On December 3, 2013, CMS will host a National Provider Call to provide an overview of the value-based payment modifier (VM) under the final 2014 Medicare Physician Fee Schedule final rule (which has not yet been released). CMS will also describe how the VM is aligned with the reporting requirements under the Physician Quality Reporting System (PQRS).
Despite continuing provider concerns, CMS has announced that it will direct Medicare administrative contractors (MACs) to activate controversial “phase 2” ordering/referral edits effective January 6, 2014. Once activated, MACs will deny claims for Medicare Part B services (including lab services and the technical component of imaging services), durable medical equipment, and Part A home health agency (HHA) services if the ordering/referring physician or other professional is not identified, is not in Medicare's enrollment records, or is not of a specialty type that may order/refer the service/item being billed. CMS had previously delayed an earlier May 1, 2013 target date for implementation due to objections by physicians and suppliers that they could experience claims denials and delays based on discrepancies between the names of the ordering physician on the 1500 claim form and in Medicare’s enrollment records. There has been no assurance from CMS, however, that these concerns have been fully resolved, and the only recourse for providers if claims are inappropriately denied claim will be to file an appeal. A CMS educational article accompanying the announcement suggests that imaging suppliers and providers bill global claims separately to prevent a denial for the professional component in the event that the new edits deny the technical component of imaging services.
The Patient-Centered Outcomes Research Institute (PCORI) was established by the ACA to support federal comparative effectiveness research efforts. Due to the resignation of a physician representative on the board, letters of nomination to fill the vacancy will be accepted through November 15, 2013.
Medicare electronic health records (EHR) incentive payments to hospitals and health care professionals topped $6.3 billion for 2012 – more than twice the $2.3 billion awarded for 2011 -- according to a GAO report entitled Electronic Health Records: Number and Characteristics of Providers Awarded Medicare Incentive Payments for 2011-2012. The proportion of eligible hospitals and professionals receiving payments also grew from 2011 to 2011, with 48% of eligible hospitals (2,291) receiving payments in 2012 compared to 777 hospitals (16%) in 2011. For 2012, 31% of eligible professionals (183,712) were awarded payments, up from 10% (58,331) in 2011. Among hospitals and professionals awarded an incentive payment for 2012, the largest proportions were in the South, the smallest proportions were in the West, and a majority were in urban areas. More than four-fifths of the hospitals were acute care hospitals and three-fifths were nonprofit hospitals, while more than half of professionals were specialty practice physicians.
As a result of the partial government shutdown, CMS is warning that it may delay until late November a series of major final rules setting a wide range of Medicare payment rates and policies for 2014. While CMS usually releases the final calendar year updates by November 1st each year, CMS is now saying that the 16-day government shutdown could push back the release date of the following rules to November 27th (or potentially later):
• CY 2014 Changes to the Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center (ASC) Payment System;
• Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2014;
• Medicare Program; End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and
• CY 2014 Home Health Prospective Payment System Final Rule.
This timeline could leave providers, suppliers, and other health care entities only a few weeks to prepare for potentially sweeping changes before they go into effect on January 1, 2014 (although certain provisions have different effective dates). For instance, stakeholder are awaiting final disposition of CMS proposals to, among many other things: expand payment bundles under the HOPPS; cut physician fee schedule reimbursement for more than 200 codes if the Medicare physician office payment exceeds the HOPPS or ASC payment; systematically reexamine payment amounts under the Clinical Laboratory Fee Schedule; establish a centralized review process for Investigational Device Exemption (IDE) coverage decisions; reduce ESRD rates by 9.4%; and revise various DMEPOS payment policies.
