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Public Comments on HHS Preliminary Plan for Retrospective Review of Existing Rules

Download Appendix C (PDF)

Most commenters wrote of general support for the Preliminary Plan.

  • “Both Executive Order 13563 and HHS’[s] Preliminary Plan for Retrospective Review of Existing Rules demonstrate a commitment to striking a proper balance when crafting regulations,” one said.

Another “strongly supports the four goals of the HHS retrospective review: transparency, increasing opportunities for public participation, setting retrospective review priorities, and strengthening the analysis of regulatory options.”

But all, of course, had various and varying tweaks they would like to see incorporated in the final version.

More an observation that a suggestion, one commenter observed “the increasingly haphazard manner in which regulatory policies are being issued and the effect that it is having on hospitals’ ability to know what the rules are and where to find them.”

Another noted that “it seems HHS is prioritizing reviews of inefficient paperwork or other reporting burdens,” but “the appeal of these low-hanging fruit should not monopolize the agency’s attention or distract it from other opportunities to use retrospective review to enhance net benefits.”

And a commenter said, “the current [Medicare Secondary Payer] regulation has not been updated in over 15 years,” asserting “the MSP system is not only failing to achieve its objectives, it is actually working against its stated goals.  They specifically “urge HHS to include the MSP regulations, 42 C.F.R. Part 411, as well as the sub-regulatory industry guidance, in the list of regulations for retrospective review.  The MSP regulations need to be updated for the 21st Century.” 

More than one commenter suggested the plan should address Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) because the current regulations CMS has issued offer “burdensome, incorrect and unclear guidance.”  More specific requests with regard to Section 111 included:

  • Give providers sufficient notice and time to adopt changes in requirements.
  • Institute reasonable thresholds for the collection of Medicare conditional payments.
  • Maintain or increase thresholds for Medicare reporting.
  • Act on plans for a user group on mass tort.
  • Allow “safe harbor” to RREs/Insurance carriers if the injured person will not provide their Social Security number.
  • Lessening penalties for inaccurate reporting.

RESPONSE:  All of these suggestions have been passed on to CMS for consideration in future rulemaking.

Medicare Part C & Part D:

  • Reimburse physicians for excessive prior authorizations or ones that are not resolved within a set period of time.
  • Prohibit prior authorizations for ongoing drug use by patients with chronic diseases.
  • Prohibit prior authorizations for standard/inexpensive drugs.
  • Require all plans to use a standard prior authorization plan.

RESPONSE:  All of these suggestions have been passed on to CMS for consideration in future rulemaking.

In order to facilitate clinical integration to better serve Medicare beneficiaries:

  • Be sure our anti-trust agencies (DOJ/FTC) provide “user-friendly guidance that clearly explains what issues must be resolved to ensure clinical integration programs comply with anti-trust law.”
  • With reference to the Stark Law prohibiting doctors from referring patients to facilities where they have a financial relationship/interest, relax the definition of “financial relationship” because there are “other laws already in place for needed oversight.”
  • The Civil Monetary Penalty (CMP) Law should be modernized “to apply only to the reduction or withholding of medically necessary services.”
  • Alter or eliminate old anti-kickback laws created to “protect patients and federal health programs from fraud and abuse by making it a felony to knowingly and willingly pay anything of value to influence the referral of federal health program business.  Today’s expanded interpretation includes any financial relationship between hospitals and doctors.”
  • “[T]he IRS will need to issue an Advisory Information Letter or a Revenue Ruling recognizing that clinical integration programs that reward private physicians for improving quality and efficiency do not violate IRS regulations.”
  • More general Medicare/Medicaid barriers, such as the “HIPAA rules generally limiting sharing patient information to providers with whom patients have a direct relationship, unless complex procedures are followed such as obtaining a patient’s permission.”

Medicare/Medicaid Coordination:

  • “Establish clear standards… that differentiate between the Medicare responsibilities in an episode of care and the Medicaid coverage obligations.”
  • “Modify third-party liability regulations to require that states utilize the most cost effective method for recovering payment for dually eligible patients.”
  • “Medicare and Medicaid claims submission should be combined with initial billing to Medicare and transfer billing of remaining non-covered care to the respective state Medicaid program.”
  • “Require States to recoup incorrect payments from the Medicare program rather than the provider.”
  • “States should be permitted to coordinate with Medicare through a claims sampling approach.”

RESPONSE:  CMS has already embarked on an Alignment Initiative, designed to better coordinate Medicare and Medicaid.  All of these suggestions have been passed on to CMS for consideration as it implements this Initiative.

