February 23, 2015

President's 2016 Budget Proposes Changes to Recovery Audit Procedures

On February 2, 2015, the White House released President Obama's budget report for fiscal year 2016. A significant portion of the report is dedicated to healthcare issues. The report proposes several reforms to the Medicare program and purports a projected savings of $407.2 billion in the next 10 years. Additionally, the report includes a $403 million multi-year investment towards preventing, detecting, and prosecuting healthcare fraud and abuse. Moreover, the 2016 budget provides for a $201 million investment to continue to fund the full Health Care Fraud and Abuse Control discretionary cap adjustment, increase funding to recovery auditors to take on more corrective actions, and provide more funds to the Medicaid Integrity Program. The President's budget states an intention to increase such funding to $4.6 billion over the next 10 years.

The budget brief published by the U.S. Department of Health and Human Services ("HHS"), proposes numerous measures in an attempt to curb the Medicare appeals backlog. Suggestions made by the Office of Medicare Hearings and Appeals ("OMHA") are summarized as follows:

  • Invest new resources at all levels of appeal to increase adjudication capacity and implement new strategies to alleviate the current backlog;
  • Take administrative actions to reduce the number of pending appeals and prevent new cases from entering the system; and
  • Propose legislative reforms that provide additional funding and new authorities to increase efficiency and address the volume of incoming appeals.
The investment increases suggested by OMHA are part of its requested budget of $140 million, a $53 million increase from fiscal year 2015. Aside from bolstered investment, OMHA also proposed several reforms that would impact the Medicare audit process. One such proposal is the implementation of a per-claim filing fee charged to providers at each level of the Medicare appeals process. The proposal allows for a refunding of the fee, but only in such instances where appellants receive a fully favorable appeal decision. OMHA projects that these filing fees will amount to $5 million, which will in turn fund 119 ALJ teams. The increase in ALJ teams is intended to decrease the backlog by improving efficiency and responsiveness.

OMHA also proposed the authorization of sampling and extrapolation techniques throughout the appeals process. This proposal would allow providers to consolidate all of their appeals into a single administrative appeal at all levels of the appeals process. If enacted, the proposal would require parties who are appealing claims included within an extrapolated overpayment, or consolidated previously, to file one appeal request for any such claims in dispute.

While HHS claims that these measures should assist in alleviating the backlog, the bulk of the reforms miss their mark. Ideally, HHS should rework the entire RAC process. For example, many industry stakeholders believe the financial incentives for RACs to deny claims are misguided. Wachler & Associates regularly counsels entities on how best to proactively prepare for an audit and mitigate audit risks. If you or your healthcare entity have questions regarding the outlined proposals, or are currently undergoing an audit and need assistance defending claims, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.


February 20, 2015

CMS Considers Shortening the Meaningful Use Reporting Period

On January 29, 2015, the Centers for Medicare and Medicaid Services ("CMS") announced that it will consider shortening the meaningful use reporting period for electronic health record ("EHR") systems. Specifically, CMS stated that it intends to reduce the 2015 reporting period from 12 months to 90 days. Under the meaningful use incentive program, providers have faced the risk of a Medicare penalty if they failed to satisfy the program's requirements. A shortened reporting period of 90 days may increase compliance with Stage 2 of the program and reduce the reporting burden on providers. Additionally, providers can schedule their reporting period for the second half of 2015, providing additional time for providers to implement the EHR systems at Stage 2.

In a statement following CMS's announcement, the President of the American Medical Association ("AMA"), Steven J. Stack, MD, expressed the organization's support of the proposed shortening of the reporting period. However, Stack criticized the incentive program, stating that "EHRs are intended to help physicians improve care for their patients, but unfortunately, today's EHR certification standards and the stringent requirements of the meaningful-use program do not support that goal and decrease efficiency."

In its announcement, CMS also stated its intent to align the meaningful use reporting periods to the calendar year in an effort to give hospitals more time to integrate the 2014 Edition software and better coordinate with CMS quality programs. Although the proposed changes to the reporting period will not delay CMS's rollout of the forthcoming Stage 3 proposed rule, expected in March, CMS plans to limit the scope of the Stage 3 proposed rule to the criteria and requirements for meaningful use in 2017 and subsequent years.

Wachler & Associates will continue to monitor CMS rule making and guidance related to EHR meaningful use criteria, as well as other breaking healthcare news. If you need help understanding the meaningful use requirements or assistance with negotiating EHR contracts, please contact an experienced healthcare attorney at 248-544-0888 or email at wapc@wachler.com.