A recent OIG report links the growing presence of physician-owned distributorships, or PODs, to increased spinal surgery volumes and potentially increased Medicare costs. The OIG notes a “substantial presence” of PODs in the spinal device market, with PODs supplying spinal devices for 19% of the spinal fusion surgeries billed to Medicare in FY 2011. According to the OIG, hospitals that purchased devices from PODs performed more spinal surgeries in 2012 than hospitals that did not purchase from PODs, and hospitals increased the rate of growth in the number of spinal surgeries after they began purchasing from PODs. Hospitals identified surgeon preference as the strongest influence on their decisions to purchase spinal devices from PODs. The OIG also disagrees with PODs’ claims that their devices cost less than those from other suppliers; rather, in the categories examined by the OIG, the devices cost the same as or more than devices from companies not owned by physicians. This fact, coupled with increased volumes, according to the OIG, could increase overall Medicare costs over time. In addition, the OIG raises concerns about inconsistencies in hospital policies regarding physician disclosure of ownership to either hospitals or their patients of interests in PODs (although the OIG suggests that the new “Sunshine Act” disclosure rules may improve the ability of hospitals and patients to identify physicians’ investment in device companies). For a case urging an alternative perspective on PODs, see the report on our sister blog, http://www.lifescienceslegalupdate.com/, about a recent complaint filed in the U.S. District Court for the Central District of California that seeks a declaration that the OIG’s Special Fraud Alert on PODs unfairly and unconstitutionally burdens First Amendment rights of free speech and due process. The complaint defends the lawfulness of the physician-owned model, and characterizes the Fraud Alert as the result of a multi-year lobbying campaign by “Big Corporations” forced to compete with small physician-owned entities. For more details, see our full report.
The Government Accountability Office (GAO) has issued two reports on trends in physician referrals to entities in which the provider or the provider's family members have a financial interest – both of which conclude that financial incentives are likely a major factor driving increases in referrals. In the first report, “Medicare: Action Needed to Address Higher Use of Anatomic Pathology Services by Providers Who Self-Refer,” the GAO concentrates on three provider specialties -- dermatology, gastroenterology, and urology -- that in 2010 accounted for 90% of referrals for self-referred anatomic pathology services (the preparation and examination of tissue samples to diagnose disease). Among other things, the report found that referrals for anatomic pathology services by these specialists (specifically services represented by CPT code 88305) substantially increased the year after they began to self-refer, compared both to before they started self-referring and to those specialists who continued to self-refer or never self-referred services. Self-referring providers of these specialties also referred more services on average than non-self-referring providers, even taking into account geography and patient characteristics. In response to the GAO’s suggestion that CMS improve its ability to identify self-referred anatomic pathology services and limit financial incentives for high levels of referrals, HHS notes that it identified CPT code 88305 as a potentially misvalued code and reduced its reimbursement by approximately 30% percent in 2013, which HHS believes has significantly reduced the financial incentives associated with self-referral for these procedures.
In a second report, “Higher Use of Costly Prostate Cancer Treatment by Providers Who Self-Refer Warrants Scrutiny,” the GAO examined self-referral of prostate cancer-related intensity-modulated radiation therapy (IMRT) services. According to the GAO, from 2006 to 2010, the number of IMRT procedures performed by self-referring groups increased rapidly (from about 80,000 to 366,000), while it declined for non-self-referring groups. This growth in self-referred services was primarily due to limited-specialty groups, particularly urologists, rather than multispecialty groups. Self-referring groups also were more likely to refer their patients for IMRT than other less costly treatments (e.g., radical prostatectomy or brachytherapy). Because Medicare providers are generally not required to disclose that they self-refer IMRT services, the GAO states that “beneficiaries may not be aware that their provider has a financial interest in recommending IMRT over alternative treatments that may be equally effective, have different risks and side effects, and are less expensive for Medicare and beneficiaries.” The GAO recommended that CMS require providers to disclose their financial interests in IMRT to their patients; which HHS does not support because, among other things, it could be complex to administer and would not address overutilization. HHS also noted that the President has proposed excluding certain services from the in-office ancillary services exception to the physician self-referral law.
