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The Centers for Medicare & Medicaid Services has suspended the effective date for the proposed Medicare coverage program for FDA-designated breakthrough devices, temporarily reversing a program that won widespread support from device makers. The program was not universally well received, however, and CMS justified the move by arguing that the process used to vet the rule was deficient.
The agency said the suspension offers a new 30-day window for additional feedback on the rule and a second 30-day window for considering the comments. At the end of those 60 days, the agency will exercise the option of revising or rescinding the rule. The Medicare Coverage of Innovative Technology (MCIT) rule was subject to the Biden administration’s Jan. 20 regulatory freeze order, which directed federal government agencies to review any rules put into effect in the final days of the Trump administration.
There were several considerations to be examined by agencies in carrying out the regulatory freeze, including whether the rulemaking process was procedurally adequate and whether the issuing agency had properly considered all the relevant facts. The CMS suspension order stated that the MCIT rule had not addressed operational issues, such as the processes needed to establish coding and payment levels. The related questions revolve in part around whether the device and related services would fall into a benefit category for the Part A hospital benefits category or the Part B physician services category.
CMS said some observers had pointed to a need to delay payment for a breakthrough device pending completion of administrative tasks, such as assignment of a CPT code, but added that the agency had previously underestimated the operational challenges referenced in those comments to the docket. Another procedural problem cited by CMS was that the agency had proposed a rule related to durable medical equipment that chronologically overlapped with the MCIT rule, and consequently stakeholders might have had difficulty responding to both proposals.
The draft MCIT rue carried the assumption that five or fewer devices would qualify for the coverage policy each year, based on the relatively small number of breakthrough devices that had been cleared or approved by the FDA. CMS cast doubt on this projection, given that the FDA’s numbers suggest that more than 400 devices have entered the breakthrough devices program. CMS acknowledged, however, that not all of these will win market access.
MCIT said to threaten ‘decades of progress’
One of the sources of negative commentary regarding the MCIT program was two medical researchers whose editorial in the Dec. 2, 2020, issue of Health Affairs included the charge that the program “threatens to erode decades of progress” in requiring adequate evidence for Medicare coverage. One of the issues cited by the authors was that the program stopped short of requiring industry to conduct the studies that would ordinarily be needed for coverage, but merely recommended that those studies be conducted.
Another point raised by the authors is that a device could easily become obsolete by the end of the MCIT coverage period of four years, thanks to the rapid pace of device iteration. They suggested that the MCIT program’s approach constitutes an unfettered path to coverage that “is a recipe for future problems.” Perhaps the most pressing long-term concern cited by the authors is the prospect that the MCIT program would amplify inflation in Medicare spending. The better solution would be to make improvements to the coverage with evidence development program, they stated, although they reiterated a previous editorial that urged CMS to incorporate cost effectiveness analyses into its coverage decisions.
The news of novel variants of the SARS-CoV-2 virus triggered a response from across the U.S. federal government, but the impact was perhaps most keenly felt at the FDA, which issued multiple guidances in response. The agency expects the new variants to have at least some impact on vaccines, but the bigger effect may be on assays, which are at some risk of returning false negative results.
The FDA had advised the public as to the potential problems associated with the novel variants in early January, making note of the potential for false negative results even with molecular tests. The agency said in the Jan. 8 statement that it was working with test developers to track the ability of their tests to detect the new variants, although the FDA indicated that there is no worse than a moderate risk that the new variants would render existing tests obsolete.
The guidance for testing indicates that the agency is considering a requirement that test developers assess their existing tests for any effect on test performance arising from the new mutations. This would be recommended for all tests should the FDA adopt such a policy, but new applications for emergency use authorizations will have to demonstrate that the test has been designed to at least minimize the impact of the new variants on test performance.
The FDA said it would prefer that any applications with genotyping claims be limited to tests that rely on whole genome sequencing, as other technologies may struggle to adequately capture emerging mutations and variants. Molecular test developers may have to evaluate the performance of those tests across all known variants at the time of test validation, but may also be required to consider the potential impact of as-yet unknown mutations.
