On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics on which FDA is seeking feedback are broad, but generally include:

  • The impact of off-label communications on public health,
  • The impact of changes in the health care system on the development of high-quality data on new uses of cleared or approved products,
  • Preserving incentives for manufacturers to seek approval for new uses, standards for truthful and non-misleading information,
  • Factors FDA should consider in monitoring and bringing enforcement actions based on off-label communications by manufacturers,
  • The extent to which data on which off-label communications are based should be publicly available, and
  • The changes FDA should consider to existing regulations governing manufacturers’ communications regarding their products.

This announcement comes in the wake of increased pressure from lawmakers, public interest groups, and regulated industry for FDA to issue guidance or propose regulatory changes to address recent litigation clarifying commercial speech protections for pharmaceutical and medical devices manufacturers under the First Amendment. On May 26, 2016, the House Committee on Energy and Commerce sent a letter to HHS Secretary Sylvia Burwell expressing concern that FDA had failed to clarify its current thinking on permissible manufacturer communications about uses of cleared and approved drugs and devices beyond the scope of their approved labeling. In the letter, the committee noted that FDA had neither issued guidance, including guidance on the permissible scope of “scientific exchange” that has been on FDA’s Guidance Agenda since 2014, nor conducted the public hearing it announced in May 2015 in connection with negotiations on the proposed 21st Century Cures bill.  The committee expressed concern that HHS was preventing FDA from issuing guidance or proposing new regulations to address a string of recent court victories for companies and individuals prosecuted for off-label communications about drug and medical devices.

In light of the current state of First Amendment commercial speech protections, which makes it clear that manufacturers’ truthful and non-misleading speech regarding their products is not unlawful even if that speech includes uses of their products that have not been approved or cleared by FDA, other stakeholders have actively encouraged FDA to issue guidance or modify its regulations to conform its regulatory oversight and enforcement activities to this reality. While stakeholder groups have been actively engaged on these issues for several years, recent examples include the February 2016 white paper issued by the Duke-Margolis Center for Health Policy outlining policy options for off-label communications, and the joint release by BIO and PhRMA of the Principles on Responsible Sharing of Truthful and Non-Misleading Information about Medicines with Health Care Professionals and Payers on July 27, 2016.

Despite pressure from interested stakeholders, FDA has yet to propose changes to its regulations or issue long-awaited guidance on a number of topics related to manufacturers’ communications regarding off-label uses of their cleared or approved products. While FDA’s 2016 Guidance Agenda, updated most recently on August 6, 2016, continues to promise guidance on manufacturer communications regarding unapproved, unlicensed, or uncleared uses of approved, licensed, or cleared human drugs, biologics, animal drugs and medical devices and the inclusion of health care economic information in promotional labeling and advertising for prescription drugs, among others, the post-election timeline for the public hearing and FDA’s ongoing collection of feedback announced in the August 31st notice may suggest that FDA is going back to the drawing board. In particular, the focus in the notice’s background discussion and in FDA’s questions on the public health impact of off-label communications may suggest that FDA is re-evaluating its position in response to the HHS concerns about broader dissemination of off-label by manufacturers that were highlighted in the Energy and Commerce committee letter.  While FDA’s notice and request for comments is a step in the right direction, it likely signals a further delay in the issuance of guidance that is needed to bring greater clarity to the currently unsettled regulatory framework for FDA’s oversight of manufacturers’ off-label communications, and a punting of these important decisions to the next administration.

On May 19th, the FDA again postponed publication of the Final Rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” to April 2017 (the “Final Rule”).  On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making (“NPRM”) was originally published in November 2013 to provide generic drug and biologics manufacturers with the ability to update safety information on their labels independently of the brand manufacturer.

The proposed rule was published in response to the decision by the Supreme Court of the United States in the case of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which held that generic drug manufacturers cannot be held liable for failure to update the safety label of a drug or biologic in violation of state “failure to warn” tort law.  FDA regulations currently require that the label of a generic drug must match the wording of the label of the corresponding name brand drug.  The Court found that, under its reading of those regulations, the generic manufacturer could not unilaterally update the generic drug’s label without violating these regulations.  As such, the Court held that FDA regulations preempt state tort law with regard to such failure to warn claims such that the generic manufacturer cannot be held liable for any failure to update the label except to match the label of the corresponding brand drug.

