 and 85/100. Randomized controlled studies are lacking, including head-to-head comparisons with other modes of treatment. NGS will review future literature as it becomes available and is provided. 
Thus the evidence is not sufficient and/or robust to support any change in coverage.

Thursday, October 12, 2017

S 794 LCD Clarity Bill

https://www.congress.gov/bill/115th-congress/senate-bill/794/text

115th CONGRESS
1st Session
S. 794

To amend title XVIII of the Social Security Act in order to improve the process whereby Medicare administrative contractors issue local coverage determinations under the Medicare program, and for other purposes.

IN THE SENATE OF THE UNITED STATES
March 30, 2017
Mr. Isakson (for himself, Mr. Carper, Mr. Boozman, and Ms. Stabenow) introduced the following bill; which was read twice and referred to the Committee on Finance

A BILL
To amend title XVIII of the Social Security Act in order to improve the process whereby Medicare administrative contractors issue local coverage determinations under the Medicare program, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “Local Coverage Determination Clarification Act of 2017”.
SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE DETERMINATION (LCD) PROCESS FOR SPECIFIED LCDS.
(a) LCD Development Process.—Section 1862(l)(5) of the Social Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following subparagraph:
“(D) PROCESS FOR ISSUING SPECIFIED LOCAL COVERAGE DETERMINATIONS.—
“(i) IN GENERAL.—In the case of a specified local coverage determination (as defined in clause (iv)) within an area by a medicare admi‘’nistrative contractor that has entered into a contract with the Secretary under section 1874A, such medicare administrative contractor must take the following actions with respect to such determination before such determination may take effect:
“(I) Publish on the public Internet website of the medicare administrative contractor a proposed version of the specified local coverage determination (in this section referred to as a ‘draft determination’), a written rationale for the draft determination, and a description of all evidence relied upon and considered by the medicare administrative contractor in the development of the draft determination.
“(II) Not later than 60 days after the date on which the medicare administrative contractor publishes the draft determination in accordance with subclause (I), convene one or more open, public meetings to review the draft determination, receive comments with respect to the draft determination, and secure the advice of an expert panel (such as a carrier advisory committee described in chapter 13 of the Medicare Program Integrity Manual in effect on August 31, 2015), with respect to the draft determination. The medicare administrative contractor shall make available means for the public to attend such meetings remotely, such as via teleconference.
“(III) With respect to each meeting convened pursuant to subclause (II), post on the public Internet website of the medicare administrative contractor, not later than 14 days after such meeting is convened, a record of the meeting minutes for such meeting.
“(IV) Provide a period for submission of written public comment on such draft determination that begins on the date on which all records required to be posted with respect to such draft determination under subclause (III) are so posted and that is not fewer than 30 days in duration.
“(ii) FINALIZING A SPECIFIED LOCAL COVERAGE DETERMINATION.—A medicare administrative contractor that has entered into a contract with the Secretary under section 1874A shall, with respect to a specified local coverage determination, post on the public Internet website of the medicare administrative contractor the following information before the specified local coverage determination (in this section referred to as the ‘final determination’) takes effect—
“(I) a response the issues raised at meetings convened pursuant to clause (i)(II) with respect to the draft determination;
“(II) the rationale for the final determination;
“(III) in the case that the medicare administrative contractor considered qualifying evidence in the development of the determination that was not described in the written notice provided pursuant to clause (i)(I), a description of such qualifying evidence; and
“(IV) an effective date for the final determination that is not less than 30 days after the date on which such determination is so posted.
“(iii) LIMITATION ON DETERMINATIONS ACROSS JURISDICTIONS.—Notwithstanding any plan under section 1862(l)(5)(A), in the case of a contract with a medicare administrative contractor under section 1874A, such medicare administrative contractor may not finalize a specified local coverage determination pursuant to clause (ii) with respect to a geographic area that applies, or has the effect of applying, outside such area. In the case that such a medicare administrative contractor wishes to adopt, with respect to a specific geographic area a specified local coverage determination developed for a different geographic area, such medicare administrative contractor may not so adopt such determination unless, prior to so adopting such determination, such medicare administrative contractor independently evaluates and considers the qualifying evidence supporting the determination as applicable to such specific geographic area and makes a local coverage determination for such area in accordance with this subparagraph.