On September 24, 2013, CMS will host a call for providers on “Program Year 2012 Quality and Resource Use Report – Mapping a Route to Success for the 2015 Value-Based Payment Modifier.” The call will focus on the 2012 Quality Resource Use Reports (QRURs), which illustrate how a group would be impacted by the final Physician Value-Based Payment Modifier policies. The QRURs will be available to authorized representatives of group practices with 25 or more eligible professionals on September 16, 2013. The provider call will cover how to interpret and use the data in the report.
CMS has pushed back indefinitely enforcement of an Affordable Care Act (ACA) provision requiring a face-to-face encounter as a condition of Medicare payment for certain durable medical equipment (DME) items.
By way of background, under CMS rules implementing section 6407 of the ACA, as a condition of payment for specified items of DME, a physician must have documented and communicated to the DME supplier that the physician or a physician assistant, a nurse practitioner, or a clinical nurse specialist has had a face-to-face encounter with the beneficiary within the six month period before the written order. The initial items subject to this rule include: items that require a written order prior to delivery under the Medicare Program Integrity Manual; items that cost more than $1,000; and items identified as particularly susceptible to fraud, waste, and abuse.
While CMS had previously set implementation dates of July 1, 2013 and then October 1, 2013, CMS is now delaying enforcement of the DME face-to-face requirement until “a date that will be announced in Calendar Year 2014." CMS explains that this delay will enable suppliers and physicians to collaborate and establish internal processes to ensure compliance with the face-to-face requirement over the next several months, but it also notes states that “suppliers and physicians who are currently implementing the face-to-face requirement should continue to do so.”
CMS is developing a “Suggested Electronic Clinical Template for Lower Limb Prostheses” to assist Medicare providers with data collection and medical documentation to support orders for lower limb prostheses. CMS is hosting several calls to allow physicians, prosthetists, and other interested parties to provide feedback on clinical elements of the document. The next call is scheduled for September 11, 2013. Comments on the proposed document also can be sent to email@example.com.
On August 6, 2013, CMS released a request for public comment on how the agency can promote greater transparency regarding physician-specific Medicare payment information. CMS is seeking input on the following specific issues:
- Whether physicians have a privacy interest in information concerning payments they receive from Medicare and, if so, how to properly weigh the balance between that privacy interest and the public interest in disclosure of Medicare payment information, including physician-identifiable reimbursement data;
- What specific policies CMS should consider with respect to disclosure of individual physician payment data that will further the goals of improving the quality and value of care, enhancing access and availability of CMS data, increasing transparency in government, and reducing fraud, waste, and abuse within CMS programs; and
- The form in which CMS should release information about individual physician payment, should CMS choose to release it (e.g., line item claim details, aggregated data at the individual physician level).
The request stems from a May 31, 2013 Florida federal district court decision that lifted a previous injunction prohibiting CMS from disclosing annual Medicare reimbursement payments to individual physicians. CMS notes that it is not considering public disclosure of any information that could directly or indirectly reveal patient-identifiable information. CMS will accept comments on this issue until September 5, 2013. A related CMS blog post is available here.
A new bill introduced in the House on August 1, 2013 by Congresswoman Jackie Speier (D-CA) and Congressman Jim McDermott (D-WI) would dramatically narrow the in-office ancillary services (IOAS) exception to the Stark law for physician groups performing imaging, pathology radiation therapy and physical therapy services. The bill (“Promoting Integrity of Medicare Act of 2013”) would amend the IOAS exception by excluding “specified non-ancillary services” from its protection. Initially, the bill identifies the following services as “non-ancillary services” excluded from the IOAS exception: (a) pathology services; (b) radiation therapy services and supplies; (c) advanced imaging services (i.e., CT, MRI and PET); and (d) physical therapy services. If adopted, the bill would prohibit, for example, a physician ordering advanced imaging services for a Medicare beneficiary if the services are performed in the ordering physician’s offices. However, referrals of low-end imaging, such as x-ray or ultrasound, would still fall within the IOAS exception.