The goal of the proposed rule is to allow certain generic drug or biologics manufacturers to update the label of the generic drug or biologic upon receipt of new safety information and with notice to the FDA.  The proposed rule would not require, under certain circumstances and for limited durations, the generic label to match the label of the brand drug; however, it would require generic manufacturers to review and monitor safety information and scientific literature regarding its drugs in the same manner as brand manufacturers must monitor and review information about their marketed compounds and biologics.  Adoption of the proposed rule would likely give state courts the freedom to impose liability upon generic manufacturers for failure-to-warn claims given that the rule would undercut the basic premise of the Supreme Court’s holding in PLIVA, Inc. v. Mensing.

This is the second time the Final Rule has been postponed.  The FDA originally closed notice and comment on March 13th, 2014 with a projected publication date for the Final Rule in September 2015.  Rather than issue the Final Rule, the FDA reopened the comment period in February 2015, held a one day public meeting, and revised the anticipated publication date of the Final Rule to the Spring of 2016.  While the NPRM was originally meant to quell public outcry over the Supreme Court’s decision not to hold generic manufacturers liable for the labeling of their drugs, the proposed rule has caused possibly even greater controversy.  Trade groups for generic manufacturers opposed the original NPRM and continue to oppose any efforts to finalize the proposed rule.  Now that the House of Representatives has passed its appropriations bill the possibility that the proposed rule may be abandoned altogether is becoming more likely.

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”).  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of Electronic Health Record (“EHR”) data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an Investigational New Drug Application or Investigational Device Exemption.

While the recommendations set forth in the Draft Guidance do not represent a significant departure from existing guidance, research sponsors, institutions and investigators should consider the extent to which their existing policies and procedures, template agreements, protocols and informed consent documents should be updated to incorporate FDA’s recommendations.

Specifically, the draft guidance provides additional detail on FDA’s expectations for the due diligence to be performed by sponsors prior to determining the adequacy of any EHR system used by a clinical investigator to capture source data for use in a clinical investigation. FDA expects sponsors to assess whether systems have adequate controls in place to ensure the confidentiality, integrity, and reliability of the data. FDA encourages the use of EHR systems certified through the ONC Health IT Certification Program, and will presume that source data collected in Health IT certified EHR systems is reliable and that the technical and software components of privacy and security protection requirements have been met. Sponsors should consider requesting additional detail in site pre-qualification questionnaires or pre-study visits regarding any EHR system utilized by clinical investigators to record source data, including whether such systems are Health IT certified. Sponsors may also consider the extent to which their existing site qualification policies and clinical trial agreements templates adequately reflect the technical requirements for sites utilizing EHR systems to record source data, the need to ensure that any updates to those systems do not impact the reliability of the security of the data, and the extent to which the data, including all required audit trails, are backed up and retained by the site to ensure necessary access by FDA.

The Draft Guidance also includes recommendations regarding the information it expects to be included in study protocols and informed consent documents. When the use of EHR systems is contemplated, FDA recommends that study protocols include a description or diagram of the electronic data flow between the EHR and the sponsor’s EDC system, along with information regarding the manner in which the data are extracted and imported from the EHR and monitored for consistency and completeness. FDA also recommends incorporation into informed consent forms of information regarding the extent of access to EHRs granted to sponsors, contract research organizations, and study monitors, as well as a description of any reasonably foreseeable risks with the use of EHRs, such as those involving an increased risk of data breaches. While information related to third party access to health information is typically addressed in informed consent documents, specific details related to access to EHRs and their associated risks are less common. Sponsors and research institutions should consider the extent to which their template informed consent documents should be updated to incorporate the best practice recommendation in the Draft Guidance.