“(iv) SPECIFIED LOCAL COVERAGE DETERMINATION DEFINED.—For purposes of this subparagraph, the term ‘specified local coverage determination’ means, with respect to a geographic area—
“(I) a new local coverage determination (regardless of whether such determination made by a medicare administrative contractor that has entered into a contract with the Secretary under section 1874A and is based upon a specified local coverage determination that previously has been made with respect to another geographic area, or by another such medicare administrative contractor);
“(II) a revised local coverage determination for such geographic area that restricts one or more existing coverage criteria for such area (such as by adding noncovered indications to an existing local coverage determination or by deleting previously covered ICD–9 or ICD–10 codes);
“(III) a revised local coverage determination that makes a substantive revision to one or more existing local coverage determinations; and
“(IV) any other local coverage determination specified by the Secretary pursuant to regulations.
“(v) QUALIFYING EVIDENCE DEFINED.—For purposes of this subparagraph, the term ‘qualifying evidence’ means either of the following:
“(I) Scientific evidence published in peer-reviewed medical literature, such as randomized clinical trials or other studies.
“(II) A general consensus of the applicable medical community (such as a consensus evinced through a recognized standard of practice in such medical community) that is supported by information provided by a recognized medical authority, such as a professional medical society.”.
(b) LCD Reconsideration Process.—Section 1869(f) of the Social Security Act (42 U.S.C. 1395ff(f)) is amended—
(1) in paragraph (2)(A), by inserting “(and, as applicable, the limitations under paragraphs (8) and (9))” before the colon;
(2) in paragraph (5), by inserting “(other than under paragraphs (8) and (9))” after “this subsection”;
(3) by redesignating paragraph (8) as paragraph (12); and
(4) by inserting after paragraph (7) the following new paragraphs:
“(8) MEDICARE ADMINISTRATIVE CONTRACTOR RECONSIDERATION PROCESS FOR SPECIFIED LOCAL COVERAGE DETERMINATIONS.—For purposes of paragraph (2)(A), the limitations described in this paragraph are that, upon the filing of a request by an interested party with respect to a specified local coverage determination by a medicare administrative contractor that has entered into a contract with the Secretary under section 1874A, the medicare administrative contractor shall reconsider such determination in accordance with the following process:
“(A) Not later than 30 days after such a request is filed with the medicare administrative contractor by the interested party with respect to such determination, the medicare administrative contractor shall—
“(i) determine whether the request is an applicable request; and
“(ii) in the case that the request is not an applicable request, inform the interested party of the reasons why such request is not an applicable request.
“(B) In the case that the medicare administrative contractor determines under subparagraph (A) that the request described in such subparagraph is an applicable request, the medicare administrative contractor shall, not later than 90 days after the date on which the request was filed with the medicare administrative contractor, take the actions described in subparagraphs (C), (D), and (E) with respect to the determination.
“(C) The action described in this subparagraph is the action of specifying whether any of the following statements is applicable to the determination:
“(i) The determination did not apply, or inaccurately applied, qualifying evidence relevant to such determination.
“(ii) The determination used language that exceeded the scope of the intended purpose of the determination.
“(iii) The determination was incorrect in its determination of whether such item or service is reasonable and necessary for the diagnosis or treatment of illness or injury under section 1862(a)(1)(A).
“(iv) The determination failed to describe, with respect to such an item or service, the clinical conditions to be used for purposes of determining whether such item or service is reasonable and necessary for the diagnosis or treatment of illness or injury under section 1862(a)(1)(A).
“(v) The determination does not apply with respect to items or services to which it was intended to apply.
“(vi) The determination is erroneous for another reason that the medicare administrative contractor identifies.
“(D) The action described in this subparagraph, with respect to the determination, is the action of taking, based on the specification under subparagraph (C) of whether any of the statements in such subparagraph applied to such determination, one or more of the following actions:
“(i) Making no change in the determination.
“(ii) Rescinding a part of the determination (including, as applicable, the entire determination).
“(iii) Modifying the determination to restrict the coverage provided under this title for an item or service that is subject to the determination.
