April 2011 Archives

April 15, 2011

Attestations To Meaningful Use Requirements Begin April 18

Registration for the meaningful use incentive program began January 1, 2011 with more then 20,000 doctors registering for the program. This program was implemented as a means to incentivize physicians and hospitals to utilize electronic medical record systems. Certain metrics were established and participants must comply with them for 90 consecutive days in order to qualify for any monetary payments. Starting on April 18th, physicians and hospitals may attest to meeting the required criteria. If they are deemed to have met these criteria, they will be eligible for incentive pay up to $44,000 over the next five years.

Achieving meaningful use is also important for physicians wishing to participate in the Medicare Shared Savings program through an Accountable Care Organization (ACO) since many of the quality performance standards are aligned with the "meaningful use" criteria in the HITECH EHR incentive program. Further, ACOs participating in the Shared Savings Program will be required to demonstrate that 50% of the ACO's primary care physicians are "meaningful users" as set forth in the HITECH EHR incentive program.

For any further information about participating or complying with the HITECH Medicare or Medicaid EHR incentive programs or for assistance with ACO formation or participation, please contact a Wachler & Associates attorney at 248-544-0888.

April 15, 2011

Phase 2 of DME Competitive Bidding Process Expected In Spring of 2011

The Durable Medical Equipment (DME) Competitive Bidding Program was implemented as a means to lower costs and improve beneficiary services in the DME industry. It consists of a bidding and selection process based on certain criteria determined by CMS. The Round 1 Rebid competition went into effect in 2009 across 9 Metropolitan Statistical Areas (MSAs) (basically large metropolitan areas). Focus now turns to Round 2, which will increase the MSAs involved by 91, bringing the total to 100. CMS anticipates that the Round 2 contracts and payment amounts will become effective January 1, 2013. A list of the current and projected MSAs where the program is or will be implemented is available on the CMS website.

We will continue to provide updates on Round 2 as the information becomes available. Compliance with the program and its participation requirements are critical to all DME providers in the MSAs. If you have any questions or concerns, please contact a Wachler & Associates attorney at 248-544-0888.

April 13, 2011

Ambulatory-care Physicians Satisfied with EHR Systems

Those practices with electronic health record systems (EHR) in place appear to be very happy with the results. A survey conducted by the Medical Group Management Association found that 72% of practices with implemented EHR systems were "satisfied" with the results. Further, those practices which have optimized their EHR systems have reported an 82% level of satisfaction.

If you have any questions or concerns about the compliance or regulatory issues involved with the implementation of a EHR system, please contact an attorney at Wachler & Associates at 248-544-0888.

April 8, 2011

Update: Face-to-Face Requirments Effective April 1, 2011

Despite efforts by various groups to have the face-to-face  encounter requirement delayed for hospices and home health agencies, the requirement became effective as of April 1, 2011.  For more information regarding this issue, please see a recently authored article by Wachler & Associates attorneys Amy K. Fehn and Jennifer Colagiovanni entitled New Audit Risk for Home Health Agencies: Face to Face Certification Requirements.

April 8, 2011

Highlights from CMS Telephone Conference on Accountable Care Organizations

On April 7, 2011 CMS held a telephone conference for hospitals to answer questions on the recently released Accountable Care Organizations proposed rule and to provide further instruction on the submission of comments to CMS for consideration.

The CMS representatives stated that more information regarding the Centers for Medicare and Medicaid Innovation Center would also be provided soon. This statement arose in light of questions regarding possibilities for ACOs that are not quite ready for the Shared Savings Program. The representatives did reiterate that, pursuant to the statute, ACOs will not be able to participate in more than one shared savings program. The representatives further stated that the required organizational structure for ACOs wishing to participate in other programs might not necessarily be the same as for the Medicare Shared Savings Program.

CMS representatives also discussed the fact that primary care services provided by rural health clinics or federally qualified health clinics would not be considered in the patient attribution process because CMS does not collect sufficient data in claims from these organizations to determine whether the services are "primary care".

The representatives also discussed the fact that information regarding the application process will be available after publication of the final rule and that they anticipate an annual application process, even though there is a three year commitment. They also stated that they contemplate opportunities for renewal after the initial three year term since this is a permanent program rather than a demonstration program.

CMS representatives also discussed that, for antitrust purposes, applicants will be required to submit information regarding the share of services in their Primary Service Area (PSA). When asked how applicants will be able to calculate this information, since it is not publically available, they stated that the data will be made available to ACO applicants in order to assist with this calculation.

CMS representatives also stated that they do not intend to provide formulas or methodologies for distribution of the shared savings from the ACOs to the participants, but that they do expect ACOs to provide this information with their application as well as an explanation as to how the distribution method will help to achieve the triple aim of better care for individuals, better health for the population and cost control.

The representatives encouraged interested parties to submit comments electronically via www.regulations.gov and by entering the file number CMS 1345-P. If you need assistance with ACO formation or submission of comments, please contact a Wachler & Associates, P.C. attorney.

April 8, 2011

Proposed Rule Relaxes DMEPOS Supplier Restrictions

CMS Recently released a proposed rule which would reverse the policy of heightening restrictions on suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  The proposed rule relaxes previously onerous rules regarding the prohibition of telemarketing and beneficiary solicitation which were implemented on September 27, 2010.  If you have any questions about how this proposed rule will affect your current compliance program, please contact a Wachler & Associates attorney at 248-544-0888.

April 6, 2011

30 Highlights from the ACO Proposed Rule

On March 31, 2011, CMS released the proposed rule implementing the Medicare Shared Savings program and establishing the requirements for Accountable Care Organizations (ACOs) that wish to participate in this program.  The following is a list of some of the highlights from this Proposed Rule.