In addition, in the Draft Guidance, FDA encourages the development and use of interoperable EDC and EHR systems to permit electronic transfer of EHR data into the eCRFs being utilized for a clinical trial, including the adoption of data standards and standardization requirements of the ONC Health Information Technology (Health IT) Certification Program. While interoperability of EHR and EDC systems offers the promise of increasing efficiency of clinical trial data collection and reducing the transcription errors that commonly result from the maintenance of this information in separate repositories, FDA acknowledges challenges related to the diverse ownership of the data and EHR systems used to capture them, and the confidentiality of clinical trial information, that will need to be overcome in order to realize the benefits offered by interoperability.

By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady

The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B Program stakeholders, including, covered entities, contract pharmacies, 340B technology vendors, and drug manufacturers.

The draft language addressed the concerns of several Committee members during the Health Subcommittee hearing on March 24, 2015 (discussed here), including the lack of clarity surrounding the patient eligibility definition, the lack of transparency on how hospital-based covered entities use 340B savings to benefit underserved patients, and the Health Resources and Services Administration’s (“HRSA”) limited authority to issue regulations and enforce 340B Program requirements. In addition, the draft language would impose several new requirements on 340B contract pharmacy arrangements. The following summarizes several key provisions included in the draft language.

Patient Eligibility Definition

The proposed language defining “patient” did not significantly deviate from the existing definition set forth in HRSA’s 1996 guidance, but added a requirement that the patient have an “in-person” clinical or medical visit at the covered entity.

New Obligations for Covered Entities

The draft language proposed several new requirements of covered entities in order to participate in the 340B Program, including the following:

  • Covered entities would pay a user fee not to exceed 0.1 percent of covered outpatient drug purchases.
  • Covered entities with high volume purchases would be required to conduct an annual independent audit of the entities’ 340B Program compliance, and provide the results to the Department of Health and Human Services (“HHS”).
  • Hospital-based covered entities (except for critical access hospitals) would be subject to substantial new reporting requirements, including the submission of an annual report detailing the following: (1) patient breakdown by payor and the aggregated amount of acquisition cost and reimbursement for covered outpatient drugs by payor, (2) the use of its 340B Program revenue relating to the access and provision of health care for the uninsured, underinsured, underserved and medically vulnerable, (3) its prevention of duplicate discounts, (4) the number of covered outpatient drugs dispensed by each of its contract pharmacies, (5) the amount of uncompensated care, and (6) the name of any third parties or vendors that administer its inventory management system or contract pharmacy arrangement.

Guidance on Contract Pharmacies

The proposed language also addressed contract pharmacies and imposed some potentially onerous obligations for covered entities and contract pharmacies. The contract pharmacy language required covered entities utilizing contract pharmacies to:

  • Have a contractual agreement in place with each contract pharmacy;
  • Register the contract pharmacy agreement and the contract pharmacy’s “distance” from the covered entity with HRSA;
  • Ensure compliance of each contract pharmacy agreement with the requirements to prevent drug diversion and duplicate discounts;
  • Develop a mechanism to track the income of the patients of the covered entity and the amount such patients pay to receive covered outpatient drugs from the contract pharmacy;
  • Maintain and ensure that each contract pharmacy maintains, auditable records;
  • Develop a process and conduct review of prescribing and dispensing records to identify irregularities; and
  • Provide annual audits of the contract pharmacy to be conducted by an independent auditor.

Expanded HHS Authority

The proposed changes would have provided HHS with the authority to establish limits on what the uninsured pay for 340B drugs and allowed HHS to impose new penalties on covered entities for non-compliance with the 340B Program. Perhaps, most significantly, the proposed language would have given HHS the authority to issue regulations addressing several areas of the 340B Program including, but not limited to, covered entity eligibility, patient definition, contract pharmacy arrangements, covered entity reporting requirements, duplicate discounts, limits on amounts charged to uninsured patients, and penalties for non-compliance.

At the International Association of Privacy Professionals (“IAPP”) Global Privacy Summit in Washington, D.C. on March 5th and March 6th, the Federal Trade Commission (“FTC”) was clear in its message that privacy was a top priority for the agency.  The FTC had a strong presence at the conference.  Three of the five Commissioners and the Director of the Bureau of Consumer Protection (Jessica Rich) all spoke at the conference and relayed a message of the importance of consumer privacy and security.  In that regard, the FTC speakers stressed the importance of:

  • informing consumers of the collection of consumer information;
  • informing consumers how such collected information will be used; and
  • providing strong safeguards for information collected.