“(iv) Modifying the determination to expand the coverage provided under this title for an item or service that is subject to the determination.
“(E) The action described in this subparagraph is the action of making publicly available a written description of the action taken under subparagraph (D) with respect to the determination.
“(9) AGENCY EVALUATION OF RECONSIDERATION DECISION.—For purposes of paragraph (2)(A), the limitations described in this paragraph are that, in the case that an interested party that filed an applicable request under paragraph (8) with respect to a specified local coverage determination files with the Secretary, on a date that is not later than 120 days after the date on which a medicare administrative contractor takes an action described under paragraph (8)(D) with respect to such determination, an appeal with respect to such decision in such form and manner as the Secretary may require, the Secretary shall, not later than 30 days after such appeal is filed—
“(A) specify which, if any, of the statements in subparagraph (C) of paragraph (8) is applicable to the determination; and
“(B) based on such specification, take one of the actions described in subparagraph (D) of such paragraph with respect to the determination.
The Secretary shall apply subparagraph (A) as though the reference to ‘the medicare administrative contractor’ in clause (vi) of paragraph (8)(C) were a reference to the Secretary.
“(10) DEFINITIONS APPLICABLE TO PARAGRAPHS (8) AND (9).—For purposes of paragraphs (8) and (9):
“(A) The term ‘applicable request’ means a request that is submitted in fiscal year 2018 or a subsequent fiscal year, that is solely with respect to a specified local coverage determination, and that includes a description of the rationale for such request and any evidence supporting such request. For purposes of the preceding sentence, the Secretary may not require, as a condition of treating a request with respect to such a determination as an applicable request, that the request contain qualifying evidence that was not considered in the development of such determination.
“(B) The term ‘interested party’ means, with respect to a specified local coverage determination within an area by a medicare administrative contractor that has entered into a contract with the Secretary under section 1874A—
“(i) a provider of services or supplier that, in such area, furnishes, provides, or supplies items or services that are subject to such determination; or
“(ii) an organization that represents such a provider of services or supplier.
“(C) The term ‘qualifying evidence’ has the meaning given such term by clause (v) of section 1862(l)(5)(D).
“(D) The term ‘specified local coverage determination’ has the meaning given such term by clause (iv) of such section.
“(11) APPOINTMENT OF OMBUDSMAN.—
“(A) IN GENERAL.—The Secretary shall, within the Centers for Medicare & Medicaid Services, appoint a Medicare Reviews and Appeals Ombudsman (referred to in this paragraph as the ‘Ombudsman’).
“(B) DUTIES.—The Ombudsman shall, with respect to specified local coverage determinations, carry out the following duties:
“(i) Provide interested parties (as defined in paragraph (10)(B)) with administrative and technical assistance in filing requests under paragraph (8) and appeals under paragraph (9).
“(ii) Make publicly available in a uniform, consistent, and easily understood format the following information for each 12-month period:
“(I) The number of requests filed with medicare administrative contractors under paragraph (8), and of appeals filed with the Secretary under paragraph (9), during such period.
“(II) With respect to such requests during such period, the number of times that medicare administrative contractors took, with respect to the actions described subparagraph (A)(iv) of such paragraph, each such action.
“(III) With respect to such appeals during such period, the number of times that the Secretary took each such action.
“(IV) With respect to the numbers made available under subclauses (I), (II), and (III), the number of each such number that is attributable to—
“(aa) each medicare administrative contractor; and
“(bb) each interested party (as defined in paragraph (10)(B)).
“(V) Measures of the responsiveness of medicare administrative contractors with respect to requests filed with such medicare administrative contractors under paragraph (8).
“(VI) Recommendations to the Secretary with respect to ways to improve—
“(aa) the efficacy and efficiency of the process described in paragraph (8); and
“(bb) communication with individuals entitled to benefits under part A or enrolled under part B, providers of services, and suppliers regarding such process.”.
(c) Promulgation Of Regulations; Application Date.—The Secretary of Health and Human Services shall promulgate regulations to carry out paragraph (5)(D) of section 1862(l) of the Social Security Act (42 U.S.C. 1395y(l)), as added by subsection (a), and paragraphs (8) and (9) of section 1869(f) of such Act (42 U.S.C. 1395ff(f)), as inserted by subsection (b), in such a manner as to ensure that the processes described in such paragraphs are fully implemented by October 1, 2017.