Physician Face to Face Encounters:

  • The Patient Protection and Affordable Care of 2010 includes rules/restrictions for Medicare payments for home health services “having a face-to-face encounter with the patient prior to certifying the need for care.” 
    RESPONSE:  CMS is revising the face-to-face requirement with respect to home health services.
  • “Repeal the current regulation with its burdensome documentation requirement.”
  • “Issue a regulation that allows home health agencies to supplement the current certification language with a physician attestation statement of the date that a face to face encounter occurred and that the finds of the encounter support the need for home health services.”
  • “Publish model documentation forms for voluntary use.”
  • “Eliminate the regulatory requirement for a narrative regarding why the patient meets Medicare coverage standards.”

RESPONSE:  CMS will be promulgating a regulation to address conditions of participation requirements for a variety of Medicare providers, including home health agencies.  CMS will be considering these comments as it develops this regulation.

Provider Enrollment, Chain, and Ownership System (PECOS) enrollment:

  • “Amend the ordering/referring physician to comply with the statutory requirement of ordering/referring physician in Medicare, not PECOS.”

RESPONSE:  This suggestion has been passed on to CMS for consideration in future rulemaking.

Outcome and Assessment Information Set (OASIS) Assessments:

  • “OASIS imposes a substantial burden on home health agencies” in the form of massive paperwork requirements.
  • “Require the collection of OASIS items for Medicare fee for service patients only.”

RESPONSE:  This suggestion had been passed on to CMS for consideration in future rulemaking.

Nursing Assessment Requirement:

  • “Allow the therapist or nurse to conduct a start of care assessment in multi-discipline cases.”

RESPONSE:  This suggestion has been passed on to CMS for consideration in future rulemaking.

Home Health Aide (HHA) Supervision:

  • “Eliminate the current supervisory regulation.”
  • “Focus aide supervisory requirements on the aide, not the patient.”
  • “Allow HHAs to establish policies for frequency of aide supervision based on the aide’s skills, experience, and past performance.”
  • “At a minimum require supervision of every aide every sixty days in at least one home while the aide is performing patient care.”
  • “Allow LPNs/LVNs to supervisor home health aides.”
  • “Allow therapist to perform aide supervision as appropriate.”

RESPONSE:  All of these suggestions have been passed on to CMS for consideration in future rulemaking.

Interpreter Services:

  • “Re-estimate provider’s actual cost to implement [rules in translation requirements] and establish requirements based on provider size.”
  • “Translate any CMS model document into languages where there are 100 or more persons residing in the country.”
  • “Allow providers to use family members and friends as interpreters.”
  • “Develop resources for providers including affordable telephone translation services, computer driven voice, and written translator programs.”
  • “Eliminate the requirement for translators to have training in medical terminology.”

RESPONSE:  All of these suggestions have been passed on to CMS for consideration in future rulemaking.

Beneficiary Notices:

  • “Allow home health agencies to combine several notices into a single form.”
  • “Eliminate the signature requirements where they exist.”
  • “Allow all notices to be made by phone and then mailed to beneficiaries.”

RESPONSE:  All of these suggestions have been passed on to CMS for consideration in future rulemaking.

Therapy reassessments:

  • “Amend the regulation to require regular reassessment… to provide for regular and ongoing redetermination of medical necessity for continued therapy services and oversight of care by a qualified therapist.”

RESPONSE:  This suggestion has been passed on to CMS for consideration in future rulemaking.


A long list of individual suggestions and considerations all of which were forwarded to CMS for consideration as it develops future rulemaking: 

Many regulations requiring a “physician” to perform procedures or at least supervise them are called unnecessary by commenters because oftentimes the work can be done just as easily by Certified Registered Nurse Anesthetists (CRNAs) and other Advanced Practice Registered Nurses (APRNs).

Similarly, this commenter wrote that current regulations, 42 CFR part 482.52(a)(4) requires unnecessary supervision by an “operating practitioner or an anesthesiologist” upping costs by increasing staff members but not safety.  This commenter summed up these particular concerns by, “suggest[ing] that all regulations and interpretive guidelines issued by CMS be reviewed with the intent of removing restrictions concerning anesthesia services provided by nurse anesthetists.”

“Unfunded mandates” such as translator services were cited by more than one commenter, noting that required “medical translator services are costly, and neither Medicare nor Medicaid compensates.”

“[T]hree out of five physicians selected their top regulatory grievances [in an AMA survey] to be associated with unfunded mandates” found in current regulations.

Reduce overlapping documentation/certification.

Update and increase the Medicare Economic Index (MEI).

Coordinate all codes, quality measures, operating rules, feedback reports and timelines associated with the Physician Quality Reporting System.

Review evaluation and management (E & M) visit guidelines to accurately reflect providers’ work.

Update Medicare regulations that “were developed decades ago within the context of cost-based reimbursement.”