The agency’s updated vaccine guidance generally follows the existing policy for questions such as documentation of chemistry, manufacturing and controls. However, the agency indicated that it has not arrived at a fixed set of expectations for the data needed to authorize a new vaccine to account for the new variants. That same uncertainty underlies the question of modifications of existing vaccines to account for the new variants and mutations. The FDA explicitly excluded any related considerations for multivalent vaccines from the scope of the guidance, at least for the time being.
Vaccine developers may not be required to conduct repeat dose toxicity studies for vaccines that are thus modified, but the FDA encourages developers to repeat their animal studies. Human studies may have to be conducted when a modified vaccine is to be administered as a booster vaccine for the corresponding prototype vaccine, and the clinical study for the modified vaccine may have to demonstrate at least non-inferiority to the prototype.
NIH; data suggest low risk of reinfection
While the FDA grapples with the dilemma created by the mutations to the SARS-CoV-2 virus, the National Institutes of Health offered some reassurance about the immune status of those who exhibit antibodies to the SARS-CoV-2 virus. The NIH said the data to date do not clearly depict how long this immunity will last, but Lynne Penberthy of the National Cancer Institute said the NIH is “nevertheless encouraged by this early finding.”
The study in question is based on antibody test results from more than three million subjects who tested positive between Jan. 1 and Aug. 23, 2020, which represented more than half of all antibody tests conducted in the U.S. over that time. Slightly less than 12% of these subjects tested positive for antibodies, but only about 0.3% of the subjects who had tested positive tested positive after 90 days tested positive again when tested by PCR. This stands in sharp contrast to those who tested negative at baseline, a group that tested positive at a rate of 3-4% at each 30-day interval out to 90 days.
NIH advised that as an observational study, these data may suffer for want of randomization of the subjects, particularly given questions about the motivation of enrollees to undertake a follow-up test. Nonetheless, the findings offer some encouragement, given the existing uncertainty over the duration of immunity.
The FDA announced an action plan for artificial intelligence in mid-January, which comes across largely as a follow-up to a discussion paper the agency posted in April 2019. The plan lays out a number of specific objectives, but the text of the plan suggests that the FDA is little farther along in its attempt to fashion a regulatory regime for AI than it was two years ago.
The action plan lists five activities that are critical to the development of a regulatory framework for AI, such as development of a draft guidance for predetermined change control plans. This draft guidance, which the FDA said should be ready for public comment at some point in 2021, will provide details on the type of information that should appear in a developer’s algorithm change protocol (ACP), but the agency is still pondering the question of the types of modifications that would fall under this requirement.
The FDA will also work toward a more robust, harmonized approach to good machine learning practices (GMLPs). The agency made note of several ongoing programs to develop GMLPs, such as those sponsored by the Association for the Advancement of Medical Instrumentation (AAMI) and the Institute of Electrical and Electronics Engineers (IEEE). Those who responded to the April 2019 artificial intelligence discussion draft are said to have cited GMLPs as a major concern, in part over the potential for conflicting requirements.
Despite the seemingly large task facing the FDA and stakeholders regarding the ACP concept, the discussion of real-world performance (RWP) monitoring may present a more difficult proposition. The collection of RWP data will be critical to ensuring the algorithm functions as intended, but the action plan raises several questions, such as how much oversight will be provided by each of the stakeholders involved in a given algorithm’s use. The volume and frequency of data submitted to the agency as part of the RWP surveillance is also as yet not well characterized, but the agency is assembling a voluntary pilot program to assist in development of a working policy.
Other questions raised in the action plan include transparency of the algorithm, including to patients, and development of regulatory science to evaluate an algorithm’s robustness and to eliminate any unintended bias. While much of the FDA’s device center is caught up in the response to the COVID-19 pandemic, the agency’s Digital Health Center of Excellence will be tasked with shepherding the AI action plan as it evolves.
Medicare Confirms Coverage of Breakthrough Devices
The Centers for Medicare & Medicaid Services followed through on its plan to offer Medicare coverage for devices reviewed by the FDA’s breakthrough devices program, but the agency also followed up on its promise to redefine the term “reasonable and necessary.” The first of these proposals will be the more quickly felt, but the redefinition of reasonable and necessary could have a profound impact on a wide range of products going forward.
