,i #aafth ,,congress #ast ,session ,h4 ,r4 #badc ,,in ,,the ,,house ,,of ,,representatives ,april #i1 #bjai,ms4 ,speier 7for herself and ,ms4 ,titus7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to prevent wasteful and abusive billing of ancillary services to the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,promoting ,integrity in ,medicare ,act of #bjai or ,,pima of #bjai4 #b4 ,findings2 purposes 7a7 ,findings ,congress finds the following3 7#a7 ,recent studies by the ,government ,accountability ,office 7,,gao7 examining self-referral practices in advanced diagnostic imaging and anatomic pathology determined that financial incentives were the most likely cause of increases in self-referrals4 7#b7 ,for advanced diagnostic imaging1 ,,gao stated that providers who self-referred made #djj1jjj more referrals for advanced imaging services than they would have if they were not self-referring1 at a cost of more than #ajj million in #bjaj4 7#c7 ,for anatomic pathology1 ,,gao found that self-referring providers likely referred over #iah1jjj more anatomic pathology services than they would have if they were not self-referring1 costing ,medicare approximately #fi1jjj1jjj more in #bjaj than if self-referral was not permitted4 7#d7 ,for radiation oncology1 ,,gao found that intensity modulated radiation therapy 7,,imrt7 utilization among self-referring groups increased by #cef percent1 with overall increases in ,,imrt utilization rates and spending due entirely to services performed by limited-specialty groups4 ,the ,,gao concluded that the higher use of ,,imrt by self-referring providers results in higher costs for ,medicare and beneficiaries4 ,to the extent that treatment decisions are driven by providers' financial interest and not by patient preference1 these increased costs are difficult to justify4 7#e7 ,for physical therapy1 ,,gao found that in the year a provider began to self-refer1 physical therapy service referrals increased at a higher rate relative to non-self-referring providers of the same specialty4 7#f7 ,noting the rapid growth of services covered by the in-office ancillary services 7,,ioas7 exception and evidence that these services are sometimes furnished inappropriately by referring physicians1 the ,medicare ,payment ,advisory ,commission 7,med,p,a,c7 stated that physician self-referral of ancillary services creates incentives to increase volume under ,medicare's current fee-for-service payment systems and the rapid volume growth contributes to ,medicare's rising financial burden on taxpayers and beneficiaries4 7#g7 ,the ,president's ,fiscal ,year #bjag ,budget includes the change to remove the four services3 advanced diagnostic imaging1 anatomic pathology1 radiation oncology1 and physical therapy from the ,,ioas exception to the ,stark ,law and cited the change as generating a savings score of #d1ihj1jjj1jjj over #aj years4 ,the nonpartisan ,congressional ,budget ,office's analysis of the ,president's ,fiscal ,year #bjag ,budget listed the change as generating a savings of #c1cjj1jjj1jjj over #aj years4 7#h7 ,according to the ,centers for ,medicare ,medicaid ,services1 a key rationale for the ,,ioas exception was to permit physicians to provide ancillary services in their offices to better inform diagnosis and treatment decisions at the time of the patient's initial office visit4 7#i7 ,it is necessary1 therefore1 to distinguish between services and procedures that were intended to be covered by the ,,ioas exception1 such as routine clinical laboratory services or simple x-rays that are provided during the patient's initial office visit1 and other health care services which were clearly not envisioned to be covered by that exception because they cannot be performed or completed during the patient's initial office visit4 7#aj7 ,according to a #bjaj ,health ,affairs study1 less than #aj percent of ,,ct1 ,,mri1 and ,nuclear ,medicine scans take place on the same day as the initial patient office visit4 7#aa7 ,according to a #bjab ,health ,affairs study1 urologists' self-referrals for anatomic pathology services of biopsy specimens is linked to increased use and volume billed along with a lower detection of prostate cancer4 7#ab7 ,according to an ,october #bjaa ,laboratory ,economics report1 there has been an increase in the number of anatomic pathology specimen units billed to the ,medicare part ,b program from #bjjf through #bjaj1 specifically for ,,cpt ,code #hhcje1 and the rate of increase billed by physician offices for this service is accelerating at a far greater pace than the rest of the provider segments4 7#ac7 ,according to a #bjac ,american ,academy of ,dermatology ,pathology ,billing paper1 arrangements involving the split of the technical and professional components of anatomic pathology services among different providers may endanger patient safety and undermine quality of care4 7#ad7 ,in ,november #bjab1 ,bloomberg ,news released an investigative report that scrutinized ordeals faced by ,california prostate cancer patients treated by a urology clinic that owns radiation therapy equipment4 ,the report found that physician self-referral resulted in a detrimental impact on patient care and drove up health care costs in the ,medicare program4 ,the ,wall ,street ,journal1 the ,washington ,post1 and the ,baltimore ,sun have also published investigations showing