The FTC speakers also announced that the FTC will be beginning a new security campaign to engage businesses of all sizes in understanding the importance of securing consumer information.  The FTC speakers also emphasized the FTC’s concern and focus on the collection of health information by organizations that are not covered under HIPAA (for example organizations developing wearable devices or other consumer driven apps).  Given the tenor of the discussions, there is no question that FTC will continue to make privacy enforcement a top priority.  As a result, device manufacturers, pharmaceutical manufacturers, and mobile health developers should remember to think beyond HIPAA when they think of U.S. privacy compliance.  For a listing of prior privacy enforcement actions by the FTC see, https://www.ftc.gov/news-events/media-resources/protecting-consumer-privacy/enforcing-privacy-promises.

By Constance Wilkinson, Alan Arville, and Jonathan Hoerner

On July 23, 2014, the Health Resources and Services Administration (“HRSA”) issued an “interpretive rule” entitled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program” (the “Interpretive Rule”).[1] The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program (the “Final Rule”).[2]

By way of background, the 340B program, created in 1992 and administered by HRSA, requires drug manufacturers to give discounts to entities covered under the law—known as “Covered Entities”—in order to have their drugs covered by Medicaid. The Affordable Care Act, along with the Medicare and Medicaid Extenders Act of 2010, expanded the definition of Covered Entities to include critical access hospitals, free-standing cancer hospitals, rural referral centers, and sole community hospitals. For these categories of Covered Entities only, drugs designated by the Food and Drug Administration as drugs “for a rare disease or condition” (“Orphan Drugs”) are excluded from covered outpatient drugs subject to mandatory 340B pricing requirements (the “340B Orphan Drug Exclusion”).[3] Other Covered Entities, such as disproportionate share hospitals, are not subject to the Orphan Drug Exclusion.

Interpretive Rule on Orphan Drugs in the 340B Drug Pricing Program

Consistent with the now vacated Final Rule, the Interpretive Rule states that the 340B Orphan Drug Exclusion only excludes Orphan Drugs when those drugs are “transferred, prescribed, sold, or otherwise used for the rare condition or disease,” for which the drug was designated orphan status. For example, even though Prozac (fluoxetine) is an Orphan Drug for the treatment of autism, under HRSA’s interpretation of the 340B Orphan Drug Exclusion, a Covered Entity subject to the 340B Orphan Drug Exclusion may purchase Prozac for its eligible patients at the 340B discount price when it is prescribed for depression, a non-orphan condition.[4] To support its position, HRSA states that its interpretation is consistent with the FDA’s interpretation of the orphan drug provisions in the Federal Food, Drug, and Cosmetic Act, including the FDA’s application of incentives for the development of orphan drugs (e.g., market exclusivity, tax credit, user fee exemption) to only the use of the drug intended to treat the rare disease or condition and not non-orphan drug indications.

The Interpretive Rule also discusses Section 340B’s requirement that prohibits certain hospitals, including free-standing cancer hospitals subject to the 340B Orphan Drug Exclusion, from purchasing covered outpatient drugs through a group purchasing organization (“GPO”). As with the Final Rule, the Interpretive Rule states that this prohibition does not apply to Orphan Drugs when they are used for the orphan designated rare condition or disease. Therefore, free-standing cancer hospitals can use a GPO to purchase an Orphan Drug for such rare condition or disease but cannot use a GPO when the drug is being used for other non-orphan purposes.

In order to facilitate the identification of drugs with an orphan designation for 340B Program purposes, the Interpretive Rule states that on the first day of the month prior to the end of the calendar quarter, HRSA will publish a listing of orphan drug designations, providing the name of the drug and the designated indication. HRSA also repeats its position in the Final Rule that a Covered Entity cannot purchase Orphan Drugs through the 340B program if the Covered Entity does not have the ability to track the indication for drug use. Notably, the Interpretive Rule does not include the requirement of the Final Rule that Covered Entities must notify HRSA if they cannot or do not wish to maintain auditable records sufficient to demonstrate compliance with the 340B Orphan Drug Exclusion.[5]

Previous Court Decision

After HRSA issued the Final Rule in July 2013, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) brought suit against HRSA claiming that the rule was invalid because it contravened the plain language of the statute.[6] First, the court determined that the Final Rule was a legislative rule, a rule which carries the force of law. Next, the court concluded that HRSA lacked the statutory authority to promulgate the Final Rule as a legislative rule.