The Medicare Coverage of Innovative Technology (MCIT) program offers coverage on the date of the FDA’s approval, clearance or grant of de novo petition, thus eliminating any lag in coverage. The concept behind MCIT can be seen in an industry proposal from 2016, which was dubbed the Provisional Accelerated Coverage to Encourage Research (PACER) initiative. This proposal was rebranded when it appeared on the Office of Management and Budget’s regulatory agenda in 2018, but the proposal seemed to fade out of view until the CMS resurrected the concept via the MCIT program in August 2020.
MCIT offers device makers four years of Medicare coverage, after which the sponsor will be faced with choosing between a national coverage determination or one of the alternatives, such as a series of local coverage determinations. However, the final rule allows device makers to apply for coverage for devices that had already gone through the breakthrough devices program, although coverage in that scenario also expires four years after the FDA grants marketing authorization.
The proposal to redefine reasonable and necessary starts with an analysis of whether the device has moved past the experimental/investigational label. A manufacturer can apply for Medicare coverage based on any coverage provided by commercial payers, but the agency declined to spell out a methodology for determining whether existing private payer coverage is sufficient to meet the new definition. CMS said it would issue sub-regulatory guidance within 12 months of the date of the final rule, although the proposal to redefine this key Medicare term would seem to be susceptible to the regulatory freeze imposed by the Biden administration Jan. 20.
The Biden administration has wasted no time in issuing a number of executive orders (EOs), including those that applied a freeze to or revoked a number of orders issued under the Trump administration. Among these is an order designed to require a cost-benefit analysis of new regulations, but the net effect is to clearly signal that the relatively restrained regulatory approach of the past four years is over.
The Trump administration issued EO 13771 Jan. 30, 2017, only 10 days after President Donald Trump was sworn into office. This order, titled, “Reducing Regulation and Controlling Regulatory Costs,” required that U.S. government agencies repeal two existing regulations for every new regulation, and to do so in a manner that is at worst cost neutral to regulated entities. This order was the subject of a number of lawsuits, but was rescinded when President Joseph Biden formally withdrew EO 13771 in an EO dated Jan. 20, 2021. This was the date of Biden’s inauguration, signaling that the new administration would waste no time in leaving its imprint on the executive branch.
Public Citizen was among those who challenged EO 13771, although the lawsuit failed to gain the desired traction in court. In 2019, the U.S. District Court for the District of Columbia indicated that Public Citizen lacked standing to sue, not the first time this litigant failed to gain much traction in court.
Another of the repealed Trump era rules was EO 13891, the final version of which noted that the order was accompanied by a relatively short comment period of only 30 days. This order took up the question of good guidance practices, although the FDA has its own working set of standard operating procedures for guidance development. The FDA would have had to amend its approach to reflect the terms of the EO 13891, had the rule withstood the change of administration.
Another withdrawn entry in the Trump administration’s rulemaking agenda was EO 13892, which stated that enforcement discretion could be applied when the defendant could demonstrate there was no intent to violate the law. Another component of this executive order echoed the Brand memo to the extent that it disallowed the practice of using non-compliance with agency guidance in federal enforcement or prosecution.
Lack of Clarity on Several Issues
There are a number of other federal department/agency actions undertaken over the past four years that may be at risk. For instance, Merrick Garland, the nominee for Attorney General of the U.S., may decide that the Granston and Brand memos are due for revision or withdrawal, assuming the Senate confirms his appointment. Garland’s tenure at the U.S. Court of Appeals for the D.C. Circuit did not seem to include a large volume of cases involving the False Claims Act, but Sen. Chuck Grassley (R-Iowa) has indicated previously that he has misgivings regarding the use of the Granston memo to dismiss qui tam litigation. Thus, any Senate hearings for Garland’s appointment might not excessively press the jurist on his views of the Granston memo.
In a separate action, the White House posted notice that it would impose a regulatory freeze for any regulations that were recently published in final version in the Federal Register. The effective date for any such regulations is pushed back 60 days, while any draft regulations that did not reach final form are to be withdrawn.