that urology groups owning radiation therapy machines have utilization rates that rise quickly and are well above national norms for radiation therapy treatment of prostate cancer4 7#ae7 ,according to a #bjaj ,med,p,a,c report1 only #c percent of outpatient physical therapy services were provided on the same day as an office visit1 only #i percent within #g days of an office visit1 and only #ad percent within #ad days of an office visit4 ,these services are not integral to the physician's initial diagnosis and do not improve patient convenience because patients must return for physical therapy treatments4 7#af7 ,in an ,april #bjah1 ,european ,urology article authored by leading urologists about ,medicare beneficiaries with prostate cancer diagnoses1 researchers found1 ,urologists practicing in single-specialty groups with an ownership interest in radiation therapy are more likely to treat men with prostate cancer1 including those with a high risk of noncancer mortality44 ,this suggests that urologists practicing in single-specialty groups with an ownership interest in radiation therapy are more likely to treat1 and even potentially overtreat1 patients with ,,imrt than those affiliated with a multispecialty practice or a group without an ownership stake4 7#ag7 ,in a ,january #bjai1 ,,jama ,oncology article1 authors systematically reviewed #ah studies to assess physicians' response to reimbursement incentives on cancer care delivery across various clinical settings4 ,across the studies1 the authors consistently found that the ability to self-refer for radiation oncology services was associated with increased use of radiation therapy4 7#ah7 ,those services intended to be covered under the ,,ioas exception are not affected by this legislation4 7#ai7 ,the exception to the ownership or investment prohibition for rural providers in the ,stark rule is not affected by this legislation4 7b7 ,purposes ,the purposes of this ,act are the following3 7#a7 ,maintain the in-office ancillary services exception and preserve its original intent by removing certain complex services from the exception--specifically1 advanced imaging1 anatomic pathology1 radiation therapy1 and physical therapy4 7#b7 ,protect patients from misaligned provider financial incentives4 7#c7 ,protect ,medicare resources by saving billions of dollars4 7#d7 ,accomplish the purposes described in paragraphs 7#a71 7#b71 and 7#c7 in a manner that does not alter the existing exception to the ownership or investment prohibition for rural providers4 #c4 ,limitation on application of physicians' services and in-office ancillary services exceptions 7a7 ,in general ,section #ahgg7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7b77 is amended-- 7#a7 in paragraph 7#a71 by inserting 1 other than specified non-ancillary services1 after section #ahfa7q772 and 7#b7 in paragraph 7#b71 by inserting 1 specified non-ancillary services1 after 7excluding infusion pumps74 7b7 ,increase of civil money penalties ,section #ahgg7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7g77 is amended-- 7#a7 in paragraph 7#c71 by inserting 1 unless such bill or claim included a bill or claim for a specified non-ancillary service1 in which case the civil money penalty shall be not more than #be1jjj for each such service before the period at the end of the first sentence2 and 7#b7 in paragraph 7#d71 by inserting 7or #aej1jjj if such referrals are for specified non-ancillary services7 after #ajj1jjj4 7c7 ,enhanced screening of claims ,section #ahgg7;g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7g77 is further amended by adding at the end the following new paragraph3 7#g7 ,compliance review for specified non-ancillary services 7,a7 ,in general ,not later than #ahj days after the date of the enactment of this paragraph1 the ,secretary1 in consultation with the ,inspector ,general of the ,department of ,health and ,human ,services1 shall review compliance with subsection 7a77#a7 with respect to referrals for specified non-ancillary services in accordance with procedures established by the ,secretary4 7,b7 ,factors in compliance review ,such procedures-- 7i7 shall1 for purposes of targeting types of entities that the ,secretary determines represent a high risk of noncompliance with subsection 7a77#a7 with respect to such billing for such specified non-ancillary services1 apply different levels of review based on such type2 and 7ii7 may include prepayment reviews1 claims audits1 focused medical review1 and computer algorithms designed to identify payment or billing anomalies4 4 7d7 ,definition of specified non-,ancillary services ,section #ahgg7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7h77 is amended by adding at the end the following new paragraphs3 7#h7 ,specified non-ancillary services 7,a7 ,subject to subparagraph 7,b71 the term specified non-ancillary service means the following3 7i7 ,anatomic pathology services1 as defined by the ,secretary and including the technical or professional component of the following3 7,i7 ,surgical pathology4 7,,ii7 ,cytopathology4 7,,iii7 ,hematology4 7,,iv7 ,blood banking4 7,v7 ,pathology consultation and clinical laboratory interpretation services4 7ii7 ,radiation therapy services and supplies1 as defined by the ,secretary4 7iii7 ,advanced diagnostic imaging studies 7as defined in section #ahcd7;e77#a77;,b774 