In addition to arguing that it had the requisite authority to issue a legislative rule, HRSA also took the alternative position that the Final Rule was not a legislative rule and should be viewed and upheld as an interpretive rule. As opposed to a legislative rule, an interpretive rule provides clarifications or explanations of a statute and does not create a new law, modify an existing law, or create an enforceable right. Even though an interpretive rule does not carry the force of law like a legislative rule, courts will generally give deference to an agency’s interpretive rule.

Calling HRSA’s argument “half-hearted,” the court noted that the Final Rule underwent notice and comment rulemaking and had a “legal effect” on the parties, two components of the D.C. Circuit’s test for a legislative rule. However, the court concluded that it lacked sufficient information to decide if the Final Rule could be considered a valid interpretive rule. HRSA declined the opportunity to make additional arguments on this issue and instead chose to separately promulgate the rule as the Interpretive Rule.

Future Implications

Immediately after HRSA released the Interpretive Rule, PhRMA filed a court document arguing that HRSA’s Interpretive Rule was an attempt to “evade the Court’s holding” that HRSA did not have authority to issue this rule.[7] Thus, it is likely that litigation will continue over the scope of HRSA’s ability to engage in rulemaking, which will likely impact HRSA’s issuance of the proposed 340B “mega-rule.” The “mega-rule” would address multiple key components of the 340B program including the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, and hospital eligibility including criteria for off-site facilities. HRSA had planned to release the “mega-rule” as early as June 2014, but given the questions surrounding HRSA’s authority to engage in rule-making, the “mega-rule” will likely continue to be delayed.

In the absence of a grant of general rulemaking authority in the 340B statute, HRSA’s custom has been to administer the 340B program through a series of Notices issued through the Federal Register, as well as other sub-regulatory guidance. Whether HRSA reverts to this practice as a result of, or in the absence of, a judicial determination regarding its rulemaking authority remains to be seen.


ENDNOTES

[1] HHS HRSA, Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program, (July 21, 2014), http://www.hrsa.gov/opa/programrequirements/interpretiverule/.

[2] 340 Drug Pricing Program, 42 C.F.R. pt. 10 (2014).

[3] Public Health Service Act § 340B(e), 42 U.S.C. 256b(a) (2012).

[4] Pharm. Research & Mfrs. of Am. v. United States HHS, No. 13-1501, 2014 U.S. Dist. LEXIS 70894, at *2 (D.D.C. May 23, 2014).

[5] 340 Drug Pricing Program, 42 C.F.R. § 10.21(c)(3).

[6] Pharm. Research & Mfrs. of Am. v. United States HHS, No. 13-1501, 2014 U.S. Dist. LEXIS 70894 (D.D.C. May 23, 2014).

[7] Supplemental Memorandum in Support of PhRMA’s Motion for Miscellaneous Relief, ECF No. 52.

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for reporting information and making that information available online to the public, it has yet to publish final regulations. As recently as May 2012, it posted a blog notice on its website announcing that manufacturers will not be required to start collecting data until January 1, 2013. The reason given for the delay was that it simply needed time to sort through the over 300 comments that were received.

The second event that should be good news to manufacturers comes from Vermont. Vermont, along with eight other states and the District of Columbia, already have laws requiring manufacturers to report payments to physicians as well as financial penalties for failing to submit reports. Even though the Sunshine Act supersedes those state laws, any part of a state law that contains different or broader reporting requirements than the federal law remains in effect. However, since CMS has not published its regulations, answering that question may be more difficult than it appears at first. The good news is that the Vermont Attorney General has offered a limited amnesty to manufacturers of medical devices and biologics (but not pharmaceuticals) who did not report during any period between July 1, 2009 and December 31, 2011. The reprieve waives the penalties, but not registration fees or penalties under other state laws. While a complete report is not required immediately, the offer is for a limited time only and is good through October 1, 2012. Any inquiries should be sent to the Vermont Attorney General’s office at prescribedproducts@atg.state.vt.us.