There are exceptions to these two requirements, including instances in which agency or department directors make a compelling case for an exception, but the order also notes that guidance, not just rules, may be part of the freeze/review mandate. There is no indication as yet as to whether the Biden administration will address the August 2020 HHS order rescinding the FDA’s authority to regulate lab-developed tests, however, a question that may surface in the House as the VALID Act is inevitably resurrected on Capitol Hill.
The administrative levers at the U.S. Department of Health and Human Services will change hands shortly, but the current administration has taken two actions that each could have a significant impact going forward. HHS finalized a November 2020 draft rule stipulating a decennial review of regulations, while the second action sets an enforcement policy that in part seems to reflect the terms of a memo released by the Department of Justice in January 2018.
HHS had proposed a decennial review of regulations issued by its agencies under the Regulatory Flexibility Act of 1980, which proposed that the review include a consideration of whether a rule should be modified or rescinded. The proposed change was justified in part by a retrospective examination of regulations posted prior to 1990 by means of an artificial intelligence algorithm, which determined that 85% of these legacy regulations had never been edited.
The final rule, announced Jan. 8, is dubbed the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET), and retains the 10-year lookback interval provided by the draft. Any regulation that is 10 years old as of the date of the final rule must be examined within five years of the effective date of the rule, more than twice the two-year term of compliance provided by the draft.
One difficulty for the authors of this rule is that it does not go into force until 60 days until after its appearance in the Federal Register, suggesting the incoming administration will have ample opportunity to repeal it. Given the robust history of bipartisan support for such actions as cited in the HHS press release, however, the next administration at HHS may believe there is some justification for leaving it in place.
Rebranding the Brand memo
HHS posted a second final rule in mid-January, which is “designed to enhance” department practices in the context of transparency and fairness in civil enforcement actions. The Jan. 12 announcement for the rule was followed Jan. 13 by a formal statement by HHS chief of staff Brian Harrison, which states that the rule pertains to parties caught up in administrative enforcement and adjudication proceedings.
An example of this policy is that HHS will conduct its in-house adjudications in a manner that more strongly resembles those conducted in federal court, but also that enforcement discretion may be exercised for defendants who had acted in good faith when they breached the law. Harrison said the department’s civil enforcement division activity can readily cripple small businesses and individuals, and that HHS owes it to these entities to ensure that any such proceedings are fair and transparent.
Among other things, the final rule reinforces the HHS commitment to prohibit the practice of treating non-compliance with “a standard or practice” that appears nowhere but in HHS agency guidance “as itself a violation of the law.”
The HHS announcement would seem to echo the Brand memo, which the Department of Justice disclosed in January 2018. DOJ characterized the memo as a prohibition of the conversion of agency guidance documents into binding rules during civil enforcement actions. The scope of this policy was presumably limited to the actions of federal attorneys, although the memo itself states that its terms are applicable when those attorneys are handling affirmative civil enforcement cases for client agencies. Among these client agencies is the FDA.
That understanding was reinforced by a presentation made by Deputy Assistant Attorney General Ethan Davis in February 2018. The conference at which Davis spoke dealt with the off-label promotion question that has vexed the FDA for a number of years, and Davis noted that the department’s civil division collaborates closely with the FDA.
In addition to the provision regarding agency guidance, the HHS rule requires that all civil administrative inspections be conducted according to published rules of procedure. The rule also requires that the department provide written notice and opportunity to respond before taking any civil enforcement action with legal consequence, although HHS said exceptions exist.
Negotiations are underway between the FDA and industry regarding MDUFA V, the fifth medical device user fee agreement, but there are still some issues with the current agreement. One of those, according to industry representatives, is that the agency still has not hired all the staff it had committed to under MDUFA IV, an omission they say must be corrected expeditiously.
According to the transcript for the Oct. 27, 2020, meeting for MDUFA V, Janet Trunzo, senior vice president for regulatory affairs at the Advanced Medical Technology Association (AdvaMed), said user fees promote rather than distract the FDA from fulfilling its mission of protecting public health. Trunzo also said user fees have allowed the FDA’s Center for Devices and Radiological Health to hire hundreds of scientists, engineers and medical officers, and that interactive reviews have enabled a faster, leaner resolution of issues encountered in premarket submissions.