February 17, 2015

CMS Modifies Manual Medical Review Process for Outpatient Therapy Claims Above Cap

The Protecting Access to Medicare Act of 2014 extended the process for exceptions to Medicare's outpatient therapy caps through March 2015. Exceptions to Medicare's outpatient therapy caps are allowed for medically necessary and reasonably therapy services. However, claims above $3,700 for physical therapy and speech language pathology services combined, and above $3,700 for occupational therapy services, are subject to manual medical review by recovery audit contractors (RACs). The caps are calculated per beneficiary, per year. While manual medical reviews of outpatient therapy claims above the cap were put on hold last year, existing RACs received approval on January 16, 2015 to resume sending additional documentation requests (ADRs) to Part B providers.

However, CMS recently introduced a new post-payment review system that requires RACs to review outpatient therapy claims using a new manual medical review process. RACs will now be required to review claims using a tiered approach to ADRs. The process allows for 100% review of provider claims above the $3,700 therapy caps ("eligible claims"), but prevents the RACs from requesting large and potentially unmanageable amounts of records at one time.

Beginning in January 2015, the new manual medical review process permits RACs to review 100% of a provider's eligible claims using a 5-step approach to ADRs. A RAC's first ADR may only review one claim, but additional ADRs may request records for an increasing percentage of claims. The second ADR may review up to 10% of eligible claims, the third ADR may review up to 25% of eligible claims, and the fourth ADR may review up to 50% of eligible claims. Finally, a RAC's fifth ADR to a particular provider may review 100% of the provider's total eligible claims. Please note that the new tiered approach retains the RAC's cycle of 45 days between ADRs.

The new manual review process meets the congressional mandate of a 100% review rate for outpatient therapy claims above the outpatient therapy cap. However, CMS believes the new manual review process will meet the congressional mandate in a more equitable manner. For now, the review process is limited to claims reviewed by existing RACs for claims made from March 1, 2014 to December 31, 2014. CMS has not yet finalized the process for claims made in 2015. The manual medical review process is also limited to claims made by Part B outpatient therapy providers, including but not limited to therapists' private offices, offices of physicians, Part B skilled nursing facilities (SNFs), home health agencies (HHAs), and hospital outpatient departments.

Wachler & Associates represents all types of therapy providers in a variety of matters, including responding to ADRs and appealing Medicare overpayment demands. If you or your healthcare entity has any questions regarding Medicare's new manual medical review process for therapy claims above the outpatient therapy cap, or seek help in defending an overpayment demand by a RAC, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To stay up to date on healthcare regulatory developments, subscribe to our blog by adding your email address in the window on the top right of this page.

February 6, 2015

Pharmaceutical Company Pays $39 million to Settle Anti-Kickback and False Claims Allegations

On January 9, 2015, the Federal Bureau of Investigations and Department of Justice, along with several state Medicaid programs, announced that Daiichi Sankyo Inc. ("Daiichi"), a U.S. subsidiary of a Japanese pharmaceutical company, agreed to pay $39 million to settle alleged violations of the Anti-Kickback Statute and False Claims Act ("FCA").

In March 2010, a qui tam lawsuit was filed in the U.S. District Court for the District of Massachusetts. The allegation contained in the lawsuit related to speaker programs that Daiichi hosted between January 2004 and March 2011. The qui tam plaintiff, a former Daiichi sales representative, asserted that Daiichi inappropriately compensated physicians that participated in the speaker programs. The six primary allegations included:

  • The program honoraria recipient only spoke to member of his or her own staff in his or her own office;
  • Physicians took turns accepting speaker honoraria for duplicative discussions;
  • The audience include the honoraria's spouse;
  • The honoraria recipient did not speak at all because the event was previously canceled;
  • The program dinners exceeded Daiichi's internal cost limitation of $140 per person; and
  • Drugs that were promoted at the programs (Azor, Benicar, Tribenzor, and Welchol) were used for off-label purposes.
The Government contended that the meals, honoraria, and other remuneration paid to participating physicians amounted to illegal kickbacks that ultimately induced the physicians to prescribe the drugs for off-label use. Furthermore, this resulted in pharmacies unknowingly submitting false prescription drug claims because prescriptions for off-label uses are typically not eligible for reimbursement.

In addition to paying $39 million, Diiachi agreed to enter into a corporate integrity agreement that obligates it to implement dramatic internal reforms over the next five years. Specifically, the corporate integrity agreement mandates that Diiachi enact compliance programs to prevent similar improper practices from reoccurring. For the qui tam plaintiff's services, the former employee will receive $6.1 million of the Government's recovery.

Wachler & Associates regularly counsels providers regarding the FCA, Anti-Kickback Statute, and other federal and state fraud and abuse laws and assists in developing compliance programs to address these laws. If you or your healthcare entity have any questions regarding the FCA, Anti-Kickback Statute, and/or other federal and state fraud and abuse laws, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.