21CC LCD Text (Section 4009)

https://www.congress.gov/bill/114th-congress/house-bill/34/text


SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.

    (a) In General.--Section 1862(l)(5) of the Social Security Act (42 
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new 
subparagraph:
                    ``(D) Local coverage determinations.--The Secretary 
                shall require each Medicare administrative contractor 
                that develops a local coverage determination to make 
                available on the Internet website of such contractor and 
                on the Medicare Internet website, at least 45 days 
                before the effective date of such determination, the 
                following information:
                          ``(i) Such determination in its entirety.
                          ``(ii) Where and when the proposed 
                      determination was first made public.
                          ``(iii) Hyperlinks to the proposed 
                      determination and a response to comments submitted 
                      to the contractor with respect to such proposed 
                      determination.
                          ``(iv) A summary of evidence that was 
                      considered by the contractor during the 
                      development of such determination and a list of 
                      the sources of such evidence.
                          ``(v) An explanation of the rationale that 
                      supports such determination.''.

    (b) <<NOTE: 42 USC 1395y note.>>  Effective Date.--The amendment 
made by subsection (a) shall apply with respect to local coverage 
determinations that are proposed or revised on or after the date that is 
180 days after the date of enactment of this Act.

Sunday, October 8, 2017

Footnote


45 CFR 147.133 Moral Exceptions and CFR on Religious Exceptions



§147.133 Moral exemptions in connection with coverage of certain preventive health services. 

(a)  Objecting entities.  (1) Guidelines issued under §147.130(a)(1)(iv) by the Health
Resources and Services Administration must not provide for or support the requirement of
coverage or payments for contraceptive services with respect to a group health plan established
or maintained by an objecting organization, or health insurance coverage offered or arranged by
an objecting organization, and thus the Health Resources and Service Administration will
exempt from any guidelines’ requirements that relate to the provision of contraceptive services:
(i)  A group health plan and health insurance coverage provided in connection with a
group health plan to the extent one of the following non-governmental plan sponsors object as
specified in paragraph (a)(2) of this section:
(A)  A nonprofit organization; or
(B)  A for-profit entity that has no publicly traded ownership interests (for this purpose, a
publicly traded ownership interest is any class of common equity securities required to be
registered under section 12 of the Securities Exchange Act of 1934); 
(ii)  An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of
student health insurance coverage, to the extent that institution objects as specified in paragraph
(a)(2) of this section.  In the case of student health insurance coverage, this section is applicable
in a manner comparable to its applicability to group health insurance coverage provided in
connection with a group health plan established or maintained by a plan sponsor that is an
employer, and references to “plan participants and beneficiaries” will be interpreted as references
to student enrollees and their covered dependents; and
(iii)  A health insurance issuer offering group or individual insurance coverage to the
extent the issuer objects as specified in paragraph (a)(2) of this section.  Where a health
insurance issuer providing group health insurance coverage is exempt under paragraph (a)(1)(iii)
of this section, the group health plan established or maintained by the plan sponsor with which
the health insurance issuer contracts remains subject to any requirement to provide coverage for
contraceptive services under Guidelines issued under §147.130(a)(1)(iv) unless it is also exempt
from that requirement.
(2)  The exemption of this paragraph (a) will apply to the extent that an entity described
in paragraph (a)(1) of this section objects to its establishing, maintaining, providing, offering, or
arranging (as applicable) coverage or payments for some or all contraceptive services, or for a
plan, issuer, or third party administrator that provides or arranges such coverage or payments,
based on its sincerely held moral convictions.
(b)  Objecting individuals.  Guidelines issued under §147.130(a)(1)(iv) by the Health
Resources and Services Administration must not provide for or support the requirement of
coverage or payments for contraceptive services with respect to individuals who object as
specified in this paragraph (b), and nothing in §147.130(a)(1)(iv), 26 CFR 54.9815–
2713(a)(1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health
insurance issuer offering group or individual health insurance coverage, and as applicable, a
willing plan sponsor of a group health plan, from offering a separate policy, certificate or
contract of insurance or a separate group health plan or benefit package option, to any individual
who objects to coverage or payments for some or all contraceptive services based on sincerely
held moral convictions.