Nonetheless, Trunzo recommended that the agency complete the hiring of all staff that were agreed to and funded by MDUFA IV “as soon as possible.”
That perspective was echoed by Mark Leahey, president and CEO of the Medical Device Manufacturers Association. Leahey expressed some concern about the ever-rising volumes of user fees with each agreement, but added that the agency has yet to make approximately 50 hires agreed upon under MUFA IV.
Leahey also questions the FDA’s method for calculating the cost of each full-time equivalent (FTE) employee. He said the agency’s practice is to divide the total device review budget by the number of FTEs to arrive at the cost per FTE. Device makers are waiting for some information from the agency about this calculation, Leahey said, adding that industry seeks to arrive at a more appropriate approach for making such calculations.
Fees Supplemental, not Primary Revenue Sources
MDMA’s Leahey said the primary responsibility for FDA’s funding sources is congressional appropriations, and that user fees were always seen as supplemental to appropriations. That perspective should be maintained as the negotiations grind on, he said.
The first device user fee program yielded $144 million and jumped to $312 million under MFUFA II. The volume of fees doubled in each of the following iterations and will amount to more than $1 billion under MDUFA IV when all is said and done. Leahey said user fees amounted to more than $200 million in fiscal year 2019 alone.
Peter Weems, senior director of policy and strategy at the Medical Imaging & Technology Alliance, did not specifically call out the dollar figure for the next user fee program, but did state that MITA does not anticipate any need for major new programmatic initiatives or major new commitments. The association’s position is that all programs assembled with the help of user fees should be revisited to determine which should be sustained going forward, and which should be halted if there is a determination that the need is no longer there.
FDA commissioner Stephen Hahn had no reservations about another expansion of total user fees. Hahn stated that the device user fee program and the associated resources “are only a fraction of the size of the programs for prescription and generic drug user fees.” This fact makes the success of the device user fee programs “all the more remarkable,” he stated.
Hahn said he is concerned about the long-term health of the device user fee program, given the pace of innovation in the device industry. The next user fee agreement will give stakeholders a chance “to see what investments we can make in human resources and programs” that enhance communication between sponsors and the agency, he said, a statement he applied to registries as well. Hahn more or less reiterated that view toward the end of his remarks, stating that the negotiations will also provide an opportunity “to consider how we can provide technological, programmatic and other resources to the device team,” including human resources.
The medical device regulatory office for the European Commission (EC) finalized a guidance for risk categorization of in vitro diagnostics (IVDs), but concerns about the related implementation date persist. Despite the fact that the original implementation deadline was suspended for a year, many of the affected parties are arguing that industry needs at least another year to implement the new regulations because of the impact of the COVID-19 pandemic on the IVD ecosystem in Europe.
The Nov. 13, 2020, risk classification document by the EC’s Medical Devices Coordination Group (MCDG) employs a four-tier risk scheme, with class D the highest risk category per the manufacturer’s statement of intended use. Any software used with an IVD would necessarily fall into the same risk category as the device with which the software is used.
Despite that the implementation date for the overall IVD regulation has already been suspended for a year, MedTech Europe preemptively argued in July that a number of crucial elements in the regulatory ecosystem are not yet in place. Among the missing building blocks cited by MedTech Europe is a body of guidance documents that are up to the task of explaining the regulations, but the association also noted that there is an insufficient number of notified bodies to handle the impending volume of test recertifications.
Serge Bernasconi, CEO of MedTech Europe, stated that the diagnostics industry is still committed to assisting in the effort to recover from the COVID-19 pandemic, but said the impact of the pandemic on the IVDR implementation “has been considerable, and this must be neither underestimated nor ignored.” In an attached position paper, MedTech Europe called for a delay beyond the existing implementation date of May 26, 2022, but offers no specifics regarding the term of any additional delay.
Ambiguity in Intended Use a Possible Problem
The document is divided into seven rules for risk classification, such rule 2, which covers devices intended for use in blood grouping. Product labeling should clearly spell out the intended use of the diagnostic and the related risk classification, and any ambiguity on this point may lead to a higher risk classification than that proposed by the test maker. There is also some variability within tests for a specific biological agent. The guidelines state, for instance, that a screening test for syphilis would likely fall into class D, but a test to diagnose syphilis in the individual is more likely to be deemed a C risk device.