In addition, the bill would require enhanced CMS review of so-called “non-ancillary services” to identify those creating a high risk of Stark Law noncompliance, including using prepayment reviews, claims audits, focused medical review, or computer algorithms. The bill would also create higher penalties for referrals of “non-ancillary services” by imposing upon those referrals civil monetary penalties that are greater than the penalties currently authorized for other violations of the Stark law.
The bill was introduced after others in the federal government have criticized self-referral. A September 2012 study by the Government Accounting Office found that the number of advanced imaging services ordered by physicians increased when the services were performed in the referring physician’s office. The GAO recommended that CMS improve its ability to identify self-referral of advanced imaging services and address increases in these services. More recently, the Obama Administration’s proposed federal budget for fiscal year 2014 suggested excluding radiation therapy, therapy services, and advanced imaging from the IOAS exception, except in cases where a practice meets certain accountability standards. No action on the bill, the GAO recommendation or the Obama budget has been taken to date.
Data collection under the ACA Physician Payment Sunshine Act begins on August 1, 2013. To assist covered manufacturers of pharmaceuticals or medical devices with reporting obligations, CMS has announced new “OPEN PAYMENTS” mobile applications that could be used to track payments and other financial transfers. While physicians are not required to report any information, CMS notes that they could use this technology to help validate reports submitted by manufacturers about payments the physicians have received. In addition, CMS is compiling answers to frequently-asked-questions on the Sunshine Act. On June 22, 2013, CME released a notice in the Federal Register concerning the collection of information under the Sunshine Act, specifically related to the following subjects: registration; attestation; dispute resolution and corrections; record retention; and submitting an assumptions document. Comments are due to CMS by September 20, 2013. Finally, CMS is hosting an educational call on August 8, 2013 for physicians and teaching hospitals on the Sunshine Act policy, with a focus on third party payments, indirect payments, and the Physician Resource Toolkit.
CMS has just announced that it is delaying enforcement of an Affordable Care Act provision requiring a face-to-face encounter as a condition of Medicare payment for certain durable medical equipment (DME) items from July 1, 2013 to October 1, 2013. Under the regulations implementing the face-to-face requirement, a physician must have documented and communicated to the DME supplier that the physician or a physician assistant, a nurse practitioner, or a clinical nurse specialist has had a face-to-face encounter with the beneficiary within the six month period before the written order as a condition of payment for specified items of DME. The initial items subject to this provision include: items that currently require a written order prior to delivery under the Medicare Program Integrity Manual; items that cost more than $1,000; and items identified as particularly susceptible to fraud, waste, and abuse. CMS provides a current list of the applicable items here.
CMS is pushing back the compliance date in light of “concerns that some providers and suppliers may need additional time to establish operational protocols necessary to comply” with the ACA requirement. CMS expects suppliers and physicians who order specified DME items will use these extra months to collaborate and establish internal compliance processes. CMS and its contractors also will communicate with the provider community to ensure it is informed about the policy. CMS intends to “start actively enforcing and will expect full compliance with the DME face-to-face requirements beginning on October 1, 2013.”
On July 31, 2013, CMS is hosting a National Provider Call entitled “Choosing Your Physician Quality Reporting System (PQRS) Group Reporting Mechanism and Implications for the Value-based Payment Modifier.” The target audience for the call is physicians and physician group practices, practice managers, medical and specialty societies, and payers/insurers.
Today the House Energy and Commerce Health Subcommittee is holding a hearing on "Reforming SGR (Sustainable Growth Rate): Prioritizing Quality in a Modernized Physician Payment System." The panel also is seeking comments on draft legislative language; comments will be accepted until June 10, 2013.