“Regulation should be cost effective,” establishing “a safe haven for innovation and encourag[ing] the pursuit of excellence.”

Be careful that laws/regulations do not impede progress improving patient care.

Electronic Health Records (EHR) were created and incentives offered to encourage their proliferation, but one commenter called the process “overly complex and confusing,” saying that in order to make EHR a really successful national program it will require “[s]implified regulations.”

Many commenters cited excessive provider reporting and information gathering as a significant burden, with one urging “CMS to align the measures used for various Medicare programs whenever possible to reduce [the] provider reporting burden.”

Many outdated Medicare regulations need to be updated/eliminated.

There are too many program integrity audits, with one commenter saying “the flood of new auditing programs, such as the introduction of Recovery Audit Contractors (RACs),” is increasingly unmanageable and redundant.

“CMS’s condition code 44 rule is unworkable and in need of modernization,” and should be simplified.

The Clinical Laboratory Improvement Amendment (CLIA) should be updated because penalties for minor infractions can be too severe.

Review “all Medicare regulations that should have been amended based on the statute and legislative intent of Section 1861(g) of the Social Security Act (SSA).”

Review and revise the multiple procedure payment reduction (MPPR) policy for outpatient therapy.

Update Medicaid rules to mandate that occupational therapy services should “only be delivered by a qualified occupational therapist (OT) or an occupational therapy assistant (OTA) under appropriate supervision.”

Carefully monitor regulations of the Affordable Care Act (ACA) to ensure interagency cooperation.

Work with the Office of Management and Budget (OMB) to generate quality assessments of the costs and burdens of new regulations.

Greater emphasis on the development of regulations so there is less need to review and alter them in the future.

Prioritize reviews of regulations that impose “significant administrative and financial burdens.”

Set up a transition plan for the Medical Loss Ratio (MLR) to “provide a better glide path to the 2014 insurance market reforms.”

Streamline redundant and overlapping health information privacy rules.

An undue burden is placed on the property-casualty insurance industry “by administrators who have demonstrated a lack of understanding of the industry.”

Research training and certification programs required annually can be reviewed and in many cases changed to re-training/re-certification every two years.

HHS should alter requirements that “animal care and use protocols be reviewed every three years and replace it with a requirement to match the period of time of the animal protocol to the length of the grant.”

“Regulatory actions that seek to improve the Medicare physician payment system must adequately reimburse medical practices for services.  Excessive penalties and onerous thresholds damage the stability of incentive programs and stall the adoption of health information technology.”

“Eliminate a redundant Medicare system and standardize provider credentialing through adoption of the Council for Affordable Quality Healthcare [CAQH] Universal Provider Datasource [UPD] currently used by private sector payers and state Medicaid programs.”

“It is imperative that CMS work to better integrate and align Physician Quality Reporting System (PQRS) requirements with the requirements of other Medicare quality reporting initiatives.”

“Timely and meaningful feedback and assistance with identifying and correcting unsatisfactory reporting throughout the year is critical.”

“Standardiz[e]  exceptions and eliminat[e] seemingly conflicting requirements placed on healthcare providers.”

“[2003 and 2005 HIPAA security regulations] have proven sufficient…Additional onerous and costly requirements serve only to impede the cost-effective provision of quality care.”

“[W]e continue to be concerned with the lack of pilot testing prior to national implementation of complex and costly new standards such as HIPAA Version 5010 and ICD-10.”

“HHS has empowered numerous contractors to interact with and audit healthcare providers…[our] members continue to report inconsistencies in the guidance given by various contractors, delays in correspondence on the part of contractors and continued confusion about the contractors’ specific identity and authority…We urge the agency to ensure that all its auditors perform their duties consistently and transparently to maximize provider understanding and compliance with government requirements.”

“Review limited English proficiency and hearing impaired translator mandates and consider potential unintended consequences.”

“Any standards from an outside standards development organization that is to be incorporated into a FDA rule or guidance to the same federal notice and comment processes and other requirements of the Administrative Procedures Act (APA).  Similarly, directives applicable to the development of federal rules should be followed prior to adopting these outside organizations’ standards.”

“When FDA develops proposed rules and guidance, take into consideration the effects on the entire drug supply chain system.”

Review the “therapy incident-to” rule.  “The regulations disallowed Medicare Part B payments to be made for outpatient rehabilitation therapy services provided as incident to services when furnished by…health professionals who did not meet certain qualifications….[We believe the rule is] flawed and the imposition of the therapy restriction continues to harm patients by limiting access to much needed therapy services.”

“[T]he proliferation of new burdensome, and in some cases unnecessary, regulations imposed on home health agencies have put a strain on their financial and human resources.”

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