The guidelines are intended to apply uniformly across technologies, although two tests using the same specimen type may or may not be deemed to fall into the same risk classification. Tests and any associated devices, including software as a medical device, that are used to detect exposure to or the presence of a transmissible agent in the blood, blood components or other organs would be class D devices when those tissue products are intended for transplant, transfusion or administration of cells for therapeutic uses. However, a class D designation might not attach to the same test for such pathogens when conducted for other purposes.
Also among the rules listed in the guidelines are those for devices for self-testing and tests for sexually transmitted diseases. Companion diagnostic tests would fall under class C, as are tests to determine the stage of the disease. Conversely pregnancy tests and tests for fertility are slotted into class B. The guidelines provide classification for instruments, reagents and calibrators as well. Test developers will be liable for annual surveillance assessments for class C and D tests, but not for class A and B tests.
The U.S. Department of Health and Human Services posted a notice of proposed rulemaking requiring HHS agencies to periodically assess their regulations to determine whether a regulation is reviewable under the Regulatory Flexibility Act (RFA) of 1980. Under the proposed rule, any regulation issued by an HHS agency becomes null at 10 years unless a confirmatory review is conducted, but the rule has a short activation time, given the impending change of administration at the White House.
The Nov. 4 HHS statement asserts that federal government agencies should retrospectively re-examine the initial projections of the impact of a rule to determine whether the rule should be amended or rescinded. HHS stated that an analysis of HHS data performed by an artificial intelligence (AI) algorithm disclosed that 85 percent of the regulations issued by HHS agencies before 1990 have not been edited. HHS Secretary Alex Azar said the proposed rule would help ensure that the affected agencies are fulfilling their responsibilities “in a way that maximizes benefits, minimizes costs, and keeps up with the times.”
Several types of regulations would not be subject to the proposed rule, such as regulations issued jointly by two or more agencies. Any regulations that are exempt from rulemaking requirements under the Administrative Procedures Act would also be exempt (the RFA was an amendment to the Administrative Procedures Act).
The statement lists similar actions undertaken by every president to hold office since 1978, along with statements in support of routine regulatory review from members of the Obama and George H. W. Bush administrations. The Organization for Economic Cooperation and Development (OECD) is also among the entities that have recommended this type of review function, with OECD recommending that regulations be subject to a sunset to incentivize the review.
One of the issues that surfaced during the AI review of HHS regulations is that the U.S. Code of Federal Regulations (CFR) bears nearly 300 references to portions of the CFR that no longer exist. There are 50 references to requirements to submit paperwork in triplicate or quadruplicate, and 114 sections with no regulatory entity listed. HHS stated that a number of regulations that have been relaxed to aid in the response to the COVID-19 pandemic would also be subject to review.
HHS acknowledged the problem with the proposed rule in the event the 2020 presidential election failed to return President Donald Trump for a second term. The comment period ends Jan. 4, 2021, but HHS said that whether it finalizes the rule and the time frame for doing so “depends on the comments received during the public comment period.” Inauguration day is Jan. 20, 2021, leaving HHS with only 16 calendar days to act on the proposal once the comment period closes.
HHS Using Algorithms in Regulatory ‘Clean-up’ Initiative
The Nov. 4 HHS statement’s references to the use of AI for regulatory review were expounded on in a Nov. 17 HHS statement describing the use of a new department-wide regulatory clean-up initiative, which uses both AI and natural language processing (NLP) technologies. The intent of this program is to identify entries in the CFR that call for correction, such as the incorrect citations mentioned in the Nov. 4 HHS statement. The process used by HHS also examined the CFR for misspellings, typographical errors, and erroneous language, but the HHS statement also tabulated the CFR at approximately 185,000 pages, a testimonial to the complexity of compliance.
This regulatory clean-up program is part of a final rule that is effective Dec. 16, and which takes aim at administrative, non-substantive changes that will clean up HHS agency regulations. This final rule is based on a pilot program that employed the same algorithms to analyze a limited section of the HHS portion of the CFR. The statement describes this pilot program as having demonstrated that federal agencies can execute “a cost-effective, enterprise-wide approach to regulatory reform that could improve accountability and transparency.”