On April 25, 2013, CMS announced that, due to technical issues, it is delaying implementation of the Phase 2 ordering and referring denial edits until further notice. By way of background, CMS plans to implement edits that will deny claims for Medicare Part B services (including the technical/non-interpretation component of imaging services, lab services, and durable medical equipment) and Part A home health agency services if the ordering/referring physician or other professional is not identified, is not in Medicare's enrollment records, or is not of a specialty type that may order/refer the service/item being billed. While CMS intended to require Medicare contractors to activate these edits effective May 1, 2013, concerns had been raised by physicians and suppliers that they could experience claims denials and delays based on discrepancies between the names of the ordering physician on the 1500 claim form and in Medicare’s enrollment records. CMS expects to announce a new implementation date in the near future.
MedPAC has released its annual report to Congress on Medicare Payment Policy, including payment update recommendations for all the major Medicare FFS payment systems and limited Medicare Advantage (MA) recommendations. The report also includes data on the status of the MA and Medicare Part D programs, including information about enrollment, plan options, and beneficiary cost-sharing. Note that while MedPAC’s recommendations are not binding, Congress and CMS often take into account MedPAC’s assessments when updating Medicare payment policies. Major recommendations include the following (many of which were included in previous reports):
- Congress should increase payment rates for inpatient and outpatient hospital prospective payment systems by 1%, and require the difference between the statutory update and the recommended 1% update be used to offset payment increases due to documentation and coding changes and to recover past overpayments.
- Congress should repeal the sustainable growth rate (SGR) system for physician services and replace it with a 10-year path of statutory fee-schedule updates. This proposal, first offered in October 2011, would combine a freeze in payment levels for primary care and, for all other services, annual payment reductions followed by a freeze. MedPAC also endorsed the collection of data to establish more accurate work and practice expense values; budget-neutral changes to improve data on which relative value unit weights are based and to redistribute payments to underpriced services, and changes to the structure of accountable care organization shared savings payments.
- Congress should eliminate the ambulatory surgical center (ASC) payment update for 2014, require ASCs to submit cost data, and direct the Secretary to implement a value-based purchasing program for ASCs by 2016.
- Congress should eliminate the skilled nursing facility market basket update, and direct the Secretary to revise the prospective payment system for SNFs and begin a process of rebasing payment as soon as practicable.
- MedPAC reiterates previous recommendations to rebase home health rates, eliminate the market basket update, revise the home health case-mix system to rely on patient characteristics to set payment for therapy and nontherapy services, establish a per episode copay for home health episodes that are not preceded by hospitalization or post-acute care use, and expand program integrity efforts.
- Congress should eliminate the update to hospice rates for FY 2014 and adopt a series of previous MedPAC recommendations addressing payment and program integrity reforms.
- Congress should eliminate the 2014 updates for outpatient dialysis services, inpatient rehabilitation facilities, and long-term care hospitals.
- With regard to Medicare Advantage, Congress should allow the authority for most MA chronic care special needs plans (SNPs) to expire (with certain exceptions) and allow MA plans to enhance benefit designs for individuals with specific chronic or disabling conditions. MedPAC also recommends that Congress permanently reauthorize dual-eligible special needs plans (D–SNPs) that assume clinical and financial responsibility for Medicare and Medicaid benefits (with certain changes) and allow the authority for all other D–SNPs to expire.
Effective May 1, 2013, Medicare contractors will activate edits that will deny claims for Medicare Part B (including imaging and lab services), DME, and Part A home health agency (HHA) services if the ordering/referring physician or other professional is not identified, is not in Medicare's enrollment records, or is not of a specialty type that may order/refer the service/item being billed. Concerns have been raised by physicians and suppliers that they could experience claims denials and delays after May 1 based on discrepancies between the names of the ordering physician on the 1500 claim form and in Medicare’s enrollment records. CMS is holding a March 20, 2013 National Provider Call to discuss these new requirements.
On February 14, 2013, the House Energy and Commerce Health Subcommittee is holding a hearing entitled “SGR: Data, Measures and Models; Building a Future Medicare Physician Payment System.”