January 29, 2015

HHS Sets Timelines for Focus of Reimbursement to Shift from Quantity to Quality

On January 26, 2015, the U.S. Department of Health and Human Services ("HHS"), for the first time ever, announced a timeline and corresponding goals to shift the basis of Medicare reimbursement away from the quantity of care provided towards the quality furnished to beneficiaries. With the passage of the Patient Protection and Affordable Care Act ("ACA") in 2010, Congress created several new payment models, including Accountable Care Organizations ("ACOs"), primary care medical homes, and new models of payment bundling for care. These models all share the commonality that they incentivize physicians to coordinate care for their beneficiaries, maintain quality, and control costs. With the proliferation of these models that focus on quality over quantity, HHS was compelled to reform the Medicare reimbursement process.

Specifically, HHS announced its goal of tying 30 percent of fee-for-service Medicare payments to quality output through alternative payment models, like ACOs or bundled payment arrangements, by the end of 2016. Furthermore, HHS plans on increasing that amount to 50 percent by the end of 2018. If this goal is met, half of all payments to physicians and hospitals will be made through alternative payment models by 2018. Additionally, HHS set a timeline for tying 85 percent of fee-for-service, or traditional, Medicare payments to quality output by 2016 through the Hospital Value Based Purchasing and Hospital Readmissions Reduction Programs. This number is also set to increase to 90% by 2018.

To accomplish this, HHS has created the Health Care Payment Learning and Action Network ("the Network"). The Network is an organization made up of health care stakeholders including private payers, consumers, providers, employers, and state Medicaid programs. The Network, which will hold its first meeting in March 2015, plans to expand alternative payment models nationwide into all areas of health care. HHS hopes that the intensity exhibited by the Network will even surpass its initial goals for program expansion.

In a separate announcement, the President of the American Medical Association, Robert Wah, MD, stated that the HHS timeline "aligns with the [AMA's] commitment to work toward innovative care delivery reform."

In 2011, Medicare essentially made zero payments to providers through alternative payment models. However, today the use of alternative payment models has increased to about 20 percent of all Medicare payments. HHS has already noted significant savings from the use of alternative payment models--reporting a $417 million savings to Medicare as a result of ACO programs. Moreover hospital readmissions have been reduced by eight percent, which is 150,000 fewer readmissions from January 2012 to December 2013.

If you or your healthcare entity have any questions regarding the implementation of new alternative payment models, please contact an experienced healthcare attorney by phone at 248-544-0888 or via email at wapc@wachler.com. Wachler & Associates will continue to keep you updated on HHS and Medicare news. If you are interested, please subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

January 28, 2015

CMS Announces New RAC Contract for DME, Home Health and Hospice Claims

On December 30, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that they had awarded the Region 5 Recovery Audit Contract (RAC) to Connolly, LLC. CMS contracts with RACs to identify and correct improper payments. Connolly, which has been the RAC for Region C, was awarded the Region 5 contract which covers claims for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), home healthcare and hospice providers. With the awarding of the new RAC contract focused on DME, home health and hospice providers, these provider types can expect increased scrutiny of their Medicare claims.

CMS also outlined a number of "improvements" to the RAC program that will take effect with each new RAC contract awarded, beginning with the Region 5 contract awarded on December 30, 2014.

One of the "improvements" brought by the new RAC program is that the CMS has reduced the RAC look-back period to 6 months from the date of service for patient status reviews where hospitals submitted the claim within 3 months of the date of service. Previously, the look-back period for RACs was from 3 years and hospitals had to submit a claim within one year from the date of service in order to comply with the timely filing rules, leaving hospitals with the inability to rebill denials from patient status reviews. Another improvement is that the CMS has established new Additional Documentation Request (ADR) limits based on a provider's compliance with Medicare rules. Specifically, the ADR limits will align with providers' denial rates (i.e., providers with low denial rates will have lower ADR limits), and ADR limits will be adjusted as a providers' denial rates decrease.

With the new RAC contract awarded, DME, home health and hospice providers should be prepared for increased audit activity from the new RAC. If you are currently undergoing an audit and need assistance defending claims denials, or have any questions about how to proactively prepare for an audit or mitigate audit risk, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To continue to stay updated on healthcare news, please subscribe to the Wachler & Associates health law blog by adding your email address and clicking 'Subscribe' in the window on the top right of this page.

January 13, 2015

House Republicans Release Proposal to Eliminate Two-Midnight Rule

In November 2014, Republicans in the U.S. House of Representatives circulated a "discussion draft," which proposed significant reforms to the process by which Medicare reimburses hospitals for short stays. Perhaps most notably, the GOP proposal would eliminate the two-midnight rule. Since its enactment, the two-midnight rule has remained controversial among healthcare providers. Under the two-midnight rule, an admission is appropriate only when the patient remains in the hospital for two midnights. However, since its adoption, the rule has created confusion and elicited criticism from providers who claim that it undermines their clinical decision-making process. Acknowledging the issue, the Centers for Medicare and Medicaid Services (CMS) limited enforcement of the two-midnight rule and solicited stakeholders for suggestions on improving it.