7iv7 ,physical therapy services 7as described in paragraph 7#f77;,b774 7v7 ,any other service that the ,secretary has determined is not usually provided and completed as part of the office visit to a physician's office in which the service is determined to be necessary4 7,b7 ,the term specified non-ancillary service does not include the following3 7i7 ,any service that is furnished-- 7,i7 in an urban area 7as defined in section #ahhf7;d77#b77;,d77 to an individual who resides in a rural area 7as defined in such section72 and 7,,ii7 to such individual in its entirety on the same day as the day on which1 with respect to the condition for which the service is furnished1 the initial office visit of the individual for such condition occurs4 7ii7 ,any service that is furnished-- 7,i7 by a provider of services or supplier participating in an accountable care organization that participates in the shared savings program established under section #ahii2 and 7,,ii7 to a ,medicare fee-for-service beneficiary 7as defined in section #ahii7;h77#c77 assigned to such accountable care organization4 7iii7 ,any service that is furnished by a provider or supplier pursuant to the participation of the provider or supplier in a payment and service delivery model selected under section #aaae;,a7a74 7iv7 ,any service that is provided by an integrated multi-specialty group practice4 7#i7 ,integrated multi-specialty group practice ,the term integrated multi-specialty group practice means a group practice1 as defined by the ,secretary1 that-- 7,a7 consists of at least-- 7i7 primary care physicians who provide primary care services 7as defined in section #ahdb7;i77#d772 and 7ii7 seven or more different and distinct physician specialties 7not including subspecialties7 which are practiced by physicians who are board certified in the physician specialty associated with the services that they provide2 7,b7 is governed by a governing body that has made a determination 7and has documented such determination7 that the system is focused on-- 7i7 promoting accountability for the quality1 cost1 and overall care for individuals entitled to benefits under part ,a or enrolled in part ,b1 including by managing and coordinating care for such individuals2 and 7ii7 encouraging investment in infrastructure and redesigned care processes for high quality and efficient service delivery for patients1 including individuals described in clause 7i72 7,c7 engages in risk-based payment arrangements with government and commercial payers1 including shared savings1 bundled payment arrangements1 withholds1 and capitated payment arrangements2 and 7,d7 meets1 with respect to the program under this title1 such cost reduction and quality goals as the ,secretary determines appropriate4 4 7e7 ,construction ,nothing in this section 7or the amendments made by this section7 shall be construed to affect the authority of the ,secretary of ,health and ,human ,services to waive under section #ahii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7 the requirements imposed under the provisions of this section 7or such amendments7 or to affect the authority of the ,secretary to implement the provisions under section #ahdh7q7 of such ,act 7#db ,u4,s4,c4 #aciew-#d7q77 7relating to the eligible professionals ,merit-,based ,incentive ,payment ,system under the ,medicare program7 or section #ahcc7z7 of such ,act 7#db ,u4,s4,c4 #aciel7z77 7relating to incentive payments for participation in eligible alternative payment models under such program74 7f7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after the first day of the first month beginning more than #ab months after the date of the enactment of this ,act4 #d4 ,clarification of certain entities subject to stark rule and anti-markup rule ,section #ahgg7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7h77 is further amended by adding at the end the following new paragraph3 7#aj7 ,clarification of certain entities subject to anti-markup rule ,in applying this section1 the term entity shall include a physician's practice when it bills under this title for the technical component or the professional component of a specified non-ancillary service1 including when such service is billed in compliance with section #ahdb7n77#a74 4 #e4 ,clarification of supervision of technical component of anatomic pathology services ,section #ahfa7s77#ag7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#ag77 is amended-- 7#a7 by striking and at the end of subparagraph 7,a72 7#b7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 and 7#c7 by inserting after subparagraph 7,a7 the following new subparagraph3 7,b7 with regard to the provision of the technical component of anatomic pathology services1 meets the applicable supervision requirements for laboratories certified in the subspecialty of histopathology1 pursuant to section #cec of the ,public ,health ,service ,act2 and 4 #f4 ,exemption from budget neutrality under physician fee schedule ,section #ahdh7;c77#b77;,b77v7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;c77#b77;,b77v77 is amended by adding at the end the following new subclause3 7,,xii7 ,changes to limitations on certain physician referrals ,effective for fee schedules established beginning with #bjai1 reduced expenditures attributable to the ,promoting ,integrity in ,medicare ,act of #bjai4 4