1. The proposed rule contemplates two models: a "one-sided" model in which providers do not share risk and a "two-sided" model in which providers share in risk and realize greater return on the shared savings.

2. ACOs must commit to participate in the shared savings program for three years.  Providers who select the "one-sided" option will need to agree to share risk in their final year of participation.  If an ACO wants to terminate early, they will need to give a 60 day notice to CMS, as well as a notice to beneficiaries, and will forfeit a portion of previously earned shared savings that was withheld by CMS.

3. A primary care ACO participant can only participate in one ACO, while specialists and hospitals will be able to participate with multiple ACOs.  ACO participates will be defined by tax identification number (TIN).  The proposed rule clarifies that a primary care provider or supplier could potentially be affiliated with more than one TIN and, thus, could participate in more than one ACO.

4. Participants in the Medicare Shared Savings program may not participate in other Medicare programs that involve shared savings, such as the Independence at Home project or other models created by the CMS Innovation Center.  This determination will also be made based on TIN number rather than NPI number.  That is, providers could participate through more than one entity with separate TIN numbers.

5. An ACO must have shared governance which provides all ACO participants with appropriate proportionate control over the decision making process.  ACO participants must have at least 75 percent control of the governing body.

6. ACOs must also allow Medicare beneficiaries to participate in governance.

7. An ACO must have a leadership team which has demonstrated the ability to influence or direct clinical practice to improve efficiency processes and outcomes.

8. ACOs must have physician-directed quality assurance and process improvement committees.

9. An ACO must develop and implement evidence-based medical practice or clinical guidelines and processes for delivering care consistent with the goals of "triple aim" (better individual care, better population health and lower costs).

10. ACOs will need IT infrastructure to allow for collection and evaluation of data.

11. Beneficiaries will be assigned on a retrospective basis - based on which primary care physician they receive a plurality of primary care services from during the calendar year in question.

12. CMS will pay ACOs directly and the ACOs will establish a structure for distributing the shared savings among participants.

13. An ACO must take accountability for at least 5,000 Medicare beneficiaries. If an ACO's assigned population falls below 5,000 during the program, the ACO will receive a warning and be placed on a corrective action plan.

14. ACOs will be required to demonstrate patient centeredness principles.

15. Beneficiaries will retain freedom of choice and any marketing from an ACO will be reviewed by CMS to ensure that it does not mislead beneficiaries into thinking that they must forfeit their freedom of choice.

16. Each ACO must have a compliance plan that meets certain criteria set forth by CMS, including without limitation, a compliance officer, training programs, and reporting mechanisms.

17. Although patients will be assigned retrospectively, CMS will also provide ACOs with historical data to determine their expected beneficiary population.

18. Beneficiaries must be given the right to "opt-out" of certain data sharing between CMS and the ACO and must be notified of this right.

19. In the course of a 3 year agreement ACOs cannot add participants (TINs), but can delete participants and can add or delete NPIs (e.g., a provider leaves their group practice).

20. If an ACO is terminated voluntarily or involuntarily during the initial three year commitment, they cannot reapply as an ACO until that time period is over.

21. ACOs must post signs in facilities of participating providers/suppliers and must give written information/notice informing patients of the ACO's participation in the Medicare Shared Savings Program.

22. CMS has proposed 65 initial quality benchmarks. Many of these are identical to the "meaningful use" criteria in the EHR incentive program or PQRS benchmarks. In the initial year, CMS is considering judging ACOs only on the accuracy of their reporting, rather than actual measures.

23. If an ACO meets quality benchmarks, it will be eligible for shared savings of either 50% or 60% depending on whether the ACO has agreed to participate in risk of losses.

24. Most ACOs will have to reach a net savings threshold before sharing begins, although certain ACOs are excepted from this requirement if they are small, rural, and non-hospital based.

25. CMS is proposing to withhold 25% of all shared savings payments to ACOs in order to protect the program in the event that the ACO owes money to CMS as part of the shared losses.

26. ACOs believed to be avoiding "at risk" beneficiaries will be put on a corrective action plan.

27. CMS will establish a fair administrative process for denial of applications, termination, etc. The proposed process will include an in person/telephone reconsideration and another level of written review.

28. The FTC has issued guidance creating a safety zone for ACOs that have less than 30% market share and an expedited review process for those above 30%. ACOs with greater than 50% market share will be required to obtain an expedited review and provide an approval letter to CMS with their application.

29. CMS and the OIG are proposing to waive the requirements of the Stark law, the Anti-Kickback statute and the Gainsharing CMP as they relate to payments made by an ACO to its participants resulting from the Medicare Shared Savings program.

30. Applications are expected to be approved or denied at the end of the calendar year in which they are submitted. The start date is expected to be January 1 of each year, but for the first year, CMS is considering allowing some entities to begin on July 1 and to commit to a 3 ½ year term

While the Medicare Shared Savings Program is just one of many new payment programs included as part of the Affordable Care Act, what sets the Medicare Shared Savings Program apart is that this is not a demonstration program. This is a permanent program that will allow providers who join eligible ACOs to share in savings provided that they can meet the necessary quality measures and create savings. However, the payment methodologies may develop over time. While not every ACO will be chosen for inclusion in the Medicare Shared Savings Program, this new program creates interesting possibilities for providers who wish to focus on quality and cost savings. If you are interested in submitting comments regarding the proposed rule or would like assistance in forming an ACO, please contact Andrew Wachler, Amy Fehn or Alicia Chandler.

April 1, 2011

Proposed Law Would Protect Michigan Hospitals That Apologize To Patients For Mistakes

The proposed legislation would allow Michigan healthcare providers to apologize to patients without fear that those comments will be used against them in legal proceedings.  The law will not provide total immunity to comments, but allow for greater leeway when it comes to expressing remorse for procedures that did not achieve the desired result.