The discussion draft also proposes the establishment of a new Medicare payment system for hospital stays. Under the proposal, the payment system would go into effect in fiscal year 2020 and unify the currently separate inpatient and outpatient payment systems. During the five years before the implementation, CMS would be tasked with developing a transitional, per-diem payment system for short-term hospital stays. Additionally, CMS would restrain Recovery Audit Contractors (RAC) until the new payment system is adopted. This reprieve is important when establishing a new payment system because of the RAC program's onerous presence in the healthcare industry. Just last year, the RAC program recouped over $3 billion in Medicare overpayments, and audit appeals have created such a backlog that many appellants are waiting over three years for a decision. The backlog of appeals violates the statutory requirement for Administrative Law Judges to decide Medicare appeals within 90 days of the request for hearing.

Also included in the GOP's discussion draft is a partial elimination of the Patient Protection and Affordable Care Act's (ACA) moratorium on the expansion of physician-owned hospitals. Currently, the law prohibits new physician-owned hospitals, expansion of existing physician-owned hospitals, and an increase in the percentage of physician ownership in existing physician-owned hospitals. Any reduction of the physician-owned hospital limitation would be welcomed news in the physician community. Further, in an effort to curb costs, the proposal also includes provisions that would promulgate a nationwide bundled payment program. Upon analyzing these proposals, many stakeholders believe that the circulation of the discussion draft indicates the direction of the anticipated Medicare debate in Congress and expect several of these provisions to be at the forefront of discussions in the next congressional session.

Wachler & Associates has been involved in policy formation regarding the two-midnight rule and we believe that any change to the rule will have widespread impact on providers and the Recovery Audit program. Our firm will continue to monitor breaking national healthcare news and provide timely updates. If you have questions regarding the discussion draft, the two-midnight rule, the moratorium on physician-owned hospitals, or any other health law compliance matter, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To remain updated on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

December 22, 2014

Final Rule Tightens Provider Enrollment Policies, Expands CMS Authority

On December 3, 2014, the Centers for Medicare and Medicaid Services ("CMS") released a final rule that broadens its authority to deny providers or suppliers from enrolling in Medicare and revoke providers already participating. The final rule, which is scheduled to go into effect on February 3, 2015, permits CMS to deny or revoke enrollment of providers with abusive billing patterns or practices, deny enrollment of providers affiliated with unpaid Medicare debt and deny or revoke enrollment of providers if a managing employee has been convicted of certain felonies.

CMS plans to identify improper billing by analyzing several factors such as:

  • The percentage of denied claims;
  • The reason for the denials; and
  • The length of any billing irregularities.

Providers and suppliers affiliated with entities with unpaid Medicare debt may prevent the enrollment denial or revocation if they agree to a structured repayment plan or pay the debt in full. The purpose of this provision is to prevent entities from incurring substantial Medicare debt, exiting the program and then re-enrolling as a new entity. Currently, CMS can only deny enrollment to those who have overpayments. The final rule explicitly expands this power to include Medicare debt, which includes overpayments as well as other financial obligations.

The final rule also authorizes CMS to deny or revoke enrollment to entities that continue to retain a managing employee that has been convicted of a certain felonies within the past ten years. CMS identified felonies that it deems detrimental to beneficiaries and the Medicare program, including assault, income tax evasion, and embezzlement.

The final rule also restricts reimbursement for ambulance suppliers by eliminating their ability to bill Medicare for the year prior to their enrollment. Additionally, the final rule brings ambulance providers into the same fold as practitioners by requiring that they submit all claims within sixty days of enrollment revocation. CMS estimates that these provisions will save Medicare $327 million annually.

Wachler & Associates regularly counsels providers regarding CMS rules and regulations. If you have any questions about CMS' final rule, or how the new billing parameters may impact your practice, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To continue to stay updated on healthcare news, please subscribe to the Wachler & Associates health law blog by adding your email address and clicking 'Subscribe' in the window on the top right of this page.

December 17, 2014

Medicare Pilot Program Requires Prior Authorization for Ambulance Transport Services

On December 1, 2014, the Centers for Medicare and Medicaid Services ("CMS") launched a three-year pilot program ("the program") in an effort to curb improper Medicare payments to ambulances providers. Under the program, CMS requires prior authorization for repetitive, scheduled, non-emergent ambulance transport claims billed using the following HCPCS codes: (1) A0425 - BLS/ALS mileage, per mile; (2) A0426 - Ambulance service, Advanced Life Support (ALS), non-emergency transport, Level 1; and (3) A0428 - Ambulance service, Basic Life Support (BLS), non-emergency transport. CMS defines a "repetitive ambulance service" as medically necessary ambulance transportation services that are furnished three or more times in a ten-day period, or at least once per week for at least three weeks. According to CMS, these services are often used by elderly beneficiaries that require transportation for dialysis, cancer, or wound treatment.