RELIGIOUS EXCEPTIONS

 

DEPARTMENT OF LABOR 
Employee Benefits Security Administration 
For the reasons set forth in the preamble, the Department of Labor amends 29 CFR part 
2590 as follows: 
PART 2590—RULES AND REGULATIONS FOR GROUP HEALTH PLANS 
            6.  The authority citation for part 2590 continues to read as follows: 
            AUTHORITY: 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 
1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 
1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-
343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended 
by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Secretary of 
Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012). 
7.  Section 2590.715-2713 is amended by revising paragraphs (a)(1) introductory text and 
(a)(1)(iv) to read as follows: 
§ 2590.715-2713 Coverage of preventive health services. 
            (a)  Services--(1)  In general. Beginning at the time described in paragraph (b) of this section and subject to § 2590.715-2713A, a group health plan, or a health insurance issuer offering group health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for— 
*     *     *     *     *    
            (iv)  With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by  the Health Resources and Services Administration for purposes of section 2713(a)(4) of the 
Public Health Service Act, subject to 45 CFR 147.131 and 147.132. 
*     *     *     *     *    
            8.  Section 2590.715-2713A is revised to read as follows: 
§ 2590.715-2713A   Accommodations in connection with coverage of preventive health services. 
(a)  Eligible organizations for optional accommodation.  An eligible organization is an organization that meets the criteria of paragraphs (a)(1) through (4) of this section. 
(1)  The organization is an objecting entity described in 45 CFR 147.132(a)(1)(i) or (ii); 
(2)  Notwithstanding its exempt status under 45 CFR 147.132(a), the organization voluntarily seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (b) or (c) of this section as applicable; and 
(3)  [Reserved] 
(4)  The organization self-certifies in the form and manner specified by the Secretary or provides notice to the Secretary of the Department of Health and Human Services as described in paragraph (b) or (c) of this section.  To qualify as an eligible organization, the organization must make such self-certification or notice available for examination upon request by the first day of the first plan year to which the accommodation in paragraph (b) or (c) of this section applies.  
The self-certification or notice must be executed by a person authorized to make the certification or provide the notice on behalf of the organization, and must be maintained in a manner consistent with the record retention requirements under section 107 of ERISA. 
(5)  An eligible organization may revoke its use of the accommodation process, and its issuer or third party administrator must provide participants and beneficiaries written notice of  



such revocation as specified in guidance issued by the Secretary of the Department of Health and Human Services.  If contraceptive coverage is currently being offered by an issuer or third party administrator through the accommodation process, the revocation will be effective on the first day of the first plan year that begins on or after 30 days after the date of the revocation (to allow for the provision of notice to plan participants in cases where contraceptive benefits will no longer be provided).  Alternatively, an eligible organization may give 60-days notice pursuant to PHS Act section 2715(d)(4) and § 2590.715-2715(b), if applicable, to revoke its use of the accommodation process. 
(b)  Optional accommodation - self-insured group health plans. (1)  A group health plan established or maintained by an eligible organization that provides benefits on a self-insured basis may voluntarily elect an optional accommodation under which its third party administrator(s) will provide or arrange payments for all or a subset of contraceptive services for one or more plan years.  To invoke the optional accommodation process: 
(i)  The eligible organization or its plan must contract with one or more third party administrators. 
(ii)  The eligible organization must provide either a copy of the self-certification to each third party administrator or a notice to the Secretary of the Department of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage of all or a subset of contraceptive services. 
(A)  When a copy of the self-certification is provided directly to a third party administrator, such self-certification must include notice that obligations of the third party administrator are set forth in § 2510.3-16 of this chapter and this section.   


  

(B)  When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 
147.145(a) or a church plan within the meaning of section 3(33) of ERISA); and the name and contact information for any of the plan’s third party administrators.  If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of the Department of Health and Human Services for the optional accommodation process to remain in effect.  The Department of Labor (working with the Department of Health and Human Services), will send a separate notification to each of the plan’s third party administrators informing the third party administrator that the Secretary of the Department of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under § 2510.3-16 of 
this chapter and this section. 
(2)  If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph (b)(1)(ii) of this section, and is willing to enter into or remain in a contractual relationship with the eligible organization or its plan to provide administrative services for the plan, then the third party administrator will provide or arrange payments for contraceptive services, using one of the following methods—  