The HHS statement further emphasizes the deregulatory agenda of the Trump administration, and HHS deputy secretary Eric Hargan said HHS accounted for more than half the regulatory savings achieved by the federal government between fiscal years 2017 and 2019. Hargan said HHS is the first cabinet agency to use AI and NLP to conduct a regulatory clean-up that will eliminate “archaic, obsolete and inconsistent rules.”
The Department of Health and Human Services has responded to concerns about compliance dates for healthcare IT with an interim final rule that relaxes those deadlines by nearly half a year. According to the Oct. 29 HHS press release, vendors of health IT systems have until April 5, 2021, to comply with information blocking provisions of the 21st Century Cures Act, a delay some saw as critical due to the COVID-19 public health emergency.
The Office of the National Coordinator (ONC) had released the final rule March 9, 2020, which in addition to the information blocking provisions included certification requirements for application programming interfaces (APIs). ONC director Don Rucker emphasized that this latest delay does not eliminate the rules requiring greater patient access to their health information, but is intended to allow developers to focus on the pandemic.
In April 2020, the ONC exercised enforcement discretion by adding three months to several of the compliance deadlines included in the March final rule, making the Oct. 29 delay the second such announcement this year. In addition to the delay until April 2021 for the Cures Act’s information blocking provisions, the ONC will allow developers until Dec. 31, 2022, to demonstrate that their software complies with the updated requirements for API functionality.
The Healthcare Information and Management Systems Society Inc., (HIMSS) of Chicago, said the announcement allows the health care sector to focus on the pandemic while sustaining a path forward toward greater patient access to their own information. HIMSS stated that the scope of the information blocking provisions will expand in October 2022, prior to which developers will have to demonstrate only that they are providing access to a limited number of elements initially included in the U.S. Core Data for Interoperability. This will allow developers to become more accustomed to these requirements prior to the compliance date of Oct. 6, 2022, when the full scope of a patient’s electronic health information becomes mandatorily accessible to patients.
The American Health Information Management Association (AHIMA), also headquartered in Chicago, applauded the delay in an Oct. 29 statement. AHIMA CEO Wylecia Wiggs Harris, said the additional delay “is a prudent decision, as the reallocation of resources due to the COVID-19 pandemic has made it challenging for many health information professionals to ensure their institutions are sufficiently in compliance.” Harris thanked ONC “for being cognizant of the realities health information professionals are encountering during the COVID-19 pandemic.”
CMS Resets Two DME Policies
The Centers for Medicare & Medicaid Services released two policy changes, one each for competitive bidding for durable medical equipment (DME), and the other for how items are categorized under the Medicare Part B DME benefit. Of the two, the more immediate impact on patients may be created by the Oct. 27 CMS proposal to classify all continuous glucose monitors (CGMs) as DME, providing broader coverage of CGMs than has been available up to now. At present, Medicare covers these devices only when approved by the FDA for use in making treatment decisions for those with diabetes, such as changes to insulin dosage or to diet.
The policy change would provide coverage for CGMs for more routine considerations, such as potentially hazardous overnight glucose excursions. CMS also made note of the fact that one in every three Medicare beneficiaries suffers from diabetes. The proposed rule would also expand the DME classification of external infusion pumps to permit more in-home use.
The second CMS announcement regarding DME for the week ending Oct. 30 stated that the competitive bidding program would be delayed again for most items. Two items, off-the-shelf (OTS) knee and back braces, will be subject to bidding in 2021, and CMS indicated that the bidding process may save $600 million over the three years of the bidding program for these two items.
The 2021 round of bidding had originally included non-invasive ventilators, a category the agency removed because of the COVID-19 pandemic. OTS back and knee braces were not included in previous bidding programs, but bidding for the other 13 categories was dropped because previous bidding rounds failed to deliver on the anticipated savings.
The American Association for Homecare lent its support to the changes to the bidding program, stating that the program has established a price floor for the 13 devices that will be exempt from bidding year. The statement also recommended that bidding for these products be permanently ended.