The prior authorization the process requires the ambulance provider to request provisional affirmation of coverage by CMS before a service is rendered to a beneficiary and before a claim is submitted for payment. CMS believes that prior authorization will ensure that the ambulance service is medically necessary and meets the applicable Medicare coverage criteria. According to CMS, the Medicare Administrative Contractor (MAC) will make every effort to review the prior authorization request and postmark decisions letters win ten business days. Each prior authorization decision may affirm up to 40 round trips per request in a 60-day period. The prior authorization request submitted by an ambulance provider must include:

  • The beneficiary's name, Medicare number, and date of birth;
  • The physician's name, national provide identifier ("NPI"), and address;
  • The provider/provider's name, NPI, and address;
  • Procedure codes;
  • Submission date of the prior authorization request;
  • Start of the 60-day period;
  • Indicate is the request is an initial or resubmission review;
  • Physician certification statement;
  • Number of transports requested;
  • Documentation from the medical record to support the medical necessity of repetitive transports;
  • Information on the origin and destination of the transports; and
  • Any other relevant document as deemed necessary by the Contractor to process the prior authorization.
For prior authorization requests denied by CMS, the ambulance provider can resolve any identified deficiencies in the request and resubmit the request; this can be done an unlimited number of times. The provider may also choose to provide the service and submit the claim for payment, even when the prior authorization is denied; however, any claim submitted will be denied, and payment can be sought through the Medicare appeals process. Finally, if an ambulance provider has not requested prior authorization before the fourth round trip, any subsequent claim will be stopped and reviewed on a prepayment review basis.

The initial stages of the pilot program apply only to ambulance providers located in South Carolina, New Jersey and Pennsylvania, and do not include ambulance transports included in a covered Part A stay or provided by an institutionally-based ambulance provider. However, even if currently outside the scope of the pilot program, providers should be alerted to CMS's recent scrutiny of ambulance transport services and may be a sign that providers could be targeted for Medicare audits in the future. If you are an ambulance provider and have any questions regarding the new prior authorization rules or the implications that the new pilot program may have on your practice, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.

December 12, 2014

CMS Issues Proposed Rule Postponing ACO Penalties

On December 1, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would postpone penalties against accountable care organizations (ACOs) for three years. The proposed rule is one of the latest measures CMS has taken to encourage ACOs to stay in the Medicare Shared Savings Program. In 2012, as part of the rollout of the Patient Protection and Affordable Care Act, the Medicare Shared Savings Program was initiated in an effort to curb spending, while improving quality of care. Since its enactment, industry stakeholders have pushed for leniency, primarily because the Medicare Shared Savings Program penalizes ACOs after the first three years unless the ACOs voluntarily take on financial risk earlier, in exchange for larger bonuses if they perform well. While policymakers supported the penalties as a means of incentivizing change in the healthcare market, providers, particularly less experienced providers, pushed back--arguing that a more moderate approach would ease the financial risk and foster more growth. Recently, the National Association of ACOs released the results of a survey, which reported that approximately 200 of the 300 ACOs in the program were somewhat or highly unlikely to continue if they were required to accept penalties.

With the issuance of the proposed rule, CMS conveyed that it wants less experienced ACOs to remain in the program. By postponing the penalties, CMS acknowledged that some ACOs might not be ready to accept the financial risks and fear these providers might exit the program in lieu of exposing their entity to liability.

However, ACOs must abide by specific criteria if they want to take advantage of the postponement. Under the proposed rule, ACOs must have reduced their spending in their first two years in the program and be prepared to assume the financial risk of penalties after six years. Additionally, CMS plans to encourage ACOs to exit the safer track and take on more risk by decreasing the safe track bonuses from fifty percent to forty percent. Furthermore, CMS proposed a third track, which would implement new methods to determine which patients are included in the ACO. Specifically, the ACOs would start the year with a list of patients, and manage those patients' costs and care. This new system should benefit ACOs because CMS will identify the patients at the start of the year, allowing for more focused improvement efforts. Lastly, the third track will also include potential bonuses and penalties.

Wachler & Associates frequently counsels healthcare providers regarding ACOs, compliance with ACO requirements, and other healthcare fraud and abuse laws. If you have any questions regarding ACOs or how CMS's proposed rule may impact your healthcare entity, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.

December 5, 2014

Deadlines for Certification with the American Board of Radiology Approaching Quickly

The American Board of Radiology's ("ABR") Board Eligibility Policy, implemented on January 1, 2012, limited the period of time that may elapse between the completion of residency training and achievement of Board Certification. Because a number of radiologists had completed their residencies but not yet achieved Board Certification when the policy went into effect, the ABR established a transitional phase-in period with specific time limits on the Board Eligibility period.