For more information, contact the author at rwanerman@ebglaw.com.

As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:

 

 

1. Flexibility. 

 

 "Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande’s advice and avoids being too proscriptive in launching the Share Savings Program. To me, the biggest risk to the program is being deemed a failure for having gone down too narrow a path that turns out to be unsuccessful.

 

Useful approaches have been suggested for tiering ACOs and providing for related payment methodologies based on levels of ACO capability. If some form of risk sharing model is going to be included along with simple share savings, let’s not at the outset go so far along the risk axis that many start-up but promising ACOs would be excluded. Flexibility will encourage positive experimentation and inclusiveness in the interest of learning over time.

 

 

2. Discipline.

 

 At the same time, the ACO regulations need to have teeth. Despite the ongoing policy debates about how to measure quality and value, we know enough now for CMS to provide strong minimum requirements that will separate ACOs that show real promise from those that do not. In order to qualify for bonus or risk-based payments, ACOs will need to demonstrate both the current capability and the future capacity to further the triple aim goals of accountable care–improved patient outcomes, patient satisfaction and cost efficiency.

 

Such evidence will then justify appropriate recognition and protection under the fraud and abuse laws and antitrust laws, among others. And the discipline must be ongoing and progressive–continued qualification and continued improvement. Failure to maintain such qualification must have consequences–both financial and legal.

  

3. Simplicity.

 

One of the risk factors in the success of the Medicare Shared Savings Program is that it will be too complicated to implement effectively. There are a million ideas out there about ACOs–regarding structure and governance, assigning beneficiaries, what measures to use, how to allocate savings, etc.

 

Failure to construct a manageable pathway and an understandable set of rules at the outset–for diverse providers to follow and for consumers to understand and embrace–will severely threaten the ultimate success of the program. It would be easy to try to do too much too fast due to the pressure to "bend the cost curve," among others. I hope that CMS keeps it simple, straightforward and understandable with achievable program goals.

 

4. Patience.

 

Even if the regulations evidence flexibility, discipline and simplicity, we will need to be patient. "We" means CMS, Congress, private payers, providers and consumers. This program is one component of a broader set of ideas relating to health care payment and delivery reform in both public and commercial settings. The overall goal is to achieve the triple aim stated above–or as CMS Administrator Berwick often puts it, "better care, better health and lower costs"–through a variety of means and over time.

 

The Affordable Care Act in its entirety encompasses new quality reporting requirements, value-based purchasing programs, bundling pilots, gainsharing demonstrations, readmissions penalties and other methods of "testing, testing." Not to mention the efforts of the new Center for Medicare and Medicaid Innovation. If the Medicare Shared Savings Program tries to do too much too quickly on its own and the goals are not measured and paced, it inevitably will be judged unfairly and will not make as helpful a contribution as it otherwise might.

 

5. Harmony.

 

Another word I might have chosen here is coordination, but coordination is a means to harmonizing the activities and impact of the relevant federal agencies involved in ACO implementation, the various payment and delivery reform components of the Affordable Care Act and the public and private sector initiatives in this arena. Is such harmony too much to hope for? Perhaps, but it should be a goal and it should be achievable over time.

 

CMS, OIG, FTC and DOJ already have evidenced coordination in the days before and following their October 5, 2010 public workshop on the antitrust issues and fraud and abuse issues related to ACOs. Coordinated guidance is reasonable to expect. The ACA explicitly allows for the coordination of ideas and best practices in accountable care efforts in connection with both governmental and commercial health care payment practices. It certainly is within the power of Secretary Sebelius and Administrator Berwick to harmonize the implementation of Sections 3021, 3022 and 3023 of the ACA, along with the many other provisions that relate to achieving accountable care.

 

                                                   *                    *                   *

The ACO regulations should be out soon. They of course will constitute a start, not a finish. There will be much more work to be done. But my wish–and I am hopeful–is that they lay out a constructive and manageable pathway that fits with others in helping to advance the triple aim.

 

Doug Hastings