(i)  Provide payments for the contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or  
(ii)  Arrange for an issuer or other entity to provide payments for contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. 
(3)  If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the Federally facilitated Exchange user fee for a participating issuer pursuant to 45 CFR 156.50(d). 
(4)  A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section.  
(5) Where an otherwise eligible organization does not contract with a third party administrator and it files a self-certification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not apply, and the otherwise eligible organization is under no requirement to provide coverage or payments for contraceptive services to which it objects.  The plan administrator for that otherwise eligible organization may, if it and the otherwise eligible organization choose, arrange for payments for contraceptive services from  


an issuer or other entity in accordance with paragraph (b)(2)(ii) of this section, and such issuer or other entity may receive reimbursements in accordance with paragraph (b)(3) of this section. 
(c)  Optional accommodation - insured group health plans—(1)  General rule. A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers may voluntarily elect an optional accommodation under which its health insurance issuer(s) will provide payments for all or a subset of contraceptive services for one or more plan years.  To invoke the optional accommodation process: 
(i)  The eligible organization or its plan must contract with one or more health insurance issuers. 
(ii)  The eligible organization must provide either a copy of the self-certification to each issuer providing coverage in connection with the plan or a notice to the Secretary of the Department of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage for all or a subset of contraceptive services. 
(A) When a self-certification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 2590.715-2713.  
(B)  When a notice is provided to the Secretary of the Department of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable) but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 
CFR 147.145(a) or a church plan within the meaning of section 3(33) of ERISA); and the name  

and contact information for any of the plan’s health insurance issuers.  If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Department Health and Human Services for the optional accommodation process to remain in effect.  The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer 
that the Secretary of Health and Human Services has received a notice under paragraph (c)(2)(ii) of this section and describing the obligations of the issuer under this section. 
(2)  If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (c)(2)(ii) of this section and does not have its own objection as described in 45 CFR 147.132 to 
providing the contraceptive services to which the eligible organization objects, then the issuer will provide payments for contraceptive services as follows—   
(i)  The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 2590.715-2713(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan. 
            (ii)  With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), or impose any premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. The issuer must segregate premium revenue collected from the eligible organization from the monies used to provide payments for contraceptive services. The issuer must provide payments for contraceptive 
services in a manner that is consistent with the requirements under sections 2706, 2709, 2711,  



2713, 2719, and 2719A of the PHS Act, as incorporated into section 715 of ERISA.  If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 2590.715-2713(a)(1)(iv), the issuer is required to provide payments only for those contraceptive services for which the group health plan does not provide coverage.  However, the issuer may provide payments for all contraceptive services, at the issuer’s option. 
(3)  A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (c)(1)(ii) of this section.   
(d)  Notice of availability of separate payments for contraceptive services - self-insured 
and insured group health plans.  For each plan year to which the optional accommodation in paragraph (b) or (c) of this section is to apply, a third party administrator required to provide or arrange payments for contraceptive services pursuant to paragraph (b) of this section, and an 
issuer required to provide payments for contraceptive services pursuant to paragraph (c) of this section, must provide to plan participants and beneficiaries written notice of the availability of separate payments for contraceptive services contemporaneous with (to the extent possible), but separate from, any application materials distributed in connection with enrollment (or re-enrollment) in group health coverage that is effective beginning on the first day of each applicable plan year.  The notice must specify that the eligible organization does not administer 
or fund contraceptive benefits, but that the third party administrator or issuer, as applicable, provides or arranges separate payments for contraceptive services, and must provide contact information for questions and complaints.  The following model language, or substantially 
similar language, may be used to satisfy the notice requirement of this paragraph (d): “Your   

employer has certified that your group health plan qualifies for an accommodation with respect to the Federal requirement to cover all Food and Drug Administration-approved contraceptive services for women, as prescribed by a health care provider, without cost sharing.  This means that your employer will not contract, arrange, pay,or refer for contraceptive coverage. Instead, [name of third party administrator/health insurance issuer] will provide or arrange separate 
payments for contraceptive services that you use, without cost sharing and at no other cost, for so long as you are enrolled in your group health plan.  Your employer will not administer or fund these payments.  If you have any questions about this notice, contact [contact information for third party administrator/health insurance issuer].” 
(e)  Definition.  For the purposes of this section, reference to “contraceptive” services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 2590.715-
2713(a)(1)(iv). 
            (f)  Severability.  Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. 
                                                 