Importantly, the dates chosen by the ABR as the deadlines for achieving certification for certain radiologists are quickly approaching. For diagnostic radiology and radiation oncology, the termination dates for board eligibility status are as follows:

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As a result, radiologists who completed their training in 2004 or before but continue in the examination process are facing possible termination of "board eligibility" as soon as the end of this year. After the period of board eligibility expires, radiologists who have not achieved Board Certification will no longer be considered by the ABR to be "board eligible," and will no longer be permitted to designate themselves as such for credentialing purposes.

Moreover, re-entry into the certification process will require substantial effort. To return to "board eligible" status, the candidate must complete an additional year of training in a department with an Accreditation Council for Graduate Medical Education (ACGME)-accredited or Royal College of Physicians and Surgeons of Canada (RCPSC)-accredited diagnostic radiology or radiation oncology residency program. Additionally, the ABR must approve the additional year of training before it begins and the training must begin after expiration of board eligibility. During this one-year period, the candidate's status will be "not certified, not board eligible." Following the one-year training, the program director must attest to the candidate's successful completion. Once the ABR receives confirmation, the candidate will reenter the certification process and must pass the Core and Certifying examinations. Candidates will have a six-year period to pass the examinations.

Wachler & Associates will continue to monitor and provide timely updates on important ABR developments. If you have any questions regarding your board eligibility status, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To remain updated on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

November 12, 2014

CMS Announces Increased Reimbursement for Telehealth

On October 31, 2014, the Centers for Medicare and Medicaid Services (CMS) released its CY 2015 Physician Fee Schedule Final Rule. The rule included several important changes as it relates to telehealth services. With respect to reimbursement rates, in the final rule CMS increased Medicare payments to telehealth originating sites by 0.8 percent.

In addition, the final rule provides seven new procedure codes that cover the following telehealth services:

  • Psychotherapy services (CPT codes 90845, 90846, and 90847);
  • Prolonged services in the office (CPT codes 99354 and 99355); and
  • Annual wellness visits (HCPCS codes G0438 and G0239).
For billing purposes, the originating site fee will be $24.83. CMS also introduced new CPT code 99490, which allows physicians to bill Medicare for chronic care management. The monthly, unadjusted, non-facility fee will be $42.60. Most importantly, CPT 99490 is considered a physician service and is, therefore, available nationwide and not restricted to rural-only telehealth.

Although these changes in the final rule have been received by many telehealth advocates and providers as welcomed developments, CMS did not eliminate the requirement for patients to be located in a rural area in order to receive telehealth services, despite suggestions from many commenters in response to the 2015 Physician Fee Schedule proposed rule to expand the reach of telehealth.

If you or your healthcare entity have any questions regarding telehealth or implications of the final rule on your telehealth practice, or are interested in introducing telehealth into your practice, please contact an experienced healthcare attorney by phone at 248-544-0888 or via email at wapc@wachler.com. Wachler & Associates will continue to keep you updated on telehealth developments, as well as other healthcare news. If you are interested, please subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

November 5, 2014

CMS Finalizes Home Health Prospective Payment System Rule

On October 30, 2014, the Centers for Medicare and Medicaid Services (CMS) announced its final rule regarding changes to the Medicare home health care prospective payment system. The changes, which are set to go into effect in calendar year 2015, will reduce payments to home health agencies (HHAs) by approximately .30 percent, or $60 million. This decrease comes as a result of the 2.1 percent home health payment update percentage. Additionally, the decrease implements the second year of the four-year phase in of the rebasing adjustments promulgated by Section 3131(a) of the Affordable Care Act.

CMS stated that the final rule is one of several to be released for calendar year 2015 aimed at reflecting a broader strategy to deliver better care at lower cost by increasing delivery efficiency. Provisions in the final rule should transition the healthcare system into one that values quality over quantity by focusing on reforms such as helping manage and improve chronic diseases, measuring for better health outcomes, focusing on disease prevention and fostering a more-efficient and coordinated system.

The Medicare program reimburses HHAs through a prospective payment system that pays higher rates for beneficiaries with greater needs. Currently, all HHAs must provide relevant data from patient assessments, which CMS uses to annually determine payment rates. In order to qualify for the Medicare home health benefit, a beneficiary must be cared for by a physician, require physical therapy or speech-language pathology, require intermittent skilled nursing care, or continue to need occupational therapy. Additionally, the beneficiary is required to be homebound and receive services from a Medicare-approved HHA. Outlined below are changes that the final rule makes to various aspects related to the home health prospective payment system.

Face-to-Face Encounter Regulatory Requirements Reform- Under the ACA, certifying physicians, or allowed non-physician providers, are required to have a face-to-face encounter with a beneficiary before the physician certifies the beneficiary's home health benefit eligibility. Under current requirements, the encounter must occur within 90 days before care begins, or within 30 days after care begins. In addition, part of the documentation must include a "brief narrative" that explains why the clinical findings during the encounter support that the patient is homebound and needs skilled services.

In the final rule, CMS finalized three changes to the face-to-face encounter documentation requirements that are effective for start of care episodes beginning on or after January 1, 2015. First, CMS eliminated the current narrative requirement for most services. The certifying physician must still certify that the face-to-face encounter occurred, that the encounter was related to the primary reason for home health services and document the date of such encounter. CMS will require the certifying physician to provide documentation in their medical records, or when applicable the acute/post-acute care facility's medical records, to be used as the basis for certification of the beneficiary's eligibility for home health services. CMS confirmed that the medical records should include the visit note from the face-to-face encounter. Second, CMS finalized that if a HHA claim is denied, the related physician claim for certifying or re-certifying the beneficiary's eligibility is considered non-covered as well because there is no longer a respective claim for Medicare-covered home health services. Lastly, CMS clarified that face-to-face encounters are required for certifications, rather than initial episodes. CMS also noted that certification, as opposed to re-certification, is typically considered to be whenever a new assessment is completed to initiate care.

Therapy Reassessments Modifications- The final rule eliminated the 13th and 19th visit reassessment requirements for therapists. Instead, for episodes beginning on or after January 1, 2015, a qualified therapist, not an assistant, is required to provide the needed services and reassess the patient at least once every 30 days. CMS hopes this change will reduce the burden on HHAs who formerly had to count visits. Additionally, the new policy should reduce the risk of non-covered stays, allowing therapists to focus on providing higher quality of care.

Conditions of Participation Changes for Speech-language Pathologists- In the final rule, CMS changed the Home Health Conditions of Participation for speech language pathologists (SLPs) in an effort to provide more flexibility by deferring to State licensure requirements. Following the implementation, an SLP is an individual that meets one of the following requirements:

  • Has a master's or doctoral degree in speech-language pathology, and is licensed as a speech-language pathologist by the state where they furnish services; or
  • Has a master's or doctoral degree in speech-language pathology, and successfully completed 350 hours of supervised clinical practicum (or is on the process of accumulating such supervised clinical experience), has at least nine months of supervised full-time speech-language pathology experience after obtaining a master's or doctoral degree in speech-language pathology or related field, and has successfully completed a national examination approved by the Secretary.
Wachler & Associates regularly counsels healthcare providers regarding rules and regulations involving Medicare compliance and reimbursement, including application to home health agencies. If you have questions about how CMS's final rule may impact your agency, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To stay updated on breaking healthcare news, please subscribe to the Wachler & Associates health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

November 4, 2014

Office of Medicare Hearings and Appeals Hosts Second Medicare Appellant Forum

On October 29th, the Office of Medicare Hearings and Appeals (OMHA) hosted its second Appellant Forum in Washington, D.C. OMHA is responsible for the Administrative Law Judge (ALJ) level of the Medicare administrative process, and thus operates the third level of appeals for Medicare audit denials. The Appellant Forum was intended to provide updates to Medicare audit appellants on the status of OMHA operations and to relay information regarding OMHA initiatives to reduce backlog in the processing of Medicare appeals.

Representatives from Wachler & Associates attended the Appellant Forum and gained valuable information for appellants facing delays in Medicare ALJ appeals. OMHA's Chief ALJ, Hon. Nancy Griswold, explained the historical backdrop that led to OMHA's current backlog in appeals and described OMHA's attempts to find a "holistic solution" to ALJ workload.

Judge Griswold also updated providers on statistics regarding OMHA's appellant workload. She explained that Medicare Part A and Part B appeals amount to 99% of the appeals pending at the ALJ level. Further, that despite increased productivity by ALJs, OMHA currently receives 4 times the amount of appeals per day as the ALJ's are able to adjudicate per day. In January 2014, OMHA received 14,000 appeal receipts per week. The unprecedented amount of appeals has caused OMHA to fail to meet its 90-day statutory requirement for adjudication. As of September 2014, the average wait time for an ALJ decision was 514 days, which again marked a significant increase from the fiscal year 2013 average.