CMS-9940-IFC                                                            155  

DEPARTMENT OF HEALTH AND HUMAN SERVICES 
For the reasons set forth in the preamble, the Department of Health and Human Services 
amends 45 CFR part 147 as follows: 
PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP 
AND INDIVIDUAL HEALTH INSURANCE MARKETS 
9.  The authority citation for part 147 continues to read as follows: 
Authority:  Secs 2701 through 2763, 2791, and 2792 of the Public Health Service Act 
(42 USC 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended. 
10.  Section 147.130 is amended by revising paragraphs (a)(1) introductory text and 
(a)(1)(iv) to read as follows: 
§ 147.130 Coverage of preventive health services. 
(a) *     *     *      
(1)  In general.  Beginning at the time described in paragraph (b) of this section and subject to §§ 147.131 and 147.132, a group health plan, or a health insurance issuer offering group or individual health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for— 
*     *     *     *     *  
(iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the 
Public Health Service Act, subject to §§ 147.131 and 147.132. 
*     *     *     *     * 
            11.  Section 147.131 is revised to read as follows:  


CMS-9940-IFC                                                            156  

§ 147.131 Accommodations in connection with coverage of certain preventive health 
services. 
            (a) – (b)  [Reserved] 
            (c)  Eligible organizations for optional accommodation.  An eligible organization is an organization that meets the criteria of paragraphs (c)(1) through (3) of this section. 
(1)  The organization is an objecting entity described in § 147.132(a)(1)(i) or (ii). 
(2)  Notwithstanding its exempt status under § 147.132(a), the organization voluntarily 
seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (d) of this section; and 
(3)  The organization self-certifies in the form and manner specified by the Secretary or provides notice to the Secretary as described in paragraph (d) of this section.  To qualify as an eligible organization, the organization must make such self-certification or notice available for examination upon request by the first day of the first plan year to which the accommodation in paragraph (d) of this section applies.  The self-certification or notice must be executed by a person authorized to make the certification or provide the notice on behalf of the organization, 
and must be maintained in a manner consistent with the record retention requirements under section 107 of ERISA. 
(4)  An eligible organization may revoke its use of the accommodation process, and its issuer must provide participants and beneficiaries written notice of such revocation as specified in guidance issued by the Secretary of the Department of Health and Human Services.  If contraceptive coverage is currently being offered by an issuer through the accommodation process, the revocation will be effective on the first day of the first plan year that begins on or 
after 30 days after the date of the revocation (to allow for the provision of notice to plan  
participants in cases where contraceptive benefits will no longer be provided).  Alternatively, an eligible organization may give 60-days notice pursuant to section 2715(d)(4) of the PHS Act and § 147.200(b), if applicable, to revoke its use of the accommodation process. 
(d)  Optional accommodation—insured group health plans—(1)  General rule.  A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers may voluntarily elect an optional accommodation under which its health insurance issuer(s) will provide payments for all or a subset of contraceptive services for one or more plan years.  To invoke the optional accommodation process: 
(i)  The eligible organization or its plan must contract with one or more health insurance issuers. 
(ii)  The eligible organization must provide either a copy of the self-certification to each issuer providing coverage in connection with the plan or a notice to the Secretary of the Department of Health and Human Services that it is an eligible organization and of its objection as described in § 147.132 to coverage for all or a subset of contraceptive services. 
(A)  When a self-certification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 147.130(a)(iv).  
(B)  When a notice is provided to the Secretary of the Department of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in § 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable) but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is a student health insurance plan within the meaning of §  



147.145(a) or a church plan within the meaning of section 3(33) of ERISA); and the name and contact information for any of the plan’s health insurance issuers.  If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of the Department of Health and Human Services for the optional accommodation to remain in effect.  The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the 
issuer that the Secretary of the Deparement of Health and Human Services has received a notice under paragraph (d)(1)(ii) of this section and describing the obligations of the issuer under this section.  
(2)  If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (d)(1)(ii) of this section and does not have an objection as described in § 147.132 to providing the contraceptive services identified in the self-certification or the notification from the Department of Health and Human Services, then the issuer will provide payments for 
contraceptive services as follows— 
(i)  The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 141.130(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan. 
            (ii)  With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries.  The issuer must segregate premium revenue  

   

collected from the eligible organization from the monies used to provide payments for contraceptive services.  The issuer must provide payments for contraceptive services in a manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713, 2719, and 2719A 
of the PHS Act.  If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 147.130(a)(1)(iv), the issuer is required to provide payments only for those contraceptive services for which the group health plan does not provide coverage.  However, the issuer may provide payments for all contraceptive services, at the issuer’s option. 
(3)  A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (d)(1)(ii) of this section.   
(e)  Notice of availability of separate payments for contraceptive services - insured group health plans and student health insurance coverage.  For each plan year to which the optional accommodation in paragraph (d) of this section is to apply, an issuer required to provide payments for contraceptive services pursuant to paragraph (d) of this section must provide to plan participants and beneficiaries written notice of the availability of separate payments for contraceptive services contemporaneous with (to the extent possible), but separate from, any application materials distributed in connection with enrollment (or re-enrollment) in group health coverage that is effective beginning on the first day of each applicable plan year.  The notice 
must specify that the eligible organization does not administer or fund contraceptive benefits, but that the issuer provides separate payments for contraceptive services, and must provide contact information for questions and complaints.  The following model language, or substantially similar language, may be used to satisfy the notice requirement of this paragraph (e) “Your  


[employer/institution of higher education] has certified that your [group health plan/student health insurance coverage] qualifies for an accommodation with respect to the Federal requirement to cover all Food and Drug Administration-approved contraceptive services for women, as prescribed by a health care provider, without cost sharing.  This means that your [employer/institution of higher education] will not contract, arrange, pay, or refer for contraceptive coverage.  Instead, [name of health insurance issuer] will provide separate payments for contraceptive services that you use, without cost sharing and at no other cost, for so long as you are enrolled in your [group health plan/student health insurance coverage].  Your [employer/institution of higher education] will not administer or fund these payments . If you have any questions about this notice, contact [contact information for health insurance issuer].” 
(f)  Definition.  For the purposes of this section, reference to “contraceptive” services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 147.130(a)(1)(iv). 
(g)  Severability.  Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. 
12.  Add § 147.132 to read as follows: 
§ 147.132 Religious exemptions in connection with coverage of certain preventive health 
services. 

(a)  Objecting entities. (1)  Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, and thus the Health Resources and Service Administration will exempt from any guidelines’ requirements that relate to the provision of contraceptive services: 
(i)  A group health plan and health insurance coverage provided in connection with a group health plan to the extent the non-governmental plan sponsor objects as specified in paragraph (a)(2) of this section.  Such non-governmental plan sponsors include, but are not limited to, the following entities-- 
(A)  A church, an integrated auxiliary of a church, a convention or association of 
churches, or a religious order.  
(B)  A nonprofit organization. 
(C)  A closely held for-profit entity.   
(D)  A for-profit entity that is not closely held. 
(E)  Any other non-governmental employer. 
(ii)  An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (a)(2) of this section.  In the case of student health insurance coverage, this section is applicable in a manner comparable to its applicability to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer, and references to “plan participants and beneficiaries” will be interpreted as references 
to student enrollees and their covered dependents; and  
(iii)  A health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (a)(2) of this section.  Where a health insurance issuer providing group health insurance coverage is exempt under this paragraph 
(a)(1)(iii), the plan remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that requirement.  
(2)  The exemption of this paragraph (a) will apply to the extent that an entity described in paragraph (a)(1) of this section objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage, payments, or a plan that provides coverage or payments for some or all contraceptive services, based on its sincerely held religious beliefs. 
(b)  Objecting individuals.  Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to individuals who object as specified in this paragraph (b), and nothing in § 147.130(a)(1)(iv), 26 CFR 54.9815–2713(a)(1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health 
insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate benefit package option, or a separate policy, certificate or contract of insurance, to any individual who objects to coverage or payments for some or all contraceptive services based on sincerely held religious beliefs. 
(c)  Definition.  For the purposes of this section, reference to “contraceptive” services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 147.130(a)(1)(iv).  

(d)  Severability.  Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. 









[Billing Codes: 4830-01-P; 4510-029-P; 4120-01-P; 6325-64] 
[FR Doc. 2017-21851 Filed: 10/6/2017 11:15 am; Publication Date:  10/13/2017]