The Appellant Forum highlighted several OMHA initiatives to address ALJ workload and pending appeals. First, OMHA received an 18.6% increase in appropriations for FY 2014, which allowed OMHA to open a Kansas City Field Office and increase adjudication staff and other resources. Additionally, OMHA has several IT initiatives under way to streamline the appeals process and improve efficiency. OMHA's IT initiatives include an "ALJ Appeal Status Information System" or AASIS, which provides appellants access to basic information regarding their appeals. OMHA hopes to roll out AASIS by the end of 2014. AASIS is OMHA's interim solution until their permanent appeal portal is in place. OMHA's permanent electronic appeal portal will be named the Electronic Case Adjudication and Processing Environment, or ECAPE. ECAPE, which is still in the development phase, will allow appellants to electronically file requests for hearing, submit electronic evidence, share records, communicate with OMHA, view ALJ assignment status, and other functions. ECAPE will be OMHA's long term solution to the modernizing the Medicare audit ALJ appeal process.

The Appellant Forum also updated appellants on two important pilot programs that were introduced by OMHA during the initial Appellant Forum in February. OMHA's Statistical Sampling pilot is intended to allow appellants to adjudicate large volumes of appeals by drawing a random sample of claims to adjudicate before an ALJ, and then extrapolating the results of the sample to the universe of claims at issue. Jason Green, Director of OHMA's Program Evaluation and Policy Division, explained that no appeals have been adjudicated via this method and that OMHA is exploring ways to tweak the pilot's strict eligibility criteria in order to make the pilot more available to appellants. OMHA's other pilot program, the Settlement Conference Facilitation (SCF) Pilot, follows a mediation model and brings appellants and CMS together to work towards a mutually agreeable resolution of the claims. Mr. Green, who our firm views as an invaluable person in OMHA's attempt to resolve the ALJ backlog, explained that only one SCF has occurred and the parties failed to reach an agreement. Mr. Green is hopeful that the forthcoming SCF conferences will be more successful.

In all, the Appellant Forum served to update providers and suppliers on OMHA's ALJ workload and their efforts to reduce current backlog. OMHA acknowledged that their current ability to meet the 90-day requirement negatively affects the provider community, and that they continue to look for holistic solutions to reduce workload to a sustainable volume.

Wachler & Associates continues to stay up to date on issues facing Medicare audit appellants. Our attorneys work with OMHA on a regular basis and provide input on the ALJ appeals process. We currently represent providers appealing audits through the Settlement Conference Facilitation pilot program, and have experience using statistical samples to appeal large volume audits. Our firm will continue to update you regarding developments in OMHA's ALJ appeal backlog and any other developments in the Medicare audit landscape.

If you or your healthcare entity have any questions regarding OMHA's Appellant Forum or Medicare appeals pilot programs, or need assistance in defending Medicare, Medicaid or Third Party Payer audits, please contact an experienced healthcare attorney at (248) 544-0888 or by visiting our website, www.wachler.com.

October 28, 2014

CMS Extends Fraud and Abuse Waivers for ACO Shared Savings Program

On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) extended its interim final rule regarding fraud and abuse waivers for accountable care organizations (ACOs) that participate in the Medicare Shared Savings Program. The Medicare Shared Savings Program was one of the initial steps taken under the Affordable Care Act to both increase quality and lower costs in the Medicare program. ACOs that participate in the Medicare Shared Savings Program can share in the savings generated to Medicare.

Originally, the interim final rule was published in the November 2, 2011 Federal Register, and had the typical three-year period before becoming a final rule. The continuation of the interim final rule extends the timeline for an additional year, establishing a new deadline of November 2, 2015. The interim final rule offers five waivers to ACOs, which allow healthcare entities to form and operate ACOs without fear of violating federal fraud and abuse laws. The ACO waivers include:

  • An ACO participation waiver;
  • An ACO pre-participation waiver;
  • A compliance with the Physician Self-Referral (Stark) law waiver for the Gainsharing Civil Monetary Penalties (CMP) and Anti-Kickback Statute (AKS);
  • A shared savings distribution waiver; and
  • A patient incentive waiver.

    CMS offered these exemptions to the Stark law, AKS, and Gainsharing CMP to encourage ACOs to participate in the Medicare Shared Savings Program. Noting the success of the waivers, CMS extended the deadline in an attempt to prevent disruptions in the ongoing operations of ACOs. Additionally, CMS was concerned that the expiration of the interim final rule would result in considerable legal uncertainty for ACOs and, in turn, place the success of the Medicare Shared Savings Program at risk. In its announcement, CMS adamantly affirmed its commitment to establishing ACO waivers.

    CMS's deadline extension also allows time for further comments from providers, policymakers, and others with a stake in the interim final rule. Specifically, CMS requested input regarding:

  • Whether the existing waivers serve the needs of ACOs and Medicare;
  • How and to what extent ACOs are using the waivers;
  • Whether the waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
  • Whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.

    Wachler & Associates regularly counsels healthcare providers regarding compliance with ACO requirements, the Stark Law, AKS, and other fraud and abuse laws. If you have any questions regarding ACOs or how CMS's interim final rule and ACO waivers may impact your health care entity, or seek assistance in commenting on any of the provisions, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.

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